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Protamine

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Protamine

INDICATIONS

Protamine Sulfate (protamine (protamines) s) Injection, USP is indicated in the treatment of heparin overdosage.

DOSAGE AND ADMINISTRATION

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.

The dosage of protamine sulfate (protamine (protamines) s) should be guided by blood coagulation studies (see WARNINGS).Parenteral drug products should be visually inspected for particulate matter and discolouration prior to administration, whenever solution and container permit.

Availability

Product Number

C22905 Protamine Sulfate (protamine (protamines) s) Injection, USP 10 mg/mL, 5 mL flip-top vials in packages of 25.

C22930 Protamine Sulfate (protamine (protamines) s) Injection, USP 10 mg/mL, 25 mL fill in a 30 mL flip-top vial, individually packaged.

Store at controlled room temperature, between 15 and 30°C. Do not freeze.

Note: The 25 mL vials are designed for antiheparin treatment in certain cases in which large doses of heparin have been given during surgery and are to be neutralized by large doses of protamine sulfate (protamine (protamines) s) after surgical procedures.

PHARMACEUTICAL PARTNERS OF CANADA, A Division of Abraxis BioScience, Inc. Richmond Hill,ON L4B 3P6. 1-877-821-7724. FDA Rev date: 12/5/2002

Last reviewed on RxList: 11/21/2008
This monograph has been modified to include the generic and brand name in many instances.

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