Indications

Prophylaxis and treatment of haemorrhagic disease in the newborn.
Haemorrhage or risk of haemorrhage due to severe hypoprothrombinemia (deficiency of clotting factors II, VII, IX, X) from various causes, including:
- Overdosage of coumarin-type anticoagulants
- Combination with phenylbutazone
- Hypovitaminosis K (e.g., obstructive jaundice, liver/intestinal disorders, prolonged use of antibiotics, sulphonamides, salicylates)
Prevention and treatment of bleeding due to vitamin K deficiency.

Pharmacology

Phytomenadione (Vitamin K1) is a procoagulant factor.
It acts as a cofactor in hepatic carboxylase system, enabling post-translational carboxylation of clotting factors II, VII, IX, X and inhibitors protein C & S.
Deficiency leads to haemorrhagic disease, especially in newborns.
Administration restores synthesis of coagulation factors, reversing abnormal coagulation and bleeding.
Ineffective in hereditary hypoprothrombinemia or hypoprothrombinemia due to severe hepatic failure.

Dosage & Administration

Prophylaxis (Neonates):
- 2 mg orally at birth or just after.
- 2 mg on 4th–5th day.
- 2 mg on 28th–30th day.
- If oral route unsuitable → 2 mg IM or IV.
Children >1 year: 5–10 mg orally.
- Single 1 mg IM if oral doses uncertain (especially breast-fed infants).
Therapy: Initially 1 mg IV, further doses as required based on coagulation status.
Neonates with risk factors (prematurity, birth asphyxia, obstructive jaundice, maternal anticoagulant/antiepileptic use):
- 1 mg IM/IV at birth if oral route unsuitable.
- IM/IV dose should not exceed 0.4 mg/kg in premature infants <2.5 kg.
- Further doses based on coagulation status.
Total protection requires 3 prophylactic oral doses as per schedule.

Interactions

Contraindications

Side Effects

Rare reports of anaphylactoid reactions, venous irritation, or phlebitis after parenteral use.

Precautions & Warnings

Careful monitoring of coagulation parameters is necessary in patients with severe liver impairment.