Vitamin K (Phytomenadione)

Product: Konakion MM Paediatric / Phytomenadione 2 mg/0.2 ml solution for injection — a 2 mg in 0.2 ml presentation (10 mg per ml). Oral administration uses the oral dispensers supplied in the pack: after breaking the ampoule open, withdraw 0.2 ml of solution into the dispenser up to the mark (0.2 ml = 2 mg vitamin K) and drop the contents directly into the baby's mouth. CAUTION FROM THE LABEL: care is required when calculating and measuring the dose in relation to the baby's weight — ten-times dosing errors are common. For injection volumes of 0.04 ml (0.4 mg) to 0.1 ml (1 mg), 0.5 ml syringes with 0.01 ml graduations are recommended. Oral prophylaxis is insufficient in patients with underlying cholestatic liver disease and malabsorption. Further oral doses in breast-fed infants have been advised, but safety and efficacy data for those additional doses are limited. Treatment of VKDB may need to be accompanied by more immediately effective treatment such as transfusion of blood or blood clotting factors, to compensate for severe blood loss and the delayed response to vitamin K. Administration by intravenous infusion is not recommended because the product must not be diluted or mixed with other parenteral medicines; if required, the dose may be injected into the lower part of an infusion set containing 5% dextrose or 0.9% sodium chloride running at 0.7 ml/minute or faster. SECONDARY INDICATION NOT PUBLISHED AS THIS PAGE'S DOSE — antidote to coumarin-type anticoagulants in infants and children: no dose-ranging studies have been performed, the doses in the SPC are described as suggested only, the intravenous route is mandatory, and it is advisable to consult a haematologist. For patients continuing warfarin the suggested dose for partial reversal is 30 micrograms/kg intravenously (this presentation is only suitable for administering 30 micrograms/kg in children weighing over 13 kg); for complete reversal of a warfarin overdose the suggested dose is 250-300 micrograms/kg intravenously (this presentation is only suitable for that dose in children weighing over 1.6 kg). Vitamin K administration is likely to interfere with warfarin anticoagulation for 2-3 weeks, and the earliest effect of vitamin K treatment is at 4 to 6 hours, so coagulation factor concentrates may be indicated in severe haemorrhage. Paediatric and neonatal dosing should in addition be checked against a children's formulary and local neonatal policy before administration.

This per-kilogram figure is the label's own dose for PRETERM NEONATES OF LESS THAN 36 WEEKS GESTATION WEIGHING LESS THAN 2.5 kg: 0.4 mg/kg (equivalent to 0.04 ml/kg) intramuscularly or intravenously at birth or soon after birth, and the SPC states that this parenteral dose should not be exceeded. It is a single birth dose, not a daily total. Healthy neonates of 36 weeks gestation and older, preterm neonates weighing 2.5 kg or greater, and term neonates at special risk receive a fixed 1 mg parenteral dose instead, not this weight-based dose — see adultDose. SPC weight table for preterm babies at birth: 1 kg, 0.4 mg, 0.04 ml; 1.5 kg, 0.6 mg, 0.06 ml; 2 kg, 0.8 mg, 0.08 ml; 2.5 kg, 1 mg, 0.1 ml; over 2.5 kg, 1 mg, 0.1 ml. CAUTION FROM THE LABEL: care is required when calculating and measuring the dose in relation to the baby's weight — ten-times dosing errors are common; use 0.5 ml syringes with 0.01 ml graduations for volumes of 0.04 ml to 0.1 ml. Parenteral administration to premature babies weighing less than 2.5 kg may increase the risk of kernicterus (bilirubin encephalopathy). Verify against a children's formulary and local neonatal policy.