Protamine sulfate is indicated in the treatment of heparin overdosage.

Each mg of protamine sulfate neutralizes approximately 90 USP units of heparin activity derived from lung tissue or about 115 USP units of heparin activity derived from intestinal mucosa.

Protamine Sulfate Injection should be given by very slow intravenous injection over a 10-minute period in doses not to exceed 50 mg ( see WARNINGS ).

Protamine sulfate is intended for injection without further dilution; however, if further dilution is desired, D5-W or normal saline may be used. Diluted solutions should not be stored since they contain no preservative.

Protamine sulfate should not be mixed with other drugs without knowledge of their compatibility, because protamine sulfate 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 sulfate required also decreases rapidly with the time elapsed following intravenous injection of heparin. For example, if the protamine sulfate is administered 30 minutes after the heparin, one half the usual dose may be sufficient.

The dosage of protamine sulfate should be guided by blood coagulation studies ( see WARNINGS).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Vials:

25 mL (No. 735) (1s) NDC 0002-1462-01

Vials should be stored in the refrigerator between 2° and 8°C (35.6° and 46.4°F).

CAUTION The total dose of protamine sulfate contained in Vials No. 735 is 250 mg of activity in 25 mL.

The large-size vials (No. 735) are designed for antiheparin treatment only when large doses of heparin have been given during surgery and are to be neutralized by large doses of protamine sulfate after surgical procedures.

CAUTION Federal (USA) law prohibits dispensing without prespcription.

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