phytonadione 5 mg
1 INDICATIONS AND USAGE Phytonadione tablets are indicated for the treatment of adults with 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. Anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives. Hypoprothrombinemia secondary to antibacterial therapy. Hypoprothrombinemia secondary to factors limiting absorpsion or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis. Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. Phytonadione is a vitamin K replacement indicated for the treatment of adults with 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: Anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives. (1) Hypoprothrombinemia secondary to antibacterial therapy. (1) 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. (1) Other drug-induced hypoprothrombinemia where it is definitively shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. (1)
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16 HOW SUPPLIED/STORAGE AND HANDLING
PHYTONADIONE Tablets USP, 5 mg are supplied as light yellow to yellow colored, round, scored tablets, debossed with “AA” and “05” on either side of scoring and plain on the other side. They are available as follows: Bottles of 30: NDC 42291-566-30 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Always protect
PHYTONADIONE tablets, USP from light. Store in tightly closed original container and carton until contents have been used.
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