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- Neutralisation of the anticoagulant action of unfractionated heparin
- Partial neutralisation of the anticoagulant action of low molecular weight heparin
- Haemorrhagic syndromes resulting from accidental heparin overdosage
Forms and strengths, route of administration
- 50 mg protamine sulfate in 5 ml ampoule (10 mg/ml) for slow IV injection
Concentration may be expressed in antiheparin units (AHU): 1000 AHU = 10 mg.
Depends on the amount of heparin to be neutralised.
- If administered between 0 and 30 minutes after the heparin injection, 1 mg of protamine sulfate (100 AHU) neutralises 100 units of heparin.
- If more than 30 minutes have elapsed since the heparin injection, the dose of protamine to be given should be one half the dose of heparin injected.
- Do not administer more than 50 mg for any one dose
- 1 mg of protamine sulfate (100 AHU) neutralises 100 units of nadroparin. The dose of protamine to be given is equal to that of the nadroparin injected.
- According to clinical response. Monitor coagulation parameters.
Contra-indications, adverse effects, precautions
- May cause: hypotension, bradycardia and dyspnoea; allergic reactions, notably in diabetics treated by protamine-insulin.
- If excessive doses are used, haemorrhage may persist or reappear, as protamine sulfate itself has some anticoagulant activity.
- Administer by very slow IV (over 10 minutes) in order to reduce risks of hypotension and bradycardia.
- Pregnancy: no contra-indication
- Breast-feeding: no contra-indication
- In the case of nadroparin overdose, it is recommended to administer 1 or 2 units of fresh whole blood at the same time to counteract its activity against Factor Xa.
- Anticoagulant effect of protamine may vary according to the origin of the heparin: follow manufacturer's recommendations.
- Protamine sulfate may be used to neutralize the effect of heparin before surgery.
– To be kept refrigerated (2 °C to 8 °C)