Phytomenadione (Vitamin K1) is indicated for the following conditions:

• 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, and X) of various causes, including:
• Overdose of coumarin-type anticoagulants
• Combination with phenylbutazone
• Other forms of vitamin K deficiency such as obstructive jaundice, liver and intestinal disorders
• Prolonged use of antibiotics, sulphonamides, or salicylates
• Prevention and treatment of bleeding due to vitamin K deficiency.

Phytomenadione acts as a procoagulant factor. As a component of the hepatic carboxylase system, it is involved in the post-translational carboxylation of clotting factors II (prothrombin), VII, IX, and X, as well as anticoagulant proteins C and S. Phytomenadione is not effective in hereditary hypoprothrombinemia or in cases caused by severe liver failure. Deficiency of vitamin K increases the risk of bleeding, particularly in newborns. Administration of Phytomenadione restores the synthesis of clotting factors in the liver, corrects abnormal coagulation, and controls bleeding caused by vitamin K deficiency.

Prophylaxis: Mild Hemorrhage or hemorrhagic tendency: The usual dose for Neonates is 2 mg orally at or just after birth. Then 2 mg on 4 -5 day and another 2 mg on 28 -30 day orally. If the oral route is unsuitable then 2 mg of drug can be administered by IM or IV route.

Children over 1 year of age: Could be given 5-10 mg orally. A single 1 mg (0.1 ml) dose IM is recommended in children who are not assured of receiving a second oral dose or, in the case of breast-fed children, who are not assured of receiving a third oral dose.

Therapy: Initially, 1 mg by intravenous injection, with further doses as required, based on the clinical picture and coagulation status.

Neonates with special risk factors: Pre-maturity, birth asphyxia (inadequate intake of oxygen by the baby during birth process), obstructive jaundice, inability to swallow, maternal use of anticoagulants or anti-epileptics

• 1 mg intramuscularly or intravenously at birth or shortly after birth if the oral route is unsuitable.
• Intramuscular and intravenous doses should not exceed 0.4 mg/kg in premature infants weighing less than 2.5 kg.
• The size and frequency of further doses should be based on coagulation status.

To ensure a total protection of the newborns, 3 prophylactic doses of Vitamin K should be administered orally following the dosing schedule mentioned above.

Phytomenadione antagonizes the effect of coumarin-type anticoagulants. Concomitant use with anticonvulsant drugs may reduce the effectiveness of vitamin K1.

It is contraindicated in patients with known hypersensitivity to any of its components.

Rare and unconfirmed reports include possible anaphylactoid reactions and venous irritation or phlebitis following parenteral administration of Phytomenadione injection.

Careful monitoring of coagulation parameters is required in patients with severely impaired liver function after administration of Phytomenadione.

Vitamin K preparations

Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.