Protamine Sulfate 10 mg/mL, 50 mg/mL Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 10 mg/mL, 50 mg/mL

Reference Brands: -

Category: Critical Care

Protamine sulfate injection for intravenous reversal of heparin in cardiac surgery, critical care and heparin overdose, for hospital pharmacies, importers, distributors and tender buyers.

Product Description:

Protamine sulfate is a strongly basic, low-molecular-weight protein, traditionally purified from salmon sperm. Its positive charges bind negatively charged heparin into a stable complex with no anticoagulant activity, making it the standard antidote for unfractionated heparin. It reverses low-molecular-weight heparins only partly, leaving some anti-Xa activity. It is given only by slow intravenous injection or infusion. The page lists 10 mg/mL, the usual concentration, and 50 mg/mL; some markets label in heparin-neutralising units, so check the label basis.

Its main use is at the end of cardiopulmonary bypass and other vascular surgery, and in heparin overdose or bleeding. Roughly 1 mg neutralises 100 units of heparin still circulating, with dosing guided by the activated clotting time. Fast injection can cause hypotension, bradycardia, flushing and breathlessness, and severe anaphylactoid reactions occur rarely. Fish allergy, earlier exposure through protamine insulins and vasectomy raise the risk. Excess protamine is itself weakly anticoagulant, so overdosing is avoided.

Sourcing notes. Protamine sulfate is a prescription-only medicine for theatres and critical care. Ask for the CTD or ACTD dossier and the heparin-neutralisation potency assay for each lot, the key quality figure, plus a statement on the source species. Vials are usually kept at 2-8 °C and not frozen, though some products allow room temperature, so confirm the label. Request a CoA with sterility and endotoxin results, the GMP certificate and a CoPP, and state concentration, vial volume and label basis.