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Composition : PROTAMINE-50MG/5ML
Description : PROTA 50MG/5ML INJ
Route Of Administration : PARENTERAL
Pack : 1

Drug Ingredient Information



Information for patients
Drug Information Protamine Sulfate (protamine (protamines) s) Injection, USP is indicated in the treatment of heparin overdosage.
Drug Alert
Alert Hyperheparinemia or bleeding has been reported in experimental animals and in some patients 30 minutes to 18 hours after cardiac surgery (under cardiopulmonary bypass) in spite of complete neutralization of heparin by adequate doses of protamine sulfate (protamine (protamines) s) at the end of the operation. Therefore, it is important to keep the patient under close observation after cardiac surgery. Additional doses of protamine sulfate (protamine (protamines) s) should be administered if indicated by coagulation studies, such as the heparin titration test with protamine (protamines) and the determination of plasma thrombin time. Too-rapid administration of protamine sulfate (protamine (protamines) s) can cause severe hypotensive and anaphylactoid-like reactions Facilities to treat shock should be available.
Before Consuming the Medicine
Avoid Drug Because of the anticoagulant effect of protamine (protamines) , it is unwise to give more than 100 mg over a short period unless there is certain knowledge of a larger requirement. Previous exposure to protamine (protamines) through use of protamine (protamines) -containing insulins or during heparin neutralization may predispose susceptible individuals to the development of untoward reactions from the subsequent use of this drug. Reports of the presence of antiprotamine (protamines) antibodies in the serums of infertile or vasectomized men suggest that some of these individuals may react to the use of protamine (protamines) sulfate. Patients with a history of allergy to fish may develop hypersensitivity reactions to protamine (protamines) , although to date no relationship has been established between allergic reactions to protamine (protamines) and fish allergy.
Drug Special Care Carcinogenesis, Mutagenesis, Impairment of Fertility Studies have not been performed to determine potential for carcinogenicity,mutagenicity or impairment of fertility Usage in Children Safety and effectiveness in children have not been established.
Drug Drug Interactions Protamine sulfate (protamine (protamines) s) has been shown to be incompatible with certain antibiotics, including several of the cephalosporins and penicillins
Drug Pregnancy Interaction Animal reproduction studies have not been conducted with protamine sulfate (protamine (protamines) s) . It is also not known whether protamine sulfate (protamine (protamines) s) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Protamine sulfate (protamine (protamines) s) should be given to a pregnant woman only if clearly needed.
Drug Breast feeding Interaction It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when protamine sulfate (protamine (protamines) s) is administered to a nursing woman.
Drug Machinery Interaction no data available
Drug More Information no data available
How to take the Medicine
Consumption Info Protamine sulfate (protamine (protamines) s) is contraindicated in patients who have shown previous intolerance to the drug.
Drug quanitty Each mg of protamine sulfate (protamine (protamines) s) will neutralize approximately 90 USP units of heparin activity derived from beef lung tissue or about 115 USP units of heparin activity derived from porcine intestinal mucosa. Protamine Sulfate (protamine (protamines) s) Injection,USP should be given by very slow intravenous injection in doses not to exceed 50 mg of protamine sulfate (protamine (protamines) s) in any 10-minute period (see WARNINGS). Protamine sulfate (protamine (protamines) s) is intended for injection without further dilution; however,if further dilution is desired, 5% Dextrose Injection,or 0.9% Sodium Chloride Injection may be used. Diluted solutions should not be stored since they contain no preservative. Protamine sulfate (protamine (protamines) s) should not be mixed with other drugs without knowledge of their compatibility, because protamine sulfate (protamine (protamines) s) has been shown to be incompatible with certain antibiotics,including several of the cephalosporins and penicillins. Because heparin disappears rapidly from the circulation, the dose of protamine (protamines) sulfate required also decreases rapidly with the time elapsed following intravenous injection of heparin.For example, if the protamine sulfate (protamine (protamines) s) is administered 30 minutes after the heparin, one-half the usual dose may be sufficient.
Drug Dose no data available
Excess Drug Consumption Because of the anticoagulant effect of protamine sulfate (protamine (protamines) s) , overdosage of this drug may theoretically result in hemorrhage.However, in one study, overdosage of 600 to 800 mg of intravenous protamine sulfate (protamine (protamines) s) had only minimal, transient effects on blood coagulation tests.The patient should be followed with coagulation studies and treated symptomatically.
Forgot Drug Consumption contact your doctor
Stop Drug Consumption do not stop the medicine before informing your doctor
Possible Side Effects
General Information no data available
Common Drug Side Effects Intravenous injections of protamine (protamines) may cause a sudden fall in blood pressure, bradycardia, pulmonary hypertension, dyspnea, or transitory flushing and a feeling of warmth. There have been reports of anaphylaxis that resulted in respiratory embarrassment (see PRECAUTIONS).Other reported adverse reactions include systemic hypertension, nausea, vomiting and lassitude. Back pain has been reported rarely in conscious patients undergoing such procedures as cardiac catheterization. Because fatal reactions often resembling anaphylaxis have been reported after administration of protamine sulfate (protamine (protamines) s) , the drug should be given only when resuscitation techniques and treatment of anaphylactoid shock are readily available.
Rare Drug Side Effects no data available
Very Rare Drug Side Effects no data available
Drug Side Effects Symptoms no data available
How to Store the Medicine
How to Store the Medicine Consult your pharmacist. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

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