Oseltamivir: Drug information

Copyright 1978-2013 Lexicomp, Inc. All rights reserved. (For additional information see "Oseltamivir: Patient drug information" and see "Oseltamivir: Pediatric drug information" ) For abbreviations and symbols that may be used in Lexicomp (show table )

Special Alerts
Expanded Pediatric Use for Oseltamivir (Tamiflu®) December 2012

The Food and Drug Administration (FDA) has expanded the use of oseltamivir (Tamiflu®) for the treatment of influenza in children as young as 2 weeks old who have shown symptoms of influenza for ≤2 days. Previously, Tamiflu® was only FDA approved for influenza treatment in children ≥1 year of age.

Recommended dosing for influenza treatment in children <1 year is 3 mg/kg twice daily for 5 days which requires that each dose be calculated using the child’s exact weight. In addition, these smaller doses will require that the pharmacist provide a proper dosing device so that parents can accurately measure and administer the correct dose. The dosing device that is currently packaged with Tamiflu® powder for oral suspension will not accurately measure the dose and should not be used for children <1 year of age.

For more information, see http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm333205.htm?source =govdelivery

Brand Names: U.S.
 Tamiflu

Brand Names: Canada
 Tamiflu®

Pharmacologic Category
 Antiviral Agent;

Neuraminidase Inhibitor

Dosing: Adult
Influenza prophylaxis: Oral: 75 mg once daily; initiate prophylaxis within 48 hours of contact with an infected individual; duration of prophylaxis: 10 days (manufacturer recommendation) or alternatively 7 days (CDC, 2012). During community outbreaks, duration of protection lasts for length of dosing period; safety and efficacy have been

demonstrated for use up to 6 weeks in immunocompetent patients and safety has been demonstrated for use up to 12 weeks in patients who are immunocompromised. Prophylaxis (institutional outbreak; CDC, 2012): Continue for ≥2 weeks and until ~7 days after identification of illness onset in the last patient Influenza treatment: Oral: 75 mg twice daily initiated within 48 hours of onset of symptoms; duration of treatment: 5 days Note: Hospitalized patients with severe influenza infection may require longer (eg, ≥10 days) treatment courses. Some experts also recommend empirically doubling the treatment dose. Initiate as early as possible in any hospitalized patient with suspected/confirmed influenza regardless of the time of presentation from symptom onset (CDC, 2011); may be administered via naso- or orogastric tube in mechanically-ventilated patients (Taylor, 2008).

Dosing: Pediatric
(For additional information see "Oseltamivir: Pediatric drug information" ) Influenza prophylaxis: Oral: Initiate prophylaxis within 48 hours of contact with an infected individual Manufacturer’s recommendation: Children: 1-12 years: ≤15 kg: 30 mg once daily >15 kg to ≤23 kg: 45 mg once daily >23 kg to ≤40 kg: 60 mg once daily >40 kg: 75 mg once daily Adolescents ≥13 years: Refer to adult dosing. Alternate recommendations: Children 3-11 months (unlabeled dosing; AAP, 2010): Note: Dosing based on age (use only if weight not available) 3-5 months: 20 mg once daily 6-11 months: 25 mg once daily Children <12 months (unlabeled dosing, CDC, 2012): Note: Prophylaxis is not recommended for infants <3 months of age unless clinically critical; weightbased dosing recommendations are not intended for premature neonates: 3 mg/kg/dose once daily Children 3-23 months (unlabeled dosing, IDSA/PIDS, 2011): 3-8 months: 3 mg/kg/dose once daily (do not exceed maximum dose of weightbased dosing) 9-23 months: 3.5 mg/kg/dose once daily (do not exceed maximum dose of weight-based dosing) Prophylaxis duration:

Individual/household exposure: Manufacturer recommendation: 10 days Alternate recommendations: 7 days (CDC, 2012) Community/institutional outbreak: Manufacturer recommendation: May be used for up to 6 weeks Alternate recommendations: Continue for ≥2 weeks and until ~7 days after identification of illness onset in the last patient (CDC, 2012) or until influenza activity in community subsides or immunity obtained from immunization (IDSA/PIDS, 2011). During community outbreaks, duration of protection lasts for length of dosing period; safety and efficacy have been demonstrated for use up to 6 weeks in immunocompetent patients and safety has been demonstrated for use up to 12 weeks in patients who are immunocompromised. Influenza treatment: Oral: Initiate treatment within 48 hours of onset of symptoms; duration of treatment: 5 days unless severely ill and hospitalized. Note: Hospitalized patients may require longer (eg, ≥10 days) treatment courses. Some experts also recommend empirically doubling the treatment dose. Doubling the dose in adult outpatients was not associated with increased adverse events. As no double-dose studies have been published in children, use caution. Initiate as early as possible in any hospitalized patient with suspected/confirmed influenza regardless of the time of presentation from symptom onset (CDC, 2011); may be administered via naso- or orogastric tube in mechanicallyventilated patients (Taylor, 2008). Manufacturer’s recommendation: Note: The following dosing is also supported by some clinicians (IDSA/PIDS, 2011): Infants ≥2 weeks: 3 mg/kg/dose twice daily Children: 1-12 years: ≤15 kg: 30 mg twice daily >15 kg to ≤23 kg: 45 mg twice daily >23 kg to ≤40 kg: 60 mg twice daily >40 kg: 75 mg twice daily Adolescents ≥13 years: Refer to adult dosing. Alternate recommendations: Infants <2 weeks (unlabeled dosing, CDC, 2012): Note: Weight-based dosing recommendations are not intended for premature neonates: 3 mg/kg/dose twice daily. Infants <12 months (unlabeled dosing; AAP, 2010): Note: Dosing based on age (use only if weight not available): <3 months: 12 mg twice daily 3-5 months: 20 mg twice daily 6-11 months: 25 mg twice daily

then 30 mg every 7 days for 10-14 days Hemodialysis: Children >1 year (unlabeled dose.S.5 mg/kg/dose twice daily Dosing: Geriatric Refer to adult dosing.S. labeling: Clcr 10-30 mL/minute: 75 mg once daily for 5 days Canadian labeling: Clcr >30-60 mL/minute: 30 mg twice daily for 5 days Clcr 10-30 mL/minute: 30 mg once daily for 5 days High-dose treatment (unlabeled [eg.5 mg after each hemodialysis session >15 kg to ≤23 kg: 10 mg after each hemodialysis session >23 kg to ≤40 kg: 15 mg after each hemodialysis session >40 kg: 30 mg after each hemodialysis session Adults: Unlabeled dose: 30 mg after every other session (Robson. Dosing: Renal Impairment Treatment: Adults: U.S. 2006) Canadian labeling (not in U.Infants and Children <24 months (unlabeled dosing. 2011): Note: Do not exceed maximum dose of weight-based dosing. consider 150 mg once daily Prophylaxis: Adults: U. labeling): . 2006) Canadian labeling (not in U. labeling): Treatment: 30 mg prior to start of dialysis Prophylaxis: 30 mg prior to start of dialysis.S. 2010): ≤15 kg: 7. Schreuder. Infants. IDSA/PIDS. premature: 1 mg/kg/dose twice daily 0-8 months: 3 mg/kg/dose twice daily 9-23 months: 3. labeling: Clcr 10-30 mL/minute: 75 mg every other day or 30 mg once daily Canadian labeling: Clcr >30-60 mL/minute: 30 mg once daily for 10-14 days Clcr 10-30 mL/minute: 30 mg every other day for 10-14 days CAPD: Adults: Unlabeled dose: 30 mg once weekly (Robson. severely-ill hospitalized patients with 2009 H1N1 influenza]): Currently no data are available.

sodium benzoate. consult specific product labeling. Mechanically-ventilated critically-ill patients: May administer via naso. Use Treatment of uncomplicated acute illness due to influenza (A or B) infection in children ≥2 weeks and adults who have been symptomatic for no more than 2 days. Capsules may be opened and mixed with sweetened liquid (eg. then administer 30 mg after each dialysis session over period of 5 days Prophylaxis: 30 mg prior to dialysis. prophylaxis against influenza (A or B) infection in children ≥1 year of age and adults The Advisory Committee on Immunization Practices (ACIP) recommends that treatment be considered for the following: • Persons with severe.S. shake well. take with food to improve tolerance. Capsule. particularly for generics). chocolate syrup). No Administration May be administered without regard to meals. as base: Tamiflu: 6 mg/mL (60 mL) [contains saccharin sodium. if symptomatic between dialysis sessions. as phosphate: Tamiflu: 30 mg. a smaller volume [ie. For a 150 mg dose. 2008).Children <2 years of age (highest risk in children <6 months of age) . Excipient information presented when available (limited. tutti-frutti flavor] Generic Equivalent Available: U. follow with a 10 mL sterile water flush (Taylor. <10 mL] oral syringe should be used in place of the supplied oral syringe to ensure accurate dosing). then 30 mg after every other dialysis session for period of 10-14 days Dosing: Hepatic Impairment Mild-to-moderate impairment: No adjustment necessary Severe impairment: Pharmacokinetics and safety have not been evaluated Dosage Forms: U. complicated or progressive illness • Hospitalized persons • Persons at higher risk for influenza complications: . 75 mg Suspension Reconstituted. dissolve powder from two 75 mg capsules in 20 mL of sterile water and inject down the NG/OG tube.or orogastric (NG/OG) tube. 45 mg.S.Treatment: 30 mg prior to dialysis. Oral. Oral. Administer oral suspension using the supplied oral syringe (exception: for children <1 year.

American Indians and Alaskan Natives . Thera-Flu® Other safety concerns: Oseltamivir (Tamiflu®) oral suspension is available in a 6 mg/mL concentration and is packaged with an oral syringe calibrated in milliliters up to a total of 10 mL. nonhigh-risk outpatients with confirmed or suspected influenza based on clinical judgment when treatment can be started within 48 hours of illness onset. Medication Safety Issues Sound-alike/look-alike issues: Tamiflu® may be confused with Tambocor™. the handling of respiratory secretions. • Postexposure prophylaxis may be considered for unvaccinated healthcare workers who had occupational exposure without protective equipment.Adults ≥65 years of age .Residents of nursing homes or other chronic care facilities • Use may also be considered for previously healthy. cerebral palsy. moderate to severe developmental delay.. or that can increase the risk of aspiration . The ACIP recommends that treatment and prophylaxis be given to children <1 year of age when indicated.Persons with neurologic/neuromuscular conditions (including conditions such as spinal cord injuries. • Pre-exposure prophylaxis should only be used for persons at very high risk of influenza complications who cannot be otherwise protected at times of high risk for exposure. or immunosuppression (including immunosuppression caused by medications or HIV) . • Prophylaxis should also be administered to all eligible residents of institutions that house patients at high risk when needed to control outbreaks. Instructions to the patient should be provided based on these units of . who are at higher risk of influenza complications.Persons <19 years of age on long-term aspirin therapy .Persons with chronic metabolic diseases (including diabetes mellitus).Persons with chronic disorders of the pulmonary (including asthma) or cardiovascular systems (except hypertension) .Persons who are morbidly obese (BMI ≥40) . mental retardation. renal dysfunction. hepatic disease. seizure disorders. hematologic disorders (including sickle cell disease). or muscular dystrophy) which may compromise respiratory function. The ACIP recommends that prophylaxis be considered for the following: • Postexposure prophylaxis may be considered for family or close contacts of suspected or confirmed cases.Pregnant or postpartum women (≤2 weeks after delivery) . stroke. and who have not been vaccinated against the circulating strain at the time of the exposure.

seizure. use a lower calibrated (ie. fracture. severe dermatologic reactions) have been associated with use. Disease-related concerns: • Cardiovascular disease: Use with caution in patients with chronic cardiac disease. Stevens-Johnson syndrome. an extemporaneously prepared suspension may be compounded to provide a 6 mg/mL concentration. delirium. liver function tests abnormal. • Hepatic impairment: Use with caution in patients with severe hepatic impairment. confusion. efficacy has not been established. angina.measure (ie. dosage adjustment is required for creatinine clearance <30 mL/minute. diarrhea (1% to 3%) Ocular: Conjunctivitis (1%) Respiratory: Epistaxis (1%) <1% (Limited to important or life-threatening): Allergy. mL). • Neuropsychiatric events: Rare occurrences of neuropsychiatric events (including confusion. toxic epidermal necrolysis Contraindications Hypersensitivity to oseltamivir or any component of the formulation Warnings/Precautions Concerns related to adverse effects: • Anaphylaxis/hypersensitivity: Rare but severe hypersensitivity reactions (anaphylaxis. <10 mL) oral syringe to ensure accurate dosing. hemorrhagic colitis. Adverse Reactions Significant >10%: Gastrointestinal: Vomiting (2% to 15%) 1% to 10%: Gastrointestinal: Nausea (4% to 10%). gastrointestinal bleeding. When providing oseltamivir suspension for children <1 year of age. Special populations: . • Renal impairment: Use with caution in patients with renal impairment. efficacy has not been established. hepatitis. arrhythmia. hallucinations. abdominal pain (2% to 5%). and/or self-injury) have been reported primarily in pediatric patients from postmarketing surveillance. anaphylactic/anaphylactoid reaction. direct causation is difficult to establish (influenza infection may also be associated with behavioral and neurologic changes). pseudomembranous colitis. • Respiratory disease: Use with caution in patients with respiratory disease. When commercially-prepared oseltamivir oral suspension is not available. Monitor closely for signs of any unusual behavior. pyrexia. safety and efficacy have not been established. neuropsychiatric events. swelling of face or tongue. erythema multiforme.

Oseltamivir and zanamivir are currently recommended for the treatment or prophylaxis of influenza in pregnant women and women up to 2 weeks postpartum. Drug Interactions (For additional information: Launch Lexi-Interact™ Drug Interactions Program ) Influenza Virus Vaccine (Live/Attenuated): Antiviral Agents (Influenza A and B) may diminish the therapeutic effect of Influenza Virus Vaccine (Live/Attenuated). Oseltamivir and zanamivir are currently recommended as an adjunct to vaccination and should not be used as a substitute for vaccination in pregnant women (consult current CDC guidelines). An increased risk of adverse neonatal outcomes has generally not been observed following maternal use of oseltamivir during pregnancy. the CDC recommends that treatment may still be beneficial and should be started in hospitalized patients with severe. Oseltamivir phosphate and its active metabolite oseltamivir carboxylate cross the placenta (in vitro data). Risk D: Consider therapy modification Pregnancy Risk Factor C (show table) Pregnancy Implications In animal reproduction studies. Metabolism/Transport Effects None known. Risk D: Consider therapy modification Probenecid: May increase serum concentrations of the active metabolite(s) of Oseltamivir. Other warnings/precautions: • Appropriate use: Oseltamivir is not a substitute for the influenza virus vaccine. Management: Avoid antiinfluenza antivirals during the period beginning 48 hours prior to and ending 2 weeks after vaccine administration. such as thrombocytopenia. . It has not been shown to prevent primary or concomitant bacterial infections that may occur with influenza virus. The rate of each abnormality remained within the background rate of occurrence in the species studied. a dose-dependent increase in the rates of minor skeleton abnormalities was found in exposed offspring. reduced oseltamivir dose may be necessary. Antiviral treatment should begin within 48 hours of symptom onset. safety and efficacy for treatment or prophylaxis in immunocompromised patients have not been established. Treatment should not be delayed while awaiting results of laboratory tests for influenza. Untreated influenza infection is associated with an increased risk of adverse events to the fetus and an increased risk of complications or death to the mother. Persons receiving these agents within 2 weeks of the live intranasal spray vaccine should receive a repeat vaccine dose. Increase monitoring for adverse events. complicated or progressive illness if >48 hours. Management: Consider a change in therapy when using oseltamivir together with probenecid.• Immunocompromised patients: Use with caution in immunocompromised patients. Nonhospitalized persons who are not at high risk for developing severe or complicated illness and who have a mild disease are not likely to benefit if treatment is started >48 hours after symptom onset. However. Nonhospitalized persons who are already beginning to recover do not need treatment.

Lactation Enters breast milk/not recommended Breast-Feeding Considerations Small amounts of oseltamivir and oseltamivir carboxylate have been detected in breast milk. and/or delirium Critically-ill patients: Repeat rRT-PCR or viral culture may help to determine on-going viral replication International Brand Names  Ao Er Fei (CL). Monitoring Parameters Signs or symptoms of unusual behavior.S. The CDC recommends that women infected with the influenza virus follow general precautions (eg. and cough and secretions can be controlled. Influenza may cause serious illness in postpartum women and prompt evaluation for febrile respiratory illnesses is recommended. frequent hand washing) to decrease viral transmission to the child. changing into a clean gown or clothing. These measures may help decrease (but not eliminate) the risk of transmitting influenza to the newborn. The pricing data should be used for benchmarking purposes only. respectively.74 45 mg (10): $111.74 75 mg (10): $121. Infant care should be performed by a noninfected person when possible (consult current CDC guidelines). including attempts at self-injury. breast-feeding while taking oseltamivir can be continued.80 Suspension (reconstituted) (Tamiflu Oral) 6 mg/mL (60 mL): $121.80 Disclaimer: The pricing data provided represent a median AWP and/or AAWP price for the brand and/or generic product. According to the CDC. and strict hand hygiene should be continued by the mother for ≥7 days after the onset of symptoms or until symptom-free for 24 hours. breast milk can be expressed and bottle-fed to the infant by another person who is well. Mothers with influenza-like illnesses at delivery should consider avoiding close contact with the infant until they have received 48 hours of antiviral medication. During this time. and as such should not be used to set or adjudicate any prices for charging or reimbursement functions. . Protective measures. fever has resolved. Pricing data is updated monthly. (Medi-Span®) Capsules (Tamiflu Oral) 30 mg (10): $111. Dietary Considerations Take without regard to meals.  GPO-A-Flu (TH). confusion. take with food to improve tolerance. such as wearing a face mask. Breast-feeding is not recommended by the manufacturer. Pricing: U.

Omiflu (MY);

Tamiflu (AR, AT, AU, BE, BG, BR, CH, CL, CN, CO, CZ, DE, DK, EC, EE, ES, FI, FR, GB, GR, HK, HN, HU, IE, IL, IT, JP, KP, MT, MX, NL, NO, NZ, PE, PH, PK, PL, PT, PY, RU, SE, SG, SK, TH, TR, TW, UY)

Mechanism of Action
Oseltamivir, a prodrug, is hydrolyzed to the active form, oseltamivir carboxylate (OC). OC inhibits influenza virus neuraminidase, an enzyme known to cleave the budding viral progeny from its cellular envelope attachment point (neuraminic acid) just prior to release.

Pharmacodynamics/Kinetics
Absorption: Well absorbed Distribution: Vd: 23-26 L (oseltamivir carboxylate) Protein binding, plasma: Oseltamivir carboxylate: 3%; Oseltamivir: 42% Metabolism: Hepatic (90%) to oseltamivir carboxylate; neither the parent drug nor active metabolite has any effect on the cytochrome P450 system Bioavailability: 75% as oseltamivir carboxylate Half-life elimination: Oseltamivir: 1-3 hours; Oseltamivir carboxylate: 6-10 hours Excretion: Urine (>90% as oseltamivir carboxylate); feces Use of UpToDate is subject to the Subscription and License Agreement. REFERENCES 1. American Academy of Pediatrics, Committee on Infectious Diseases, “Policy, Statement -Recommendations for Prevention and Control of influenza in Children, 2010-2011,” Pediatrics, 2010, 126(4):816-26. [PubMed 20805143] 2. Aoki FY, Allen UD, Stiver HG, et al, AMMI Canada Guidelines, "The Use of Antiviral Drugs for Influenza: Guidance for Practitioners 2012/2013,” Can J Infect Dis Med Microbiol, 2012, 23(4):e79-92. Available at http://www.ammi.ca/media/48038/14791_aoki_final.pdf.pdf. 3. Bradley JS, Byington CL, Shah SS, et al. “The Management of Community-Acquired Pneumonia in Infants and Children Older Than 3 Months of Age: Clinical Practice Guidelines by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America”, Clin Infect Dis, 2011, 53(7):e25-76. [PubMed21880587] 4. Centers for Disease Control and Prevention (CDC), “Intensive-Care Patients With Severe Novel Influenza A (H1N1) Virus Infection - Michigan, June 2009,” MMWR Morb Mortal Wkly Rep, 2009, 58(27):749-52. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5827a4.htm [PubMed 19609249] 5. Centers for Disease Control and Prevention (CDC), “Influenza Antiviral Medications: Summary for Clinicians.” Available at http://www.cdc.gov/flu/professionals/antivirals/summaryclinicians.htm. Accessed on November 26, 2012. 6. Centers for Disease Control and Prevention (CDC), "Influenza Division, National Center for Immunization and Respiratory Diseases. Antiviral Agents for the Treatment and Chemoprophylaxis of Influenza --- Recommendations of the Advisory Committee on Immunization Practices (ACIP)," MMWR Surveill Summ, 2011, 60(1):1-28. [PubMed 21248682] 7. Harper SA, Bradley JS, Englund JA, et al, “Seasonal Influenza in Adults and Children -Diagnosis, Treatment, Chemoprophylaxis, and Institutional Outbreak Management: Clinical

8. 9. 10. 11.

12. 13.

14.

Practice Guidelines of the Infectious Diseases Society of America,” Clin Infect Dis, 2009, 48(8):1003-32. [PubMed 19281331] He G, Massarella J, and Ward P, “Clinical Pharmacokinetics of the Prodrug Oseltamivir and Its Active Metabolite Ro 64-0802,” Clin Pharmacokinet, 1999, 37(6):471-84. [PubMed 10628898] Jain S, Kamimoto L, Bramley AM, et al, “Hospitalized Patients With 2009 H1N1 Influenza in the United States, April-June 2009,” N Engl J Med, 2009, 361(20):1935-44. [PubMed 19815859] Okumura A, Kubota T, and Kato T, “Oseltamivir and Delirious Behavior in Children With Influenza,” Pediatr Infect Dis J, 2006, 25(6):572. Robson R, Buttimore A, Lynn K, et al, “The Pharmacokinetics and Tolerability of Oseltamivir Suspension in Patients on Haemodialysis and Continuous Ambulatory Peritoneal Dialysis,” Nephrol Dial Transplant, 2006, 21(9):2556-62. [PubMed 16799169] Schreuder MF, van der Flier M, Knops NB, et al, “Oseltamivir Dosing in Children Undergoing Hemodialysis,” Clin Infect Dis, 2010, 50(10):1427-8. [PubMed 20397934] Taylor WRJ, Thinh BN, Anh GT, et al, “Oseltamivir is Adequately Absorbed Following Nasogastric Administration to Adult Patients With Severe H5N1 Influenza,” PLoS One, 2008, 3(10):e3410. [PubMed18923671] Wentges-van Holthe N, van Eijkeren M, and van der Laan JW, “Oseltamivir and Breastfeeding,” Int J Infect Dis, 2008, 12(4):451. [PubMed 18243025] Topic 9460 Version 45.0

Ribavirin: Drug information
Copyright 1978-2013 Lexicomp, Inc. All rights reserved. (For additional information see "Ribavirin: Patient drug information" and see "Ribavirin: Pediatric drug information") For abbreviations and symbols that may be used in Lexicomp (show table)

ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.

Brand Names: U.S.
 Copegus®;

Rebetol®;

Ribasphere®;

Ribasphere® RibaPak®;

Virazole®

Brand Names: Canada
 Virazole®

Pharmacologic Category
 Antiviral Agent

Dosing: Adult
Note: Oral solution may be used those unable to swallow capsules. Chronic hepatitis C monoinfection (in combination with peginterferon alfa-2b): Oral capsule, oral solution (Rebetol®, Ribasphere®): Note: Recommended therapy duration [manufacturer labeling]: Genotype 1: 48 weeks; genotypes 2,3: 24 weeks); recommended therapy duration for patients who previously failed therapy: 48 weeks [regardless of genotype]) ≤65 kg: 800 mg daily (400 mg in the morning and evening) 66-80 kg: 1000 mg daily (400 mg in the morning, 600 mg in the evening) 81-105 kg: 1200 mg daily (600 mg in the morning, 600 mg in the evening) >105 kg: 1400 mg daily (600 mg in the morning, 800 mg in the evening) Chronic hepatitis C monoinfection (in combination with interferon alfa-2b): Oral capsule (Rebetol®, Ribasphere®): Note: Individualized therapy duration [manufacturer labeling] 24-48 weeks): ≤75 kg: 1000 mg daily (400 mg in the morning, 600 mg in the evening) >75 kg: 1200 mg daily (600 mg in the morning, 600 mg in the evening) Chronic hepatitis C monoinfection (in combination with peginterferon alfa-2a): Oral tablet (Copegus®, Ribasphere®): Genotype 1,4: <75 kg: 1000 mg daily in 2 divided doses for 48 weeks ≥75 kg: 1200 mg daily in 2 divided doses for 48 weeks Genotype 2,3: 800 mg daily in 2 divided doses for 24 weeks Chronic hepatitis C coinfection with HIV (in combination with peginterferon alfa-2a): Oral tablet (Copegus®, Ribasphere®): 800 mg daily in 2 divided doses for 48 weeks (regardless of genotype)

Alternative recommendation: American Association for the Study of Liver Diseases (AASLD) guidelines:Adults with chronic hepatitis C infection (Ghany, 2009): Treatment of choice: Ribavirin plus peginterferon; clinical condition and ability of patient to tolerate therapy should be evaluated to determine length and/or likely benefit of therapy. Recommended treatment duration (AASLD guidelines): Genotypes 1,4: 48 weeks; Genotypes 2,3: 24 weeks; Coinfection with HIV: 48 weeks.

Liu. all other genotypes: 48 weeks Oral capsule. Dosage and protocol may be institution specific. (Boeckh. 2006.3: 24 weeks. Liu. Dosing: Geriatric Refer to adult dosing. 2007. Dosing: Pediatric (For additional information see "Ribavirin: Pediatric drug information") Chronic hepatitis C monoinfection (in combination with pegylated or nonpegylated interferon alfa-2b): Children ≥3 years: Oral capsule or solution (Rebetol®. 2010) Note: Heart/lung transplant recipients also received IVIG. 2007. Ribasphere®): Note: Oral solution should be used in children <47 kg.3: 24 weeks. Recommended therapy duration (manufacturer labeling): Genotypes 2. all other genotypes: 48 weeks 23-33 kg: 400 mg daily (200 mg in the morning and evening) 34-46 kg: 600 mg daily (200 mg in the morning and 400 mg in the evening) 47-59 kg: 800 mg daily (400 mg in the morning and evening) 60-74 kg: 1000 mg daily (400 mg in the morning and 600 mg in the evening) ≥75 kg: 1200 mg daily (600 mg in the morning and evening) RSV infection: Infants and Children: Aerosol inhalation: Use with Viratek® small particle aerosol generator (SPAG-2): A concentration of 20 mg/mL (6 g reconstituted with 300 mL of sterile water without preservatives) administered for 12-18 hours/day for 3 days. methylprednisolone and palivizumab. children who start treatment prior to age 18 years should continue on pediatric dosing regimen through therapy completion. oral solution dosing recommendations: <47 kg: 15 mg/kg/day in 2 divided doses (morning and evening) as oral solution 47-59 kg: 800 mg daily (400 mg in morning and evening) 60-73 kg: 1000 mg daily (400 mg in morning and 600 mg in the evening) >73 kg: 1200 mg daily (600 mg in morning and evening) Alternative recommendations: American Association for the Study of Liver Diseases (AASLD) guidelines: Children 2-17 years with chronic hepatitis C infection (Ghany. up to 7 days in length. Chemaly. . or those unable to swallow capsules. 2009): Treatment of choice: Ribavirin 15 mg/kg daily (in combination with SubQ peginterferon alfa-2b) once weekly for 48 weeks Chronic hepatitis C monoinfection (in combination with peginterferon alfa-2a): Children ≥5 years: Oral tablet (Copegus®): Note: Assess child’s ability to swallow tablet. Recommended therapy duration (manufacturer labeling): Genotypes 2. Children who start treatment prior to age 18 years should continue on pediatric dosing regimen through therapy completion. 2010).RSV infection in hematopoietic cell or heart/lung transplant recipients (unlabeled use): Aerosol inhalation: 2000 mg (over 2 hours) every 8 hours (Boeckh.

Copegus® tablets: Adults: Clcr >50 mL/minute: No dosage adjustments are recommended. if appropriate. oral solution: First reduction: Decrease to 12 mg/kg/day Second reduction: Decrease to 8 mg/kg/day Children ≥5 years: Oral tablets (Copegus®): 23-33 kg: Decrease dose to 200 mg daily (in the morning) 34-59 kg: Decrease dose to 400 mg daily (200 mg in the morning and evening) ≥60 kg: Decrease dose to 600 mg daily (200 mg in the mo rning and 400 mg in the evening) Adults: Oral capsules. ESRD requiring hemodialysis: 200 mg once daily. until the adverse reactions resolve or decrease in severity. oral solution: First reduction: ≤105 kg: Decrease by 200 mg daily. Ribasphere® capsules: Adults: Clcr ≥50 mL/minute: No dosage adjustments are recommended. >105 kg: Decrease by 400 mg daily .Dosing: Renal Impairment CHC infection: Oral: Rebetol® capsules/solution. Note: The dose of Copegus® should not be further modified in patients with renal impairment. Clcr 30-50 mL/minute: Alternate 200 mg and 400 mg every other day. Dosing: Adjustment for Toxicity Patient without cardiac history: Hemoglobin <10 g/dL: Children ≥3 years: Oral capsules. Clcr <50 mL/minute: Use is contraindicated. Clcr <50 mL/minute: Use is not recommended. Clcr <30 mL/minute: 200 mg once daily. If abnormalitis persist after restarting. therapy should be discontinued. Ribasphere® tablets: Adults: Clcr ≥50 mL/minute: No dosage adjustments are recommended. If severe adverse reactions or laboratory abnormalities develop it should be discontinued. Dosing: Hepatic Impairment CHC infection: Hepatic decompensation (Child-Pugh class B and C): Manufacturer’s labeling: Oral tablets: Use contraindicated.

tablets: Permanently discontinue treatment. solution.5 g/dL: Children and Adults: Oral capsules. neutrophils <500 mm : Children and Adults: Oral capsules. consult specific product labeling. solution: Permanently discontinue treatment. tablets: Permanently discontinue treatment. Platelets <50 x 10 /L: Children: Oral capsules. Creatinine (serum) >2 mg/dL: Children: Oral capsules. WBC <1000 mm . Excipient information presented when available (limited. WBC <1000 mm . Platelets <25 x 10 /L: Adults: Oral capsules. Platelets <50 x 10 /L: Children: Oral capsules. 400 mg in the evening) Hemoglobin has decreased >2 g/dL during any 4-week period of treatment: Adults: Oral capsules. solution: Permanently discontinue treatment. solution: Permanently discontinue treatment.5 g/dL: Children and Adults: Oral capsules. 400 mg in the evening) Hemoglobin <12 g/dL after 4 weeks of reduced dose: Children and Adults: Oral capsules. solution. solution: Permanently discontinue treatment. .Second reduction: Decrease by an additional 200 mg daily (not weightbased) Oral tablets: Decrease dose to 600 mg daily (200 mg in the morning. 9 9 3 3 Patient with cardiac history: Hemoglobin has decreased ≥2 g/dL during any 4-week period of treatment: Children: Oral capsules. 9 9 3 3 Dosage Forms: U. solution: Permanently discontinue treatment.S. 400 mg in the evening) Hemoglobin <8. solution: Permanently discontinue treatment. particularly for generics). solution: Permanently discontinue treatment. solution: Decrease dose by 200 mg daily Oral tablets: 600 mg (200 mg in the morning. tablets: Permanently discontinue treatment. solution. Creatinine (serum) >2 mg/dL at any time during therapy: Children: Oral capsules. Platelets <25 x 10 /L: Adults: Oral capsules. solution: Weekly evaluation and hematologic testing Children ≥5 years: Oral tablets (Copegus®): 23-33 kg: Decrease dose to 200 mg daily (in the morning) 34-59 kg: Decrease dose to 400 mg daily (200 mg in the morning and evening) ≥60 kg: 600 mg daily (200 mg in the morning. neutrophils <500 mm : Children and Adults: Oral capsules. Hemoglobin <8. solution: Permanently discontinue treatment.

or broken.gov/downloads/Drugs/DrugSafety/ucm111342. 600 mg Tablet. this deposition can lead to malfunction or obstruction of the expiratory valve. oral: 200 mg Rebetol®: 200 mg Ribasphere®: 200 mg Powder for solution.pdf Administration Inhalation: Ribavirin should be administered in well-ventilated rooms (at least 6 air changes/hour). Solutions in SPAG-2 unit should be discarded at least every 24 hours and when the liquid level is low before adding newly reconstituted solution. Yes: Capsule. Rebetol®: http://www. 400 mg.fda. for nebulization: Virazole®: 6 g [reconstituted product contains ribavirin 20 mg/mL] Solution. oral [dose-pack]: Ribasphere® RibaPak® 600: 200 mg AM dose. must be dispensed with this medication: Copegus®: http://www.Capsule. a breathing circuit filter in the expiratory line. which is available with the product information and as follows. Use oral solution for children <47 kg. ribavirin can potentially be deposited in the ventilator delivery system depending on temperature. Oral: Administer concurrently with interferon alfa injection.pdf Ribasphere®: http://www. humidity.gov/downloads/Drugs/DrugSafety/ucm088576.S. oral: 200 mg Copegus®: 200 mg Ribasphere®: 200 mg. 400 mg PM dose (14s. sodium benzoate. The use of one-way valves in the inspiratory lines.pdf. oral: Rebetol®: 40 mg/mL (100 mL) [contains propylene glycol. and electrostatic forces. crushed. 56s) Ribasphere® RibaPak® 1200: 600 mg AM dose. In mechanically-ventilated patients. and frequent monitoring and filter replacement have been effective in preventing these problems. Should not be mixed with other aerosolized medication. Capsule should not be opened. chewed. tablet Medication Guide An FDA-approved patient medication guide. 400 mg PM dose (14s. 56s) Ribasphere® RibaPak® 1000: 600 mg AM dose.fda. bubblegum flavor] Tablet.fda. 400 mg PM dose (14s. resulting in inadvertently high positive end-expiratory pressures. . 56s) Ribasphere® RibaPak® 800: 400 mg AM dose.gov/downloads/Drugs/DrugSafety/ucm089017. 56s) Generic Equivalent Available: U. 600 mg PM dose (14s. or those who cannot swallow capsules.

Capsule, solution, tablet: Administer with food.

Hazardous agent; use appropriate precautions for handling and disposal (NIOSH, 2012).

Compatibility
Inhalation: Should not be mixed with other aerosolized medication.

Use
Inhalation: Treatment of hospitalized infants and young children with respiratory syncytial virus (RSV) infections; specially indicated for treatment of severe lower respiratory tract RSV infections in patients with an underlying compromising condition (prematurity, cardiopulmonary disease, or immunosuppression) Oral capsule: In combination with interferon alfa 2b (pegylated or nonpegylated) injection for the treatment of chronic hepatitis C in interferon alfa-naive or experienced-patients with compensated liver disease. Patients likely to fail retreatment after a prior failed course include previous nonresponders, those who received previous pegylated interferon treatment, patients who have significant bridging fibrosis or cirrhosis, or those with genotype 1 infection. Oral solution: In combination with interferon alfa-2b (pegylated or nonpegylated) injection for the treatment of chronic hepatitis C in interferon alfa-naive or experienced patients ≥3 years of age with compensated liver disease. Patients likely to fail retreatment after a prior failed course include previous nonresponders, those who received previous pegylated interferon treatment, patients who have significant bridging fibrosis or cirrhosis, or those with genotype 1 infection. Oral tablet: In combination with peginterferon alfa-2a (Pegasys®) injection for the treatment of chronic hepatitis C in patients with compensated liver disease who were previously untreated with alpha interferons, and in adult chronic hepatitis C patients coinfected with HIV.

Use - Unlabeled
Inhalation: Treatment for RSV in adult hematopoietic stem cell or heart/lung transplant recipients Used in other viral infections including influenza A and B and adenovirus

Medication Safety Issues
Sound-alike/look-alike issues: Ribavirin may be confused with riboflavin, rifampin, Robaxin®

Adverse Reactions Significant
Inhalation: 1% to 10%: Central nervous system: Fatigue, headache, insomnia Gastrointestinal: Nausea, anorexia Hematologic: Anemia

<1% (Limited to important or life-threatening): Hypotension, cardiac arrest, digitalis toxicity, conjunctivitis, mild bronchospasm, worsening of respiratory function, apnea Note: Incidence of adverse effects (approximate) in healthcare workers: Headache (51%); conjunctivitis (32%); rhinitis, nausea, rash, dizziness, pharyngitis, and lacrimation (10% to 20%); bronchospasm and/or chest pain (case reports in individuals with underlying airway disease)

Oral (all adverse reactions are documented while receiving combination therapy with alfa interferons; percentages as reported in adults unless noted, most common pediatric adverse reactions were similar to adults); asterisked (*) percentages are those similar to interferon therapy alone: >10%: Central nervous system: Fatigue (60% to 70% [30% in pediatric patients])*, headache (43% to 66%)*, fever (32% to 55%)*, insomnia (26% to 41% [9% in pediatric patients]), depression (20% to 36%)*, irritability (23% to 33%), dizziness (14% to 26%), impaired concentration (10% to 21%)*, emotional lability (7% to 12%)* Dermatologic: Alopecia (27% to 36% [17% in pediatric patients]), pruritus (13% to 29% [11% in pediatric patients]), rash (5% to 28%), dry skin (10% to 24%), dermatitis (≤16%) Endocrine and metabolic: Growth suppression (pediatric) percentile decrease (≥15 percentiles: weight 43%; height 25%), hyperuricemia (33% to 38%) Gastrointestinal: Nausea (25% to 47% [18% in pediatric patients]), anorexia (21% to 32%), weight decrease (10% to 29%), vomiting (9% to 25%)*, diarrhea (10% to 22%), dyspepsia (6% to 16%), abdominal pain (8% to 13%), xerostomia (≤12%), RUQ pain (≤12%) Hematologic: Leukopenia (6% to 45%), neutropenia (8% to 42%; grade 4: 2% to 11%; 40% with HIV coinfection), hemoglobin decreased (11% to 35%), anemia (11% to 17%), thrombocytopenia (<1% to 15%), lymphopenia (12% to 14%), hemolytic anemia (10% to 13%) Hepatic: Bilirubin increase (10% to 32%) Neuromuscular & skeletal: Myalgia (40% to 64% [17% in pediatric patients])*, rigors (25% to 48%), arthralgia (22% to 34%)*, musculoskeletal pain (19% to 28% [35% in pediatric patients]) Respiratory: Upper respiratory tract infection (60% in pediatric patients), dyspnea (13% to 26%), cough (7% to 23%), pharyngitis (≤13%), sinusitis (≤12%)* Miscellaneous: Flu-like syndrome (13% to 18% [up to 91% in pediatric patients])*, viral infection (≤12%), diaphoresis (≤11%) 1% to 10%: Cardiovascular: Chest pain (5% to 9%)*, flushing (≤4%) Central nervous system: Pain (≤10%), mood alteration (≤6%; 9% with HIV coinfection), agitation (5% to 8%), nervousness (6%)*, memory impairment (≤6%), malaise (≤6%), suicidal ideation (adolescents: 2%; adults: 1%)

Dermatologic: Eczema (4% to 5%) Endocrine & metabolic: Menstrual disorder (≤7%), hypothyroidism (≤5%) Gastrointestinal: Taste perversion (4% to 9%), constipation (5%) Hepatic: Hepatomegaly (4%), transaminases decompensation (2% with HIV coinfection) increased (1% to 3%), hepatic

Neuromuscular & skeletal: Weakness (9% to 10%), back pain (5%) Ocular: Blurred vision (≤6%), conjunctivitis (≤5%) Respiratory: Rhinitis (≤8%), exertional dyspnea (≤7%) Miscellaneous: Fungal infection (≤6%), bacterial infection (3% to 5%) <1% (Limited to important or life-threatening): Aggression, angina, anxiety, aplastic anemia, arrhythmia; autoimmune disorders (systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis); bone marrow suppression, cerebral hemorrhage, cholangitis, colitis, coma, corneal ulcer, dehydration, diabetes mellitus, drug abuse relapse/overdose, exfoliative dermatitis, fatty liver, hearing impairment/loss, gastrointestinal bleeding, gout, hallucination, hepatic dysfunction, hyper-/hypothyroidism, hypersensitivity (including anaphylaxis, angioedema, bronchoconstriction, and urticaria), macular edema, myositis, optic neuritis, papilledema, pancreatitis, peptic ulcer, peripheral neuropathy, pneumonitis, psychosis, psychotic disorder, pulmonary dysfunction, pulmonary embolism, pulmonary infiltrates, pure red cell aplasia, retinal artery/vein thrombosis, retinal detachment, retinal hemorrhage, retinopathy, sarcoidosis exacerbation; skin reactions (erythema multiforme, exfoliative dermatitis, urticaria, vesiculobullous eruptions); Stevens-Johnson syndrome, suicide, thrombotic thrombocytopenic purpura, thyroid function test abnormalities; transplant rejection (kidney, liver); vision loss Note: Incidence of headache, fever, suicidal ideation, and vomiting are higher in children.

Contraindications
Inhalation: Hypersensitivity to ribavirin or any component of the formulation; women who are pregnant or may become pregnant Oral formulations: Hypersensitivity to ribavirin or any component of the formulation; women who are pregnant or may become pregnant; males whose female partners are pregnant; patients with hemoglobinopathies (eg, thalassemia major, sickle cell anemia); patients with autoimmune hepatitis; concomitant use with didanosine Ribasphere® capsules and Rebetol® capsules/solution: Additional contraindications: Patients with a Clcr<50 mL/minute Oral combination therapy: Refer to individual monographs for Interferon Alfa-2b (Intron® A), Peginterferon Alfa-2b, and Peginterferon Alfa-2a (Pegasys®) for additional contraindication information.

Warnings/Precautions
Concerns related to adverse effects: • Hemolytic anemia: [U.S. Boxed Warning]: Hemolytic anemia is the primary clinical toxicity of oral therapy; anemia associated with ribavirin may worsen underlying cardiac disease and lead to fatal and nonfatal myocardial infarctions. Avoid use in patients with significant/unstable cardiac

angioedema.disease.S. dosage adjustment or discontinuation may be required. retinopathy. monitor blood sugars closely. patients should be instructed to brush teeth twice daily and have regular dental exams. diabetic or hypertensive retinopathy) require periodic follow up. anaphylaxis. discontinue immediately with signs or symptoms of severe skin reactions. • Hypersensitivity reactions: Acute hypersensitivity reactions (eg. those with preexisting ophthalmologic disorders (eg. • Diabetes: Has occurred with combination therapy. Assess cardiac function before initiation of therapy. All patients require an eye exam at baseline. assess electrocardiogram prior to and periodically during treatment. including Stevens -Johnson syndrome and exfoliative dermatitis have been reported (rarely) with combination therapy. and urticaria) have been observed (rarely) with combination therapy. Disease-related concerns: • Hepatic impairment: Risk of hepatic decompensation in chronic hepatitis C patients treated with combination therapy. Concurrent drug therapy issues: Combination therapy with alfa interferons: • Autoimmune/infectious disorders: Have occurred with combination therapy. retinal artery/vein thrombosis. • Hepatitis C: Appropriate use: [U. Assess hemoglobin and hematocrit at baseline and. • Bone marrow suppression: Pancytopenia has occurred with combination therapy and concomitant use of azathioprine. • Dental and periodontal disorders: Have been reported with combination therapy. Xerostomia may contribute to and/or exacerbate dental disorders. • Dermatologic reactions: Severe cutaneous reactions. retinal detachment) have occurred with combination therapy. If any deterioration in cardiovascular status occurs. discontinue combination therapy and azathioprine if occurs. Discontinue therapy in patients with new or worsening ophthalmologic disorders. optic neuritis. at minimum. weeks 2 and 4 of therapy since initial drop may be significant. discontinue therapy. use with caution in patients with autoimmune disease or severe infection. discontinue immediately with signs or symptoms of severe hypersensitivity reactions. . Patients with renal dysfunction and/or those >50 years of age should be carefully assessed for development of anemia. Boxed Warning]: Ribavirin monotherapy is not effective for chronic hepatitis C infection and should not be used alone for hepatitis C. • Renal impairment: Use with caution in patients with renal impairment. If patient has underlying cardiac disease. Use caution in patients with baseline risk of severe anemia. monitor hepatic function closely and discontinue therapy immediately if evidence of hepatic decompensation is observed. observed in ~10% to 13% of patients when alfa interferons were combined with ribavirin. Anemia usually occurs within 1-2 weeks of therapy initiation. onset occurs within 3-7 weeks. may be reversible (usually within 4-6 weeks). bronchoconstriction. macular edema. • Ophthalmologic disorders: Serious disorders (eg.

including sarcoidosis (exacerbation reported). Growth should be closely monitored in pediatric patients during therapy and post-treatment until growth catch up has occurred. interrupt therapy if pancreatitis is suspected and discontinue if confirmed. • Pregnancy: [U.• Pancreatitis: Has occurred with combination therapy. consider monitoring for anemia 1-2 weeks posttreatment. sudden deterioration of respiratory function has been observed. Monitor renal function closely. Boxed Warning]: Use with caution in patients requiring assisted ventilation because precipitation of the drug in the respiratory equipment may interfere with safe and effective patient ventilation. pneumonitis. and gonadotoxic. Avoid use in patients with a psychiatric history. and for at least 6 months after treatment. monitor carefully in patients with COPD and asthma for deterioration of respiratory function. Other warnings/precautions: • Appropriate use: Safety and efficacy have not been established in patients who have failed other alfa interferon therapy. Dosage form specific issues: • Inhalation: [U. • Psychiatric disorders: Severe psychiatric events have occurred including depression and suicidal behavior during combination therapy. ribavirin may cause a reduction in growth velocity in pediatric patients for the length of treatment. • Pediatric: In combination therapy with alfa interferons. decreases were noted in weight and height for age z-scores and normative growth curve percentiles. pneumonia [rarely fatal]) have been associated with combination therapy. during therapy. tumor-promoting. Special populations: • Elderly: Use with caution in the elderly. 2012).S. pulmonary infiltrates. Ribavirin is potentially mutagenic.4% vs 1%).S. Special handling: • Hazardous agent: Use appropriate precautions for handling and disposal (NIOSH. received organ transplants. discontinue if severe psychiatric symptoms occur. Pregnant healthcare workers may consider unnecessary occupational exposure. Suicidal ideation or attempts occurred more often in pediatric patients versus reports in adults during treatment and offtherapy follow. Healthcare professionals or family members who are pregnant (or may become pregnant) should be counseled about potential risks of exposure and counseled about risk reduction strategies. Avoid pregnancy in female patients and female partners of male patients. a small percentage did not. Although anemia has not been reported with inhalation therapy. At two-year follow up after treatment. Delay in weight and height increases have been noted in children treated with combination therapy. use with caution in patients with pulmonary disease. ribavirin has been detected in healthcare workers' urine. or been coinfected . A negative pregnancy test is required before initiation and monthly thereafter. • Pulmonary events: Pulmonary symptoms (eg. In clinical studies. Boxed Warning]: Significant teratogenic effects have been observed in all animal studies. two forms of contraception should be used. however. dyspnea.up (2. most children had returned to their baseline normative growth curve percentiles. may be more susceptible to adverse effects such as anemia.

Risk X: Avoid combination Influenza Virus Vaccine (Live/Attenuated): Antiviral Agents (Influenza A and B) may diminish the therapeutic effect of Influenza Virus Vaccine (Live/Attenuated). Management: Due to significantly increased risk of anemia. Persons receiving these agents within 2 weeks of the live intranasal spray vaccine should receive a repeat vaccine dose.with hepatitis B or HIV (ribavirin tablets [Copegus®. Hemolytic anemia has been observed. Metabolism/Transport Effects None known. the risk/severity of anemia may be increased. Hemoglobin at initiation must be ≥12 g/dL (women) or ≥13 g/dL (men) in CHC monoinfected patients and ≥11 g/dL (women) or ≥12 g/dL (men) in CHC and HIV coinfected patients. ribavirin inhalation is approved for severe RSV infection in children. monitor patients extra closely for signs/symptoms of myelosuppression. Lactic acidosis may occur. Risk D: Consider therapy modification Interferons (Alfa): May enhance the adverse/toxic effect of Ribavirin. Risk D: Consider therapy modification Ethanol/Nutrition/Herb Interactions Food: Oral: High-fat meal increases the AUC and Cmax. Ribavirin may increase serum concentrations of the active metabolite(s) of Didanosine. consider even closer monitoring for anemia than routinely recommended for ribavirin. Drug Interactions (For additional information: Launch Lexi-Interact™ Drug Interactions Program ) AzaTHIOprine: Ribavirin may increase serum concentrations of the active metabolite(s) of AzaTHIOprine. RSV. Specifically. Risk C: Monitor therapy Reverse Transcriptase Inhibitors (Nucleoside): Ribavirin may enhance the hepatotoxic effect of Reverse Transcriptase Inhibitors (Nucleoside). Management: Avoid antiinfluenza antivirals during the period beginning 48 hours prior to and ending 2 weeks after vaccine administration. Management: Consider using alternative agent(s) when possible. while concentrations of active 6-thioguanine nucleotides may be decreased. concentrations of potentially myelotoxic methylated metabolites may be increased. Oral ribavirin should not be used for adenovirus. Alternative therapies should be considered when clinically possible. Risk D: Consider therapy modification Didanosine: Ribavirin may enhance the adverse/toxic effect of Didanosine. Other dosage forms and combinations should be taken consistently in regards to food. Pregnancy Risk Factor X (show table) . influenza or parainfluenza infections. particularly for patients with other risk factors. When these drugs are used in combination. Management: Capsule (in combination with peginterferon alfa-2b) and tablet should be administered with food. Risk D: Consider therapy modification Zidovudine: May enhance the adverse/toxic effect of Ribavirin. Ribasphere®] may be used in HIV coinfected patients unless CD4+ cell count is <100 cells/microliter and HIV-1 3 RNA <5000 cells/mm ). Specifically.

68 . solution.Pregnancy Implications [U.74 Capsules (Ribasphere Oral) 200 mg (70): $328.S.S.37 Tablets (Copegus Oral) 200 mg (168): $3305. Pricing: U. If pregnancy occurs during use or within 6 months after treatment.67 400 & 600 mg (14): $288.14 Solution (Rebetol Oral) 40 mg/mL (100 mL): $232.34 600 mg (14): $346. If patient or female partner becomes pregnant during treatment. Lactation Excretion in breast milk unknown/not recommended Dietary Considerations Capsules. report to the ribavirin pregnancy registry (800-593-2214).38 Tablets (RibaPak Oral) 400 mg (14): $230.01 Tablets (Ribasphere Oral) 200 mg (168): $474. Boxed Warning]: Significant teratogenic effects have been observed in all animal studies at ~0. continue contraceptive measures for at least 6 months after completion of therapy. and tablets should be taken with food.00 400 mg (56): $922. (Medi-Span®) Capsules (Rebetol Oral) 200 mg (70): $741. Avoid pregnancy in female patients and female partners of male patients during therapy by using two effective forms of contraception. Negative pregnancy test is required before initiation and monthly thereafter.01 times the maximum recommended daily human dose.44 Capsules (Ribavirin Oral) 200 mg (56): $556. Use is contraindicated in pregnancy.29 Misc (RibaPak Oral) 200 & 400 mg (14): $219.80 Solution (reconstituted) (Virazole Inhalation) 6 g (1): $6212. she should be counseled about potential risks of exposure.

Monitoring Parameters Inhalation: Respiratory function. then every 4 weeks thereafter. 5 and 8. and as such should not be used to set or adjudicate any prices for charging or reimbursement functions. pregnancy screening (if woman of childbearing age) and ECG (if preexisting cardiac abnormalities) are also recommended. + + Reference Range Rapid virological response (RVR): Absence of detectable HCV RNA after 4 weeks of treatment Early viral response (EVR): ≥2-log decrease in HCV RNA after 12 weeks of treatment . In pediatric patients. hematologic tests should be at treatment weeks 2 and 4. respectively. CBC with differential.3) for 24 weeks (if tolerated) and then evaluate HCV RNA levels (Ghany.000/mm (75. monitor growth closely during and after treatment. 3. hemoglobin.00 Disclaimer: The pricing data provided represent a median AWP and/or AAWP price for the brand and/or generic product. Pricing data is updated monthly. 2009). In pediatric clinical studies. Pretreatment and monthly pregnancy test up to 6 months following discontinuation of therapy for women of childbearing age. pretreatment ECG in patients with pre-existing cardiac disease. Note:Discontinuation of therapy may be considered after 12 weeks in patients with HCV (genotypes 1. reticulocyte count.000/mm for coinfection with HIV) ANC ≥1500/mm 3 3 3 3 Hemoglobin ≥12 g/dL for women and ≥13 g/dL for men (11 g/dL for HIV coinfected women and 12 g/dL for HIV coinfected men) TSH and T4 within normal limits or adequately controlled CD4 cell count ≥200 cells/microL or CD4 cell count 100-200 cells/microL and HIV-1 RNA <5000 copies/mL for coinfection with HIV Serum HCV RNA (pretreatment. and 24 weeks after completion of therapy). and pregnancy tests monthly during and for 6 months after treatment discontinuation. dental exams.000/mm for cirrhosis or 70. The pricing data should be used for benchmarking purposes only. week 12 and week 24. I & O Oral: For combination treatment: pretreatment hematological and biochemical tests are recommended for all patients. In adults. hematologic and biochemical assessments were made at weeks 1. Baseline values used in adult clinical trials: Platelet count ≥90. TSH at week 12. biochemical tests at week 4.02 Tablets (Ribavirin Oral) 200 mg (168): $1390.600 mg (56): $1384. Treat patients with HCV (genotypes 2.4) who fail to achieve an early virologic response (EVR) (defined as ≥2-log decrease in HCV RNA compared to pretreatment) or after 24 weeks with detectable HCV RNA. ophthalmic exam pretreatment (all patients) and periodically for those with pre-existing ophthalmologic disorders.

SG. PH.  Rebetol (AT. PT. FI. BE. DE. GR.   Trivorin (MX). MY. BG.  Robavin (KP). ID. GB. EC. BE. IE. FR. HK. TR. PL. EE. GR.  Desiken (MX). CO. IE. PA. DK. DO. Vibuzol (AR). NZ. PT. CZ.End of treatment response (ETR): Absence of detectable HCV RNA at end of the recommended treatment period Sustained treatment response (STR) or sustained virologic response (SVR): Absence of HCV RNA in the serum 6 months following completion of full treatment course International Brand Names  Copegus (AR.  Ribavin (IN). UY).  Vilona (MX). IT. NL. FR. NO. BG. CN. FI.  Robatrol (TW). VE). IL. AT. MX. GB. IT. SE. SK. CH. CZ. DE. AU. NZ. NO. NL. TH. . SE. IL.  Hepaviral (ID). PL. CH. EE.  Probirina (MX). MT. DK. TH. RU.  Rui Di (CL). ES.

BR. LY. CR. YE). which can be used as a marker for intracellular metabolism Protein binding: Oral: None Metabolism: Hepatically and intracellularly (forms active metabolites). SA.  Virazide (AU. single dose (Rebetol®. CY. NI. SE. Tablet: 2 hours Excretion: Inhalation: Urine (40% as unchanged drug and metabolites). 44 hours with chronic hepatitis C infection (increases to ~298 hours at steady state) Tablet. highest concentrations in respiratory tract and erythrocytes Distribution: Oral capsule: Single dose: Vd: 2825 L. SY. may be necessary for drug action Bioavailability: Oral: 64% Half-life elimination. SV. EG. dependent upon respiratory factors and method of drug delivery. inhibits influenza virus RNA polymerase activity and inhibits the initiation and elongation of RNA fragments resulting in inhibition of viral protein synthesis Pharmacodynamics/Kinetics Absorption: Inhalation: Systemic.  Virazin (KP). Viramid (IT. IR. Oral capsule: Urine (61%). LB. maximal absorption occurs with the use of aerosol generator via endotracheal tube.  Zyverin (TW) Mechanism of Action Inhibits replication of RNA and DNA viruses. OM. GB. Ribasphere®): 24 hours in healthy adults. feces (12%) Use of UpToDate is subject to the Subscription and License Agreement. serum: Inhalation: At end of inhalation period. GT. Oral capsule: Multiple doses: 3 hours. IQ. distribution significantly prolonged in the erythrocyte (16-40 days). .  Virazole (AE. BH. single dose (Copegus®): ~120-170 hours Time to peak. MX. KP). QA.5-11 hours Adults: Oral: Capsule. JO. PK). BE. plasma: Children: Inhalation: 6. HN. KW.

”Clin Infect Dis.REFERENCES 1. et al. Ahn YM." Available at http://www. [PubMed 19330875] 11. Randomized Trial. Background and Clinical Experience 40 Years After Discovery. et al.[PubMed 19761558] 14. “Aerosolized Ribavirin in Mechanically Ventilated Children With Respiratory Syncytial Virus Lower Respiratory Tract Disease: A Prospective. et al. 2011.”Hepatology. [PubMed 9819447] 7. Davis GL. Barry M. et al. Gordon SC. 1994. 92(3):5014. Accessed January 21. Chemaly RF. “American Gastroenterological Association Medical Position Statement on the Management of Hepatitis C. 12(1):38-44. [PubMed 7596373] 4. Esteban-Mur R. [PubMed 17151366] 12.[PubMed 9421694] 19. 2011. Boeckh M. et al.” Medicine (Baltimore). Smith DW. [PubMed 17173225] 5. 1991. 1996. American Academy of Pediatrics Committee on Infectious Diseases. “Respiratory Viral Infections in Adults With Hematologic Malignancies and Human Stem Cell Transplant Recipients: A Retrospective Study at a Major Cancer Center. Lauer GM and Walker BD. Strader DB.” Pediatrics. 125:635-41. [PubMed 9819446] 15. Strader DB.” Gastroenterology.cdc. McHutchison JG. 1995. “Interferon Alfa-2b Alone or in Combination With Ribavirin as Initial Treatment for Chronic Hepatitis C. "NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012. 2006.pdf. 1984. 17. 54(4):1433-44. Hoofnagle JH and Seeff LB. Dienstag JL and McHutchinson JG. Short-Duration Ribavirin Aerosol Therapy Compared With Standard Ribavirin Therapy in Children With Suspected Respiratory Syncytial Virus Infection. “Interferon Alfa-2b Alone or in Combination With Ribavirin for the Treatment of Relapse of Chronic Hepatitis C. “High-Dose. and Weill D. 130(1):22530. 2006. [PubMed 16401485] 8.” Drugs. updated November 2012.” Transp Infect Dis. Murray KF. [PubMed8545210] 2. 333(5):294-6. 2007. Li Y. 2013.” N Engl J Med. Liu V. 1998. Armstrong L. “Use of Ribavirin in the Treatment of Respiratory Syncytial Virus Infection. Bodey GP. [PubMed 16974212] 6. “A Multi-Drug Regimen for Respiratory Syncytial Virus and Parainfluenza Virus Infections in Adult Lung and Heart-Lung Transplant Recipients.[PubMed 1904551] .Ribavirin for Children With Hepatitis C.gov/niosh/docs/2012-150/pdfs/2012-150. “Prevention and Treatment Recommendations for Respiratory Syncytial Virus Infection. [PubMed 21898493] 10. Ghosh S.”Peginterferon and Ribavirin for Chronic Hepatitis C.” Pediatrics. Piedra PA. Nelson DR. et al.” N Engl J Med. 140(2):450-8. Available at http://clinicaltrials. 1993. 339(21):1493-9. 97(1):137-40.” Hepatology. International Hepatitis Interventional Therapy Group. 355(23):2444-51. Gelmini MJ.” Lancet. Dhillon GS.” Crit Care Med. [PubMed 7931890] 9. 2006.” J Pediatr.” N Engl J Med. et al. Nicholson KG. [PubMed 8143465] 16. American Academy of Pediatrics Committee on Infectious Diseases. 339(21):1485-92. “The Combination of Ribavirin and Peginterferon is Superior to Peginterferon and Placebo for Children and Adolescents With Chronic Hepatitis C. Management And Treatment Of Hepatitis C: An Update. et al. Mathers LH. Englund JA. Schiff ER. Ottolini MG and Hemming VG. 2001. Englund J. Frankel LR. [PubMed 8361820] 3. “Reassessment of the Indications for Ribavirin Therapy in Respiratory Syncytial Virus Infections. Russi M. [PubMed 21036173] 21. Gonzalez-Peralta RP. et al. et al. Ghany MG. 2010. “A Controlled Trial of Aerosolized Ribavirin in Infants Receiving Mechanical Ventilation for Severe Respiratory Syncytial Virus Infection.gov/ct2/show/NCT00100659 20. 325(1):24-9. 22(4):566-72. 18. [PubMed11439948] 13. National Institute for Occupational Safety and Health (NIOSH). "PEDS-C: Pegylated Interferon +/. 1998. Ghany MG. “Randomized Controlled Multicenter Trial of Aerosolized Ribavirin For Respiratory Syncytial Virus Upper Respiratory Tract Infection in Hematopoietic Cell Transplant Recipients. 85(5):278-87.”Gastroenterology. 345(1):4152. Rustgi V. 44(2):245-9. 49(4):1335-74. Thomas DL. “Hepatitis C Virus Infection. “Brief Report: Treatment of a Laboratory-Acquired Saria Virus Infection. “Diagnosis. “An Update on Treatment of Genotype 1 Chronic Hepatitis C Virus Infection: 2011 Practice Guideline by the American Association for the Study of Liver Diseases.” N Engl J Med. 1997. 2009. Schwarz KB. 1994. Sarnaik AP. Double-Blind. et al." NCT0010065. 2(8401):503-6 and 2(8402):562-4. “Properties of Antiviral Agents. Meert KL.” N Engl J Med. 54(6):867-84.” N Engl J Med. Hepatitis Interventional Therapy Group.

 Allergy-Time [OTC]. 52(6):82731. Sokal E.  Chlor-Trimeton Allergy [OTC]. et al.” Lancet. et al. “Peginterferon Alfa-2a Plus Ribavirin for Chronic Hepatitis C Virus Infection in Children and Adolescents. [PubMed 20400194] 23. Stephenne X. 345(8947):451. 2010.  Chlorphen [OTC].  Chlor-Trimeton [OTC].” J Hepatol.  Allergy [OTC]. Topic 9860 Version 42.S. “Water Intoxication After Nebulised Tribavirin.  Ed ChlorPed. Van Hoeck K. (For additional information see "Chlorpheniramine: Patient drug information" and see "Chlorpheniramine: Pediatric drug information") For abbreviations and symbols that may be used in Lexicomp (show table) Brand Names: U.  Allergy Relief [OTC]. Van Bever HP. Desager KS.0 Chlorpheniramine: Drug information Copyright 1978-2013 Lexicomp.22. .  Aller-Chlor [OTC]. All rights reserved. 1995. Inc. Bourgois A.  Allergy 4 Hour [OTC].

allergic rhinitis: Oral: Chlorpheniramine maleate: Immediate release: Children 2-5 years: 1 mg every 4-6 hours. allergic rhinitis: Oral: Chlorpheniramine maleate: Immediate release: 4 mg every 4-6 hours.1 Antagonist  Histamine H1 Antagonist.  Ed-Chlor-Tan.  Ed-Chlortan [OTC]. Ed Chlorped Jr [OTC]. First Generation Dosing: Adult Allergic symptoms. do not exceed 24 mg/24 hours Dosing: Pediatric (For additional information see "Chlorpheniramine: Pediatric drug information") Allergic symptoms.  Pharbechlor [OTC] Brand Names: Canada  Chlor-Tripolon®.  Ed ChlorPed [OTC]. do not exceed 24 mg/24 hours Extended release: 12 mg every 12 hours.  Histamine H.  Novo-Pheniram Pharmacologic Category  Alkylamine Derivative. do not exceed 6 mg/24 hours .

propylene glycol. as tannate: Ed-Chlor-Tan: 8 mg [scored] Tablet Extended Release. particularly for generics). sodium benzoate. Excipient information presented when available (limited. propylene glycol. contains fd&c red #40. contains fd&c yellow #10 aluminum lake] Pharbechlor: 4 mg Generic: 4 mg Tablet. saccharin sodium. Oral. as tannate: Ed ChlorPed: 2 mg/mL (60 mL) [contains aspartame. propylparaben. Oral. Extended release: Children ≥12 years: Refer to adult dosing. do not exceed 12 mg/24 hours Children ≥12 years: Refer to adult dosing. Liquid. sugar free. as maleate: Aller-Chlor: 2 mg/5 mL (118 mL) [fruit flavor] Chlor-Trimeton: 2 mg/5 mL (120 mL) [contains alcohol. cotton candy flavor] Suspension. Dosage Forms: U. contains fd&c yellow #10 (quinoline yellow)] Ed-Chlortan: 4 mg [scored. Oral. 473 mL) [alcohol free.S. propylparaben. cherry flavor] Tablet. as maleate: Ed ChlorPed: 2 mg/mL (60 mL) [contains fd&c red #40. Oral. methylparaben. as maleate: . Oral. propylene glycol. as maleate: Aller-Chlor: 4 mg [scored] Allergy: 4 mg Allergy: 4 mg [contains fd&c yellow #10 (quinoline yellow)] Allergy: 4 mg [contains fd&c yellow #10 aluminum lake] Allergy: 4 mg [scored. usp] Ed Chlorped Jr: 2 mg/5 mL (118 mL. contains fd&c yellow #10 aluminum lake] Allergy 4 Hour: 4 mg [contains fd&c yellow #10 (quinoline yellow)] Allergy Relief: 4 mg [contains fd&c yellow #10 aluminum lake] Allergy-Time: 4 mg [contains fd&c yellow #10 aluminum lake] Chlor-Trimeton: 4 mg [scored] Chlorphen: 4 mg [scored. methylparaben.Children 6-11 years: 2 mg every 4-6 hours. cotton candy flavor] Syrup. consult specific product labeling. Oral.

weakness Ocular: Diplopia Renal: Polyuria Respiratory: Pharyngitis Contraindications Hypersensitivity to chlorpheniramine maleate or any component of the formulation. Adverse Reactions Significant >10%: Central nervous system: Slight to moderate drowsiness Respiratory: Thickening of bronchial secretions 1% to 10%: Central nervous system: Headache. weight gain Genitourinary: Urinary retention Neuromuscular & skeletal: Arthralgia. Timed release oral forms are to be swallowed whole. May be product dependent Administration May be administered with food or water.Chlor-Trimeton Allergy: 12 mg [contains fd&c blue #2 aluminum lake. abdominal pain. not crushed or chewed. fd&c yellow #6 aluminum lake] Generic: 12 mg Generic Equivalent Available: U. excitability. . stenosing peptic ulcer. fatigue. diarrhea. bladder neck obstruction. pyloroduodenal obstruction. symptomatic prostate hypertrophy.moderate. Avoid use in premature and term newborns due to possible association with SIDS. appetite increase.strong). fd&c yellow #10 aluminum lake. xerostomia. Use Perennial and seasonal allergic rhinitis and other allergic symptoms including urticaria Medication Safety Issues Sound-alike/look-alike issues: Chlor-Trimeton® may be confused with Chloromycetin® BEERS Criteria medication: This drug may be potentially inappropriate for use in geriatric patients (Quality of evidence . nervousness.S. narrowangle glaucoma. fd&c yellow #6 aluminum lake] Chlor-Trimeton Allergy: 12 mg [contains fd&c yellow #6 (sunset yellow). Strength of recommendation . during acute asthmatic attacks. dizziness Gastrointestinal: Nausea.

• Respiratory disease: Use with caution in patients with asthma or other chronic breathing disorders. Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential. Risk X: Avoid combination . Inhibits CYP2D6 (weak) Drug Interactions (For additional information: Launch Lexi-Interact™ Drug Interactions Program ) Abiraterone Acetate: May increase the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy Aclidinium: May enhance the anticholinergic effect of Anticholinergics. Management: Avoid concurrent use of abiraterone with CYP2D6 substrates that have a narrow therapeutic index whenever possible. patients must be cautioned about performing tasks which require mental alertness (eg. If the anticholinergic action is a side effect of the agent. which may impair physical or mental abilities. monitor patients closely for signs/symptoms of toxicity. Special populations: • Elderly: Avoid use of this potent anticholinergic agent due to increased risk of confusion. clearance decreases in patients of advanced age (Beers Criteria). CYP3A4 (minor). constipation. dry mouth. the result may be beneficial. operating machinery or driving). • Pediatrics: Antihistamines may cause excitation in young children. Risk D: Consider therapy modification Acetylcholinesterase Inhibitors (Central): Anticholinergics may diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central). Not fo r OTC use in children <2 years of age. When concurrent use is not avoidable. Disease-related concerns: • Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease). • Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction. Concurrent drug therapy issues: • Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol. Acetylcholinesterase Inhibitors (Central) may diminish the therapeutic effect of Anticholinergics. • Thyroid dysfunction: Use with caution in patients with thyroid dysfunction. and other anticholinergic effects. Metabolism/Transport Effects Substrate of CYP2D6 (major). • Increased intraocular pressure: Use with caution in patients with increased intraocular pressure.Warnings/Precautions Concerns related to adverse effects: • CNS depression: May cause CNS depression.

Management: The manufacturer of Diclegis (doxylamine/pyridoxine). Risk D: Consider therapy modification Hyaluronidase: Antihistamines may diminish the therapeutic effect of Hyaluronidase. opioids. A histamine skin test may be used to assess persistent antihistaminic effects. Consult full interaction monograph for specific recommendations. Risk D: Consider therapy modification Darunavir: May increase the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy CYP2D6 Inhibitors (Strong): May decrease the metabolism of CYP2D6 Substrates.Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy Amphetamines: May diminish the sedative effect of Antihistamines. specifically states that use with other CNS depressants is not recommended. Risk D: Consider therapy modification . Exceptions: Levocabastine (Nasal). Management: Patients receiving antihistamines (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Risk X: Avoid combination Benzylpenicilloyl Polylysine: Antihistamines may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Risk D: Consider therapy modification CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e. Risk C: Monitor therapy ARIPiprazole: CYP2D6 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Consider avoiding other CNS depressants in patients thought to be at high risk of buprenorphine overuse or self-injection. Management: Monitor for increased aripiprazole pharmacologic effects. Larger doses of hyaluronidase may be required. intended for use in pregnancy. Exceptions: Levocabastine (Nasal). Risk C: Monitor therapy CYP2D6 Inhibitors (Moderate): May decrease the metabolism of CYP2D6 Substrates. Management: Suspend systemic H1 antagonists for benzylpenicilloyl-polylysine skin testing and delay testing until systemic antihistaminic effects have dissipated. Management: Consider reduced doses of CNS depressants used in combination with buprenorphine. Risk C: Monitor therapy Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication.g. Risk C: Monitor therapy Droperidol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Risk C: Monitor therapy Anticholinergics: May enhance the adverse/toxic effect of other Anticholinergics.. Risk C: Monitor therapy Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). barbiturates) with concomitant use. Risk D: Consider therapy modification Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine.

Risk D: Consider therapy modification Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Risk C: Monitor therapy Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Risk C: Monitor therapy Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk D: Consider therapy modification Metyrosine: CNS Depressants may enhance the sedative effect of Metyrosine. consider minimizing doses of one or more drugs. These effects are specific to the GI tract. particularly those such as driving that require alertness and coordination. Risk C: Monitor therapy Perampanel: May enhance the CNS depressant effect of CNS Depressants. When combined use is needed. Risk C: Monitor therapy Pramlintide: May enhance the anticholinergic effect of Anticholinergics.HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. until they have experience using the combination. Risk C: Monitor therapy Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. the risk of psychomotor impairment may be enhanced. Risk C: Monitor therapy Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Risk D: Consider therapy modification Tiotropium: Anticholinergics may enhance the anticholinergic effect of Tiotropium.Risk D: Consider therapy modification ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Risk C: Monitor therapy Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. Risk C: Monitor therapy Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Management: Consider alternatives to combined use. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Risk X: Avoid combination . Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities. Risk C: Monitor therapy Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergics.

62 Tablet.25 Tablets (Ed-Chlor-Tan Oral) 8 mg (100): $60. monitor for increased effects with coadministration.62 Tablets (Chlorpheniramine Maleate Oral) 4 mg (100): $2.00 Syrup (Chlor-Trimeton Oral) 2 mg/5 mL (120 mL): $4. (Medi-Span®) Liquid (Ed ChlorPed Oral) 2 mg/mL (60 mL): $21. No such dose change is recommended for women. Antihistamines may decrease maternal serum prolactin concentrations when administered prior to the establishment of nursing. urticaria. Dietary Considerations May be taken with food or water.82 Tablet. Antihistamines are not recommended for treatment of pruritus associated with intrahepatic cholestasis in pregnancy. Caution patients about effects.00 Suspension (Ed ChlorPed Oral) 2 mg/mL (60 mL): $21. Some products may contain phenylalanine.75 mg for men who are also receiving other CNS depressants. Risk D: Consider therapy modification Ethanol/Nutrition/Herb Interactions Ethanol: May increase CNS depression. Pricing: U. Avoid use with other CNS depressants at bedtime. and pruritus with rash in pregnant women (although second generation antihistamines may be preferred). controlled release (Chlorpheniramine Maleate ER Oral) 12 mg (24): $15. Antihistamines are recommended for the treatment of rhinitis. Management: Reduce the Intermezzo brand sublingual zolpidem dose to 1.00 .S. controlled release (Chlor-Trimeton Allergy Oral) 12 mg (10): $4.00 Tablets (Chlor-Trimeton Oral) 4 mg (24): $4. Pregnancy Implications Maternal chlorpheniramine use has generally not resulted in an increased risk of birth defects. Breast-Feeding Considerations Information specific to the use of chlorpheniramine is limited. avoid use with alcohol.Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem.

TN. TN. NE. SG).  Allermin (SG. SL.  Alergidryl (AR).  Allergyl (BF. SD. MW.  Alerfin (PY). Pricing data is updated monthly. TZ. respectively. NG. UG. Allerfin (BF. BJ. GH. SN. UG. CI. TW). SD. GN. MW. ZW). MR. ZM. BJ. TZ. International Brand Names  Ahiston (IL).   Aller (MY). SL. ZW). . MR. MA. ET. GH.  Antadex-H (MX). NE. SN. ET. GN. SC. The pricing data should be used for benchmarking purposes only. KE.Disclaimer: The pricing data provided represent a median AWP and/or AAWP price for the brand and/or generic product. MA. KE. NG. SC. GM. ML.  Alergitrat (AR). PH. MU. CI. ML. LR.  Analerg (UY). ZM.  Allergex (ZA). LR.   Antamin (MY. and as such should not be used to set or adjudicate any prices for charging or reimbursement functions. MU. GM. Bregamin (MX).

MA.  Chlorpheniramine DHA (HK). Cadistin (BF. SL. GH. NE. Chlorphenon (ID). BJ. KE.  Cloro-Trimeton (MX). LR.  Clorfam (CO).  Chlortrimeton (ZA). SG). NG.  Chloramine (MY. MR. IN. MU. SN.  Co-Timine (TW).  Chlorpyrimine (HK. SC. MY. ZW).  Cloroalergan (PE). GN.  Cohistan (ID). . UG. CI. MW.  Cloro Trimeton (AR). ML. TH). ZM. GM. TN.   Chlorpheno (TH). ET.  Clorotrimeton (PE. TZ. VE). SD.

CY. PK. QA. BS. BH. SY. SA. KW. SY. JO. CY. OM. GB.  Histafen (NZ). IR. KW. YE). CY. JO.  Histat (AE. YE).  Valemine (PH) Mechanism of Action . SR. QA.  Piriton (AE. IR.  Histavil (AE. SA. NL. LB. EG. JM. BH. CY. LB. BB. LY. QA. LY. EG. OM. LB.  Pirafene (BG). BH. SY. IR. JO. BH. PR. Niramine (TW).  Trimeton (IT). LY.  Orphen (ID). Derimeton (MX). JM. EG. IE.  Histatapp (TH). SA. LB. YE). BM. BS. SA. IQ. KW. IQ. BZ. GY. IQ. BM. QA. BZ. SG. EG. KW. LY. OM. IR. GY. YE). IQ. NL.  Com-Trimeton (TW). TT. SY. OM. JO.  Histal (BB.   Istamex (GR). SR.  Histin (AE. PR. TT).

Competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract. Sagrado S. (For additional information see "Acetaminophen (paracetamol): Patient drug information" and see "Acetaminophen (paracetamol): Pediatric drug information" ) For abbreviations and symbols that may be used in Lexicomp (show table ) Special Alerts Acetaminophen: Transition of Pediatric Liquid Products to Standard Concentration June 2011 Based on recommendations provided by the Food and Drug Administration (FDA). All rights reserved."Clin Pharmacokinet. 10(6):477-97. the transition has already begun and will continue into 2012. [PubMed17605150] 3. 2003) Half-life elimination: Serum: Children: 10-13 hours. "Clinical Pharmacokinetics of H1-Receptor Antagonists (The Antihistamines). American Geriatrics Society 2012 Beers Criteria Update Expert Panel. 2003. [PubMed 2866055] 4. 2003) Excretion: Urine (Sharma. The recommended mg/kg dose is unaffected and continues to be 10-15 mg/kg/dose. REFERENCES 1. and respiratory tract Pharmacodynamics/Kinetics Distribution: Vd: Children: 4-7 L/kg. Adults: 6-12 L/kg (Paton. 1985) Time to peak: 2-3 hours (Sharma. Sharma A and Hamelin BA. "Classic Histamine H1 Receptor Antagonists: A Critical Review of Their Metabolic and Pharmacokinetic Fate from a Bird's Eye View. 60(4):616-31. "Evaluation of Enantioselective Binding of Antihistamines to Human Serum Albumin by ACE. [PubMed 22376048] 2." J Am Geriatr Soc.8 mL) will now be the same as children’s acetaminophen products (160 mg/5 mL) and as a result. Adults: 14-24 hours (Paton. . 2003) Use of UpToDate is subject to the Subscription and License Agreement. 1985. 2007) Metabolism: Hepatic via CYP450 enzymes (including CYP2D6 and other unidentified enzymes) to active and inactive metabolites." Electrophoresis. 4(2):105-29. The concentration of acetaminophen infant drops (previously 80 mg/0. Inc. Paton DM and Webster DR. blood vessels. new dosing on a volume-per-weight (or volume-per-age) basis will apply. all over-thecounter (OTC) pediatric single-ingredient acetaminophen liquid products will transition to a single concentration of 160 mg/5 mL. Villanueva-Camañas RM. Martínez-Gómez MA. et al. 28(15):2635-43. 2012.0 Acetaminophen (paracetamol): Drug information Copyright 1978-2013 Lexicomp." Curr Drug Metab. 1985) Protein binding: 33% (range: 29% to 37%) (Martínez-Gómez. significant first-pass effect (Sharma.[PubMed 12678691] Topic 8860 Version 52. 2007. "American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults.

Little Fevers™ [OTC].   Aspirin Free Anacin® Extra Strength [OTC]. Cetafen® Extra [OTC]. Healthcare professionals should verify product concentration prior to providing dosing information.Healthcare professionals should be aware that during this transition.html Brand Names: U.  APAP 500 [OTC].  Cetafen® [OTC]. Parents may continue to use either product.  Feverall® [OTC].   Mapap® Extra Strength [OTC]. acetaminophen infant drop products with both the new and old concentrations may be available on pharmacy shelves. Mapap® Infant's [OTC]. but should verify concentration and use according to labeled dosing directions. Additional information can be found at http://www.tylenolprofessional.S. .com/index.  Excedrin® Tension Headache [OTC].  Mapap® Arthritis Pain [OTC].   Infantaire [OTC].  Acephen™ [OTC].  Mapap® Children's [OTC].

  Non-Aspirin Pain Reliever [OTC]. Q-Pap Extra Strength [OTC].  Q-Pap [OTC].   Q-Pap Children's [OTC].  Silapap Children's [OTC].  Mapap® [OTC]. Nortemp Children's [OTC].  Pain Eze [OTC]. .  RapiMed® Children's [OTC].  Q-Pap Infant's [OTC].  Silapap Infant's [OTC]. Mapap® Junior Rapid Tabs [OTC].  Pain & Fever Children's [OTC].  Ofirmev™.  RapiMed® Junior [OTC].

 Tylenol® [OTC].  Valorin [OTC] Brand Names: Canada  Abenol®.  Valorin Extra [OTC]. Meltaways [OTC].  Novo-Gesic.  Tylenol® Children's Meltaways [OTC].  Atasol®.  Apo-Acetaminophen®.  Tylenol® Extra Strength [OTC]. Tylenol® Jr.  Tylenol® Children's [OTC].   Tylenol® Infant's Concentrated [OTC] [DSC]. Triaminic™ Children's Fever Reducer Pain Reliever [OTC]. .  Tylenol® Arthritis Pain Extended Relief [OTC].  Tylenol® 8 Hour [OTC].

Pain or fever: Oral: Note: OTC dosing recommendations may vary by product and/or manufacturer. see table. the following age-based doses may be used. Pain or fever: Oral: Note: OTC dosing recommendations may vary by product and/or manufacturer. do not exceed 5 doses (2. Pediatrix.5 mg/kg every 4 hours.6 g) in 24 hours. Limit acetaminophen dose from all sources (prescription and OTC) to <4 g daily. maximum single dose: 750 mg/dose.   Tempra®. alternatively.75 g daily) ≥50 kg: 650 mg every 4 hours or 1000 mg every 6 hours. Regular release: 325-650 mg every 4-6 hours or 1000 mg 3-4 times daily (maximum: 4 g daily) Extended release: 1300 mg every 8 hours (maximum: 3. maximum daily dose: 4 g daily Dosing: Pediatric (For additional information see "Acetaminophen (paracetamol): Pediatric drug information" ) Note: No dose adjustment required if converting between different acetaminophen formulations. Miscellaneous Dosing: Adult Note: No dose adjustment required if converting between different acetaminophen formulations.V. Limit acetaminophen dose from all sources (prescription and OTC) to <4 g daily. maximum daily dose: 75 mg/kg/day (≤3.9 g daily) Rectal: 325-650 mg every 4-6 hours or 1000 mg 3-4 times daily (maximum: 4 g daily) I. Children ≥12 years and Adolescents: Refer to adult dosing.: <50 kg: 15 mg/kg every 6 hours or 12. maximum single dose: 1000 mg/dose. Tylenol® Pharmacologic Category  Analgesic. Infants and Children <12 years: 10-15 mg/kg/dose every 4-6 hours as needed. Acetaminophen Pediatric Dosing (Oral)1 .

maximum single dose: 15 mg/kg/dose.1 8. use of weight to select dose is preferred. maximum daily dose: 75 mg/kg/day (≤3. then use age.4-8. Children ≥12 years and Adolescents: Refer to adult dosing.3 5. OTC labeling instructs consumer to consult with physician for dosing instructions in children under 2 years of age.5 mg/kg every 4 hours.6 32. optimal doses and dosing frequency to ensure efficacy and safety have not yet been established (Buck.7-43. Dosing: Renal Impairment .3-32.8 10.7 21. I. weight in kg listed here is derived from pounds and rounded.8-27.4-21. 2. Note: Although the perioperative use of high-dose rectal acetaminophen (eg.Weight (kg) 1 Weight (lbs) Age Dosage (mg) Manufacturer's recommendations. 2001). kg weight listed also is adjusted to allow for continuous weight ranges in kg.3 16. if weight is not available.75 g daily) Adolescents: Refer to adult dosing. Dosing: Geriatric Refer to adult dosing.7-5. do not exceed 5 doses (2.9-16.6 g) in 24 hours. its routine use remains controversial.2 6-11 12-17 18-23 24-35 36-47 48-59 60-71 72-95 0-3 mo 4-11 mo 1-2 y 2-3 y 4-5 y 6-8 y 9-10 y 11 y 40 80 120 160 240 320 400 480 Rectal: Infants and Children <12 years: 10-20 mg/kg/dose every 4-6 hours as needed.: Children 2-12 years: 15 mg/kg every 6 hours or 12.2-10.V.2 27. Manufacturer’s recommendations are based on weight in pounds (OTC labeling). 25-45 mg/kg/dose) has been investigated in several studies.

CRRT: No adjustments necessary. However. extended release. cases of hepatotoxicity at daily acetaminophen dosages <4 g daily have been reported. although no specific dosage adjustments are provided.Oral (Aronoff. Dosing: Hepatic Impairment Oral: Use with caution. 2007): Children: Clcr <10 mL/minute: Administer every 8 hours. Intermittent hemodialysis or peritoneal dialysis: No adjustment necessary.: Clcr ≤30 mL/minute: Use with caution. oral: .V.V. manufacturer’s labeling suggests a reduced total daily dosage may be warranted. consider decreasing daily dose and extending dosing interval. Avoid chronic use in hepatic impairment. Limited.S. low-dose therapy is usually well tolerated in hepatic disease/cirrhosis. [DSC] = Discontinued product Caplet. Excipient information presented when available (limited. Adults: Clcr 10-50 mL/minute: Administer every 6 hours. oral: Mapap® Arthritis Pain: 650 mg Tylenol® 8 Hour: 650 mg Tylenol® Arthritis Pain Extended Relief: 650 mg Capsule. I. CRRT: Administer every 8 hours. Clcr <10 mL/minute: Administer every 8 hours.: Mild-to-moderate impairment: Use with caution in hepatic impairment or active liver disease. particularly for generics). consult specific product labeling. I. Dosage Forms: U. oral: 500 mg Cetafen® Extra: 500 mg Mapap® Extra Strength: 500 mg Mapap® Extra Strength: 500 mg [scored] Pain Eze: 650 mg Tylenol®: 325 mg Tylenol® Extra Strength: 500 mg Caplet. Intermittent hemodialysis or peritoneal dialysis: Administer every 8 hours. Severe impairment: Use is contraindicated.

sodium benzoate. cherry flavor] Solution. cherry flavor] Q-Pap Children's: 160 mg/5 mL (118 mL) [ethanol free. sugar free. 473 mL) [ethanol free. sodium benzoate. oral: 500 mg Excedrin® Tension Headache: 500 mg [contains caffeine 65 mg/geltab] Injection. oral: 160 mg/5 mL (5 mL.8 mL (15 mL [DSC]) Infantaire: 80 mg/0. cherry flavor] Gelcap. sodium benzoate. sugar free. sodium benzoate. solution [preservative free]: Ofirmev™: 10 mg/mL (100 mL) Liquid. sodium 2 mg/5 mL. 473 mL) [ethanol free. gluten free. cherry flavor] . oral: 500 mg Mapap®: 500 mg Gelcap. contains propylene glycol. cherry flavor] Solution. rapid release. sodium benzoate. 30 mL) Little Fevers™: 80 mg/mL (30 mL) [dye free. contains propylene glycol. cherry flavor] Tylenol® Extra Strength: 500 mg/15 mL (240 mL) [ethanol free. oral: Mapap® Children's: 160 mg/5 mL (118 mL. oral: 500 mg Elixir. cherry flavor] Q-Pap Children's: 160 mg/5 mL (118 mL. sugar free. 237 mL. grape flavor] Silapap Children's: 160 mg/5 mL (118 mL. contains benzoic acid. 30 mL) [ethanol free. oral: 160 mg/5 mL (120 mL. contains propylene glycol. fruit flavor] Silapap Infant's: 80 mg/0. contains propylene glycol. propylene glycol. contains propylene glycol. ethanol free.8 mL (15 mL. sodium benzoate. sodium benzoate.8 mL (15 mL) [fruit flavor] Q-Pap Infant's: 80 mg/0. sodium benzoate. 473 mL) [ethanol free. 480 mL) [ethanol free. contains pr opylene glycol. 10 mL. 500 mg/5 mL (240 mL) APAP 500: 500 mg/5 mL (237 mL) [ethanol free.Mapap® Extra Strength: 500 mg Captab. sodium 2 mg/5 mL. sodium 1 mg/5 mL.8 mL (15 mL) [ethanol free. oral [drops]: 80 mg/0. contains propylene glycol. oral: 500 mg Tylenol® Extra Strength: 500 mg Geltab. sodium 9 mg/15 mL. 20 mL) Pain & Fever Children's: 160 mg/5 mL (118 mL. berry flavor] Mapap®: 80 mg/0.8 mL (15 mL. 473 mL). cherry flavor] Mapap® Extra Strength: 500 mg/5 mL (237 mL) [contains propylene glycol. contains propylene glycol. sodium benzoate.

contains sodium 2 mg/5 mL.8 mL (15 mL [DSC]. sodium benzoate. 10. 100s). contains sodium 2 mg/5 mL. 20. 30 mL [DSC]) [ethanol free. sodium benzoate.3 mL) Mapap® Children's: 160 mg/5 mL (118 mL) [ethanol free. sodium benzoate. cotton candy flavor] Pain & Fever Children's: 160 mg/5 mL (60 mL) [ethanol free. contains sodium 2 mg/5 mL. cherry flavor] Tylenol® Children's: 160 mg/5 mL (120 mL) [ethanol free. 325 mg (6s. 650 mg (12s. sodium benzoate. sodium benzoate. 50s). 50s. 30 mL [DSC]) [ethanol free. contains propylene glycol. oral: 160 mg/5 mL (5 mL. cherry flavor] Tylenol® Infant's Concentrated: 80 mg/0. cherry flavor] Tylenol® Children's: 160 mg/5 mL (120 mL) [ethanol free. contains propylene glycol. cherry flavor] Q-Pap Children's: 160 mg/5 mL (118 mL) [ethanol free. cherry flavor] Q-Pap Children's: 160 mg/5 mL (118 mL) [ethanol free. contains propylene glycol. cherry flavor] Mapap® Infant's: 160 mg/5 mL (59 mL) [dye free. sodium benzoate. 650 mg (12s) Acephen™: 120 mg (12s.8 mL (30 mL [DSC]) [dye free. contains propylene glycol. bubblegum flavor] Tylenol® Children's: 160 mg/5 mL (60 mL. grape flavor] Syrup.15 mL. 120 mg (6s. 50s. sodium 2 mg/5 mL. rectal: 120 mg (12s). bubblegum flavor] Q-Pap Children's: 160 mg/5 mL (118 mL) [ethanol free.8 mL (15 mL. sodium benzoate. ethanol free.Suppository. contains propylene glycol. 100s). contains sodium benzoate. sodium benzoate. sodium benzoate. contains propylene glycol. cherry flavor] Tylenol® Infant's Concentrated: 80 mg/0. sodium benzoate. 50s).8 mL (15 mL [DSC]. 50s. 30 mL) [ethanol free. cherry flavor] Tylenol® Infant's Concentrated: 80 mg/0. contains sodium benzoate. sodium 2 mg/5 mL. ethanol free. cherry flavor] Nortemp Children's: 160 mg/5 mL (118 mL) [ethanol free. sodium 2 mg/5 mL. sodium benzoate. grape flavor] Tylenol® Children's: 160 mg/5 mL (120 mL) [ethanol free. 100s) Feverall®: 80 mg (6s. 650 mg (50s) Suspension. contains propylene glycol. 12s. 120 mL) [ethanol free. 50s). 325 mg (12s). grape flavor] Tylenol® Children's: 160 mg/5 mL (120 mL) [dye free. sodium benzoate. strawberry flavor] Suspension. contains propylene glycol. oral: . 325 mg (6s. sodium benzoate. sodium 2 mg/5 mL. contains propylene glycol. oral [drops]: Mapap® Infant's: 80 mg/0. contains propylene glycol. contains propylene glycol.

bubblegum flavor] Triaminic™ Children's Fever Reducer Pain Reliever: 160 mg/5 mL (118 mL) [contains sodium 5 mg/5 mL. Injection: For I. sugar free. bubblegum flavor] RapiMed® Children's: 80 mg [gluten free. sodium benzoate. oral: 325 mg. Meltaways: 160 mg [grape flavor] Generic Equivalent Available: U. orally disintegrating. sugar free. chewable.Triaminic™ Children's Fever Reducer Pain Reliever: 160 mg/5 mL (118 mL) [contains benzoic acid. grape flavor] Tylenol® Jr. injectable formulation Administration Suspension. grape flavor] Tablet. Yes: Excludes extended release products. 160 mg Mapap® Children's: 80 mg [bubblegum flavor] Mapap® Children's: 80 mg [grape flavor] Mapap® Junior Rapid Tabs: 160 mg [bubblegum flavor] RapiMed® Children's: 80 mg [gluten free. sugar free.S. oral: Shake well before pouring a dose. . infusion only. Meltaways: 160 mg [bubblegum flavor] Tylenol® Jr. sugar free. wild grape flavor] Tylenol® Children's Meltaways: 80 mg [scored. oral: 80 mg. bubblegum flavor] RapiMed® Junior: 160 mg [gluten free. May administer undiluted over 15 minutes. wild grape flavor] RapiMed® Junior: 160 mg [gluten free. oral: 80 mg Mapap® Children's: 80 mg [fruit flavor] Tablet. 500 mg Aspirin Free Anacin® Extra Strength: 500 mg Cetafen®: 325 mg Mapap®: 325 mg Non-Aspirin Pain Reliever: 325 mg Q-Pap: 325 mg [scored] Q-Pap Extra Strength: 500 mg [scored] Tylenol®: 325 mg Tylenol® Extra Strength: 500 mg Valorin: 325 mg [sugar free] Valorin Extra: 500 mg [sugar free] Tablet. sodium 6 mg/5 mL.V. bubblegum flavor] Tylenol® Children's Meltaways: 80 mg [scored.

sufentanil. dexamethasone sodium phosphate. the former infant acetaminophen concentration (80 mg/0. D5W. Do not exceed the maximum recommended daily dose of acetaminophen. butorphanol. However.S. nalbuphine. hydroxyzine. Dipen brand name for diltiazem [Greece] Duorol [Spain] may be confused with Diuril brand name for chlorothiazide [U. diphenhydramine. LR. dolasetron. droperidol. cimetidine. ISMP.S. lidocaine.V. midazolam. NS Y-site administration: Compatible: Buprenorphine. Use Treatment of mild-to-moderate pain and fever (analgesic/antipyretic) I.: Additional indication: Management of moderate-to-severe pain when combined with opioid analgesia Medication Safety Issues Sound-alike/look-alike issues: Acephen® may be confused with AcipHex® FeverALL® may be confused with Fiberall® Triaminic™ Children's Fever Reducer Pain Reliever may be confused with Triaminic® cough and cold products Tylenol® may be confused with atenolol. as well as pharmacy preparation of doses. hydrocortisone sodium succinate. lorazepam. meperidine. Depin brand name for nifedipine [India]. Injection: Reports of 10-fold overdose errors using the parenteral product have occurred in the U. mannitol. calculation of doses in "mg" and subsequent administration of the dose in "mL" using the commercially available concentration of 10 mg/mL contributed to these errors. morphine. granisetron. 2012). metoclopramide. ondansetron. Expressing doses as mgand mL.S. methylprednisolone sodium succinate. potassium chloride. Infant concentration change: The new infant acetaminophen concentration (160 mg/5 mL) is available. International issues: Depon [Greece] may be confused with Depen brand name for penicillamine [U. and Europe.. Tylenol® PM. Check concentrations closely prior to administering or dispensing (November 2011). Tylox® Other safety concerns: Duplicate therapy issues: This product contains acetaminophen. 2012. which may be a component of combination products. prochlorperazine. may decrease error potential (Dart. hydromorphone. D5NS. D10W. fentanyl.. All children’s liquid acetaminophen products will now be the same 160 mg/5 mL concentration.Compatibility Stable in D5LR. Mexico] Adverse Reactions Significant . heparin.8 mL) may still be available in some pharmacies until supplies run out.]. timolol.S. ketorolac. Canada] Paralen [Czech Republic] may be confused with Aralen brand name for chloroquine [U.

alkaline phosphatase increased Renal: Ammonia increased. pleural effusion. children ≥5%) 1% to 10%: Cardiovascular: Edema (peripheral). leukopenia) Hepatic: Bilirubin increased. pain in extremity. hypoxia. uric acid. children ≥1%). dyspnea. glucose.V. trismus Ocular: Periorbital edema Renal: Oliguria (children ≥1%) Respiratory: Atelectasis (children ≥5%). breath sounds abnormal.: >10%: Gastrointestinal: Nausea (adults 34%. hypervolemia. stridor. rash Endocrine & metabolic: hypophosphatemia Hypoalbuminemia. children ≥5%). agitation (children ≥5%). analgesic nephropathy Miscellaneous: Hypersensitivity reactions (rare) I. bicarbonate. vomiting (adults 15%. may decrease sodium. children ≥1%). nephrotoxicity with chronic overdose. hypokalemia. diarrhea Hematologic: Anemia Hepatic: Transaminases increased Local: Infusion site pain Neuromuscular & skeletal: Muscle spasms. pulmonary edema. hypomagnesemia. fatigue Dermatologic: Pruritus (children ≥5%). blood dyscrasias (neutropenia. calcium Hematologic: Anemia. tachycardia Central nervous system: Headache (adults 10%. anxiety. Gastrointestinal: Constipation (children ≥5%). hypersensitivity reactions Contraindications Hypersensitivity to acetaminophen or any component of the formulation. insomnia (adults 7%. Rectal: Frequency not defined: Dermatologic: Rash Endocrine & metabolic: May increase chloride. abdominal pain. pancytopenia.Oral. hypo/hypertension. wheezing All formulations: <1% (Limited to important or life-threatening): Anaphylaxis (rare). severe hepatic impairment or severe active liver disease (Ofirmev™) Warnings/Precautions Concerns related to adverse effects: .

• G6PD deficiency: Use with caution in patients with known G6PD deficiency. in addition. use of the intravenous formulation is contraindicated in patients with severe hepatic impairment or severe active liver disease. due to dehydration or blood loss). Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Disease-related concerns: • Ethanol use: Use with caution in patients with alcoholic liver disease. Consult full interaction monograph for specific recommendations. and 2) increase the risk of liver damage. Risk C: Monitor therapy . CYP3A4 (minor). CYP2D6 (minor). discontinue immediately if symptoms of allergic or hypersensitivity reactions occur. CYP2E1 (minor). • Hypovolemia: Use the intravenous formulation with caution in patients with severe hypovolemia (eg. This may 1) diminish the effect of acetaminophen. • Self-medication (OTC use): When used for self-medication. • Renal impairment: Use with caution in patients with severe renal impairment.• Hepatotoxicity: May cause severe hepatotoxicity on acute overdose. hepatotoxicity is usually associated with excessive acetaminophen intake (>4 g/day). OTC labeling limits the maximum daily dose to ≤3250 mg (dosage form specific). Risk C: Monitor therapy ARIPiprazole: CYP3A4 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Use with caution in patients with chronic malnutrition. Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential. Metabolism/Transport Effects Substrate of CYP1A2 (minor). • Hypersensitivity/anaphylactic reactions: Hypersensitivity and anaphylactic reactions have been reported. Inhibits CYP3A4 (weak) Drug Interactions (For additional information: Launch Lexi-Interact™ Drug Interactions Program ) Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. • Hepatic impairment: Use with caution in patients with hepatic impairment or active liver disease. Other warnings/precautions: • Dosage limit: Limit acetaminophen dose from all sources (prescription and OTC) to <4 g/day. CYP2C9 (minor). consuming ≥3 alcoholic drinks/day may increase the risk of liver damage. CYP2A6 (minor). rare reports of hemolysis have occurred. patients should be instructed to contact healthcare provider if used for fever lasting >3 days or for pain lasting >10 days in adults or >5 days in children. Management: Monitor for increased aripiprazole pharmacologic effects. consider dosing adjustments. chronic daily dosing in adults has resulted in liver damage in some patients.

Combinations of these agents may increase the likelihood of significant methemoglobinemia. and 2) increase the risk of liver damage.. Risk D: Consider therapy modification . Risk C: Monitor therapy Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Management: Monitor patients for signs of methemoglobinemia (e. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen.g. possibly increasing the potential for formation of the toxic NAPQI metabolite. Management: Monitor patients for signs of methemoglobinemia (e. Risk D: Consider therapy modification Metyrapone: May increase the serum concentration of Acetaminophen. cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Risk C: Monitor therapy Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. This may 1) diminish the effect of acetaminophen. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Probenecid may also limit the formation of at least one major non-toxic metabolite. Risk C: Monitor therapy Pimozide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Pimozide. Risk X: Avoid combination Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Risk D: Consider therapy modification Imatinib: Acetaminophen may enhance the hepatotoxic effect of Imatinib. Risk C: Monitor therapy Busulfan: Acetaminophen may increase the serum concentration of Busulfan. Risk C: Monitor therapy Lomitapide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lomitapide. Risk C: Monitor therapy Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy CarBAMazepine: May increase the metabolism of Acetaminophen. Risk C: Monitor therapy Mipomersen: Acetaminophen may enhance the hepatotoxic effect of Mipomersen.Barbiturates: May increase the metabolism of Acetaminophen. Management: Limit the maximum adult dose of lomitapide to 30 mg daily when used in combination with any weak CYP3A4 inhibitor. hypoxia..g. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy Cholestyramine Resin: May decrease the absorption of Acetaminophen. cyanosis) when nitric oxide is used in combination with other agents associated with development of methemoglobinemia. Dasatinib may increase the serum concentration of Acetaminophen. metyrapone may shift the metabolism towards the oxidative route that produces a hepatotoxic metabolite. More importantly. Avoid lidocaine/prilocaine. hypoxia. by inhibiting the conjugative metabolism of acetaminophen. Risk C: Monitor therapy Probenecid: May increase the serum concentration of Acetaminophen. and 2) increase the risk of liver damage. This may 1) diminish the effect of acetaminophen. Risk D: Consider therapy modification Dasatinib: Acetaminophen may enhance the hepatotoxic effect of Dasatinib.

Most likely with daily acetaminophen doses >1. an increase in fetal death or spontaneous abortion may be seen following maternal overdose if treatment is delayed. Risk C: Monitor therapy Ethanol/Nutrition/Herb Interactions Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day. An increased risk of teratogenic effects has not been observed following maternal use of acetaminophen during pregnancy. Adverse reactions have generally not been observed. The use of acetaminophen in normal doses during pregnancy is not associated with an increased risk of miscarriage or still birth. Frequent maternal use of acetaminophen during pregnancy may be associated with wheezing and asthma in early childhood.3 g for >1 week. Prenatal constriction of the ductus arteriosus has been noted in case reports following maternal use during the third trimester. and urine immediately after delivery. however. a rash caused by acetaminophen exposure was reported in one breast-feeding infant. however. Food: Rate of absorption may be decreased when given with food. is classified as pregnancy category C. Acetaminophen crosses the placenta and can be detected in cord blood. SORAfenib may increase the serum concentration of Acetaminophen. Herb/Nutraceutical: St John's wort may decrease acetaminophen levels.S. acetaminophen I. newborn serum. Risk D: Consider therapy modification Vitamin K Antagonists (eg. The absorption may be delayed and the bioavailability of acetaminophen may be decreased in some women during pregnancy due to delayed gastric emptying. therefore. Pregnancy Risk Factor C (intravenous) (show table) Pregnancy Implications Animal reproduction studies have not been conducted with intravenous acetaminophen.32 . warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists.V. Pricing: U.63 Chewable (Tylenol Go Tabs Extra Strength Oral) 500 mg (12): $3.SORAfenib: Acetaminophen may enhance the hepatotoxic effect of SORAfenib. Lactation Enters breast milk/use caution (AAP rates “compatible”. AAP 2001 update pending) Breast-Feeding Considerations Low concentrations of acetaminophen are excreted into breast milk and can be detected in the urine of nursing infants. Dietary Considerations Some products may contain phenylalanine and/or sodium. (Medi-Span®) Chewable (Acetaminophen Oral) 80 mg (30): $2.

88 Suspension (Tylenol Childrens Oral) 160 mg/5 mL (120 mL): $5.30 325 mg (50): $32.69 Suspension (Tylenol Childrens/Flav Creator Oral) 160 mg/5 mL (120 mL): $8.90 160 mg/5 mL (118 mL): $5.48 Suppository (Feverall Rectal) 80 mg (6): $4.70 Solution (Ofirmev Intravenous) 10 mg/mL (100 mL): $14.81 325 mg (6): $4.32 Solution (Acetaminophen Oral) 160 mg/5 mL (10.8 mL (30 mL): $8.75 650 mg (12): $8.86 Liquid (Tylenol Extra Strength Oral) 1000 mg/30 mL (240 mL): $5.23 Pack (Stanback Aspirin Free Oral) 950 mg (2): $0.00 Syrup (Triaminic Fever Reducer Oral) .10 Suspension (Tylenol Infants Oral) 80 mg/0.92 Suppository (Acephen Rectal) 120 mg (50): $30.08 Suspension (Nortemp Oral) 160 mg/5 mL (118 mL): $5.22 Liquid (Tylenol Oral) 500 mg/15 mL (240 mL): $5.56 Solution (Little Fevers Fever-Pain Rel Oral) 80 mg/mL (30 mL): $4.81 650 mg (50): $33.15 mL): $0.Gel (ElixSure Fever/Pain Oral) 160 mg/5 mL (120 mL): $4.81 120 mg (6): $4.

85 Tablets (Acetaminophen Oral) 325 mg (100): $4.66 Tablet. orally-disintegrating (Tylenol Childrens Meltaways Oral) 80 mg (30): $3.160 mg/5 mL (118 mL): $4.75 Tablets (Mapap Extra Strength Oral) 500 mg (50): $3.61 Tablet.20 500 mg (100): $3.54 Disclaimer: The pricing data provided represent a median AWP and/or AAWP price for the brand and/or generic product. controlled release (Tylenol 8 Hour Oral) 650 mg (100): $10. The pricing data should be used for benchmarking purposes only.95 Tablet.94 Tablet.25 Tablets (Tylenol Extra Strength Oral) 500 mg (100): $9. respectively.29 Tablets (Pharbetol Extra Strength Oral) 500 mg (100): $2.96 Tablets (Tylenol Oral) 325 mg (100): $7. orally-disintegrating (Tylenol Jr Meltaways Oral) 160 mg (24): $4. Pricing data is updated monthly. Monitoring Parameters Serum APAP levels: Where acute overdose suspected and with long-term use in patients with hepatic disease. relief of pain or fever International Brand Names .97 Tablets (Pharbetol Oral) 325 mg (100): $2. orally-disintegrating (Mapap Childrens Oral) 80 mg (30): $2. controlled release (Tylenol Arthritis Pain Oral) 650 mg (24): $3. and as such should not be used to set or adjudicate any prices for charging or reimbursement functions.85 Tablet.04 Tablets (Excedrin Tension Headache Oral) 500-65 mg (50): $5.

 Acetamol (IT).   Acamoli Baby (IL).   Adinol (MX).  Alvedon (SE).  Afebryl (LU).  Acamol To-Go (IL).  ACET suppositories (SG). IL).  Afebrin (HK).  Alginox (EC).  Acetalgin (CH). Adorem (CO). . Acamoli Forte suppositories for Kids (IL). A-Mol (TH).  Alcocin (IN).  Acamol (CN.

KW. ET. LB. NG. LR.  Arfen (BF. GM. GN. YE). IQ. . BH. OM. JO. MW. LY. ZW). SA.  Analphen (MX). IR.  Aptamol (IN).  Atamel (PE). BJ. MA. ML. SC. IQ. EG. JO. SN. BH. SG). SY. Ametrex (CO). CI.  Biogesic Suspension (HK).  Benuron (JP). TN.  ben-u-ron (HU). SA. SD. KE. QA.  Biogesic (PH.  Avadol (MY).  Angela (TH). CY. KW. TZ. LY. EG. UG. MY.  Ben-U-Ron (CH. ZM. LB. GH. MU. OM. SL. IR. CY.  Amol (AE. MR. PT). NE. SY.  Analgiser (AE. YE). QA.

TZ. MU. GN. JO. LU). KW. . IE. TN.  Children's S Tylenol (KP).  Biopain (PH). QA. CY. UG.  Curpol (LU). ML. LR. SN. MW. NE. YE. GH. BF.  Dafalgan odis (LU). ZW). SY. LY.  Children's Bufferin (CL).  Cetta (TH). SL. TH. ET.   Calpol (AE. ZM. PR. SD. Claradol (MA).  Croix Blanche (LU). BJ. JP. BH. IQ.  Dafalgan (BE. SC. NG. IR. EG. MA. OM. Calapol (ID). GM. MR. KE.  Cotemp (TH). CI. Causalon (AR).   Christamol (HK). SA.  Cemol (TH). LB.

 Dolgesic (ES).  Dolomol (AE. YE). BH. LB.  Dolprone (LU).  Dolorol (ZA). HN. MA). LY. CY. SA. OM. IR.  Dol-Stop (LU). Denamol (TH). SY. JO. EG. NI.  Doliprane (FR. .  Dolex (UY). QA.  Dolan Infantil (GT. IQ.  Dolitabs (FR).  Daga (TH). SV). IN.  Dolviran (MX). KW.  Dismifen (MX).  Doluvital (MX).  Dirox (AR).

PA. DO.  Enelfa (LU).  Geluprane 500 (FR). Hoemal (MY. LU).  Gelocatil (ES).   Efferalgan (HU.   Hedex (IE). NI. GT.  Febridol (AU). SV). Efferalgan 500 (CR.  Fervex (BR). SG).  Febrile Free (PH). Dymadon (AU). HN. .  Fortolin (HK). EE.  Filanc (MX).  Europain (HK).  Efferalganodis (FR).

 Lupocet (HR).  Mypara (TH).  Mafidol (PE). Momentum (LU). LU).  Lotemp (TH).  Mexalen (AT.  Lemgrip (BE. Lekadol (HR). . CZ. HU).   Minopan (KP).  Lonarid mono (LU).  Mejoralito Pediátrico (MX).  Mejoralito Junior (MX).  Metagesic (PH).  Nalgesik (ID).

ID. GH. UG. IE. . QA. NZ). NG. GM. NE. CY. Napafen (EC). ZW). Panadon (HR). CN. HK.  Pamol (DK. FI.  Panadol Actifast (MY. LR. NL. MA.  Naprex (ID). CZ. OM. ML. LB. SG). PE. BH. TH. PK. GN. SL. TZ. JO.  Nordinet Infantil (MX). YE. IL. CI.  Napamol (ZA). ET. TN. SD. LY. Neuridon (LU). EE. KE. SC. IR. BJ. SY. NZ. RU. PL. ZM. IT. MU.  Napran (PH). MR. SG. SN. TW. FR.  Panadol (AE. BG. BE.  Panamax (AU). HU. GR. AU. EG.  Pacimol (IN). LU. BF. IQ. KW. GB. SA.   Panadol for Children (SG).   NEBS (JP). CH.  Panadol Extend (SG). PT. MW.

 Panodil (DK.  Parcemol Forte (HK). TW). Paramol (IL.  Paracetamol-ratiopharm (LU).   Paralgin (AU).   Paracetamol (HR).  Parapaed Junior (NZ).   Parapaed Six Plus (NZ).  Parageniol (PY). Paracetamol Pharmavit (HU). SE).  Paracet (NO).  Para-IV (PH).  Paramol Kat Drops (IL). . Parcemol (HK). NO.  Paragin (TH).  Parapaed (DE).

 Raperon (KP).  Plicet (HR).   Penral-Night (KP).  Perfalgan (AT. GB. CZ. Perdolan Mono (LU).  Pharmacen-M (MX). NL.  Pedipan (KP).  Pe-Tam (LU). EE. DK. IE. TR. RU.  Paximol (SG).  Poro (MY. PH. FR. FI. SG. DE. AU. NZ. NO. ZA). SE. SK. TH). GR.  Rapidol (CN). PT. CH.  Perfusalgan (BE). MT.  Pinex (NO). PL. BG. IT. IN. . Parvid (PH).

MW. GH. Salzone (BF. KE. TZ. MA. ZM. SN. GH. GM. MR. SL. MA.   Rubophen (HU). MW. Setopain ER (KP).  Sinedol (DO. UG. UG.  Saridon (CO).  Sedalito (MX). MU. ML.  Sanmol Infusion (ID).   Setopain (KP).  Rhinapen elixir (KP). ZW). TN. CI. . GN. BJ. ET. TN. KE.  Remedol (PR).  Revanin (BF. ZW). LR. SD. BJ. GM. ML. TZ. SN. SC. ZM. NG. SL. SC. GN.  Sensamol (IL). SD. NG. LR. NE.  Selegesic (PH). MR. MU. ET. NE. MX). Reliv (SE). CI.

 Teramol (PH).  Tylenol Acetaminophen Extended Relief (CL). VE). JP.  Tylenol (BR. TH.   Toniker (TW). LU.  Tafirol (PE). Supadol mono (LU).  Tempol (MY).  Suspen ER (KP).  Tempte (TW). CH. PT.  Tylenol 8-hour (TH). .  Tasmen (KP). Turpan (ID).  Tamoliv (ID).  Tempra (EC. DE. MX. ID. JP. PH. MX). KP.  Teramol Forte (PH).

PA. SA. OM. JO. LY. KW. JM.: Analgesic: 1 hour Duration: I. VE).  Xebramol (TH). SY. minimal absorption from stomach. BZ. LB. 8% to 43% at toxic concentrations . TT). BS.: Antipyretic: ≥6 hours Absorption: Primarily absorbed in small intestine (rate of absorption dependent upon gastric emptying). BM. EG. Oral: Analgesia: 4-6 hours I. Antipyretic: Within 30 minutes Peak effect: I.V.V. BH..V. YE). Tylenol ER (KP). GY. produces antipyresis from inhibition of hypothalamic heat-regulating center Pharmacodynamics/Kinetics Onset of action: Oral: <1 hour I. MX. varies by dosage form Distribution: ~1 L/kg at therapeutic doses Protein binding: 10% to 25% at therapeutic concentrations. NI.   Winadol (CO. HN. believed to inhibit the synthesis of prostaglandins in the central nervous system and work peripherally to block pain impulse generation. Winasorb (CR. GT. IQ. SR. SV).V.  XL-Dol Infantil (MX) Mechanism of Action Although not fully elucidated.  Tylenol Extra Fuerte (PY).: Analgesia: 5-10 minutes. DO.  Tylex (BB.  Tylenol Forte (AE. CY. IR. QA.

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1996. 1995. Risk Factor for Toxic Liver Injury?” Eur J Clin Nutr. “Aminotransferase Elevations in Healthy Adults Receiving 4 Grams of Acetaminophen Daily: A Randomized Controlled Trial. Akhtar J. [PubMed7657281] Topic 9242 Version 53. after receiving codeine in the usual dosage range for pain relief following tonsillectomy and/or adenoidectomy for obstructive sleep apnea syndrome. 1995. Zimmerman HJ and Maddrey WC. Three deaths occurred in children that had evidence of a genetic variation (“ultrarapid metabolizers”) which results in faster and more complete conversion of codeine to morphine. [PubMed 3059186] 39.” JAMA. “Comparison of Naproxen and Acetaminophen in a Two Year Study of Treatment of Osteoarthritis of the Knee. Howland MA. 1993. 1995. Woo OF. Kim SY. “The Potential Interaction Between Oral Anticoagulants and Acetaminophen in Everyday Practice. “Acetaminophen (Paracetamol) Hepatotoxicity With Regular Intake of Alcohol: Analysis of Instances of Therapeutic Misadventure. The product labeling for codeine is being updated with a contraindication and boxed warning regarding its use as an analgesic in children undergoing tonsillectomy and/or adenoidectomy. 33(5):508-9. [PubMed 14749742] 48. Anderson IB. Analysis of the National Multicenter Study (1976 to 1985). “Pediatric Acetaminophen Ingestion: A Prospective Study of Referral Criteria. 2002. Watkins PB. van der Steeg J. [PubMed 12426965] 41. (For additional information see "Codeine: Patient drug information" and see "Codeine: Pediatric drug information") For abbreviations and symbols that may be used in Lexicomp (show table ) Special Alerts FDA Warns of Codeine Use in Children After Tonsillectomy and/or Adenoidectomy February 2013 The FDA has issued a Drug Safety Communication after reviewing reports of children who developed serious adverse effects. [PubMed16820551] 43. et al. 296(1):87-93. et al. van den Bemt PM. The estimated incidence of this genetic variation is ~1-7 per 100 people. et al. Kaplowitz N. Whitcomb DC and Block GD. Inc. Geven LM. Russmann S. 22(3):767-3. “Initial Prothrombin Time as a Predictor of Acetaminophen-Induced Hepatotoxicity. Kulig KW. et al.” Clin Toxicol. et al. including death.” Pharm World Sci. Junker E. possibly leading to overdose or death. [PubMed 7990219] 44. Kuitert NA.” Arthritis Rheum.” J Toxicol Clin Toxicol. and Caravati EM. “Pharmacokinetics of Extended Relief vs Regular Release Tylenol® in a Simulated Human Overdose. 33(5):508. 1994. 1988. 58(2):23843. Knapp GL. . Ward JR. “Decreased Glutathione in Patients With Anorexia Nervosa. et al.” N Engl J Med. Tseng J.38. “Association of Acetaminophen Hepatotoxicity With Fasting and Ethanol Use. Yerman B. All rights reserved. [PubMed 8216413] 45. 1995. Smilkstein MJ. Egger MJ. Williams HJ. but may be higher in some ethnic groups. 36(9):1196206.” Clin Toxicol. “Shorter Duration of N-Acetylcysteine (NAC) for Acute Acetaminophen Poisoning. 47. Stork CM. 319(24):1557-62. “Efficacy of Oral N-Acetylcysteine in the Treatment of Acetaminophen Overdose. et al. et al. 2006. 46. Burkhart K. 24(5):2014. 272(23):1845-50. 42.” Clin Toxicol. Rees S.” Hepatology. 34(2):15762. [PubMed 8618248] 40. Zenger F. 33(5):530. Slattery JT.0 Codeine: Drug information Copyright 1978-2013 Lexicomp.” JAMA. 2004.

Note: The American Pain Society recommends an initial dose of 30-60 mg for adults with moderate pain (American Pain Society. Opioid.Healthcare professionals should not prescribe codeine to children for pain after these procedures. Pain management (analgesic): Oral: Immediate release (tablet.  ratio-Codeine Pharmacologic Category  Analgesic. patients requiring higher doses should be switched to an opioid approved for use in severe pain. In patients who receive both Codeine Contin® and an immediate release or combination codeine product for breakthrough pain. oral solution): Initial: 15-60 mg every 4 hours as needed.fda. not available in U.  Antitussive Dosing: Adult Note: These are guidelines and do not represent the maximum doses that may be required in all patients. maximum total daily dose: 360 mg/day. unusual sleepiness. Brand Names: Canada  Codeine Contin®.S. Alternative analgesics should be used in this setting.gov/Drugs/DrugSafety/ucm339112.  PMS-Codeine.htm. codeine should only be used if the benefits are anticipated to outweigh the risks. patients with prior opioid exposure may require higher initial doses.): Note: Titrate at intervals of ≥48 hours until adequate analgesia has been achieved. the rescue dose of immediate release codeine product should be ≤12. Further information may be found at http://www.5% of the total daily Codeine Contin® dose. .S. consult the product labeling or www. confusion. or difficult or noisy breathing) should stop codeine administration and seek medical attention immediately. Parents and caregivers who observe signs of overdose in a child (eg. See Warnings/Precautions section for a concise summary of this information. Doses should be titrated to pain relief/prevention. For management of other types of pain in children. Boxed Warning The FDA-approved labeling includes a boxed warning. For verbatim wording of the boxed warning. Daily doses >600 mg/day should not be used. ALERT: U. Controlled release: Codeine Contin® (Canadian availability.gov.fda. 2008).

A ~25% lower dose of Codeine Contin® should then be initiated.5-1 mg/kg/dose every 4 hours as needed. calculate an equivalent daily dose of immediate release codeine. codeine with Number of 30 mg Codeine Combination Tablets Daily ≤6 7-9 10-12 >12 Initial Dose of Maintenance Dose of Codeine Codeine Contin® Contin® 50 mg every 12 h 100 mg every 12 h 150 mg every 12 h 200 mg every 12 h 100 mg every 12 h 150 mg every 12 h 200 mg every 12 h 200-300 every 12 h (maximum: 300 mg every 12 h) Conversion from another opioid analgesic: Using the patient’s current opioid dose. Discontinuation of therapy: Note: Gradual dose reduction is recommended if clinically appropriate. equally divided into 2 daily doses. Initially reduce the total daily dose by 50% and administer equally divided into 2 daily doses for 2 days followed by a 25% reduction every 2 days thereafter. Therefore. 2008) Dosing: Geriatric . Smith. Doses should be titrated to pain relief/prevention. Note: The American College of Chest Physicians does not recommend the routine use of codeine as an antitussive in patients with upper respiratory infections (Bolser. unlabeled use): Oral: Immediate release (tablet. Dosing: Pediatric (For additional information see "Codeine: Pediatric drug information" ) Note: These are guidelines and do not represent the maximum doses that may be required in all patients.Opioid-naive patients: Initial: 50 mg every 12 hours Conversion from immediate release codeine preparations: Immediate release codeine preparations contain ~75% codeine base. oral solution): Initial: 0. 2010). Conversion from a combination codeine acetaminophen or aspirin): See table: product (eg. patients who are switching from immediate release codeine preparations may be transferred to a ~25% lower total daily dose of Codeine Contin®.5-120 mg/day as a single dose or in divided doses (Bolser. range: 7. equally divided into 2 daily doses. Pain management (analgesic. 2006). 2006. Treatment of cough (unlabeled use): Oral: Reported doses vary. maximum: 60 mg/dose (American Pain Society.

. Yes Controlled Substance C-II Medication Guide An FDA-approved patient medication guide. Tablet. 150 mg. however. particularly for generics). 200 mg Generic Equivalent Available: U. must be dispensed with this medication: Oral solution: http://www.Refer to adult dosing.fda. Oral. 60 mg Dosage Forms: Canada Excipient information presented when available (limited. as phosphate: Generic: 15 mg/mL (2 mL). Excipient information presented when available (limited. initial lower doses or longer dosing intervals followed by careful titration are recommended. Dosing: Renal Impairment Manufacturer’s recommendations: Clearance may be reduced. consult specific product labeling. which is available with the product information and as follows. Oral. 100 mg.S. active metabolites may accumulate. 30 mg/mL (2 mL) Solution.gov/downloads/Drugs/DrugSafety/UCM302557. 2007): Clcr 10-50 mL/minute: Administer 75% of dose Clcr <10 mL/minute: Administer 50% of dose Dosing: Hepatic Impairment No dosage adjustment provided in manufacturer’s labeling (has not been studied). Injection. Initiate at lower doses or longer dosing intervals followed by careful titration. particularly for generics). Take with food or milk to decrease adverse GI effects. Dosage Forms: U. Solution. 30 mg. Alternate recommendations: The following guidelines have been used by some clinicians (Aronoff.pdf Administration May administer without regard to meals. controlled release: Codeine Contin®: 50 mg. as phosphate: Generic: 30 mg/5 mL (500 mL) Tablet. as sulfate: Generic: 15 mg. consult specific product labeling.S.

vomiting. postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy Canadian labeling: Additional contraindications (not in U. Adverse Reactions Significant Frequency not defined. dyspnea. cardiac arrest. half tablets should also be swallowed intact. headache. iodine. Lodine High alert medication: The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes which have a heightened risk of causing significant patient harm when used in error. sedation. apprehension. flushing. depression. diarrhea. circulatory /hypotension. acute or severe bronchial asthma or hypercarbia.S. weakness Ocular: Blurred vision. cor pulmonale. All strengths may be halved. agitation. nystagmus.): Tablets should be swallowed whole.Controlled release tablets: Codeine Contin® (Canadian availability. nausea. dissolve. .Unlabeled Short-term relief of cough in select patients Medication Safety Issues Sound-alike/look-alike issues: Codeine may be confused with Cardene®. delirium tremens. intracranial pressure increased.S. hyper- Central nervous system: Abnormal dreams. acute alcoholism. Cardiovascular: Bradycardia. respiratory depression Miscellaneous: Allergic reaction. syncope. or crush. vertigo Dermatologic: Pruritus. except the 50 mg tablets. rigidity. euphoria. biliary tract spasm. fatigue. shock. Use Management of mild-to-moderately-severe pain Use . constipation. tremor. diaphoresis Contraindications Hypersensitivity to codeine or any component of the formulation. lightheadedness. xerostomia Genitourinary: Urinary hesitancy/retention Neuromuscular & skeletal: Paresthesia. somnolence. not available in U. shakiness. laryngospasm. tachycardia depression. rash. anxiety. insomnia. taste disturbance. diplopia. anorexia. palpitation. presence or suspicion of paralytic ileus. hallucinations. chills. severe CNS depression. labeling): Hypersensitivity to other opioid analgesics. pancreatitis. dysphoria. drowsiness. urticaria Gastrointestinal: Abdominal cramps/pain. respiratory depression in the absence of resuscitative equipment. faintness. Cordran®. miosis. dizziness. visual disturbances Respiratory: Bronchospasm. nervousness. do not chew. disorientation. coordination impaired. respiratory arrest.

and patients with conditions associated with hypoxia. hydromorphone. The risk is increased in elderly patients. or elevated intracranial pressure. hypercapnia. • CNS depression/coma: Use with caution in patients with CNS depression or coma. • Drug abuse: Use with caution in patients with a history of drug abuse or ac ute alcoholism. chronic use may result in obstructive bowel disease. • Respiratory depression: May cause dose-related respiratory depression. potential for drug dependency exists. operating machinery or driving). thereby. . or upper airway obstruction. Warnings/Precautions Concerns related to adverse effects: • CNS depression: May cause CNS depression. • Gastrointestinal obstruction: Avoid use in patients with gastrointestinal obstruction. • Hepatic impairment: Use with caution in patients with severe hepatic impairment. levorphanol. • Adrenal insufficiency: Use with caution in patients with adrenal insufficiency. affecting neurologic examination. chronic use may result in obstructive bowel disease. oxycodone. debilitated patients. may increase amylase/lipase levels. patients must be cautioned about performing tasks which require mental alertness (eg. • Head trauma: Use with extreme caution in patients with head injury. cardiovascular disease (including acute MI). oxymorphone). • Obesity: Use with caution in patients who are morbidly obese. including Addison's disease. • Constipation: Use may cause or aggravate constipation. particularly paralytic ileus. Disease-related concerns: • Abdominal conditions: May obscure diagnosis or clinica l course of patients with acute abdominal conditions. particularly in those with underlying intestinal motility disorders. or drugs which may exaggerate hypotensive effects (including phenothiazines or general anesthetics). which may impair physical or mental abilities. Tolerance. • Hypotension: May cause hypotension. head injury. exaggerated elevation of ICP may occur. • Phenanthrene hypersensitivity: Use with caution in patients with hypersensitivity reactions to other phenanthrene-derivative opioid agonists (hydrocodone. suspected surgical abdomen. • Biliary tract impairment: Use with caution in patients with biliary tract dysfunction. intracranial lesions. ac ute pancreatitis may cause constriction of sphincter of Oddi. use with caution in patients with hypovolemia.convulsive disorders. May also interfere with pupillary response and consciousness. psychological and physical dependence may occur with prolonged use. use with or within 14 days of MAO inhibitors. increased cerebrospinal or intracranial pressure. • Prostatic hyperplasia/urinary stricture: Use with caution in patients with prostatic hyperplasia and/or urinary stricture.

Ethiopians. COPD or other obstructive pulmonary disease. 0.5% to 1% of Hispanics.5% to 1% of Chinese and Japanese. • Respiratory disease: Use with caution in patients with pre -existing respiratory compromise (hypoxia and/or hypercapnia). • Debilitated patients: Use with caution in debilitated patients. and Arabs. 3% of African-Americans. Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential . and diversion. may have extensive conversion to morphine and thus increased opioid-mediated effects. • Pediatric: [U. 1% to 10% of Caucasians. • Elderly: Use with caution in the elderly. critical respiratory depression may occur. even at therapeutic dosages. The occurrence of this phenotype is seen in 0. there is a greater potential for critical respiratory depression. and 16% to 28% of North Africans.S. may be more sensitive to adverse effects. Concurrent drug therapy issues: • Sedatives: Effects may be potentiated when used with other sedat ive drugs or ethanol. Deaths have also occurred in nursing infants after being exposed to high concentrations of morphine because the mothers were ultra-rapid metabolizers. Abrupt discontinuation following prolonged use may also lead to withdrawal symptoms. Special populations: • CYP2D6 “ultrarapid metabolizers”: Use caution in patients with two or more copies of the variant CYP2D6*2 allele. • Thyroid dysfunction: Use with caution in patients with thyroid dysfunction. Metabolism/Transport Effects Substrate of CYP2D6 (major). Boxed Warning]: Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and were found to have evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism. Consider decreasing the initial dose. Other warnings/precautions: • Abuse/misuse/diversion: Healthcare provider should be alert to the potential for abuse. Use is contraindicated in the postoperative pain management of children who have undergone tonsillectomy and/or adenoidectomy.• Renal impairment: Use with caution in patients with severe renal impairment. • Withdrawal: Concurrent use of agonist/antagonist analgesics may precipitate withdrawal symptoms and/or reduced analgesic efficacy in patients following prolonged therapy with mu opioid agonists. misuse. even at therapeutic dosages. and kyphoscoliosis or other skeletal disorder which may alter respiratory function. Dosage form specific issues: • Sulfites: Some preparations contain sulfites which may cause allergic reactions. • Seizure disorders: May induce or aggravate seizures. use with caution in patients with seizure disorders.

. This is most notable for patients receiving long-term (i. Risk C: Monitor therapy Droperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk D: Consider therapy modification Ammonium Chloride: May increase the excretion of Analgesics (Opioid). Risk C: Monitor therapy CYP2D6 Inhibitors (Strong): May diminish the therapeutic effect of Codeine.. intended for use in pregnancy. Risk C: Monitor therapy Alvimopan: Analgesics (Opioid) may enhance the adverse/toxic effect of Alvimopan. Risk C: Monitor therapy CYP2D6 Inhibitors (Moderate): May diminish the therapeutic effect of Codeine. Risk C: Monitor therapy Amphetamines: May enhance the analgesic effect of Analgesics (Opioid). Risk C: Monitor therapy . barbiturates) with concomitant use.Drug Interactions (For additional information: Launch Lexi-Interact™ Drug Interactions Program ) Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Management: The manufacturer of Diclegis (doxylamine/pyridoxine). specifically states that use with other CNS depressants is not recommended. opioids. Risk D: Consider therapy modification Desmopressin: Analgesics (Opioid) may enhance the adverse/toxic effect of Desmopressin. Risk C: Monitor therapy Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Management: Alvimopan is contraindicated in patients receiving therapeutic doses of opioids for more than 7 consecutive days immediately prior to alvimopan initiation. Management: Consider dose reductions of droperidol or of other CNS agents (e.g. These CYP2D6 inhibitors may prevent the metabolic conversion of codeine to its active metabolite morphine. Risk C: Monitor therapy Antipsychotic Agents (Phenothiazines): May enhance the hypotensive effect of Analgesics (Opioid).e. These CYP2D6 inhibitors may prevent the metabolic conversion of codeine to its active metabolite morphine. Risk C: Monitor therapy Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). more than 7 days) opiates prior to alvimopan initiation. Risk C: Monitor therapy Metyrosine: CNS Depressants may enhance the sedative effect of Metyrosine. Exceptions: Levocabastine (Nasal). Risk C: Monitor therapy Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Risk D: Consider therapy modification HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants.

Management: Seek alternatives to mixed agonist/antagonist opioids in patients receiving pure opioid agonists. This may cause serotonin syndrome. Risk C: Monitor therapy Mixed Agonist / Antagonist Opioids: May diminish the analgesic effect of Analgesics (Opioid). Risk C: Monitor therapy Perampanel: May enhance the CNS depressant effect of CNS Depressants. The formation of two major codeine metabolites (morphine and norcodeine) may be impaired by somatostatin analogs. avoid use with alcohol. Risk D: Consider therapy modification Somatostatin Analogs: May decrease the metabolism of Codeine. No such dose change is recommended for women. When combined use is needed. Avoid use with other CNS depressants at bedtime. Risk D: Consider therapy modification Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk C: Monitor therapy Thiazide Diuretics: Analgesics (Opioid) may enhance the orthostatic hypotensive effect of Thiazide Diuretics. Risk C: Monitor therapy Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine.Risk C: Monitor therapy Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Risk C: Monitor therapy ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. and monitor for symptoms of therapeutic failure/high dose requirements (or withdrawal in opioid-dependent patients) if patients receive these combinations. Management: Consider alternatives to combined use. Management: Reduce the Intermezzo brand sublingual zolpidem dose to 1. until they have experience using the combination. Risk D: Consider therapy modification Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. consider minimizing doses of one or more drugs.Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities.75 mg for men who are also receiving other CNS depressants. Risk D: Consider therapy modification Ethanol/Nutrition/Herb Interactions . Risk C: Monitor therapy Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy Succinylcholine: May enhance the bradycardic effect of Analgesics (Opioid). Risk X: Avoid combination Pegvisomant: Analgesics (Opioid) may diminish the therapeutic effect of Pegvisomant. particularly those such as driving that require alertness and coordination. Risk C: Monitor therapy Selective Serotonin Reuptake Inhibitors: Analgesics (Opioid) may enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors.

irritability. 2007. When codeine is used in breast-feeding women.05 Solution (Codeine Sulfate Oral) 30 mg/5 mL (500 mL): $128.48 . it is recommended to use the lowest dose for the shortest duration of time and observe the infant for increased sleepiness. Pricing: U. Koren. including codeine. (Medi-Span®) Solution (Codeine Phosphate Injection) 15 mg/mL (2 mL): $2. or yawning. Avoid valerian. In one case. Use of opioids during pregnancy may produce physical dependence in the neonate. excessively high serum concentrations of morphine were reported in a breast-fed infant following maternal use of acetaminophen with codeine. gotu kola (may increase CNS depression). difficulty in feeding or breathing. Herb/Nutraceutical: St John's wort may decrease codeine levels. Caution should be used since most persons are not aware if they have the genotype resulting in “ultra-rapid metabolizer” status. AAP 2001 update pending) Breast-Feeding Considerations Codeine and its metabolite (morphine) are found in breast milk and can be detected in the serum of nursing infants.50 60 mg (100): $103.Ethanol: May increase CNS depression. respiratory depression may occur in the newborn if opioids are used prior to delivery. during the first trimester of pregnancy (Broussard. The relative dose to a nursing infant has been calculated to be ~1% of the weight-adjusted maternal dose. In humans. Lactation Enters breast milk/use caution (AAP rates “compatible”.S. symptoms in the infant included feeding difficulty and lethargy. followed by death. St John's wort.44 Tablets (Codeine Sulfate Oral) 15 mg (100): $52. Symptoms of opioid withdrawal may include excessive crying. The mother was later found to be an “ultrarapid metabolizer” of codeine. Higher levels of morphine may be found in the breast milk of lactating mothers who are “ultrarapid metabolizers” of codeine. tremors. 2011). Caution patients about effects. diarrhea. sneezing. respiratory rate increased. monitor for increased effects with coadministration. or limpness (FDA. 2006). Pregnancy Risk Factor C (show table) Pregnancy Implications Adverse events have been observed in animal reproduction studies. fever. kava kava.48 30 mg (100): $56. vomiting. hyperreflexia. patients with two or more copies of the variant CYP2D6*2 allele may have extensive conversion to morphine and thus increased opioid-mediated effects.87 30 mg/mL (2 mL): $3. Opioid analgesics cross the placenta. birth defects (including some heart defects) have been associated with maternal use of opioid analgesics.

 Codedrill sans sucre (FR). respiratory and mental status. heart rate Reference Range Therapeutic: Not established International Brand Names  Actacode (AU). . CZ.  Bronchodine (BE). KP). blood pressure. respectively.Disclaimer: The pricing data provided represent a median AWP and/or AAWP price for the brand and/or generic product.  Bronchicum (DE). Monitoring Parameters Pain relief. Pricing data is updated monthly. and as such should not be used to set or adjudicate any prices for charging or reimbursement functions.  Codeine Linctus (GB).  Codant (IE).  Codein (AR. NZ). The pricing data should be used for benchmarking purposes only.  Antitussivum Burger (DE).  Codeine Phosphate (CY.  Cobitussin (TW).

 codi OPT (DE). Codeintropfen von ct (DE).  Codicompren (DE).  Codeinum Phosphorcum (PL).  Codiforton (DE).   Codeinum phosphoricum Berlin-Chemie (DE).   Codeintropfen Ribbeck (DE).  Codeinsaft von ct (DE).  Codicaps (DE).  Coderit (MX).  Coderpina (GT. HN.  Codeisan (PT). Codeinum phosphoricum Compretten (DE). Codeini phosphatis (HR). . SV).  Codenfan (FR).

 Codipront N (PH).  Compretten (DE). LU).  Dicton (DE.  Glottyl (LU).  Lertus CD (MX).  Contrapect (DE).  Kodein (NO). LU). . Codin Linctus (IN). Codipront mono (DE.  Kodein ”Dak” (DK).  Histaverin (ES).  Galcodine (GB).  Kodein Recip (SE).  Kaodene (GB).   Codipertussin (DE).

 Tussoret (DE). Tussipect Codein Tropfen Mono (DE).  Pectinfant (LU).  Tricodein Solco (AT.   Pectoral Edulcor (LU).  Tricodein (DE).  Tryasol (DE).  Tylex CD (MX).  Voltaren Forte (MX) .   Tussamag-Codeinsaft (DE).  Tussoretard (DE).  Optipect (DE). Neo-Codion[Sirup] (DE).  Para-Co (TH). Pulmocodeina (EC). CH).

et al." Am J Obstet Gynecol.[PubMed 21345403] 5. causing inhibition of ascending pain pathways. REFERENCES 1.5-1 hour Peak effect: Oral: Immediate release: 1-1. Aspirin. 3. “Managing Cough as a Defense Mechanism and as a Symptom: A Consensus Panel Report of the American College of Chest Physicians.” Contact Dermatitis. PA: American College of Physicians. “Transfer of Drugs and Other Chemicals Into Human Milk. 14(4):209-14. p 18.Mechanism of Action Binds to opioid receptors in the CNS. Broussard CS. Codeine. de Groot AC and Conemans J. [PubMed 1246497] . 1(8233):1313. Codeine. causes cough suppression by direct central action in the medulla. 39(1):6473. [PubMed 11533352] 2. 5th ed. “Analgesic Effect of Naproxen Sodium. 198. Rasmussen SA. Irwin RS. 108(3): 776-89. via CYP2D6 to morphine (active). 135. “Fatal Case of Codeine Poisoning. 57(1):1645. Berns JS. altering the perception of and response to pain. [PubMed 16428717] 4. 2011. 6.): 3. “Cough Suppressant and Pharmacologic Protussive Therapy: ACCP Evidence Based Clinical Practice Guidelines. American Academy of Pediatrics Committee on Drugs. Ferrell BA. 1976. not available in the U. Forbes JA. et al. et al. 1986. [PubMed 1670940] 9. Bioavailability: 53% Half-life elimination: ~3 hours Time to peak.” Pediatrics.” Pediatrics.” Lancet. 114(2):133-81. produces generalized CNS depression Pharmacodynamics/Kinetics Onset of action: Oral: Immediate release: 0.[PubMed 6368614] 8. 2001. Keller CK. and via CYP3A4 to norcodeine. “Danger of Actifed-C. [PubMed 3540871] 10. 2006. Cooper SA. Boulet LP.” J Clin Pharmacol. Bolser DC. Desjardins PJ. Smith JW. 1981.” J Am Geriatr Soc. Gallegos TL. Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children. 1991.3 hours Excretion: Urine (~90%. [PubMed 2941218] 7. “Pain Management in Elderly People.” Chest. "National Birth Defects Prevention Study: Maternal Treatment With Opioid Analgesics and Risk for Birth Defects. Bennett WM. Cloutier MM. and Placebo in Postimpaction Dental Pain. plasma: Immediate release: 1 hour. Ivey HH and Kattwinkel J. et al. 1984. Reefhuis J. Cardan E.[PubMed 9725800] 11. 6(5):211-8. ~10% of the total dose as unchanged drug). 1986. Controlled release (Canadian availability. Aronoff GR. feces Use of UpToDate is subject to the Subscription and License Agreement. “Allergic Urticarial Rash From Oral Codeine.” Pharmacotherapy.S. “The Relative Analgesic Efficacy of Propiram Fumarate. Morphine is further metabolized via glucuronidation to morphine-3-glucuronide and morphine-6-glucuronide (active). a Naproxen-Codeine Combination and Aspirin on the Postoperative Pain of Oral Surgery. Philadelphia. et al.” Chest. 24(1):35-42.5 hours Duration: Immediate release: 4-6 hours Distribution: ~3-6 L/kg Protein binding: ~7% to 25% Metabolism: Hepatic via UGT2B7 and UGT2B4 to codeine-6-glucuronide. 2007. 204(4):314. 129(1 Suppl):238-48.

org/pdf/sedatives. Rollins DE. Khan K and Chang J. et al. Center for Drug Evaluation and Research. All rights reserved. Accessed August 2. 1997. 2008. 2004. et al. Riel-Romero RM.fda. Zacher JL and Givone DM. 2003. Fraser GL. Kaiko RF. 30(1):119-41. “Clinical Practice Guidelines for the Sustained Use of Sedatives and Analgesics in the Critically Ill Adult. 1995. 368(9536):704. Glenview. Coursin DB. “Pharmacogenetics of Morphine Poisoning in a Breastfed Neonate of a Codeine-Prescribed Mother. 2003. 76(1): F59-60. 2002. “Adult Toxicology in Critical Care: Part II: Specific Poisonings.Positive Ion Chemical Ionization Mass Spectrometry: A Clinical Application.” Crit Care Med.” Available athttp://www. Caims J. et al.” 6th ed. “Quantitative Determination of Codeine and Its Major Metabolites in Human Hair by Gas Chromatography . 66(5):1079-89. et al. Jacobi J.htm 22. [PubMed 16920476 ] 16. 19(5):269-74. Inc.”Chest. 2006.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProvide rs/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm054717. Leikin JB. and Bada HS. Spigset O and Hagg S. “Analgesics and Breast-Feeding: Safety Considerations.” Paediatr Drugs. Seaman J. [PubMed 15252190] Topic 9291 Version 50. 1982.” Med Clin North Am. IL: American Pain Society. “Narcotics in the Elderly.  Dexamethasone Intensol. Rogers AG. “Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain. Wallenstein SL. 46(7):63945. [PubMed 9059191] 15. [PubMed 17704497] 19.” Lancet.” Cochrane Database Syst Rev. Reynolds EW. “Over-the-Counter (OTC) Medications for Acute Cough in Children and Adults in Ambulatory Settings (Review). et al. “Neonatal Abstinence Syndrome Due to Codeine. “Public Health Advisory: Use of Codeine by Some Breastfeeding Mothers May Lead to Life-Threatening Side Effects in Nursing Babies. 2010. 38:1525-28. “Neonatal Abstinence Syndrome and Cerebral Infarction Following Maternal Codeine Use During Pregnancy.” Arch Dis Child Fetal Neonatal Ed. (For additional information see "Dexamethasone (systemic): Patient drug information" and see "Dexamethasone (systemic): Pediatric drug information") For abbreviations and symbols that may be used in Lexicomp (show table) Brand Names: U.  DexPak 10 Day. [PubMed 11902253] 13.pdf. 2007.sccm.”Ann Pharmacother. Murray P. Available at http://www.0 Dexamethasone (systemic): Drug information Copyright 1978-2013 Lexicomp. Koren G. 123(3):897-922. [PubMed 10937472] 21.” Clin Pediatr.” J Anal Toxicol. and Fahey T. Mokhlesi B. 20. Chitayat D. Wilkins D. U. [PubMed 7500611] 23. [PubMed 12628894] 17. 2(3):223-38. Food and Drug Administration (FDA). Schroeder K.S. “False-Positive Urine Opiate Screening Associated With Fluoroquinolone Use. 18. 9:133. .12.  Baycadron.S. [PubMed 7132470] 14. Smith SM. 2000.

I.: 0. I. intralesional.  Dexasone®. Systemic Dosing: Adult Anti-inflammatory: Oral. DexPak 13 Day.  PMS-Dexamethasone.75-9 mg/day in divided doses every 6-12 hours Intra-articular.  Dom-Dexamethasone.4-6 mg/day .  PRO-Dexamethasone.  Corticosteroid.  DexPak 6 Day Brand Names: Canada  Apo-Dexamethasone®.  ratio-Dexamethasone Pharmacologic Category  Anti-inflammatory Agent.M.  PHL-Dexamethasone.V.  Antiemetic. or soft tissue: 0..

4 mg I.: 4-10 mg as a single dose. 9 to 12.M.6-0.5 mg by mouth every 6 hours for 48 hours (with 24-hour urine collection for 17-hydroxycorticosteroid excretion) Differentiation of Cushing's syndrome due to ACTH excess from Cushing's due to other causes: Oral: Dexamethasone 2 mg every 6 hours for 48 hours (with 24-hour urine collection for 17-hydroxycorticosteroid excretion) Multiple sclerosis (acute exacerbation): Oral: 30 mg/day for 1 week. repeated every 4 weeks (alone or as part of a regimen) Cerebral edema: I. I. 10 mg stat. then 4 mg every 12 hours for 2 days or 20 mg 1 hour before chemotherapy.5-2 mg/kg/day in divided doses every 6 hours beginning 24 hours prior to extubation and continuing for 4-6 doses afterwards Antiemetic: Prophylaxis: Oral.: 10-20 mg 15-30 minutes before treatment on each treatment day Continuous infusion regimen: Oral or I. and 17 to 20..: 4 mg every 4-6 hours Delayed nausea/vomiting: Oral: 4-10 mg 1-2 times/day for 2-4 days or 8 mg every 12 hours for 2 days./I. then switch to oral regimen. then taper off if appropriate. (should be given as sodium phosphate): 0.: 10 mg every 12 hours on each treatment day Mildly emetogenic therapy: Oral. diagnostic: Oral: 1 mg at 11 PM. followed by 4-12 mg/day for 1 month Treatment of shock: Addisonian crisis/shock (eg.V.: 1-6 mg/kg as a single I. then 10 mg 12 hours after chemotherapy. I.: 0. dose or up to 40 mg initially followed by repeat doses every 2-6 hours while shock persists Physiological replacement: Oral.V.75 mg/m /day in divided doses every 6-12 hours . I.Extubation or airway edema: Oral.V.: 40 mg/day.15 2 mg/kg/day or0.M. unresponsive to steroid therapy): I.03-0.V. which may be repeated if necessary Unresponsive shock (eg. then 4 mg every 12 hours for 4 doses Multiple myeloma: Oral. adrenal insufficiency/responsive to steroid therapy): I. I..V.V. I. (should be given as sodium phosphate) every 6 hours until response is maximized. I. draw blood at 8 AM the following day for plasma cortisol determination Cushing's syndrome. draw blood at 8 AM.V.V. days 1 to 4.M. then 8 mg every 12 hours for 4 doses..V. dosage may be reduced after 2-4 days and gradually discontinued over 5-7 days Dexamethasone suppression test (depression/suicide indicator) (unlabeled use): Oral: 1 mg at 11 PM.V.M. greater accuracy for Cushing's syndrome may be achieved by the following: Dexamethasone 0. I.V. I.

M.6-0.V. may be discontinued after staying at the same elevation for 2-3 days or if descent is initiated.V.: 0. Hemodialysis or peritoneal dialysis: Supplemental dose is not necessary. I.03-0.M. Sparrow.M. taper off over 1-6 weeks Croup (laryngotracheobronchitis): Oral.V. 2010) Dosing: Pediatric (For additional information see "Dexamethasone (systemic): Pediatric drug information") Antiemetic (prior to chemotherapy): Refer to individual protocols and emetogenic potential: 2 I..Acute mountain sickness (AMS)/high altitude cerebral edema (HACE) (unlabeled use): Prevention: Oral: 2 mg every 6 hours or 4 mg every 12 hours starting on the day of ascent. 2006) Bacterial meningitis: Infants and Children >6 weeks: I. I. 2010.75 mg/m /day in divided doses every 6-12 hours Acute mountain sickness (AMS)/high altitude cerebral edema (HACE) (unlabeled use): Oral.6 mg/kg once. 2000).15 mg/kg/dose every 6 hours. usual maximum dose: 16 mg (doses as high as 20 mg have been used) (Bjornson..: 0. I. I. I. I. 2004. 2008. I. use with caution.V. Use cautiously in the elderly in the smallest possible dose. 2010).3 mg/kg/day or 2.V.: 0.: 0. I. Pollard.08-0.15 mg/kg has been shown effective in children with mild-to-moderate croup (Russell..V.5 mg/kg/day (maximum: 16 mg/day) in divided doses every 4-6 hours. Rittichier.V. a single oral dose of 0. 2001) 2 Dosing: Geriatric Refer to adult dosing. start dexamethasone 10-20 minutes before or with the first dose of antibiotic Physiologic replacement: Oral.. Note: In situations of rapid ascent to altitudes >3500 meters (such as rescue or military operations). consider using for high altitude pulmonary edema because of associated HACE with this condition (Luks.V.: 10 mg/m /dose every 12-24 hours on days of chemotherapy for severely emetogenic chemotherapy courses Anti-inflammatory and/or immunosuppressant: Oral. I.M.5-10 2 mg/m /day in divided doses every 6-12 hours Extubation or airway edema: Oral.M. 2010) HACE: Initial: 8 mg as a single dose. 4 mg every 6 hours may be considered (Luks. Dosing: Renal Impairment No dosage adjustment provided in manufacturer’s labeling. Hegenbarth.V.15 mg/kg/day or 0.: 0. I. Maintenance: 4 mg every 6 hours until symptoms resolve (Luks. 2004.5-2 mg/kg/day in divided doses every 6 hours beginning 24 hours prior to extubation and continuing for 4-6 doses afterwards Cerebral edema: I. maintenance: 1-1.. I. Treatment: Oral. I. do not exceed a 10 day duration (Luks.. 2010).15 mg/kg/dose every 6 hours for the first 2-4 days of antibiotic treatment.: AMS: 4 mg every 6 hours (Luks.: Loading dose: 1-2 mg/kg/dose as a single dose.: 0. .M.

4 mg. consult specific product labeling. NS. cyclophosphamide. cytarabine.5 mg/5 mL (237 mL) Solution. 30 mL).V. fluconazole.Dosing: Hepatic Impairment No dosage adjustment provided in manufacturer’s labeling. 10 mL) Solution. fentanyl. granisetron. 6 mg Generic Equivalent Available: U. famotidine. dexmedetomidine.5 mg [scored. Compatibility Stable in D5W. amikacin. Oral: Dexamethasone Intensol: 1 mg/mL (30 mL) [contains alcohol. fludarabine. 500 mL) Solution. Oral: Baycadron: 0. as sodium phosphate: Generic: 4 mg/mL (1 mL. amphotericin B cholesteryl sulfate complex. unflavored flavor] Elixir. gemcitabine. caffeine citrate.5 mg. Excipient information presented when available (limited.S. acyclovir. bivalirudin. particularly for generics).5 mg/5 mL (240 mL. anidulafungin. cefepime.5 mg/5 mL (237 mL) [contains alcohol.75 mg. gallium nitrate. cladribine. allopurinol. contains fd&c red #40 aluminum lake] DexPak 13 Day: 1. amsacrine. Injection. 2 mg. contains fd&c red #40 aluminum lake] DexPak 6 Day: 1.5 mg. raspberry flavor] Generic: 0. usp. 1 mg. foscarnet. doripenem. etoposide phosphate. Oral: DexPak 10 Day: 1.5 mg [scored. fd&c red #40. 10 mg/mL (1 mL. Injection. filgrastim. propylene glycol. May be product dependent Administration Oral: Administer with meals to decrease GI upset. cisatracurium.: Administer as a 5-10 minute bolus. Y-site administration: Compatible: Acetaminophen. Oral: Generic: 0. doxorubicin. rapid injection is associated with a high incidence of perineal discomfort. Dosage Forms: U. benzoic acid. usp. aztreonam. amifostine. 5 mL. cisplatin.S. Concentrate. contains fd&c red #40 aluminum lake] Generic: 0.5 mg [scored. docetaxel. 1. doxorubicin liposome. as sodium phosphate [preservative free]: Generic: 10 mg/mL (1 mL) Tablet. 0. heparin. I. heparin with .

dimenhydrinate. Incompatible: Ciprofloxacin. promethazine. urticaria. haloperidol. hypertension. injection). wound healing impaired Endocrine & metabolic: Adrenal suppression. furosemide. petechiae. dextroamphetamine Decadron® may be confused with Percodan® Adverse Reactions Significant Frequency not defined. personality changes. vasculitis Central nervous system: Depression. diphenhydramine. dermatologic. bradycardia. perianal pruritus (following I. remifentanil. telavancin. cardiomyopathy. diagnosis of Cushing’s syndrome. Cardiovascular: Arrhythmia. hydromorphone. fragile skin. hirsutism. midazolam. vitamin B complex with C. prevention and treatment of acute mountain sickness and high altitude cerebral edema. milrinone. headache. ranitidine.Unlabeled Dexamethasone suppression test as an indicator of depression and/or risk of suicide. as a diagnostic agent. rheumatic. vinorelbine. nervous system. metoclopramide. pantoprazole. Incompatible: Doxapram. Variable (consult detailed reference):Diphenhydramine. metoclopramide. tacrolimus. accelerate fetal lung maturation in patients with preterm labor Medication Safety Issues Sound-alike/look-alike issues: Dexamethasone may be confused with desoximetasone. pseudotumor cerebri (usually following discontinuation). sodium retention . methadone. teniposide. circulatory collapse. inflammatory. insomnia. theophylline.hydrocortisone sodium succinate. melphalan. erythema. and autoimmune origin. thromboembolism. ondansetron. midazolam. renal. cardiac arrest. glucose intolerance decreased. piperacillin/tazobactam. pemetrexed. granisetron. rash. psychic disorders. morphine. emotional instability. idarubicin. skin atrophy. hetastarch in lactate electrolyte injection (Hextend®). meropenem. ondansetron. thiotepa. protein catabolism. Variable (consult detailed reference):Hydromorphone. bruising. dry skin. ketamine. mood swings. intracranial pressure increased. Use Primarily as an anti-inflammatory or immunosuppressant agent in the treatment of a variety of diseases including those of allergic. antiemetic Use . neuritis. respiratory. pituitary-adrenal axis suppression. menstrual irregularities. glycopyrrolate. alopecia. allergic dermatitis. skin test reaction impaired. levofloxacin. endocrine. propofol. edema. famotidine. syncope. sufentanil. may be used in management of cerebral edema. zidovudine. fenoldopam.V. methotrexate. neoplastic. lorazepam. sargramostim. hyperglycemia. topotecan. paclitaxel. sufentanil. palonosetron. ketorolac. sodium bicarbonate. diabetes mellitus. negative nitrogen balance. seizure. myocardial rupture (post-MI). linezolid. fosaprepitant. hyper-/hypopigmentation. oxaliplatin. carbohydrate tolerance decreased. meperidine. droperidol. chronic swelling. potassium chloride. angioedema. CHF. pantoprazole. growth suppression (children). hypertrichosis. Compatibility in syringe: Compatible: Caffeine citrate. hypokalemic alkalosis. malaise. hematologic. striae. vertigo Dermatologic: Acne. Cushing's syndrome. euphoria.

Kaposi's sarcoma. fractures. . cerebral malaria Warnings/Precautions Concerns related to adverse effects: • Adrenal suppression: May cause hypercorticism or suppression of hypothalamic pituitary-adrenal (HPA) axis. including an increase in allergic symptoms. moon face. tendon rupture. pancreatitis. muscle mass loss. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. anaphylaxis. HPA axis suppression may lead to adrenal crisis. weakness Ocular: Cataracts. Exposure to chickenpox should be avoided. Fatalities have occurred due to adrenal insufficiency in asthmatic patients during and after transfer from systemic corticosteroids to aerosol steroids. Patients receiving >20 mg per day of prednisone (or equivalent) may be most susceptible. corticosteroids should not be used to treat ocular herpes simplex. avascular necrosis. glaucoma. anaphylactoid reaction. parasthesia. gastrointestinal perforation. restrict use in active TB (only in conjunction with antituberculosis treatment). secondary malignancy Contraindications Hypersensitivity to dexamethasone or any component of the formulation. surgery. aerosol steroids do not provide the systemic steroid needed to treat patients having trauma. • Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection. systemic fungal infections. prolong or exacerbate viral infections. vertebral compression fractures. or limit response to vaccines. exophthalmos. discontinuation of therapy should be considered.Gastrointestinal: Abdominal distention. impaired wound healing. myopathy (particularly in conjunction with neuromuscular disease or neuromuscular-blocking agents). infections. if noted. weight gain Genitourinary: Altered (increased or decreased) spermatogenesis Hepatic: Hepatomegaly. hiccups. thrombophlebitis Neuromuscular & skeletal: Arthropathy. • Kaposi's sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports). peptic ulcer. aseptic necrosis (femoral and humoral heads). Corticosteroids should not be used for cerebral malaria or viral hepatitis. diaphoresis. particularly in younger children or in patients receiving high doses for prolonged periods. ulcerative esophagitis. hypersensitivity. Close observation is required in patients with latent tuberculosis and/or TB reactivity. neuropathy. transaminases increased Local: Postinjection flare (intra-articular use). or infections. nausea. appetite increased. osteoporosis. intraocular pressure increased Renal: Glucosuria Respiratory: Pulmonary edema Miscellaneous: Abnormal fat deposition. gastrointestinal hemorrhage. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids. mask acute infection (including fungal infections).

usually in patients with neuromuscular transmission disorders. long-term use has been associated with fluid retention and hypertension. methylprednisolone. may involve ocular and/or respiratory muscles. euphoria. Consider routine eye exams in chronic users. • Renal impairment: Use with caution in patients with renal impairmen t. metabolic clearance of corticosteroids increases in hyperthyroid patients and decreases in hypothyroid ones.• Myopathy: Acute myopathy has been reported with high dose corticosteroids. • Diabetes: Use with caution in patients with diabetes mellitus. • Psychiatric disturbances: Corticosteroid use may cause psychiat ric disturbances. The lowest possible dose should be used during treatment. long-term use has been associated with fluid retention. seizures have been reported with adrenal crisis. • Head injury: Increased mortality was observed in patients receiving high -dose I. may alter glucose production/regulation leading to hyperglycemia. • Ocular disease: Use with caution in patients with cataracts and/or glaucoma. including depression. High-dose corticosteroids should not be used for the management of head injury. Special populations: . • Seizure disorders: Use with caution in patients with a history of seizure disorder. monitor creatine kinase. Disease-related concerns: • Adrenal insufficiency: Dexamethasone does not provide adequate mineralocorticoid activity in adrenal insufficiency (may be employed as a single dose while cortisol assays are performed). high doses and/or longterm use of corticosteroids have been associated with increased bone loss and osteoporotic fractures. • Myocardial infarction (MI): Use with caution following acute MI. corticosteroids have been associated with myocardial rupture.V. discontinuation and/or dose reductions should be gradual. recovery may be delayed. • Thyroid disease: Changes in thyroid status may necessitate dosage adjustments. peptic ulcer. and cataracts have occurred with prolonged use. increased intraocular pressure. • Gastrointestinal disease: Use with caution in patients with GI diseases (diverticulitis. • Osteoporosis: Use with caution in patients with osteoporosis. open-angle glaucoma. • Myasthenia gravis: Use with caution in patients with myasthenia gravis. fluid retention may occur. and personality changes. including cirrhosis. mood swings. Pre-existing psychiatric conditions may be exacerbated by corticosteroid use. • Cardiovascular disease: Use with caution in patients with HF. insomnia. • Hepatic impairment: Use with caution in patients with hepatic impairment. exacerbation of symptoms has occurred especially during initial treatment with corticosteroids. ulcerative colitis) due to perforation risk.

P-glycoprotein Drug Interactions (For additional information: Launch Lexi-Interact™ Drug Interactions Program ) Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. particularly in the setting of insulin or other antidiabetic agent use. • Pediatrics: May affect growth velocity. Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential. with unknown impact on budesonide therapeutic effects. corticosteroid-mediated HPA axis suppression has led to episodes of acute adrenal crisis. Management: Consider separating doses by 2 or more hours. Risk X: Avoid combination Aminoglutethimide: May increase the metabolism of Corticosteroids (Systemic). Avoid . Budesonide enteric coated tablets could dissolve prematurely if given with drugs that lower gastric acid. CYP2C9 (weak/moderate). Risk D: Consider therapy modification ARIPiprazole: CYP3A4 Inducers may decrease the serum concentration of ARIPiprazole. CYP3A4 (strong). Reduce the oral aripiprazole dose to 10-15 mg/day if the inducer is discontinued. CYP2B6 (weak/moderate). growth should be routinely monitored in pediatric patients. In some instances. systemic corticosteroids should be used cautiously in the elderly in the smallest possible effective dose for the shortest duration. Risk X: Avoid combination Aprepitant: May increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy Antifungal Agents (Azole Derivatives. Risk C: Monitor therapy Aldesleukin: Corticosteroids may diminish the antineoplastic effect of Aldesleukin.Risk C: Monitor therapy Apixaban: CYP3A4 Inducers (Strong) may decrease the serum concentration of Apixaban. Systemic): May decrease the metabolism of Corticosteroids (Systemic).• Elderly: Because of the risk of adverse effects.Induces CYP2A6 (weak/moderate). Management: Double the oral aripiprazole dose and closely monitor clinical response. P-glycoprotein. which may manifest as enhanced hypoglycemia. Metabolism/Transport Effects Substrate of CYP3A4 (major). Risk C: Monitor therapy Amphotericin B: Corticosteroids (Systemic) may enhance the hypokalemic effect of Amphotericin B. Inhibits Pglycoprotein. Risk C: Monitor therapy Antacids: May decrease the bioavailability of Corticosteroids (Oral). Other warnings/precautions: • Discontinuation of therapy: Withdraw therapy with gradual tapering of dose. Risk D: Consider therapy modification Antidiabetic Agents: Corticosteroids (Systemic) may diminish the hypoglycemic effect of Antidiabetic Agents. Increased muscular weakness may occur.

Risk X: Avoid combination Bedaquiline: CYP3A4 Inducers (Strong) may decrease the serum concentration of Bedaquiline. Specifically. This is thought to be due to an asparaginase-related decrease in hepatic proteins responsible for dexamethasone metabolism. Management: Avoid strong CYP3A4 inducers with boceprevir when possible. Carbamazepine. and closely monitor response to boceprevir if such a combination cannot be avoided. Risk D: Consider therapy modification Bosutinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Bosutinib. Risk X: Avoid combination Barbiturates: May decrease the serum concentration of Corticosteroids (Systemic). phenytoin.Exceptions: Bepridil [Off Market]. Risk C: Monitor therapy Calcium Channel Blockers (Nondihydropyridine): May decrease the metabolism of Corticosteroids (Systemic). Risk X: Avoid combination Calcitriol: Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol. up to a maximum of 70 mg. Risk X: Avoid combination Bile Acid Sequestrants: May decrease the absorption of Corticosteroids (Oral). Risk D: Consider therapy modification Asparaginase (E. concentrations of the active monomethyl auristatin E (MMAE) component may be decreased. Risk D: Consider therapy modification Cobicistat: Dexamethasone (Systemic) may decrease the serum concentration of Cobicistat. and St. This is thought to be due to an asparaginase-related decrease in hepatic proteins responsible for dexamethasone metabolism. Risk X: Avoid combination Brentuximab Vedotin: CYP3A4 Inducers (Strong) may decrease the serum concentration of Brentuximab Vedotin. daily in pediatric patients) when coadministered with known inducers of drug clearance. phenobarbital.use of CYP3A4 inducers for more than 14 days with extended-release injectable aripiprazole. rifampin. Risk C: Monitor therapy Cabozantinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Cabozantinib. Risk C: Monitor therapy Boceprevir: CYP3A4 Inducers (Strong) may decrease the serum concentration of Boceprevir. John's wort are considered contraindicated. Risk C: Monitor therapy BCG: Immunosuppressants may diminish the therapeutic effect of BCG.Risk C: Monitor therapy Asparaginase (Erwinia): May increase the serum concentration of Dexamethasone (Systemic). coli): May increase the serum concentration of Dexamethasone (Systemic). Management: Consider using an increased caspofungin dose of 70 mg daily 2 in adults (or 70 mg/m .Risk C: Monitor therapy Axitinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Axitinib. Risk C: Monitor therapy Caspofungin: Inducers of Drug Clearance may decrease the serum concentration of Caspofungin. Risk C: Monitor therapy .

Management: Consider an alternative for one of the interacting drugs. Risk C: Monitor therapy Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. the risk for GI ulceration/irritation or GI bleeding may be increased. consider increasing dasatinib dose and monitor clinical response and toxicity closely. Risk C: Monitor therapy CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Specifically. the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Specifically. Specifically. Consult appropriate manufacturer labeling. Some combinations may be specifically contraindicated. Risk X: Avoid combination Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. the risk for GI ulceration/irritation or GI bleeding may be increased. Risk D: Consider therapy modification Dabigatran Etexilate: P-glycoprotein/ABCB1 Inducers may decrease the serum concentration of Dabigatran Etexilate. If such a combination cannot be avoided. Risk D: Consider therapy modification CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Risk C: Monitor therapy Crizotinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Crizotinib. Risk C: Monitor therapy CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates. particularly strong inducers. Risk C: Monitor therapy Deferasirox: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Deferasirox. Management: Avoid concurrent use of dabigatran with p-glycoprotein inducers when possible. Risk D: Consider therapy modification Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Closely monitor for decreased levels/effects of dabigatran if concomitantly administering p-glycoprotein inducers. Risk C: Monitor therapy . Dexamethasone (Systemic) may increase the serum concentration of CycloSPORINE (Systemic). Risk X: Avoid combination CycloSPORINE (Systemic): Dexamethasone (Systemic) may decrease the serum concentration of CycloSPORINE (Systemic).Coccidioidin Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioidin Skin Test. Risk C: Monitor therapy Deferasirox: Corticosteroids may enhance the adverse/toxic effect of Deferasirox. CycloSPORINE (Systemic) may increase the serum concentration of Dexamethasone (Systemic). Risk D: Consider therapy modification CYP3A4 Substrates: CYP3A4 Inducers (Strong) may increase the metabolism of CYP3A4 Substrates. Specifically. Management: Avoid when possible. Risk X: Avoid combination Dasatinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Dasatinib. the risk for serious infections may be increased. Risk C: Monitor therapy Conivaptan: May increase the serum concentration of CYP3A4 Substrates.

Risk C: Monitor therapy Fosaprepitant: May increase the serum concentration of Corticosteroids (Systemic).S. Risk X: Avoid combination Exemestane: CYP3A4 Inducers (Strong) may decrease the serum concentration of Exemestane. Management: Consider avoiding CYP3A4 inducing herbs in order to avoid therapeutic failure of the substrate. Risk C: Monitor therapy . Risk D: Consider therapy modification Fluconazole: May decrease the metabolism of Corticosteroids (Systemic). Risk D: Consider therapy modification Gefitinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Gefitinib. Risk D: Consider therapy modification Herbs (CYP3A4 Inducers): May increase the metabolism of CYP3A4 Substrates. Management: Patients receiving corticosteroids (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. consider gradually (in 5 mg increments) increasing the everolimus dose from 10 mg/day to 20 mg/day (adult doses). Management: Consider increasing the guanfacine dose by 2-fold when adding a strong CYP3A4 inducer. Some combinations may be specifically contraindicated. Carefully monitor clinical response and development of adverse reactions. Risk X: Avoid combination Estrogen Derivatives: May increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy Enzalutamide: CYP3A4 Inducers (Strong) may decrease the serum concentration of Enzalutamide. Management: Exemestane U. but if strong CYP3A4 inducers cannot be avoided. Consult appropriate manufacturer labeling. consider increasing gefitinib dose to 500 mg daily in patients receiving strong CYP3A4 inducers. The Canadian product labeling does not recommend a dose adjustment with concurrent use of strong CYP3A4 inducers. Titrate the guanfacine dose up to a max of 8 mg/day when starting guanfacine in a patient who is taking a strong CYP3A4 inhibitor. Risk D: Consider therapy modification Ifosfamide: CYP3A4 Inducers (Strong) may increase serum concentrations of the active metabolite(s) of Ifosfamide. Risk D: Consider therapy modification Elvitegravir: Dexamethasone (Systemic) may decrease the serum concentration of Elvitegravir. Management: In the absence of severe adverse drug reactions. Larger doses of hyaluronidase may be required. Risk C: Monitor therapy Everolimus: CYP3A4 Inducers (Strong) may decrease the serum concentration of Everolimus.Dronedarone: CYP3A4 Inducers (Strong) may decrease the serum concentration of Dronedarone. Risk X: Avoid combination Echinacea: May diminish the therapeutic effect of Immunosuppressants. Risk D: Consider therapy modification GuanFACINE: CYP3A4 Inducers (Strong) may decrease the serum concentration of GuanFACINE. Risk D: Consider therapy modification Hyaluronidase: Corticosteroids may diminish the therapeutic effect of Hyaluronidase. Management: Avoid concurrent use of strong CYP3A4 inducers. The active metabolite aprepitant is likely responsible for this effect. product labeling recommends using an increased dose (50 mg/day) in patients receiving concurrent strong CYP3A4 inducers.

500 mg/day (HER2 positive metastatic breast cancer) or 1.500 mg/day up to 5. Spiramycin. If such a combination must be used. Risk D: Consider therapy modification Lapatinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Lapatinib. Risk D: Consider therapy modification Maraviroc: CYP3A4 Inducers (Strong) may decrease the serum concentration of Maraviroc. Risk D: Consider therapy modification Indacaterol: May enhance the hypokalemic effect of Corticosteroids (Systemic). Management: If therapy overlap cannot be avoided. increase imatinib dose by at least 50% and monitor the patient's clinical response closely. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly.Imatinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Imatinib. This does not apply to patients also receiving strong CYP3A4 inhibitors. Management: Avoid mifepristone in patients who require long-term corticosteroid treatment of serious illnesses . Risk X: Avoid combination Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically. Management: Avoid this combination whenever possible. agranulocytosis.500 mg/day (hormone receptor/HER2 positive breast cancer) as tolerated. Do not use maraviroc with strong CYP3A4 inducers in patients with Clcr less than 30 mL/min. Management: Avoid concurrent use of imatinib with strong CYP3A4 inducers when possible. as tolerated. the risk for hematologic toxicity such as pancytopenia. Risk C: Monitor therapy Ivacaftor: CYP3A4 Inducers (Strong) may decrease the serum concentration of Ivacaftor. Risk C: Monitor therapy Lurasidone: CYP3A4 Inducers (Strong) may decrease the serum concentration of Lurasidone. and/or thrombocytopenia may be increased. Risk C: Monitor therapy Ixabepilone: CYP3A4 Inducers (Strong) may decrease the serum concentration of Ixabepilone. Risk X: Avoid combination Macrolide Antibiotics: May decrease the metabolism of Corticosteroids (Systemic). Risk D: Consider therapy modification Lenalidomide: Dexamethasone (Systemic) may enhance the thrombogenic effect of Lenalidomide. Risk D: Consider therapy modification Loop Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Loop Diuretics. Exceptions: Azithromycin (Systemic). Mifepristone may increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy Isoniazid: Corticosteroids (Systemic) may decrease the serum concentration of Isoniazid. Fidaxomicin.250 mg/day up to 4. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Risk X: Avoid combination Ivacaftor: May increase the serum concentration of CYP3A4 Substrates. should be considered. Risk D: Consider therapy modification Mifepristone: May diminish the therapeutic effect of Corticosteroids (Systemic). a gradual increase in ixabepilone dose from 40 mg/m to 60 mg/m (given as a 4hour infusion). consider titrating lapatinib gradually from 1. If this combination must be 2 2 used. Management: Increase maraviroc adult dose to 600 mg twice daily when used with strong CYP3A4 inducers.

Risk X: Avoid combination P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of Pglycoprotein/ABCB1 Substrates. etc. Risk X: Avoid combination Nisoldipine: CYP3A4 Inducers (Strong) may decrease the serum concentration of Nisoldipine. Risk C: Monitor therapy P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of Pglycoprotein/ABCB1 Substrates.or conditions (e. brain. carbamazepine.. At least one specific brand of nifedipine (Adalat CC) lists this combination as contraindicated.).g. may occur. Risk D: Consider therapy modification NIFEdipine: CYP3A4 Inducers (Strong) may decrease the serum concentration of NIFEdipine. Management: Consider alternatives to nifedipine for patients who are using strong CYP3A4 inducers. the risk of concurrent infection may be increased. testes.).g. for immunosuppression following transplantation). Specifically. Risk D: Consider therapy modification Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab.. T-lymphocytes. Management: Avoid use of perampanel with strong CYP3A inducers other than enzymeinducing antiepileptic drugs (EIAEDs).g. Risk X: Avoid combination NSAID (COX-2 Inhibitor): Corticosteroids (Systemic) may enhance the adverse/toxic effect of NSAID (COX-2 Inhibitor). possibly progressing to polyneuropathies and myopathies. Risk C: Monitor therapy . Risk D: Consider therapy modification Nilotinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Nilotinib. etc. Increased muscle weakness. Risk C: Monitor therapy NSAID (Nonselective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of NSAID (Nonselective). or oxcarbazepine. Risk C: Monitor therapy P-glycoprotein/ABCB1 Substrates: P-glycoprotein/ABCB1 Inducers may decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. Corticosteroid effects may be reduced by mifepristone treatment. Increase perampanel starting dose to 4 mg/day when used with EIAEDs such as phenytoin.). P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where pglycoprotein is present in large amounts (e. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where pglycoprotein is present in large amounts (e.. T-lymphocytes. brain. brain.g. Risk X: Avoid combination Neuromuscular-Blocking Agents (Nondepolarizing): May enhance the adverse neuromuscular effect of Corticosteroids (Systemic). etc. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e. Risk X: Avoid combination Perampanel: CYP3A4 Inducers (Strong) may decrease the serum concentration of Perampanel. Risk X: Avoid combination Mitotane: May decrease the serum concentration of Corticosteroids (Systemic). testes..Risk C: Monitor therapy Pazopanib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Pazopanib. T-lymphocytes. testes.

Risk C: Monitor therapy SORAfenib: CYP3A4 Inducers (Strong) may decrease the serum concentration of SORAfenib. Rifampin may be resumed the day following praziquantel completion. Risk X: Avoid combination Rivaroxaban: CYP3A4 Inducers (Strong) may decrease the serum concentration of Rivaroxaban. Discontinue rifampin 4 weeks prior to initiation of praziquantel therapy. Risk X: Avoid combination Primidone: May decrease the serum concentration of Corticosteroids (Systemic). Management: Avoid concomitant use of praziquantel with strong CYP3A4 inducers. Reduce the quetiapine dose back to the previous/regular dose within 7-14 days of discontinuing the inducer. Risk D: Consider therapy modification Quinolone Antibiotics: May enhance the adverse/toxic effect of Corticosteroids (Systemic). Risk X: Avoid combination Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Risk of tendon-related side effects. may be enhanced. Risk X: Avoid combination Salicylates: May enhance the adverse/toxic effect of Corticosteroids (Systemic). Risk D: Consider therapy modification RomiDEPsin: CYP3A4 Inducers (Strong) may decrease the serum concentration of RomiDEPsin. These specifically include gastrointestinal ulceration and bleeding. Risk X: Avoid combination . Withdrawal of corticosteroids may result in salicylate toxicity. Risk C: Monitor therapy Ranolazine: CYP3A4 Inducers (Strong) may decrease the serum concentration of Ranolazine. Risk X: Avoid combination Rifamycin Derivatives: May increase the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy Rilpivirine: Dexamethasone (Systemic) may decrease the serum concentration of Rilpivirine. Risk C: Monitor therapy QUEtiapine: CYP3A4 Inducers (Strong) may decrease the serum concentration of QUEtiapine.Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Risk X: Avoid combination Ponatinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Ponatinib. including tendonitis and rupture. Risk C: Monitor therapy Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Risk X: Avoid combination Regorafenib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Regorafenib. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Management: Quetiapine dose increases to as much as 5 times the regular dose may be required to maintain therapeutic benefit. Risk X: Avoid combination Praziquantel: CYP3A4 Inducers (Strong) may decrease the serum concentration of Praziquantel. Risk X: Avoid combination Pomalidomide: P-glycoprotein/ABCB1 Inducers may decrease the serum concentration of Pomalidomide.

Risk D: Consider therapy modification Thalidomide: Dexamethasone (Systemic) may enhance the dermatologic adverse effect of Thalidomide. Risk X: Avoid combination Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk X: Avoid combination Tadalafil: CYP3A4 Inducers (Strong) may decrease the serum concentration of Tadalafil. employ extra caution and monitor closely for excessive corticosteroid effects and diminished telaprevir effects. and this warning seems to particularly focused on more potent immunosuppressants.SUNItinib: CYP3A4 Inducers (Strong) may decrease the serum concentration of SUNItinib. Avoid use of tadalafil for pulmonary arterial hypertension in patients receiving a strong CYP3A4 inducer. consider alternatives. Risk D: Consider therapy modification Thiazide Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide Diuretics. Telaprevir may increase the serum concentration of Corticosteroids (Systemic). Risk D: Consider therapy modification Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Risk X: Avoid combination Toremifene: CYP3A4 Inducers (Strong) may decrease the serum concentration of Toremifene. Risk D: Consider therapy modification Telaprevir: Corticosteroids (Systemic) may decrease the serum concentration of Telaprevir.no standard dose adjustments recommended. Corticosteroids may decrease the serum concentration of Telaprevir. Management: Concurrent use with antirheumatic doses of methotrexate or other nondisease modifying antirheumatic drugs (non-DMARDs) is permitted. When possible. Management: If concurrent use is necessary. Management: Concurrent use of telaprevir and systemic corticosteroids is not recommended. consider increasing sunitinib dose and monitor clinical response and toxicity closely. Management: Avoid when possible. Risk X: Avoid combination Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Risk C: Monitor therapy . When possible. If used together. Risk C: Monitor therapy Ticagrelor: CYP3A4 Inducers (Strong) may decrease serum concentrations of the active metabolite(s) of Ticagrelor. increased doses of tolvaptan (with close monitoring for toxicity and clinical response) may be needed. Risk D: Consider therapy modification Telaprevir: May increase the serum concentration of Corticosteroids. Management: Concurrent use of telaprevir and systemic corticosteroids is not recommended. Risk C: Monitor therapy Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination Tolvaptan: CYP3A4 Inducers (Strong) may decrease the serum concentration of Tolvaptan. CYP3A4 Inducers (Strong) may decrease the serum concentration of Ticagrelor. consider alternatives. Management: Erectile dysfunction: monitor for decreased effectiveness . employ extra caution and monitor closely for excessive corticosteroid effects and diminished telaprevir effects. If such a combination cannot be avoided. If used together. Dexamethasone (Systemic) may enhance the thrombogenic effect of Thalidomide.

Risk X: Avoid combination Vemurafenib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Vemurafenib. More specifically. Due to its positive effect on stimulating fetal lung maturation. Risk D: Consider therapy modification Vandetanib: CYP3A4 Inducers (Strong) may decrease the serum concentration of Vandetanib. Women exposed to dexamethasone during pregnancy for the treatment of an autoimmune disease may contact the OTIS Autoimmune Diseases Study at 877-311-8972. Risk C: Monitor therapy Vaccines (Live): Corticosteroids (Systemic) may enhance the adverse/toxic effect of Vaccines (Live). Pregnancy Risk Factor C (show table) Pregnancy Implications Adverse events have been observed with corticosteroids in animal reproduction studies. Food: Dexamethasone interferes with calcium absorption. Herb/Nutraceutical: Avoid cat's claw. and is partially metabolized to an inactive metabolite by placental enzymes. Risk C: Monitor therapy Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Risk C: Monitor therapy Ethanol/Nutrition/Herb Interactions Ethanol: Avoid ethanol (may enhance gastric mucosal irritation). thereby increasing the doses of Urea Cycle Disorder Agents needed to maintain these concentrations in the target range. Risk C: Monitor therapy Urea Cycle Disorder Agents: Corticosteroids (Systemic) may diminish the therapeutic effect of Urea Cycle Disorder Agents. Risk X: Avoid combination VinCRIStine (Liposomal): P-glycoprotein/ABCB1 Inducers may decrease the serum concentration of VinCRIStine (Liposomal). Limit caffeine. Lactation . Risk C: Monitor therapy VinCRIStine (Liposomal): CYP3A4 Inducers (Strong) may decrease the serum concentration of VinCRIStine (Liposomal). Risk X: Avoid combination Warfarin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Warfarin.Ulipristal: CYP3A4 Inducers (Strong) may decrease the serum concentration of Ulipristal. the injection is often used in patients with premature labor (24-34 weeks gestation). Dexamethasone crosses the placenta. Some studies have shown an association between first trimester systemic corticosteroid use and oral clefts. adverse events in the fetus/neonate have been noted in case reports following large doses of systemic corticosteroids during pregnancy. Corticosteroids (Systemic) may increase protein catabolism and plasma ammonia concentrations. echinacea (have immunostimulant properties). Risk C: Monitor therapy Zuclopenthixol: CYP3A4 Inducers (Strong) may decrease the serum concentration of Zuclopenthixol.

54 4 mg (100): $64.69 Solution (Dexamethasone Sod Phosphate PF Injection) 10 mg/mL (1 mL): $3.5 mg/5 mL (240 mL): $63.07 Tablets (DexPak 10 Day Oral) 1.5 mg (100): $27.36 Tablets (DexPak 6 Day Oral) .25 6 mg (100): $107.68 Solution (Dexamethasone Oral) 0.75 mg (100): $36.S.5 mg/5 mL (237 mL): $63.Excretion in breast milk unknown/use caution Breast-Feeding Considerations Corticosteroids are excreted in human milk.76 0.5 mg (35): $44.10 Elixir (Dexamethasone Oral) 0.34 10 mg/mL (10 mL): $4. vitamin D.80 Tablets (Dexamethasone Oral) 0. (Medi-Span®) Concentrate (Dexamethasone Intensol Oral) 1 mg/mL (30 mL): $23. Dietary Considerations May be taken with meals to decrease GI upset.14 2 mg (100): $68. vitamin C.5 mg (51): $51.39 1 mg (100): $35.00 1.5 mg (100): $20. pyridoxine. folate. and phosphorus. Pricing: U.74 Elixir (Baycadron Oral) 0. information specific to dexamethasone has not been located.88 Solution (Dexamethasone Sodium Phosphate Injection) 4 mg/mL (5 mL): $2.94 Tablets (DexPak 13 Day Oral) 1. calcium. May need diet with increased potassium.5 mg/5 mL (237 mL): $79.

. and as such should not be used to set or adjudicate any prices for charging or reimbursement functions.  Cortidex (ID).20 Disclaimer: The pricing data provided represent a median AWP and/or AAWP price for the brand and/or generic product. DO. overnight: 8 AM cortisol <6 mcg/100 mL (dexamethasone 1 mg).  Alin (CR.  BiDexol (TH). GT. growth in children Reference Range Dexamethasone suppression test.  Corodex (UY).1. plasma cortisol determination should be made on the day after giving dose International Brand Names  Aacidexam (BE).  Cortidexason (DE). glucose. serum potassium. The pricing data should be used for benchmarking purposes only.  Cortyk (CN).  Cordex (PH). NI. Pricing data is updated monthly. occult blood loss. respectively. Monitoring Parameters Hemoglobin.5 mg (21): $31. SV).  Coenkasu (TW). PA.

MR. LR. TN. MW. NE. EG.  Dexacortal (SE). KE. GN. MA.  Decadronal (BR). QA. NG. BH. SC. CY.  Decilone (PH).  Dectancyl (AE. KW. SG). CO. PT.  Dexagel (TH).  Decdan (IN). PY. CI. LY. LB. GM.  Dexacort (PE). BR. PK. SD. EC. SN. UG. BF. ZW).  Decasone (ZA). IQ.  Desalark (IT). FR. Decadron (AR. DE. IT. GH. ET. JO. ML. SL. ZM. .  Decan (PH. MU. GR. TZ. SA. BJ. SY. IR.  Dexacort Forte (IL).  Dexaflam (DE). OM. YE).  Demexam (EC).

NZ). KW. JO.  Dexasone (HK. CZ. .  Dexmethsone (AU. SG).   Dexano (TH).  Dexalocal (CR.  Dexona (AE. Dexasolone (KP). SY. NI. IQ. DE. RU). SA. EG. QA. TH).  Dexametason (FI).  Oftan-Dexa (FI).  Lodexa (TH). NO. BG. LY. CY. CH.  Fortecortin (AT. YE).  Dexamed (CZ. BH. Dexalone (MY).  Dexazone (TW). HN. IN. PA. SV). NZ). OM. LB. IR.  Dexamethasone (IL.  Dexamin (VE).

YE. ET. LY. acetate is a long-acting repository preparation . KW. TN. OM. LB. IQ.  Spersadex (NO). MR. Onadron (TR). KE. SL.   Supertendin (DE). SN. CY. BJ.  Wymesone (IN) Mechanism of Action Decreases inflammation by suppression of neutrophil migration. GH. TW. UG. Pharmacodynamics/Kinetics Onset of action: Acetate: Prompt Duration of metabolic effect: 72 hours. NE. ZM. JO. and reversal of increased capillary permeability. TZ. PH. GM. SA. SD.  Roximeth (MY). SC. decreased production of inflammatory mediators. SY.  Penatone (MY).  Santeson (PH). PE. GR. NL. suppresses normal immune response. MU. Dexamethasone's mechanism of antiemetic activity is unknown. MA. GN. ML. ZW). CI. IR. PT. BH. MW. CN. FI. NG. LR. Thilodexine (GR). EG.  Visumetazone (IT). BF.  Vexamet (PH).  Oradexon (AE. QA.

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