Each mL ampoule contains: Phytomenadione 10 mg.
Pharmacology: Pharmacodynamics: Phytomenadione is a synthetic preparation of Vitamin K. The presence of vitamin (i.e. Vitamin K or substances with vitamin K activity) is essential for the formation within the body of prothrombin, factor VII, factor IX and factor X and the clotting inhibitors protein C and protein S. Lack of vitamin K leads to an increased tendency to haemorrhagic disease in the newborn. When an antidote to an anticoagulant is necessary it is essential to use vitamin K1 itself, as vitamin K analogues are much less effective. In the mixed micelles solution, vitamin K1 is solubilised by means of a physiological colloidal system, also found in the human body, consisting of lecithin and bile acid. Owing to the absence of organic solvents, the Phytomenadione mixed micelles solution is well tolerated on intravenous administration.
Pharmacokinetics: The fat-soluble vitamin K compounds phytomenadione require the presence of bile for their absorption from the gastrointestinal tract; the water-soluble derivatives can be absorbed in the absence of bile. Vitamin K accumulates mainly in the liver but is stored in the body only for short periods of time. Phytomenadione is rapidly metabolised to more polar metabolites and is excreted In bile and urine as glucuronide and sulfate conjugates.
Phytomenadione (Hematron) Injection is used in the prevention and treatment of hemorrhagic disease of the newborn.
Used for the following coagulation disorders caused by Vitamin K deficiency or interference with Vitamin K activity: Anticoagulant-induced hypoprothrombinemia caused by coumarin derivative; Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism. e.g., salicylates or antibiotics.
Treatment of hypoprothrombinemia secondary to factors limiting absorption or synthesis of Vitamin K.
Prevention of hemorrhagic disease of the newborn: For the prevention of hemorrhagic disease of the newborn, Phytomenadione (Hematron) in doses of 500 mcg-1 mg IM, IV or SC should be administered to the neonate within 1 hour of delivery.
Treatment of hemorrhagic disease of the newborn: For the treatment of hemorrhagic disease of the newborn, the usual dose of Phytomenadione (Hematron) is 1 mg administered IM or subcutaneously. Larger doses maybe required for neonates whose mothers have received anticoagulant therapy during pregnancy.
Anticoagulant induced Hypoprothrombinemia: ADULTS: The usual initial dose of Phytomenadione (Hematron) is 2.5-10 mg administered by IM or subcutaneous injection, although initial doses of up to 25 mg have been used in some patients. In rare instances, larger doses (e.g., 50 mg) may be required. The dose may be repeated 5-8 hours after the first parenteral dose if the initial response is not satisfactory.
CHILDREN/BABIES: The usual initial dose of Phytomenadione (Hematron) is 2.5-10 mg (babies: 11mg) administered by IM or subcutaneous injection. The dose may be repeated 6-8 hours after the first parenteral dose if the initial response is not satisfactory.
Hypoprothrombinemia from other causes: The dose of 2-25 mg may be administered to adults. Up to 50mg may be given.
Hypervitaminosis of vitamin K is unknown. Reintroduction of anti-coagulation may be affected.
Patients with a history of hypersensitivity to Phytomenadione (Hematron).
Patients with hypoprothrombinemia caused by hepatocyte damage.
Patients with cholestasis.
Phytomenadione (Hematron) is relatively non-toxic, however, severe reactions have occurred rarely during or immediately following IV and IM administration. These severe reactions, which may occur in patients receiving Phytomenadione (Hematron) for the first time, resemble hypersensitivity, shock, anaphylaxis such as cardiac and/or respiratory arrest and death. Dilution and slow infusion may not prevent severe reactions; therefore, IV and IM administration of the drug should be restricted to emergency use.
When ampoules are cut, glass fragments may be mixed and may cause side effects. Carefully cut ampoules, particularly when in use with elderly and children.
Should administer with great care to the following patients: Patient who has history and family history of asthma, rash, hives, etc.
Patient who has history of drug hypersensitivity reaction.
Patient with liver disease.
Newborn (especially preterm infant).
The end of pregnancy.
Continuous administration of high dose (hyperbilirubinemia may occurs).
Use in Elderly: Elderly patients are more sensitive to Vitamin K inj. Therefore, the recommended dose should not be exceeded.
Use in Children: Hemolysis, jaundice and hyperbilirubinemia have been reported rarely in neonates, particularly premature neonates following large doses (10-20mg) of Phytomenadione (Hematron). Consult hematologists before administering Phytomenadione (Hematron) to newborn babies. There are reports that the administration of Vitamin K injection may cause a carcinogenic effect in newborn babies. Therefore, Hematron Injection should be indicated only when oral routes of administration are not possible.
The safety of Phytomenadione (Hematron) for use in human pregnancy has not been established. Phytomenadione (Hematron) should not be used in pregnancy and lactating women unless treatment benefit exceeds its risk.
The safety of Phytomenadione (Hematron) for nursing mother has not been established whether this drug is being excreted in human breast milk. Carefully administer to nursing mothers.
Temporary flushing of the face, alteration of taste, dizziness, tachycardia, sweating, brief hypotension, dyspnea, cyanosis, chest constriction and peripheral vascular insufficiency may occur.
Bronchospasm, shock, cardiac and/or respiratory arrest may occur.
Rash, hives or anaphylaxis may occur.
Pain, edema, tenderness, delayed induration, redness, swelling, dermatitis like rash at the injection site may occur. Erythematous and indurated plaques have occurred infrequently, usually after repeated injection; rarely, these have progressed to scleroderma-like lesions that have persisted for long periods of time.
Death from hyperbilirubinemia, severe hemolytic anemia, hemoglobinuria, kernicterus and cerebral injury have been reported rarely in neonates, particularly premature neonates following large doses of Phytomenadione.
Vitamin K1 can reduce the anticoagulation effect of coumarin.
Broad-spectrum antibiotics, quinidine, quinine, high dose of salicylates can reduce the effects of Phytomenadione (Hematron).
Store at temperatures not exceeding 30°C. Protect from light. Do not freeze.
B02BA01 - phytomenadione ; Belongs to the class of vitamin K. Used in the treatment of hemorrhage.
Soln for inj (clear & pale yellow solution in amp) 10 mg/mL x 1 mL x 50's.