Finished product reference
Protamine Sulfate
Injection · Parenteral · 10 mg/1mL · 5 mL
- List code
- 1655
- Pharmacologic class
- Heparin antagonist
What it is and how it works
Protamine is a strongly basic protein that combines with strongly acidic heparin to form a stable, inactive complex, neutralising its anticoagulant effect. It only partially reverses low-molecular-weight heparins. In excess, protamine itself has a weak anticoagulant effect.
Indications
Neutralisation of unfractionated heparin after cardiopulmonary bypass, dialysis or overdose; partial reversal of low-molecular-weight heparin.
Dosage and administration (summary)
Given by slow intravenous injection (over about 10 minutes); 1 mg neutralises approximately 100 units of heparin given within the previous 15 minutes, with less required as time passes; maximum 50 mg in a single dose.
Contraindications
Hypersensitivity to protamine.
Warnings and precautions
Rapid injection may cause hypotension, bradycardia, pulmonary hypertension, dyspnoea and anaphylactoid reactions; the risk of hypersensitivity is increased in patients previously exposed to protamine (including protamine-containing insulins), those with fish allergy and vasectomised or infertile men. Monitor coagulation (e.g. aPTT or ACT) to guide dosing.
Storage and supply
Store at 2–8 °C; do not freeze.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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