Composition
- Each 1 ml ampoule contains: Phytomenadione 10 mg.
- Each tablet contains: Phytomenadione 10 mg
Properties
Haemokion® (Phytomenadione) is a lipid soluble synthetic analogue of vitamin k1 having the same type and degree of activity as the naturally occurring vitamin k1.
Haemokion® is necessary for the synthesis of blood coagulation factors II, VII, IX and X in the liver.
Haemokion® increases blood coagulation factors within 1 to 2 hours and usually controls hemorrhage within 3 to 6 hours, and a normal prothrombin time may often be obtained 12 to 14 hours after parenteral administration.
Indications
In the prevention and treatment of hypoprothrombinemia caused by vitamin K1 deficiency, e.g.:
- Oral anticoagulant-induced prothrombin deficiency
- Hypoprothrombinemia secondary to conditions limiting absorption or synthesis of vitamin K1 (e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, regional enteritis and prolonged diarrhea)
- Drug- induced hypoprothrombinemia due to interference with vitamin K1 metabolism (e.g., prolonged administration of antibiotics, or high doses of salicylates)
- Prophylaxis and therapy of hemorrhagic disease of the newborn
- Patients receiving prolonged hyperalimentation or total parenteral nutrition
Administration
If possible, discontinue or reduce the dosage of drugs interfering with coagulation mechanisms (e.g., salicylates, antibiotics).
Dose and route of administration depend on severity of condition and response obtained. Avoid oral route when clinical disorder would prevent proper absorption (e.g., biliary fistula or obstructive jaundice)
For mild hemorrhage or tendency to hemorrhage, Haemokion® tablets can be used.
For severe, life threatening hemorrhage, Haemokion® ampoules must be used.
Parental Haemokion® can be administered by subcutaneous, intramuscular, slow intravenous injection or by continues infusion of NaCl 0.9% or dextrose 5% into the lower section of the infusion set.
Dosage
Anticoagulant-induced prothrombin deficiency or hypoprothrombinemia induced by drugs or diseases: 5 mg to 25 mg initially given orally or by parenteral administration. Determine subsequent doses by prothrombin time response or clinical condition.
Hemorrhagic disease of the newborn – Prothylaxis: Single IM dose of 1 mg (0.1 ml of the ampoule) within 1 hour after birth.
Hemorrhagic disease of the newborn – Treatment: 1 mg/kg IM daily for one to three days (may be given orally in milk on the second and third day). Higher doses may be necessary if the mother has been receiving oral anticoagulants.
Prevention of hypoprothrombinemia in patients receiving prolonged hyperalimentation or total parenteral nutrition – Adults: 5-10 mg IM once weekly.
Prevention of hypoprothrombinemia in patients receiving prolonged hyperalimentation or total parenteral nutrition – Children: 2-5 mg IM once weekly.
Precautions
Immediate coagulant effect should not be expected. It takes a minimum of 1 to 2 hours for a measurable improvement in the prothrombin time. Fresh plasma or blood transfusions may be required for severe blood loss or lack of response to vitamin K.
Daily dose in neonates should not exceed 5 mg during the first few days of life on account of the immaturity of the hepatic enzyme system.
Intravenous injection of Haemokion® may, in rare cases, cause severe shock-like reaction. The preparation should, therefore, be given by very slow I.V. injection, or, where appropriate, with continues infusion of NaCl 0.9% or dextrose 5%. Should an anaphylactoid reaction nevertheless occur, I.V. epinephrine should be injected without delay followed by I.V. administration of glucocorticoids. As an additional measure, volume replacement may be performed.
Phytomenadione will not counteract the anticoagulant action of heparin.
How Supplied
- Tablets: Strips of 10 tablet in packs of 1 strip.
- Ampoules: Packs of 3 ampoules.
Storage
Protect from light.
Keep all medicaments out of reach of children
Product of: AMOUN PHARMACEUTICAL CO. El-Obour City, Cairo, Egypt. ATC Code: B02BA01