"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
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 (see DOSAGE AND ADMINISTRATION). Facilities to treat shock should be available.
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies have not been performed to determine potential for carcinogenicity,mutagenicity or impairment of fertility.
Usage in Pregnancy
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.
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.
Usage in Children
Safety and effectiveness in children have not been established.
Last reviewed on RxList: 11/21/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Protamine Information
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