Drug Study on Buscopan

Jul 31st, 2010 by kaiastillo

Inhibits muscarinic actions of acetylcholine on autonomic effectors innervated by postganglionic cholinergic neurons. May effect neural pathways originating in the inner ear to inhibit nausea and vomiting. Generic Name: Hyoscine ButylBromide Brand Name: Buscopan Classification: Belladona alkaloid, antimuscarinic Indication & Dosages:
y

Spastic states

Adults: 0.4 to 0.8 mg P.O.
y

Delirium, preanesthetic sedation and obstetric amnesia with analgesics

Adults: 0.3 to 0.65 mg I.V., I.M., or subcutaneously. Dilute solution with sterile water for injection before giving I.V. Children: 0.006mg/kg I.V., I.M., or subcutaneously. Maximum dose, 0.3 mg. Dilute solution with sterile water for solution before giving I.V.
y

To prevent nausea and vomiting from motion sickness

Adults: One Transderm-Scop, formulated to deliver 1mg scopolamine over 3 days, applied to the skin behing the ear at least 4 hours before antiemetic is needed. Or, 0.3 to 0.65 mg hydrobromide I.V., I.M. or subcutaneously. Or, 0.25 to 0.8 mg P.O. 1 hour before exposure to motion. Further doses of 0.25 to 0.8 mg may be given t.i.d., p.r.n. Children: 6 mcg/k or 200 mcg hydrobromide I.V., I.m., or subcutaneously Mode of Action:
y

Inhibits muscarinic actions of acetylcholine on autonomic effectors innervated by postganglionic cholinergic neurons. May effect neural pathways originating in the inner ear to inhibit nausea and vomiting.

Contraindication:
y

Contraindicated in patients with angleclosure glaucoma, obstructive uropathy, obstructive disease of the GI tract, asthma, chronic pulmonary disease, myasthenia gravis, paralytic ileus, intestinal atony, unstable CV status in acute hemorrhage, tachycardia from cardiac insufficiency, or toxic megacolon. Contraindicated in patients with hypersensitive to belladonna or barbiturates. Use cautiously in patients with autonomicneuropathy, hyperthyroidism, coronary artery disease, arrhythmias, heart failure, hypertension, hiatal hernia with ferlux esophagitis, hepatc or renal disease, known as suspected GI infection, or ulcerative colitis. Use cautiously in children.

y y

y

y y y y y y Duvadilan® [tab] Solvay Pharma MIMS Class : Drugs Acting on the Uterus See related Duvadilan tab (Drugs Acting on the Uterus) information Contents Indications Isoxsuprine HCl Prevention & treatment of premature labour & other undesired uterine contractions eg surgical intervention during pregnancy & . bloated feeling. vomiting. nausea. urinary hesitancy. Tell patient that if patch becomes displaced. dizziness) when transdermal system is used for longer than 72 hours. local irritation(with parenteral form). Nursing Responsibilities: y Advise patient to apply patch the night before a planned trip. rash over face or upper trunk. Transderm-Scop is effective if applied 2 or 3 hours before experiencing motion but is more effective if applied 12 hours before. nervousness. vomiting. Transdermal method releases a controlled therapeutic amount of drug. somnolence (with high dosage). headache. Side Effects: y y Frequent: Dry mouth (sometimes severe). restlessness. rambling speech. tachycardia. hot. decreased sweating. Instruct patient to remove one patch before applying another Instruct patient to wash and dry hands thoroughly before and after applying the transdermal patch (on dry skin behind the ear) and before touching the eye because pupil may dilate. visual hallucinations. or flushed skin. paranoid behavior. increased respiratory rate. and psychosis (marked by agitation. flushing. intolerance to light. followed by depression). Occasional: Blurred vision. and delusions. papillary dilation. CNSstimulations. Adverse Reaction: y Overdose may produce temporary paralysis of ciliary muscle. dry.y Use cautiously in patients in hot or humid environments. absence of bowel sounds. Advice patient to wear sunglasses for comfort Urge patient to report urinary hesitancy or urine retention. insomnia. Tell patient to discard patch after removing it and to wash application site thoroughly. EKG abnormalities. palpitations. mental confusion or excitement (particularly in the elderly and children). impotence. Alert patient to possible withdrawal signs or symptoms (nausea. headache. Advice patient that eyes may be ore sensitive to light while wearing patch. constipation. loss of taste. he should remove it and apply another patch on a fresh skin site behind the ear. hyperthermia. drug can cause heat stroke. temporary light-headedness (parenteral form).

Belongs to the class of 2 -amino-1phenylethanol derivative agents. MIMS Class ATC Classification Drugs Acting on the Uterus C04AA01 .Isoxsuprine . Isoxsuprine Hydrochloride Pronouncation: (eye-SOX-you-preen HIGH-droe-KLOR-ide) Class: Peripheral vasodilator Trade Names: Vasodilan .Tablets 20 mg Ads by Google Sinong NagBuscopan? sinongnagbuscopan. Used as peripheral vasodilators. Administration Should be taken with food (Take after meals to minimise GI discomfort.Tablets 20 mg Trade Names: Voxsuprine . Drugs should be given only if the potential benefi t justifies the potential risk to the foetus. Circulatory disturbances 20 mg orally 3-4 times daily or 10 mg parenterally 3 times daily.2-0.). Dosage Immediate suppression of uterine motility 0. View ADR Monitoring Form Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available.phHulaan kung sino'ng nagBuscopan® at puwede kang manalo ng laptop! Infinte Horizons Thailand www.Tablets 10 mg .comDrug Rehab Center Proven Methods In a Proven Drug Treatment Program .Tablets 10 mg .rehab-center-samui.cerclage.com. Adverse Drug Reactions Pregnancy Category (US FDA) Occasional transient palpitations. fall in BP or dizziness (reduce dose).5 mg/min by IV infusion or 10 mg IM 1-2 hrly. Contraindications Recent cerebral hemorrhage. Maintenance: 20 mg 3-4 times daily.

greenlife-herbal. Thousands of recovery cases! Pharmacology Stimulates skeletal beta receptors to produce vasodilation. and cardiac output) and relaxes uterus. SGS. Metabolism Partially conjugated in the blood. At higher doses. Unlabeled Uses Treatment of dysmenorrhea. peripheral vascular disease caused by arteriosclerosis obliterans. 10 min (IV). thromboangiitis obliterans. Indications and Usage Possibly effective for treatment of cerebral vascular insufficiency. Elimination The t 1/2 is approximately 1. Primarily excreted in the urine. inhibits platelet aggregation and decreases blood viscosity. Pharmacokinetics Absorption Well absorbed from the GI tract. heart rate. Raynaud's disease. use during immediate postpartum period. Dosage and Administration Adults .98% Thyroid Disease Cured www. with TGA. Onset 1 h (oral).25 h. Special Populations Neonates The t 1/2 is 1. premature labor. GMP. Contraindications Arterial bleeding. stimulates cardiac function (increased contractility.com100% Natural Herbs.5 to 3 h (near term) and 6 to 8 h (for less mature).

com China Good Copper Sulfate Best Copper Sulfate. vomiting.com .zpcopper.Thrombosisadviser.com. Learn more now! ayurstate. Adverse Reactions Cardiovascular Hypotension. Laboratory Test Interactions None well documented.PO 10 to 20 mg 3 or 4 times daily. with TGA.ph 98% Thyroid Disease Cured 100% Natural Herbs. GI Nausea. Ads by Google Sinong NagBuscopan? Hulaan kung sino'ng nagBuscopan® at puwede kang manalo ng laptop! sinongnagbuscopan. abdominal distress.com Drug Interactions None well documented.ph Heart Disease Learn more about Heart Disease and thrombosis! Visit ThrombosisAdviser www.Feed/Industrial /Tech grade. SGS. weakness. GMP.For long-term storage www. chest pain. CNS Dizziness. Dermatologic Severe rash. Ads by Google Sinong NagBuscopan? Hulaan kung sino'ng nagBuscopan® at puwede kang manalo ng laptop! sinongnagbuscopan. tachycardia. Thousands of recovery cases! www.greenlife-herbal.com.com Enlarged Prostate Facts 50% of Men over 50 have Prostate Enlargement.

lips. swelling of your face. severe rash. blurred vision). chest pain. INDICATIONS For routine management after delivery of the placenta. pounding in chest. fainting. Call your doctor at once if you have any of these serious side effects: y y y y y increased blood pressure (severe headache. seizure (convulsions).. USP (methylergonovine maleate) Injection. pain spreading to the arm or shoulder. difficulty breathing. Read All Potential Side Effects and See Pictures of Methergine » Methergine® (methylergonovine maleate) is a semi-synthetic ergot alkaloid used for the prevention and control ofpostpartum hemorrhage. nausea. Under full obstetric supervision.. tongue. weakness.. subinvolution. flushing. DOSAGE AND ADMINISTR ATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. it may be given in thesecond stage of labor following delivery of the anterior shoulder. chest pain or heavy feeling. stomach pain. Lactation Undetermined. USP DRUG DESCRIPTION WHAT ARE THE POSSIBLE SIDE EFFECTS OF METHYLERGONOVINE (METH ERGINE)? Get emergency medical help if you have any of these signs of an allergic reaction: hives. . Caution patient to avoid sudden position changes to prevent orthostatic hypotension.Precautions Pregnancy Category C . Methergine® (methylergonovine maleate) Tablets. postpartum atony andhemorrhage. feeling light-headed. pounding heartbeat. Patient Information y y Instruct patient to report the following symptoms to health care provider: Fast heartbeat. or throat. vomiting.

Also use with caution during the second stage of labor. Mutagenesis.) Orally One tablet. (SeeINDICATIONS AND USAGE .2 mg. hallucinations. (See WARNINGS. dizziness. 3 or 4 times daily in the puerperium for a maximum of 1 week.V. Hypotension has also been reported. arterial spasm (coronary and peripheral). If I. hepatic or renal involvement. May be repeated as required. Drug Abuse And Dependence Methergine® (methylergonovine maleate) has not been associated with drug abuse or dependence of either a physical or psychological nature. transient chest pains. Animal reproductive studies have not been conducted with Methergine. leg cramps. obliterative vasculardisease. diaphoresis. after delivery of the placenta. 0. WARNINGS This drug should not be administered I. It is also not known whether methylergonovine maleate can cause fetal harm or can affect reproductive capacity.Intramuscularly 1 mL. 0. without a proven causal relationship to the drug product. Carcinogenesis.V. tachycardia. dyspnea. Intravenously Dosage same as intramuscular.) . Intra-arterial or periarterial injection should be strictly avoided. thrombophlebitis. after delivery of the anterior shoulder. Use of Methergine is contraindicated during pregnancy because of its uterotonic effects. and foul taste. PRECAUTIONS General Caution should be exercised in the presence of sepsis. routinely because of the possibility of inducing sudden hypertensive and cerebrovascular accidents. Rarely observed reactions have included:acute myocardial infarction. palpitation. Methergine® (methylergonovine maleate) should be given slowly over a period of no less than 60 seconds with careful monitoring of blood pressure. administration is considered essential as a lifesaving measure. hematuria. Impairment of Fertility No long-term studies have been performed in animals to evaluate carcinogenicpotential. at intervals of 2-4 hours. Nausea and vomiting have occurred occasionally. Pregnancy Category C. The effect of the drug on mutagenesis or fertility has not been determined. The necessity for manual removal of a retained placenta should occur only rarely with proper technique and adequate allowance of time for its spontaneous separation. 1 rash. SIDE EFFECTS The most common adverse reaction is hypertension associated in several cases with seizure and/or headache. nasal congestion. water intoxication. or during the puerperium. There have been rare isolated reports of anaphylaxis. tinnitus. diarrhea. bradycardia.2 mg.

O. hypothermia. removal of offending drug by inducing emesis. H. renal. and in such cases 0. At this dosage level a small quantity of drug appears in mothers' milk. 3. reflecting the greater frequency of decreased hepatic. 3. CONTRAINDICATIONS Hypertension. Novartis Consumer Health. and the rabbit 4. 3 control of peripheral vasospasm with warmth to the extremities if needed. Recommended dosage is 1 tablet (0. the lethal dose in humans has not been established. 4. toxemia. Rx Products. in severe cases followed by hypotension. In general dose selection for an elderly patient should be cautious. Caution should be exercised when Methergine is administered to a nursing woman. 1978. especially if convulsions or coma develop. usually starting at the low end of the dosing range. B. catharsis. shortening the third stage of labor. in one case. a single convulsion. .5. Other reported clinical experience has not identified differences in response between the elderly and younger patients. The oral LD50 (in mg/kg) for the mouse is 187. 5. control of convulsions with standard anticonvulsant agents. Springer-Verlag. and. numbness. andcoma. Treatment of acute overdosage is symptomatic and includes the usual procedures of: 1. 2. 2. hypothermia. Pediatric Use Safety and effectiveness in pediatric patients have not been established. convulsions. However. Berde. rise in blood pressure.Labor and Delivery The uterotonic effect of Methergine is utilized after delivery to assist involution and decrease hemorrhage.2 mg represents an overdose of great magnitude. maintenance of adequate pulmonary ventilation. or cardiac function. Several cases of accidental Methergine injection in newborn infants have been reported. several children 1-3 years of age have accidentally ingested up to 10 tablets (2 mg) with no apparent ill effects. and Schild. abdominal pain. Novartis. 810. Because reports of overdosage with Methergine® (methylergonovine maleate) are infrequent. hypertonicity with jerking movements. New York. p. pregnancy. and supportive diuresis. Also. OVERDOSE Symptoms of acute overdose may include: nausea. 2 the rat 93. vomiting. Geriatric Use Clinical studies of Methergine did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Treatment of Acute Overdosage.2 mg) 3 or 4 times daily.: Ergot Alkaloids and Related Compounds. Medical Services Department. respiratory depression. and of concomitant disease or other drug therapy. recovery occurred in all but one case following a period of respiratory depression. Nursing Mothers Methergine® (methylergonovine maleate) may be administered orally for a maximum of 1 week postpartum to control uterine bleeding. A postpartum patient took 4 tablets at one time in error and reported paresthesias and clamminess as her only symptoms. gastric lavage. tingling of the extremities. and hypersensitivity. Inc. correction of hypotension with pressor drugs as needed.

and the decrease in bioavailability following oral administration is probably a result of first-pass metabolism in the liver. HOW TO USE: Take this medication by mouth with or without food. rate. a mean peak plasma concentration of 5918 ± 1952 pg/mL was observed at 0. and the extent of oral absorption of the I.CLINICAL PHARMACOLOG Y Methergine® (methylergonovine maleate) acts directly on the smooth muscle of the uterus and increases the tone. Many people using this medication do not have serious side effects. nausea. Consult your doctor or pharmacist for more details.1 ± 17. it induces a rapid and sustained tetanic uterotonic effect which shortens the third stage of labor and reduces blood loss. Bioavailability studies conducted in fasting healthy female volunteers have shown that oral absorption of a 0. based upon methylergonovine plasma concentrations. or dizziness may occur. after I.2. withintramuscular injection.2 mg intramuscular injection. administration. cold hands/feet. solution given orally. For a 0. Use this medication regularly to get the most benefit from it. During delivery.M. was found to be equivalent to that of the I. Pharmacokinetic studies following an I. vomiting. A delayed gastrointestinalabsorption (Tmax about 3 hours) of Methergine tablet might be observed inpostpartum women during continuous treatment with this oxytocic agent. bioavailability increased to 78%. Ergot alkaloids are mostly eliminated by hepatic metabolism and excretion. 2-5 minutes.4 mg. Grapefruit can increase the amount of this medication in your bloodstream.41 ± 0. pain/redness/swelling of arms or legs. To help you remember. When given intramuscularly.5 to 12. Tell your doctor immediately if any of these rare but serious side effects occur: fast/slow heartbeat. . and amplitude of rhythmic contractions. The plasma level decline was biphasic with a mean elimination half-life of 3. The onset of action after I.V. The volume of distribution (Vdss/F) of methylergonovine was calculated to be 56.39 hours (range 1. Tell your doctor if your condition persists or worsens.M. Dosage is based on your medical condition and response to treatment.12 ± 0. shortness of breath.82 hours.4 ± 4. usually 3 to 4 times daily for up to 1 week after delivery or as directed by your doctor. 5-10 minutes. and the plasma clearance (CLp/F) was calculated to be 14.5 liters per hour. tell your doctor or pharmacist promptly. Methylergonovine belongs to a class of drugs known as ergot alkaloids.7 hours). the extent of absorption of Methergine solution was about 25% greater than the tablet.21 hours. solution was proportional to the dose following administration of 0. If any of these effects persist or worsen. 0. The extent of absorption of the tablet. SIDE EFFECTS: Headache. The bioavailability after oral administration was reported to be about 60% with no accumulation after repeated doses. injection have shown that methylergonovine is rapidly distributed from plasma to peripheral tissues within 2-3 minutes or less. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor instructs you otherwise. These effects help to decrease bleeding. and 0. Thus. USES:This medication is used after childbirth to help stop bleeding from the uterus. It works by increasing the rate and strength of contractions and the stiffness of the uterus muscles.2 mg methylergonovine tablet was fairly rapid with a mean peak plasma concentration of 3243 ± 1308 pg/mL observed at 1. take it at the same times each day.V. administration is immediate.0 liters.1.M. and after oral administration.

Consult your doctor for more details. use machinery. contact your doctor or pharmacist. This medication passes into breast milk. You may report side effects to Health Canada at 1-866-234-2345 . which is a clear. This is not a complete list of possible side effects. seek immediate medical attention if you notice any symptoms of a serious allergic reaction. but is unlikely to harm a nursing infant. In the US Call your doctor for medical advice about side effects. . Before using this medication. or to similar ergot alkaloids (such as ergonovine). confusion. Do not store in the bathroom. It may harm an unborn baby. tell your doctor or pharmacist if you are allergic to it. seizures.Seek immediate medical attention if any of these rare but serious side effects occur: chest pain. or do any activity that requires alertness until you are sure you can perform such activities safely. itching/swelling (especially of the face/tongue/throat). viscous. liver disease. Consult your doctor before breast-feeding.Call your doctor for medical advice about side effects. high blood pressure. blood vessel disease (such as Raynaud's disease). If you notice other effects not listed above. In Canada . or if you have any other allergies. STORAGE:Store at room temperature below 77 degrees F (25 degrees C) away from light and moisture. severe dizziness. Do not drive. This medication must not be used during pregnancy. tell your doctor or pharmacist your medical history. mitral valve stenosis). USP Phytonadione is a vitamin. which can cause allergic reactions or other problems. Keep all medicines away from children and pets. This product may contain inactive ingredients. This drug may make you dizzy. vision changes. especially of: kidney disease. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. However. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product. including: rash. VITAMIN K1 INJECTION Phytonadione Injectable Emulsion. soluble in chloroform and slightly soluble in ethanol. complications during pregnancy (such as preeclampsia. heart disease (such as venoatrial shunts. odorless or nearly odorless liquid. eclampsia). PRECAUTIONS:Before taking methylergonovine. Talk to your pharmacist for more details. It is insoluble in water. trouble breathing. Limit alcoholic beverages. Properly discard this product when it is expired or no longer needed. yellow to amber. A very serious allergic reaction to this drug is rare. You may report side effects to FDA at 1-800-FDA-1088 .

all of the above diluents should be preservative-free (see WARNINGS). and regional enteritis. however. Whole blood or component therapy may be indicated if bleeding is excessive.) When intravenous administration is considered unavoidable. Benzyl alcohol as a preservative has been associated with toxicity in newborns. 5% Dextrose Injection. Therefore. ulcerative colitis. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Other diluents should not be used. IX and X when caused by vitamin K deficiency or interference with vitamin K activity. or 5% Dextrose and Sodium Chloride Injection. This therapy. Vitamin K 1 Injection 1 mg should be given either subcutaneously or intramuscularly. hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K. A prompt response (shortening of the prothrombin time in 2 to 4 hours) following administration of vitamin K1 is usually diagnostic of hemorrhagic disease of the newborn. (See Box Warning. celiac disease.. Directions for Dilution Vitamin K 1 Injection may be diluted with 0. obstructive jaundice. not exceeding 1 mg per minute. y DOSAGE AND ADMINISTRATION Whenever possible.9% Sodium Chloride Injection. Treatment of Hemorrhagic Disease of the Newborn Empiric administration of vitamin K 1 should not replace proper laboratory evaluation of the coagulation mechanism.. USP) is indicated in the following coagulation disorders which are due to faulty formation of factors II. USP) should be given by the subcutaneous route. prophylaxis and therapy of hemorrhagic disease of the newborn. Vitamin K1 Injection (Phytonadione Injectable Emulsion. . does not correct the underlying disorder and Vitamin K1 Injection should be given concurrently. sprue. Protect from light at all times. Prophylaxis of Hemorrhagic Disease of the Newborn The American Academy of Pediatrics recommends that vitamin K1 be given to the newborn.g. administration should be started immediately after mixture with the diluent. biliary fistula. the drug should be injected very slowly. salicylates. A single intramuscular dose of Vitamin K1 Injection 0. hypoprothrombinemia due to antibacterial therapy. VII.Vitamin K 1 Injection (Phytonadione Injectable Emulsion.5 to 1 mg within one hour of birth is recommended.g. e. cystic fibrosis of the pancreas. intestinal resection. whenever solution and container permit. e. Higher doses may be necessary if the mother has been receiving oral anticoagulants. When dilutions are indicated. as well as unused contents of the ampul. other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism. and failure to respond indicates another diagnosis or coagulation disorder. Vitamin K 1 Injection is indicated in: y y y y anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives. and unused portions of the dilution should be discarded.

Preventing certain bleeding or blood clotting problems. ² hypoprothrombinemia secondary to antibacterial therapy. VII. WARNINGS An immediate coagulant effect should not be expected after administration of phytonadione. since otherwise the oral vitamin K will not be absorbed SIDE EFFECTS Severe hypersensitivity reactions. IX and X when caused by vitamin K deficiency or interference with vitamin K activity.Effective for: y y y Treating and preventing vitamin K deficiency. MEPHYTON is indicated in the following coagulation disorders which are due to faulty formation of factors II. The majority of these reported events occurred following intravenous administration. Transient "flushing sensations" and "peculiar" sensations of taste have been observed with parenteral phytonadione. Reversing the effects of too much warfarin used to prevent blood clotting. Liver disease: Vitamin K is not effective for treating clotting problems caused by severe liver disease. rapid and weak pulse. Hyperbilirubinemia has been observed in the newborn following administration of parenteral phytonadione. In fact. brief hypotension. high doses of vitamin K can make clotting problems worse in these people. Phytonadione will not counteract the anticoagulant action of heparin. profuse sweating. as well as rare instances of dizziness. Most people do not experience any side effects when taking in the recommended amount each day. including anaphylactoid reactions and deaths have been reported following parenteral administration. andcyanosis. dyspnea. ² hypoprothrombinemia secondary to administration of salicylates. Vitamin K is safe for most people. . vitamin K is considered safe for pregnant and breast-feeding women. Kidney disease: Too much vitamin K can be harmful if you are receiving dialysis treatments due to kidney disease. ² hypoprothrombinemia secondary to obstructive jaundice or biliary fistulas but only if bile salts are administered concurrently. MEPHYTON tablets are indicated in: ² anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives. but don't use higher amounts without the advice of your healthcare professional. y Special Precautions & Warnings: y Pregnancy and breast-feeding: When taken in the recommended amount each day. This has occurred rarely and primarily with doses above those recommended.

(See also HOW SUPPLIED. PRECAUTIONS General Vitamin K1 is fairly rapidly degraded by light. always protect MEPHYTON from light. and of concomitant disease or other drug therapy. MEPHYTON at concentrations up to 2000 mcg/plate with or without metabolic activation. It is also not known whether MEPHYTON can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Storage. MEPHYTON should be given to a pregnant woman only if clearly needed.17 g/kg and greater than 24. Mutagenesis. and hyperbilirubinemia in newborns. Because many drugs are excreted in human milk. Nursing Mothers It is not known whether this drug is excreted in human milk. Hemolysis. particularly in premature infants. or cardiac function.) Carcinogenesis. and prothrombin timeshould be checked regularly as clinical conditions indicate. Pregnancy Pregnancy Category C: Animal reproduction studies have not been conducted with MEPHYTON. have been reported with vitamin K.18 g/kg. Store MEPHYTON in closed original carton until contents have been used. renal. Repeated large doses of vitamin K are not warranted in liver disease if the response to initial use of the vitamin is unsatisfactory. jaundice. anticoagulant therapy still being indicated. Geriatric Use Clinical studies of MEPHYTON did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. the patient is again faced with the clotting hazards existing prior to starting the anticoagulant therapy. respectively. but overzealous therapy with vitamin K1 may restore conditions which originally permitted thromboembolic phenomena. dose selection for an elderly patient should be cautious. was negative in the Ames microbial mutagen test. OVERDOSE The intravenous and oral LD50s in the mouse are approximately 1. In general.When vitamin K1 is used to correct excessive anticoagulant-induced hypoprothrombinemia. usually starting at the low end of the dosing range. Failure to respond to vitamin K may indicate a congenital coagulation defect or that the condition being treated is unresponsive to vitamin K. therefore. reflecting the greater frequency of decreased hepatic. caution should be exercised when MEPHYTON is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established with MEPHYTON. Impairment of Fertility Studies of carcinogenicity or impairment of fertility have not been performed with MEPHYTON. Phytonadione is not a clotting agent. Dosage should be kept as low as possible. . Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

phytonadione is initially concentrated in the liver. that is. be sure to take your vitamin K and warfarin exactly as directed by your doctor or pharmacist. severe dizziness. In normal animals and humans. SIDE EFFECTS: Vitamin K usually has very few side effects. PRECAUTIONS:Before taking vitamin K.CONTRAINDICATIONS Hypersensitivity to any component of this medication. A very serious allergic reaction to this drug is rare.. The resulting gammacarboxyglutamic acid residues convert the precursors into activecoagulation factors that are subsequently secreted by liver cells into the blood. in animals and humans deficient in vitamin K. Vitamin K helps to treat and prevent unusual bleeding by increasing the body's production of blood clotting factors. IX. to promote the hepatic biosynthesis of vitamin Kdependent clotting factors.. Almost no free unmetabolized vitamin K appears in bile or urine. If you are using a certain "blood thinner" drug (warfarin). You may need another dose of vitamin K. Low levels of blood clotting factors increase the risk for unusual bleeding. including: rash. and X. remember that he or she has judged that the benefit to you is greater than the risk of side effects. the pharmacological action of vitamin K is related to its normal physiological function. phytonadione is virtually devoid of pharmacodynamic activity. If your doctor has prescribed this medication.. Little is known about the metabolic fate of vitamin K. seek immediate medical attention if you notice any symptoms of a serious allergic reaction. obstructive jaundice). Oral phytonadione is adequately absorbed from the gastrointestinal tract only ifbile salts are present. seek immediate medical attention. If you develop easy bruising or bleeding. vitamin K can decrease the effects of warfarin for up to 2 weeks. or if you have any other allergies. plasma thromboplastin component (factor IX). If you have any unusual effects from taking this medicine. However. and X. which is necessary for the production via the liverof active prothrombin (factor II). itching/swelling (especially of the face/tongue/throat). VII. but the concentration declines rapidly. and Stuart factor (factor X). CLINICAL PHARMACOLOG Y MEPHYTON tablets possess the same type and degree of activity as does naturally-occurring vitamin K. warfarin) or medical conditions (e. proconvertin (factor VII). HOW TO USE: Take this medication by mouth exactly as directed by your doctor. Dosage is based on your medical condition and response to treatment. However. after an accidental cut or injury). specific.g.g. tell your doctor or pharmacist if you are allergic to it. VII. MEPHYTON tablets generally exert their effect within 6 to 10 hours. Many people using this medication do not have serious side effects. tell your doctor or pharmacist promptly.g. Low levels may be caused by certain medications (e.   . peptidebound glutamic acidresidues in inactive hepatic precursors of factors II. The prothrombin test is sensitive to the levels of three of these four factors II. Vitamin K is an essential cofactor for a microsomal enzyme that catalyzes the posttranslational carboxylation of multiple. After absorption. Very little vitamin K accumulates in tissues. Therefore. USES:Vitamin K is used to treat and prevent low levels of certain substances (blood clotting factors) that your body naturally produces. These substances help your blood to thicken and stop bleeding normally (e. trouble breathing.

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in the judgement of the physicia n. Drug Dependence: Nalbuphine HCl cannot be substituted for heroine. vasopressors and other supportive measures should be employed as indicated. driving a car or operating machinery.6. Fetal and neonatal adverse effects that have been reported followin g the administration of nalbuphine to the mother during labor include fetal tachycardia. therefore. Severe and prolonged fetal bradycardia has been reported. it should be administered with caution to ambulatory patients who should be warned to avoid such hazards. It will precipitate abstinence in such patients. IV fluids. It should only be administered to pregnant women (other than in labor) when. Permanent neurological damage attributed to fetal bradycardia has occurred. Abrupt withdrawal after chronic use can precipitate abstinence syndrome. in susceptible individuals. caution should be observed in prescribing it for emotionally unstable patients or for individuals with a history of narcotic abuse. respiratory depression at birth. Use During Labor and Delivery: The placental transfer of nalbuphine is high. the potential benefits outweigh the possible hazards. A sinusoidal fetal heart rate . Psychological and physical dependence and tolerance may follow the misuse or abuse of nalbuphine. apnea and cyanosis. Maternal administration of naloxone during labor has normalized these effects in some cases. In full-term labor. methadone or other narcotics in physically dependent individuals. Nalbuphine HCl has been shown to have a low abuse potential. Therefore. Use in Ambulatory Patients: Nalbuphine HCl may impair the mental or physical abilities required for the performance of potentially dangerous tasks eg. Contraindications Warnings Patients who are hypersensitive to nalbuphine HCl.will usually suffice for mild or moderate overdosage. When nalbuphine HCl is selected for the control of chronic pain. rapid and variable with a maternal -tofetal ratio ranging from 1:0. Potent analgesics should be used with caution in women delivering premature infants. might result in physical dependence and tolerance. Use in Pregnancy: Safe use of nalbuphine HCl in pregnancy (other than labor) has not been established. Oxygen.37 to 1:1. care should be taken to avoid increases in dosage or the frequency of administration which. 10-15 mg of nalbuphine has provided analgesia equivalent to that of 75 113 mg of meperidine with fewer maternal side effects.

Nalbuphine should only be administered when in the judgement of the physician. nalbuphine HCl should be used with caution and administered in reduced amounts. patients with renal or liver dysfunction may over -react to customary doses. headache. vomiting and lightheadedness occur less frequently. the potential benefits outweigh the possible hazards (see Warnings). from other medication. Use in pregnancy & lactation: Caution should be exercised when administered to pregnant and nursing patients. Restlessness. in contrast to morphine. cyanosis or respiratory obstruction). uremia. Nubain should be used with caution in women during labor and delivery. Adverse Drug Reactions The most commonly occurring reactions are sedation. and newborns should be monitored for respiratory depression. However. severe infection. Pain at injection site. sweating. bronchial asthma. Impaired Renal or Hepatic Function: Because nalbuphine HCl is metabolized in the liver and excreted by the kidneys. . chills. in these individu als. However. apnea. Head Injury and Increased Intracranial Pressure: The possible respiratory depressant effects and the potent ial of potent analgesics to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO 2 retention) may be markedly exaggerated in the presence of head injury. drowsiness. Therefore. potent analgesics can produce effects which may obscure the clinical course of patients with head injuries. Special Precautions Impaired Respiration: 10 mg of nalbuphine HCl causes some respiratory depression approximately equivalent to 10 mg of morphine. intracranial lesions or a preexisting increase in intracranial pressure. euphoria and impaired respiration have been infrequent. blurred vision. dry mouth and dizziness.pattern associated with the use of nalbuphine has also been reported. bradycardia and arrhythmias if Nubain has been used. and then should be administered with extreme caution. It should be administered with caution at low doses to patients with impaired respiration (eg. nausea. liver and renal function tests on patients who have received nalbuphine HCl in single and chronic dosages do not reveal any changes attributable to its administra tion. respiratory depression is not appreciably increased with higher doses of nalbuphine HCl. Therefore. nalbuphine HCl should be used in these circumstances only when essential. Respi ratory depression induced by nalbuphine HCl can be reversed by naloxone HCl when indicated. Furthermore.

View more drug interactions for Nubain Pregnancy Category (US FDA) Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal -reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled stud ies in women in the 1 sttrimester (and there is no evidence of a risk in later trimesters). S2 license number and PTR number of the prescribing practitioner shall be stated. general anesthetics. Each mL of Nubain ampoule also contains sodium chloride 2 mg. . visual hallucinations and dysphoria.g. concurrently. Storage Description Store at temperatures not exceeding 30°C. hypnotics or other CNS depressants (including alcohol) concomitantly with nalbuphine HCl may exhibit an additive effect. the dose of one or both agents should be reduced.41 mg and anhydrous citric acid 12. The pharmacist must keep a record of its sales including the name and address of the prescribing physician in an Additional Dangerous Drugs Record Book registered prior to use. pH is adjusted with hydrochloric acid. address and age of the patient . phenothiazines or other tranquilizers. address. but the benefits from use in pregnant women may be acceptable despite the risk (e. patients receiving nar cotic analgesics.62 mg. Category D: There is positive evidence of human foetal risk. sedatives. there is evidence that in non -dependent patients. or just after an injection of nalbuphine HCl. Therefore. Monitoring on the Usage: Prescriptions of Nubain shall be through an ordinary prescription form wherein the name. if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). if prolonged use/high doses at term. it will not antagonize a narcotic analgesic administered just before. When such combined therapy is contemplated.Nubain produces few if any psychotomimetic side effects eg. as well as the name.. Click to view ADR Monitoring Website Drug Interactions With Other Central Nervous System Depressants: Although nalbuphine HCl possesses narcotic antagonistic activity. sodium citrate 9.

Nalbuphine . left ventricular end diastolic pressure and cardiac work. The onset of action occurs within 2-3 min after IV administration of nalbuphine HCl and in <10 min following SC or IM injection. Clinical experience suggests that in some patients.14-triol hydrochloride. 100's. . whether administered IV. Nalbuphine HCl has the effect of lowering the cardiac work load and can be used immediately in myocardial infarction (use with caution where emesis is involved). a minimal decrease in oxygen consumption. cardiac index. naloxone.6 . SC or IM.Local & General / Analgesics (Opioid) N02AF02 .Nalbuphine HCl is (-)-17-(cyclobutylmethyl)-4. 10 mg of which is comparable in analgesic potency to 8 -10 mg of morphine sulfate. Rx Presentation/Packing Amp 10 mg/mL (preservative-free) x 1 mL x 10's. and the potent analgesic. It is a synthetic agonist-antagonist analgesic of the phenanthrene series which is chemically related to both the widely used narcotic antagonist. effects having been observed in acute and chronic pain for 3-8 hrs. analgesia may be longer lasting than from comparable doses of morphine. oxymorphone. The t½ of nalbuphine is 5 hrs. Used to relieve pain. Belongs to the class of morphinan derivative opioids. Hemodynamic studies in patients with severe arteriosclerotic heart changes reveal that nalbuphine HCl has circula tory effects similar to those of morphine ie.5 epoxymorphinan-3. Nalbuphine HCl antagonist activity is ¼ as potent as nalorphine and approximately 1/40 that of naloxone. Mechanism of Action Pharmacology: Nalbuphine HCl is a potent analgesic. MIMS Class ATC Classification Poison Schedule Anaesthetics .

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