PHYTOMENADIONE = VITAMIN K1 injectable

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    Prescription under medical supervision

     

    Therapeutic action

    • Vitamin, anti-haemorrhagic

    Indications

    • Prophylaxis and treatment of haemorrhagic disease of the newborn

    Forms and strengths, route of administration

    • 2 mg ampoule (10 mg/ml, 0.2 ml), for oral administration, IM or slow IV injection

    Dosage

    Prophylaxis of haemorrhagic disease of the newborn
    By IM route, the day of birth:

    • Neonate < 1.5 kg: 0.5 mg single dose
    • Neonate ≥ 1.5 kg: 1 mg single dose

     

    Treatment of haemorrhagic disease of the newborn
    By IM or slow IV route:
    1 mg every 8 hours if necessary, depending on clinical evolution and coagulation tests results

    Contra-indications, adverse effects, precautions

    • May cause: allergic reactions, especially by IV route; haematoma at IM injection site.
    • Pregnancy: no contra-indication
    • Breast-feeding: no contra-indication

    Remarks

    • Also comes in 10 mg ampoules (10 mg/ml, 1 ml) for use in adults only (treatment of haemorrhage due to antivitamin K agents, etc.) .
    • Vitamin K1 is also used as prophylaxis for neonatal hypoprothrombinemia in mothers treated with enzyme-inducing drugs (rifampicin, rifabutin, phenobarbital, phenytoin, carbamazepine) during pregnancy. Use 10 mg ampoules (10 mg/ml, 1 ml): administer 10 mg/day of vitamin K1 by oral route for 15 days before birth. This maternal prevention does not change the need for IM administration of vitamin K1 in neonates. 
    • Do not dilute or mix with other drugs in the same syringe.

    Storage

     
    – Below 25 °C