PHYTOMENADIONE = VITAMIN K1 injectable

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 -