PROTAMINE injectable

Therapeutic action

• Neutralisation of the anticoagulant action of unfractionated heparin
• Partial neutralisation of the anticoagulant action of low molecular weight heparin

Indications

• 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.

Dosage

Depends on the amount of heparin to be neutralised.

Heparin overdosage

• 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 per dose

Enoxaparin overdosage

• Do not administer more than 50 mg per dose.

Duration

• 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

Remarks

• 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.

Storage