Protamine
Class: Antiheparin Agents
CAS Number: 9009-65-8
Warning
Possible severe hypotension, cardiovascular collapse, noncardiogenic pulmonary edema, catastrophic pulmonary vasoconstriction, and pulmonary hypertension with rapid IV injection, high doses, repeated doses, or previous exposure to protamine or protamine-containing drugs (e.g., insulin). Other possible risk factors include known sensitivity to fish, vasectomy, severe left ventricular dysfunction, and abnormal pulmonary hemodynamics. Weigh risk against anticipated benefit of protamine therapy in patients with risk factors. Administer only when facilities and equipment for treatment of such reactions are readily available. (See Sensitivity Reactions under Cautions.)
Protamine should not be used for bleeding that occurs without prior exposure to heparin.
Introduction
Heparin antagonist; prepared from the sperm or mature testes of salmon or related species.
Uses for Protamine
Heparin Overdosage
Treatment of severe heparin overdosage.
Do not use for minor bleeding during heparin therapy. (See Boxed Warning.) Heparin withdrawal usually corrects minor overdosage or bleeding within a few hours.
Heparin Neutralization during Extracorporeal Circulation
Neutralization of heparin administered during extracorporeal circulation† in arterial and cardiac surgery or dialysis procedures.
Heparin Neutralization in Pregnant Women Near Delivery
Neutralization of anticoagulant effect of heparin to reduce risk of bleeding near delivery† in pregnant women receiving heparin therapy who go into spontaneous labor.
Low Molecular Weight Heparin Overdosage
Has been used for treatment of low molecular weight (LMW) heparin (e.g., dalteparin, enoxaparin, tinzaparin [no longer commercially available in the US]) overdosage†. However, neutralization of an LMW heparin is not complete even with multiple doses of protamine. (See Actions.)
Protamine Dosage and Administration
General
Heparin Overdosage
With severe heparin overdosage, discontinue heparin and administer protamine sulfate immediately. Blood transfusions may be required for massive blood loss.
Dose of protamine sulfate determined by dose of heparin received, route of administration, time elapsed since heparin was given, and blood coagulation studies. Generally, 1 mg of protamine sulfate will neutralize no less than 100 units of heparin sodium.
Blood heparin concentrations decrease rapidly after IV administration of heparin; dose of protamine sulfate required in the treatment of IV heparin overdosage also decreases rapidly as time elapses.
Monitor therapeutic response through coagulation studies (aPTT, activated coagulation time [ACT], heparin titration test with protamine, plasma thrombin time).
Additional doses of protamine sulfate may be required in patients with heparin rebound (e.g., as may occur during extrac...
