PROTAMINE injectable

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    Prescription under medical supervision

     

    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 for any one dose

     

    Nadroparin overdosage

    • 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.

    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

    • 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.

    Storage

     
    –  To be kept refrigerated (2 °C to 8 °C)