Composition
Inj Per ml: 10 mg (2 mg/0.2 ml) in mixed micelles; amp. Drops 2%: Vitamin K 2%; 2.5 ml. Tab: Vitamin K 10 mg.
Indications & Dosage
Haemorrhage associated with hypoprothrombinae-mia,hypoprothrom binaemia, Vitamin K deficiency: ORAL OR BY SC OR IV INJ: Adults: Initially, 2.6-25 mg, rarely up to 50 mg. Neonatal prophylaxis ofvitamin-K deficiency bleeding: BY IM INJ: 1 mg by single injection at birth. For preterm neonates: 400 mcg/kg (max 1mg) may be given by IV if IM not possible; since IV administration may not provide the prolonged protection of the IM injection, subsequently vitamin K should be given by oral doses. For babies not at risk of bleeding disorders: Orally two doses of a colloidal preparation of phytomenadione 2mg should be given in the first wk, the first dose being given at birth and the second at 47days. For exclusively breast-fed babies, a third dose of phytomenadione 2 mg is given at 1 month of age. alternatively, one dose of 1 mg by mouthat birth to protect from the risk of vitamin K deficiency bleeding in the first wk. For exclusively breast-fed babies, further doses of phytomenadione 1 mg are given orally at weekly intervals for 12 weeks. Neonatal hypoprothrombinaemia or vitamin-K deficiency bleeding: BY IV INJ: Neonate: 1 mg repeated 8 hourly if necessary. Neonatal biliary atresia and liver disease: ORAL: Neonate: 1 mg daily. Reversal of coumarin anticoagulation when continued anticoagulation required or if no significant bleeding: BY IV INJ: Children 1moth-18 yrs, 15-30 mcg/kg (max 1 mg) as a single dose, repeated as necessary. Reversal of coumarin anticoagulation when anticoagulation not required or if significant bleeding; treatment of haemorrhage associated with vitamin-K deficiency: BY IV INJ: 1 month-18 yrs: 250-300 mcg/kg (max 10 mg) as a single dose.
Administration
Whenever possible, give by the SC route. When IV administration is considered unavoidable, inject the drug very slowly, not exceeding 1 mg/min.Dilute in NS, DOW or DONS. All these dilu-ents should be preservative free. Do not use other diluents.
Stability
Store at15C-30.0 (59.F-86.F). Protect from light. Store ampoules in tray until time of use,
Precautions
Elderly, pregnancy, lactation, renal and hepatic impairment, ineffective in hereditary hypoprothrombinaemia, hypoprothrombinemia caused by severe liver disease.
Interactions
Warfarin.
Pregnancy
Caution advised
Lactation
Caution advised
Side Effects
Hyperbilirubinemia, jaundice, anaphylactoid reactions may occur with inj. flushes, sweating, cyanosis. Haemolytic anaemia has been reported rarely in neonates following large doses.