Phytomenadione (Vitamin K1)

The pinned product, Konakion MM 10 mg/ml solution for injection (eMC product 9755), is licensed in section 4.1 'as an antidote to anticoagulant drugs of the coumarin type in the treatment of haemorrhage or threatened haemorrhage, associated with a low blood level of prothrombin or factor VII', and is the adult/adolescent 10 mg/1 ml presentation, so the indication matches. ROUTES THIS CARD DOES NOT COVER: oral - this is an injection SPC ('for intravenous injection') and no oral dose is given. The IM route is contraindicated: 'This medicine should not be administered intramuscularly because the IM route exhibits depot characteristics and continued release of vitamin K1 would lead to difficulties with the re-institution of anticoagulation therapy' and IM injections in anticoagulated subjects risk haematoma. Severe haemorrhage: 'The coumarin anticoagulant should be withdrawn' and vitamin K1 given with PCC (or FFP); coagulation profiles must be monitored daily until acceptable levels are reached, more frequently in severe cases. Reversal of anticoagulation prior to surgery: patients who require emergency surgery that can be delayed for 6-12 hours can be given 5 mg intravenous vitamin K1; if surgery cannot be delayed, PCC can be given in addition and the INR checked before surgery. Dosing applies to warfarin: 'There are limited data regarding reversal of the effects of other anticoagulants, such as acenocoumarol or phenprocoumon ... different doses of vitamin K1 may be required.' Vitamin K1 is not an antidote to heparin. Large doses (not more than 40 mg per day) should be avoided if it is intended to continue anticoagulant therapy, as there is no experience above 40 mg per day. Use in patients with mechanical heart valves is generally to be avoided unless there is major bleeding; fresh frozen plasma should be used when such patients are transfused for severe or fatal haemorrhage. Elderly: more sensitive to reversal; dosage at the lower end of the recommended ranges. Infusion in adults: dilute with 55 ml of 5% glucose before slowly infusing, freshly prepared and protected from light; do not dilute or mix with other injectables, but it may be injected into the lower part of an infusion apparatus. Paediatric: not carded here. The SPC advises consulting a haematologist for any child aged 1 to 18 years, states that there have been no dose ranging studies in children with haemorrhage, and directs neonates and babies to the separate Konakion MM Paediatric product; use a children's formulary and specialist advice.