Phytomenadione (Oral)

Phytomenadione is indicated for the prevention of Vitamin K Deficiency Bleeding (VKDB) in newborn babies.

Vitamin K1 is an essential co-factor in the hepatic synthesis of prothrombin (factor II) and other blood clotting factors (factor VII, IX, X). Vitamin K1 does not readily cross the placenta barrier from mother to child and is poorly excreted in breast milk. Low levels at birth may lead to the development of the hemorrhagic disease of the newborn (HDN). Administration of Phytomenadione promotes the synthesis of essential coagulation factors in the liver and minimizes the risk of Vitamin K1 Deficiency Bleeding (VKDB). After oral administration of Phytomenadione, it is absorbed from small intestine and taken up by the liver, even in the absence of biliary and pancreatic secretions. Its plasma half-life is 2-3 hours.

The contents of Vitamin K1 capsule should be administered by cutting the narrow tubular tip off the capsule and squeezing the liquid into the baby’s mouth.

• One Vitamin K1 (1 mg) capsule is to be administered at birth and another dose should be given if the first dose is spat out.
• For babies who are being exclusively breastfed, a dose of 1 mg once weekly for 12 weeks is recommended for the prevention of late Vitamin K Deficiency Bleeding.

Vitamin K1 acts as an antidote to the anticoagulant drugs of the coumarin type, therefore concomitant use is not recommended except in the treatment of warfarin overdosage. It is not an antidote to heparin.

Further doses of Vitamin K1 soft gelatin capsules should be avoided to any baby showing evidence of hypersensitivity to any of the constituents of the product.

No adverse effects have been associated with oral administration.

Not relevant.

Before giving Vitamin K1, physicians' advice should be taken for babies currently on treatment with warfarin for protein C or protein S deficiency.

Vitamin-K Preparations

Store in a cool and dry place. Protect from light and keep out of reach of children. Do not freeze.