Each 1 ml ampoule contains 10 mg phytomenadione (phytonadione).
Anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives.
Prophylaxis and therapy of hemorrhagic disease of the newborn.
Hypoprothrombinemia due to antibacterial therapy.
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.
Other drug induced hypoprothrobinemia where it is definitely shown that the result is due to interference with vitamin K metabolism e.g., salicylates.
Protect from light at all times. (See table.)
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Severe reactions, including fatalities, have occurred and immediately after INTRAVENOUS injection of Phytomenadione, and to avoid rapid infusion. Serve reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest.
Transient "flushing sensations" and "peculiar" sensations of taste have been observed, as well as rare instance 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 phytomenadione.
The ampoules should be protected from light. The recommended maximum storage temperature is 25°C and solution should not be frozen. The ampoule solution must be clear when used. Improper storage can cause turbidity or phase separation. In such cases, ampoules must not be used.
B02BA01 - phytomenadione ; Belongs to the class of vitamin K. Used in the treatment of hemorrhage.
Inj (amp) 10 mg/mL x 1's.