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GLN-003 Antimicrobial Stewardship Guidelines
GLN-003 Antimicrobial Stewardship Guidelines
GLN-003
Applies to All clinical staff including physicians, pharmacists, nurses, technicians and others
involved in patient care.
1. Introduction
Topics
I- Introduction 5
3. References 92
4. Approvals 95
Definitions:
1. Sequential therapy: changing to the oral version of the same compound .
Example: Levofloxacin 500mg IV Q24H to levofloxacin 500mg PO Q24H.
2. Switch therapy: changing to an oral drug that is a different compound and has the same potency.
Example: Levofloxacin 500mg IV Q24H to ciprofloxacin 500mg PO Q12H.
3. Step-down therapy: changing to an oral drug that is a different compound and has different
frequency, dose, or spectrum of activity.
Example: Ampicillin-sulbactam 1.5gm IV Q6H to amoxicillin-clavulanic acid 875mg/125mg PO
Q12H.
Potential advantages of changing from IV to PO antibiotics
1. Removal of intravenous catheter
2. Reduce length of stay
3. Reduce volume of fluid administered to patient
4. Increase patient satisfaction and comfort
5. Decreased possibility for phlebitis
6. Decreased costs
Criteria for IV to Oral Switch
Functioning GI tract
Receiving other oral medications
Tolerating diet
No nausea, vomiting, or profuse diarrhea
Patient is clinically stable
Absence of life-threatening infection (e.g., bacteremia, endocarditis, febrile neutropenia, meningitis,
osteomyelitis, sepsis, or septic shock)
Patient has received IV therapy for at least 48 hours
Afebrile for >24 hours
Normalizing WBC
Conditions in which SWITCH TO ORAL THERAPY should be considered:
Pneumonia
Skin and soft tissue infections
Urinary tract infections
Uncomplicated gram negative bacteremia
Intra-abdominal infections without deep seated collections.
2- Antimicrobial Resistance:
Antimicrobial resistance is reported as the percentage of isolates resistant to a single agent and as a
resistance rate (the number of resistant isolates, divided by the total number tested, per 1,000 patient-
days).
Antimicrobial resistance is often tracked through the development of an antibiogram in collaboration
with a microbiology laboratory.
Resistance attribution to a facility can occur regardless of ASP activity as when a patient infected with
drug-resistant organisms is transferred among facilities.
3- Antimicrobial Expenditures
Antimicrobial costs can be based on purchased or administered over certain period of time.
Antibiotic cost per patient day
When evaluating costs, it is important to recognize that appropriate ASP interventions may actually
increase costs in cases where higher-cost agents are considered optimal.
4- C.difficile rates:
Number of patients with documented C.difficile infection divided by the number of patients admitted to the
ward over certain period of time.
It can be used as a measurable Adverse Drug Reaction for antibiotic associated C.difficile nosocomial
(confirmed) or antibiotic associated diarrhea (unconfirmed).
5- Interventions:
Tally of the number and type of interventions made and accepted
Drug CrCl > 50 mL/min CrCl 10 – 50 mL/min CrCl < 10 mL/min Intermittent CRRT
Hemodialysis
(IHD)
then 7.5
mg/kg
q24–
48h
Amoxicillin Usual dose: 250 – 500 mg CrCl 10–30: 250 – 500 mg 250 – 500 mg q24h 250 – 500 mg No data
(PO) q8h or 875 mg q12h q12h q24h;
H pylori: 1,000 mg q12h administer
additional dose
at the end of
dialysis
Amoxicillin Usual dose: CrCl 10 – 30: 250 – 500 mg q24h 250-500 mg No data
/clavulanate 250-500mg q8h 250 – 500 mg q12h q24h;
(PO) or 875 mg q12h administer
CAP: 2,000 mg ER q12h additional dose
at the end of
dialysis
Ampicillin Mild/uncomplicated: Mild/uncomplicated: 1 g Mild/uncomplicated Mild/ CVVH:
(IV) 1 – 2 g q6h q6–8h : uncomplicated: 2 g q8–
Meningitis/endovascular: 2 g Meningitis/endovascular: 2 1 g q12h 1 g q12h 12H
q4h g q6–12h Meningitis CVVH
Meningitis/ /endovascular: DF: 2 g
endovascular: 2 g 2 g q12–24h q6–8h
q12–24h; or 1 g q8h Mening
itis
2 g q6h
Ampicillin 1.5 – 3 g q6h CrCl < 30: 1.5 – 3 g q12h CrCl < 15: 1.5 – 3 g 1.5 – 3 g q12– 3 g q6–
/sulbactam q24h 24h Dose daily, 8ha
but after HD on
HD days
Vancomycin 15 – 20 15 – 20
(IV) mg/kg x 1, mg/kg x
then re- 1, then 10
dose per – 15
algorithm mg/kg
q24h
Lincosamides
Clindamycin IV 20-40 mg/kg/day (divided q6-8h)
Macrolides
Azithromycin PO 5-12 mg/kg/day (once daily)
Adverse Effects
i. Red Man Syndrome is characterized by hypotension and/or a maculopapular rash appearing on the face,
neck, trunk, and/or upper extremities.
ii. If this occurs, slow the infusion rate (e.g. to 90-120 mins per 1 gm.) ± increase the dilution volume ±
recommend diphenhydramine 25-50mg premedication.
B. Loading Dose
1. Targeted populations:
▪ Preferred in seriously ill (e.g. severe sepsis or septic shock requiring coverage for S. aureus, meningitis,
pneumonia, osteomyelitis, endocarditis, and bacteremia)
2. Standard load for patients with normal renal function: 25-30mg/kg TBW
Potential indications:
●Structural lung disease (including cystic fibrosis)
●Frequent healthcare exposures
●Prior repeated antibiotic exposures
●Critical illness with severe infection (including central nervous system infections, necrotizing
fasciitis, neutropenic fever, burns)
●Infections due to pathogens with high intrinsic resistance and predilection for developing acquired
resistance during therapy (eg, P. aeruginosa, Burkholderiacepacia, Acinetobacter baumannii)
Goal target attainments by beta-lactam class:
The higher dose of piperacillin-tazobactam (4.5 g) is used case of critical illness, cystic fibrosis or in cases
of infections with pathogens that have high, but still susceptible, MICs to piperacillin-tazobactam when
alternative agents are not appropriate.
Δ Some studies have also used a 3-hour infusion time for cefepime.
פ The higher dose of meropenem is used in patients with infections of the central nervous system or other
life-threatening infections such as necrotizing fasciitis.
Exclusion Criteria:
Monitoring:
Initial Monitoring
Single level drawn 8-12 hours after first dose (from
the start of infusion)
Use nomogram to confirm/modify dosage interval
Only applicable for 7 mg/kg
Gentamicin/tobramycin (7 mg/kg/dose): Plot level
on graph
Amikacin (15 mg/kg/dose): Divide level in half,
then plot on graph
Monitoring:
Timing of Levels
Peaks Troughs
Initial levels 30 minutes after second dose 30-60 minutes before second
dose
Maintenance levels Weekly peaks/troughs for prolonged duration of therapy
Acute renal changes
Changes in dosing regimen
Goal levels
Antibiotic Target Peak Target Trough
Gentamicin/Tobramycin 20 – 30 mcg/mL < 1 – 2 mcg/mL
Amikacin 40 – 60 mcg/mL < 4 – 8 mcg/mL
1. Rationale:
For patients receiving mechanical ventilation, aerosolized antibiotics delivered via an efficient
system may achieve airway-drug concentrations 100–300-fold higher than the MIC of most bacteria,
including MDR pathogens, with reduced systemic toxicity and reduced pressure for selection of
resistant organisms. It can be used also when IV antibiotics may cause deleterious side effects.
There are 4 proposed clinical settings for inhaled antibiotics, including prevention, monotherapy,
adjunct therapy with IV antibiotics, and treatment of extensively drug-resistant and even pan drug-
resistant pathogens.
2016 IDSA Guideline on VAP suggests augmenting parenteral therapy with inhaled antibiotics,
especially for highly resistant bacteria.
All patients receiving aerosolized antibiotics should be pretreated with aerosolized
albuterol 2.5mg prior to each dose.
Aerosolized antibiotics are reserved mainly for adjunctive therapy in these patients with multidrug-
resistant (MDR) pathogens.
3. Literature Review:
1- Retrospective cohort study of patients with microbiologically documented VAP who received i.v. colistin
with or without inhaled colistin. Seventy-eight patients with VAP received i.v. plus inhaled colistin, whereas
43 patients received i.v. colistin alone. The use of inhaled colistin was independently associated with the
cure of VAP in a multivariable analysis (OR 2.53, 95% CI 1.11-5.76). Independent predictors of mortality
were a higher APACHE II score (OR 1.12, 95% CI 1.04-1.20), presence of malignancy (OR 4.11, 95% CI
1.18-14.23) and lower daily dosage of i.v. colistin (OR 0.81, 95% CI 0.68-0.96). The outcome of VAP was
better in patients who received inhaled colistin with i.v. colistin than those who received i.v. colistin alone.
There was no difference in all-cause in-hospital and ICU mortality between the two groups. Randomized
controlled trials are needed to evaluate further the role of inhaled colistin in VAP. (Clin Microbiol Infect.
2010 Aug;16(8):1230-6. doi: 10.1111/j.1469-0691.2009.03040.x. Epub 2009 Sep 2.)
2- A randomized nonblinded controlled trial was performed on ninety patients with VAP. Patients were
randomized into three equal groups: Group I received IV amikacin 20 mg/kg/24 h and meropenem 2 g over
30 min/8 h. Group II received the same as Group I in addition to nebulized amikacin 25 mg/kg/day every 8
h. Group III received IV amikacin 20 mg/kg/24 h, nebulized amikacin 25 mg/kg/day every 8 h, and
meropenem 2 g diluted in 240 ml normal saline over 3 h/8 h. The primary outcome was the clinical outcome
of VAP. Secondary outcomes were microbiological outcome, VAP-related mortality, duration of MV, ICU
stay, and nephrotoxicity.
Results: Group II and Group III compared to Group I showed higher incidence of clinical cure (53.33% in
Group II and 66.67% in Group III vs. 26.67% in Group I, P = 0.007). Group II compared to Group I showed
significant reduction in ventilator days (5.32 ± 1.86 vs. 7.3 ± 2.1 days, respectively, P < 0.001) and reduction
in ICU days (11.87 ± 2.6 vs. 15.3 ± 3.1 days, respectively, P < 0.001). Group III compared to Group II
showed significant reduction in ventilator days (4.22 ± 1.32 vs. 5.32 ± 1.86, respectively, P = 0.011) and
highly significant reduction in ICU days (9.21 ± 1.17 vs. 11.87 ± 2.6, respectively, P < 0.001). All groups
were comparable as regards nephrotoxicity or mortality.
Conclusions: Adding nebulized amikacin to systemic antibiotics in patients with VAP caused by
Gram-negative MDRO may offer efficacy benefits, and the use of extended infusions of meropenem
Measurements and main results: AA eradicated 26 of 27 organisms present at randomization compared with
2 of 23 organisms with placebo (P < 0.0001). AA eradicated the original resistant organism on culture and
Gram stain at end of treatment in 14 out of 16 patients compared with 1 of 11 for placebo (P < 0.001). New
drug resistance to AA was not seen. Compared with AA, resistance to systemic antibiotics significantly
increased in placebo patients (P = 0.03). Compared with placebo, AA significantly reduced Clinical
Pulmonary Infection Score (mean ± SEM, 9.3 ± 2.7 to 5.3 ± 2.6 vs. 8.0 ± 23 to 8.6 ± 2.10; P = 0.0008).
Conclusions: In chronically intubated critically ill patients, AA successfully eradicated existing
MDRO organisms and reduced the pressure from systemic agents for new respiratory resistance.
Clinical trial registered with www.clinicaltrials.gov (NCT 01878643). (Am J Respir Crit Care Med
. 2014 May 15;189(10):1225-33. doi: 10.1164/rccm.201312-2161OC.
4. Adverse events:
Airway irritation that may lead to bronchospasm. Pretreatment with albuterol may prevent this effect.
5. Pharmacokinetics of antibiotics:
Antibiotics with concentration-dependent effects (ie, greater area under the curve/minimum inhibitory
concentration ratio) are typically chosen for aerosolization, as it is possible to achieve high concentrations in
the airway to maximize bacterial killing. Different from time-dependent antibiotics (time over minimum
inhibitory concentration of 90%), concentration-dependent antibiotics do not need to be present in the target
tissue for a long period of time, usually requiring frequent administration.
Meningitis Prophylaxis
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Adult and children > 8 years Doxycycline 100 mg PO BID+ Gentamicin 5 mg/kg IV OD * 7 days
with non-localizing disease OR
Doxycycline 100 mg PO BID+ Rifampin 600-900 mg PO OD *6
weeks
Adult and children > 8 years Doxycycline 100 mg PO BID+ Rifampin 600-900 mg PO OD both *3
with months
spondylitis/arthritis/sacroileitis PLUS, gentamicin IV 5 mg/kg OD for first 7 days
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Risk factors that warrant broad empiric antimicrobial coverage for intra-abdominal infections
Factors associated with mortality
Age >70 years, medical comorbidity
Immunocompromising condition, high severity of illness (ie, sepsis)
Extensive peritoneal involvement or diffuse peritonitis
Delay in initial intervention (source control) >24 hours
Inability to achieve adequate debridement or drainage control
Infection Regimen
Low risk Single agent regimen
community-acquired Ertapenem 1g IV once daily OR
intra-abdominal Piperacillin-tazobactam 3.375g IV every 6 hours
infections Combination regimen with metronidazole
Cefazolin 1 to 2 g IV every 8 hours OR
Cefuroxime 1.5g IV every 8 hours OR
Ceftriaxone 2g IV once daily OR
Cefotaxime 2g IV every 8 hours OR
Ciprofloxacin 400mg IV every 12 hours or 500mg PO q12h OR
Levofloxacin 750mg IV or PO once daily
PLUS:
Metronidazole 500 mg IV or PO every 8 hours
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Therapy of Native Valve Caused by Highly Penicillin-Susceptible VGS and Streptococcus gallolyticus
(bovis)
Empiric regimen No of Comment
weeks
Aqueous crystalline penicillin G sodium 12–18 4 Preferred in most patients >65 y or patients
million U/24 h IV either continuously or in 4 or 6 with impairment of eighth cranial nerve
equally divided doses. function or renal function. Ampicillin 2 g
IV every 4 h is a reasonable alternative to
penicillin if a penicillin shortage exists.
Ceftriaxone sodium 2 g/24 h IV/IM in 1 dose 4
Aqueous crystalline penicillin G sodium 12–18 2 2-wk regimen not intended for patients with
million U/24 h IV either continuously or in 4 or 6 known cardiac or extracardiac abscess or
equally divided doses. OR for those with creatinine clearance of < 20
Ceftriaxone sodium 2 g/24 h IV/IM ml/min, impaired eighth cranial nerve
PLUS function.
Gentamicin sulfate 3 mg/kg per 24 h IV or IM in
1 dose
Vancomycin hydrochloride 30 mg/kg per 24 h IV 4 Vancomycin therapy is reasonable only
in 2 equally divided doses for patients unable to tolerate penicillin or
ceftriaxone.
Therapy of NVE Caused by Strains of VGS and Streptococcus gallolyticus (bovis) Relatively Resistant
to Penicillin
Penicillin G sodium 24 million U/24 h IV either 4 For penicillin-resistant (MIC ≥0.5
continuously or in 4–6 equally divided doses μg/mL) VGS strains with a combination of
PLUS ampicillin or penicillin plus gentamicin.
Ampicillin 2 g IV every 4 h is a
Gentamicin sulfate 3 mg/kg per 24 h IV or IM in reasonable alternative to penicillin
1 dose 2 Ceftriaxone may be a reasonable
alternative treatment option for VGS
isolates that are susceptible to ceftriaxone
Vancomycin hydrochloride 30 mg/kg per 24 h IV 4 Vancomycin therapy is reasonable only
in 2 equally divided doses for patients unable to tolerate penicillin or
ceftriaxone therapy.
Therapy for NVE Caused by Staphylococci
Oxacillin-susceptible strains 6 For penicillin-allergic (non-anaphylactoid
Nafcillin or oxacillin 12 g/24 h IV in 4–6 equally type) patients
divided doses Cefazolin 6 g/24 h IV in 3 equally
divided doses
Oxacillin-resistant strains 6
Therapy for Endocarditis Involving a Native or Prosthetic Valve or Other Prosthetic Material
Resulting from Enterococcus Species Caused by Strains Resistant to Penicillin, Aminoglycosides, and
Vancomycin
Linezolid 600 mg IV or orally every 12 h Cardiac valve replacement may be necessary for cure
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Acute cystitis in adult female without signs or symptoms of upper urinary tract
infections
Urine culture should be Primary regimen Alternative regimen
performed
TMP/SMX double strength 1 tab BID In case of allergy or
ONLY IF: -
for 3 days OR contraindications:
History of multiple
Nitrofurantoin 100 mg orally BID for 5 Ciprofloxacin 250 mg PO
UTIs OR MDRO
days (Not in patients with CrCl <50 Q12H for 3 days OR
infection(s)
ml/min) Cephalexin 500 mg PO Q12H
for 3 days
Amoxicillin/clavulanate PO 1
gm BID
Acute cystitis in adult male
Primary regimen Alternative regimen
TMP/SMX double strength 1-tab BID Amoxicillin/clavulanate PO 1
for 7 days OR gm BID OR
Ciprofloxacin 750 mg PO Q12H for 7 Cefdinir 300 mg BID for 7
days OR days
Levofloxacin 750 mg PO q24h for 7
days OR
Nitrofurantoin 100 mg orally BID for 7
days
Acute pyelonephritis Primary regimen Alternative regimen
Women age 18-40 years, Patients at LOW-RISK for resistant Patients at LOW-RISK for
Temp> 102 F, definite bacteria: resistant bacteria:
costovertebral tenderness
Ciprofloxacin 500 mg PO Q12H for 5- Gentamicin 5 mg/kg q24h
Obtain urine and blood
7 days or 400 mg IV BID
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Risk factors that warrant broad empiric antimicrobial coverage for intra-abdominal infections
Factors associated with mortality
Age >70 years
Medical comorbidity
Immunocompromising condition
High severity of illness (ie, sepsis)
Extensive peritoneal involvement or diffuse peritonitis
Delay in initial intervention (source control) >24 hours
Inability to achieve adequate debridement or drainage control
Factors associated with infection with antibiotic-resistant bacteria
Healthcare-acquired infection
Travel to areas with higher rates of antibiotic-resistant organisms* within the few weeks prior to
infection onset or if antibiotics were received during travel
Known colonization with antibiotic-resistant organisms
Single Agent Regimen
Piperacillin- tazobactam 4.5gm IV /8 hour
Imipenem 500 mg IV /6 hours
Meropenem 1 gm IV /8 hours
Combination regimen
Cefepime 2 gm IV q8h
Ceftazidime 2gm IV q8h
PLUS:
Metronidazole 500mg IV or PO q8h
PLUS (to provide enterococcal coverage, particularly in those with
postoperative infection, immunocompromising condition, valvular heart
disease, or prosthetic intravascular materials)
Ampicillin 2 g IV q4h
Vancomycin 15 to 20 mg/kg IV every q8-12h
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• Stop antibiotics that are no longer indicated, especially broad-‐spectrum antibiotics (fluoroquinolones,
clindamycin, piperacillin-‐tazobactam, cephalosporins) as they increase the risk for CDI
• Stop use of any anti‐diarrheal/ant peristaltic agents
• Consider discontinuation of proton pump inhibitors (PPIs)
• If high clinical suspicion of CDI: initiate antibiotic therapy before laboratory confirmation
RISK FACTORS FOR CDI
≥ 65 years of age
Exposure to antibiotics in previous 90 days
Hospitalization in previous 30 days
Recent GI surgery
Antimicrobial agents that may induce Clostridioides
Frequently associated Occasionally associated Rarely associated
Fluroquinolone Macrolides Aminoglycosides
Clindamycin Trimethoprim/sulphamethoxazole Metronidazole
Cephalosporine (broad spectrum) Vancomycin
Penicillin (broad spectrum) Tetracycline
Clinical definition Treatment
Initial infection
Non severe disease Vancomycin 125 mg orally 4 times daily for 10 days, OR
WBC<15,000 cells/mL Metronidazole 500 mg orally 3 times daily for 10 days¶
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Management
Fever in the first 48 hours and up to 4 days, unlikely to represent wound infection.
No systemic illness Systemic illness
No wound infection, observe. Wound drainage or marked local signs of inflammation
Yes No
Gram stain to rule out streptococci and Seek other sources of
clostridia fever
None Either found
Seek other Open wound, debride,
sources of start penicillin and
fever clindamycin
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2. 2% chlorhexidine gluconate in 70% isopropyl alcohol solution was used for skin preparation. Povidone
iodine was used for skin preparation (povidone iodine was used if patient sensitive or for head and neck
surgeries)
3. The patient’s temperature was maintained above 36°C in the preoperative period (excludes cardiac
surgery)
4. The known diabetic patient’s glucose level was kept < 11 mmol/l throughout the operation.
General Surgery
1. Colorectal 1- Cefazolin 1- Metronidazole 500mg IV
Appendectomy 2 g IV stat (weight<120 kg) Children dose:15mg/kg,
(uncomplicated) 3 g IV stat for weight > 120kg) IV single dose
Repeat dose 4 hours after the PLUS
first dose if still in surgery. Gentamicin 4.5 mg/kg IV.
Children dose: Cefazolin Children dose 2.5mg/kg
30mg/kg) IV single dose
IV
PLUS
Metronidazole 500mg IV stat
Children Metronidazole
dose:15mg/kg IV.
2- Cefuroxime
1.5 gm
Children dose: 50 mg/kg
For colorectal surgery:
In addition to systemic antibiotics and
mechanical bowel preparation (if no
contraindication), the following oral
antibiotic regimen is administered:
Neomycin 1 g of PO PLUS
Erythromycin base 1 g at 1 PM,
2 PM, and 11 PM,
OR
Neomycin 2 g PO PLUS
Metronidazole 2 g PO at 7 PM
and 11 PM the day before an 8
AM operation.
Bariatric surgery
Gastroduodonal 1- Cefazolin 1- Clindamycin
2 g IV stat (weight<120 kg) 900 mg
3 g IV stat for weight > 120kg) Children dose: 10mg/kg IV
Repeat dose 4 hours after the PLUS
first dose if still in surgery.
Levofloxacin
Children dose: Cefazolin
30mg/kg) IV single dose 500 mg IV
2- Cefuroxime 1.5 gm Children dose: 10 mg/kg IV
Children dose: 50 mg/kg
Illeal involvement 1- Cefazolin 1- Metronidazole
2 g IV stat (weight<120 kg) 500mg
3 g IV stat for weight > 120kg) children dose:15mg/kg
Repeat dose 4 hours after the 7.5mg/kg if body weight
first dose if still in surgery. <1.2kg IV single dose
Children dose: Cefazolin PLUS
30mg/kg) IV single dose Levofloxacin
PLUS 500 mg IV
Metronidazole Children dose: 10 mg/kg IV
500mg
children dose:15mg/kg
7.5mg/kg if body weight <1.2kg
IV single dose
2- Cefuroxime 1.5 gm
Children dose: 50 mg/kg
Cardiothoracic
1- Cefazolin 1- Vancomycin IV
2 g IV stat (weight<120 kg) 15-20 mg/kg
3 g IV stat for weight > 120kg)
Plastic
Clean with risk factors or clean- 1- Clindamycin 900mg IV stat
contaminated
Children dose:10mg/kg IV
1-Cefazolin single dose OR
2 g IV stat (weight<120 kg)
3 g IV stat for weight > 120kg) 2- Vancomycin 1 g IV stat
Repeat dose 4 hours after the Children dose: 15 mg/kg IV
first dose if still in surgery.
Children dose: Cefazolin
30mg/kg) IV single dose OR
2- Cefuroxime 1.5 gm
Ophthalmic
Topical Moxifloxacin 1 drop Cefazolin 1–2.5 mg
every 5–15 min for 5 doses at Intracameral
the end of procedure
Cefazolin 100 mg by
subconjunctival injection
3.16 Morris AM. Antimicrobial stewardship programs: appropriate measures and metrics to study their
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3.32 Lipsky, Benjamin A., et al. "Executive summary: 2012 Infectious Diseases Society of America clinical
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