Inj. K MM paediatric: Each ampoule contains 2 mg of Phytomenadione in 0.2 ml of clear bile acid/lecithin mixed-micelle (MM) solution.
Vitamin K1 is an antagonist of coumarin-type anticoagulants, e.g. Phenprocoumon. It does not, however, neutralise the activity of Heparin; Protamine is the antagonist of Heparin.
Vitamin K1 is ineffective in hereditary hypoprothrombinemia or hypoprothrombinemia induced by severe hepatic failure.
Lack of Vitamin K1 leads to an increased tendency to haemorrhagic disease in the newborn. Vitamin K1 administration, which promotes synthesis of the above-mentioned coagulation factors by the liver, can reverse an abnormal coagulation status and bleeding due to vitamin K1 deficiency.
Prophylaxis and treatment of haemorrhagic disease in the newborn.
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 (equivalent to 0.04 ml/kg) in premature infants weighing less than 2.5 kg (see Precautions).
The size and frequency of further doses should be based on coagulation status.
Use in elderly: Elderly patients tend to be more sensitive to reversal of anticoagulation with Inj. K MM. The dosage for this patient group should therefore be at the lower end of the ranges recommended.
When patients with severely impaired liver function are treated, the formation of prothrombin may be impaired. Therefore, careful monitoring of the coagulation parameters is necessary after administration of Inj. K MM.
In potentially fatal and severe haemorrhage due to overdosage of coumarin anticoagulants, IV injections of Inj. K MM should be accompanied by a more immediately effective treatment, such as transfusions of whole blood or blood-clotting factors. When patients with prosthetic heart valves are given transfusions for the treatment of severe or potentially fatal haemorrhages, fresh frozen plasma should be used.
Large doses of Inj. K should be avoided if it is intended to continue with anticoagulant therapy.
Parenteral administration may be associated with an increased risk of kernicterus in premature infants weighing less than 2.5 kg.
Coadministration of anticonvulsants can impair the action of vitamin K1.