protamine

FDA Drug Profile

Drug Details

Generic Name
protamine
Brand Names
N/A
Application Number
Sponsor
Yuki Gosei Kogyo Co., Ltd.
NDC Codes
1
Dosage Forms
POWDER
Routes
N/A
Active Ingredients
PROTAMINE

Indications and Usage

INDICATIONS AND USAGE: Protamine Sulfate Injection, USP is indicated in the treatment of heparin overdosage.

Warnings

WARNINGS: 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 at the end of the operation. It is important to keep the patient under close observation after cardiac surgery. Additional doses of protamine sulfate should be administered if indicated by coagulation studies, such as the heparin titration test with protamine and the determination of plasma thrombin time. Too-rapid administration of protamine sulfate can cause severe hypotensive and anaphylactoid reactions (see DOSAGE AND ADMINISTRATION and WARNINGS ). Facilities to treat shock should be available.