Konakion MM

What it is

KONAKION MM contains phytomenadione (Vitamin K1), which is 2-methyl-3-phytyl-1,4-naphthaquinone. The ampoule contains 10 mg/1 mL phytomenadione in a mixed micelles solution composed of glycocholic acid and lecithin in an aqueous solution.

Approved indications

— Haemorrhage or threatened haemorrhage as a result of severe hypoprothrombinaemia due to overdosage of anticoagulants of the dicoumarol type, or to other forms of hypovitaminosis K such as obstructive jaundice, liver and intestinal disorders, or prolonged administration of antibiotics, sulfonamides or salicylates.

Dosing overview

For severe or life-threatening haemorrhage during anticoagulant therapy, KONAKION MM is given by slow intravenous injection (in at least 30 seconds) in a dose of 5–10 mg together with fresh frozen plasma and prothrombin complex concentrate. For warfarin-induced asymptomatic high INR (5–9), the oral dose is 1.0 to 2.5 mg for initial reversal (with an additional 1.0 to 2.0 mg if INR remains high after 24 hours), or 0.5 to 1.0 mg intravenously; for INR greater than 9, the oral dose is 2.5 to 5.0 mg or 1.0 mg intravenously. In clinically well children over one year with asymptomatic high INR (greater than 8), a single dose of 30 micrograms per kilogram or one tenth of the full intravenous adult dose has been reported to be effective.

Key safety warnings

Vitamin K inhibits the therapeutic effect of coumarin anticoagulants and creates a risk of thrombosis. In patients receiving KONAKION MM to reverse coumarin anticoagulation, restoring blood clotting ability restores the risk of thrombosis, possibly even to an increased extent. Elderly patients tend to be more sensitive to reversal of anticoagulation with KONAKION MM, and dosage in this group should be at the lower end of the recommended range. Careful monitoring of the INR is necessary after administration of KONAKION MM in patients with severely impaired liver function. In severe liver disease, KONAKION MM should be discontinued if no significant effect is noted within 1–2 days after the initial dose.

Contraindications

KONAKION MM is contraindicated in patients with known hypersensitivity to any of its constituents. KONAKION MM should not be used for patients with pronounced allergic diathesis. KONAKION MM ampoules should not be administered intramuscularly as this route exhibits depot characteristics which may cause difficulties in re-institution of anticoagulant therapy, and intramuscular administration of medications to anticoagulated patients carries a risk of haematoma formation. KONAKION MM is contraindicated in pregnant women.

PBS listing

KONAKION MM injection 10 mg in 1 mL is listed on the PBS as one unrestricted item with an ex-manufacturer price of A$11.32.

Regulatory history

KONAKION MM phytomenadione 10 mg/1 mL ampoule was first registered on the Australian Register of Therapeutic Goods on 8 October 1997. A paediatric variant, KONAKION MM PAEDIATRIC phytomenadione 2 mg/0.2 mL injection ampoule, was registered on 7 February 2000.