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Vitamin K1 Injection
10mg/1ml I.M./I.V.
COMPOSITION:
Each 1ml ampoule contains:
Vitamin K1 10mg.
DESCRIPTION:
Vitamin K1 Injection is a yellow, sterile, nonpyrogenic aqueous dispersion available for injection by the intravenous, intramuscular and subcutaneous routes. Each ampoule contains phytonadione 2 or 10 mg, polyoxyethylated fatty acid derivative 70 mg, dextrose, hydrous 37.5 mg in water for injection; benzyl alcohol 9 mg added as preservative. May contain hydrochloric acid for pH adjustment. pH is 6.3 (5.0 to 7.0). Phytonadione is oxygen sensitive.
INDICATIONS AND USAGE:
Vitamin K1 Injection is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity.
Vitamin K1 Injection is indicated in:
1,anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives;
2,prophylaxis and therapy of hemorrhagic disease of the newborn;
3,hypoprothrombinemia due to antibacterial therapy;
4,hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis;
5,other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.
DOSAGE AND ADMINISTRATION:
Vitamin K1 Injection should be given by intramuscular. When intravenous administration is considered unavoidable, the drug should be injected very slowly, not exceeding 1 mg per minute.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Or prescription by the physician.
CONTRAINDICATION:
Hypersensitivity to any component of this medication.
ADVERSE REACTIONS:
Deaths have occurred after intravenous and intramuscular administration. (See Box Warning.)
Transient "flushing sensations" and "peculiar" sensations of taste have been observed, as well as rare instances of dizziness, rapid and weak pulse, profuse sweating, brief hypotension, dyspnea, and cyanosis.
Pain, swelling, and tenderness at the injection site may occur.
The possibility of allergic sensitivity including an anaphylactoid reaction, should be kept in mind.
Infrequently, usually after repeated injection, erythematous, indurated, pruritic plaques have occurred; rarely, these have progressed to scleroderma-like lesions that have persisted for long periods. In other cases, these lesions have resembled erythema perstans.
Hyperbilirubinemia has been observed in the newborn following administration of phytonadione. This has occurred rarely and primarily with doses above those recommended.
STORAGE:
In a cool place and away from light.
PRESENTATION:
Box of 10 ampoules of 1ml
SHELF LIFE:
Three years.
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Audited Supplier 
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