Phytomenadione = Vitamin K1 Injectable

Generic Name: Phytomenadione

Brand Names:

Availability: Easily Available

Drug Class: Vitamin Supplementation

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 treatedwith enzyme-inducing antituberculosis drugs (rifampicin, rifabutin) 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