Phytonadione

Clinical summary

Indications and usage Phytonadione Injectable Emulsion 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. Phytonadione Injectable Emulsion is indicated in: 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 hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates. Standard dosing Whenever possible, Phytonadione Injectable Emulsion, USP should be given by the subcutaneous route (See Box Warning). When intravenous administration is considered unavoidable, the drug should be injected very slowly, not exceeding 1 mg per minute. Protect from light at all times. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Directions for Dilution Phytonadione injectable emulsion, USP may be diluted with 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or 5% Dextrose and Sodium Chloride Injection. Benzyl alcohol as a preservative has been associated with toxicity in newborns. Therefore, all of the above diluents should be preservative-free (See WARNINGS ). Other diluents should not be used . When dilutions are indicated, administration should be started immediately after mixture with the diluent, and unused portions of the dilution should be discarded, as well as unused contents of the ampul. Prophylaxis of Hemorrhagic Disease of the Newborn The American Academy of Pediatrics recommends that Phytonadione be given to the newborn. A single intramuscular dose of phytonadione injectable emulsion, USP 0.5 to 1 mg within one hour of birth is recommended. Treatment of Hemorrhagic Disease of the Newborn Empiric administration of Phytonadione should not replace proper laboratory evaluation of the coagulation mechanism. A prompt response (shortening of the prothrombin time in 2 to 4 hours) following administration of Phytonadione is usually diagnostic of hemorrhagic disease of the newborn, and failure to respond indicates another diagnosis or coagulation disorder. Phytonadione injectable emulsion, USP 1 mg should be given either subcutaneously or intramuscularly. Higher doses may be necessary if the mother has been receiving oral anticoagulants. Whole blood or component therapy may be indicated if bleeding is excessive. This therapy, however, does not correct the underlying disorder and phytonadione injectable emulsion, USP should be given concurrently. Anticoagulant-Induced Prothrombin Deficiency in Adults To correct excessively prolonged prothrombin time caused by oral anticoagulant therapy—2.5 to 10 mg or up to 25 mg initially is recommended. In rare instances 50 mg may be required. Frequency and amount of subsequent doses should be determined by prothrombin time response or clinical condition (See WARNINGS ). If in 6 to 8 hours after parenteral administration the prothrombin time has not been shortened satisfactorily, the dose should be repeated. Phytonadione Injectable Emulsion, USP Summary of Dosage Guidelines (See circular text for details) Newborns Dosage Hemorrhagic Disease of the Newborn Prophylaxis 0.5 to 1 mg IM within 1 hour of birth Treatment 1 mg SC or IM (Higher doses may be necessary if the mother has been receiving oral anticoagulants) Adults Initial Dosage Anticoagulant-Induced Prothrombin Deficiency (caused by coumarin or indanedione derivatives) 2.5 mg to 10 mg or up to 25 mg (rarely 50 mg) Hypoprothrombinemia Due to other causes (Antibiotics; Salicylates or other drugs; Factors limiting absorption or synthesis) 2.5 mg to 25 mg or more (rarely up to 50 mg) In the event of shock or excessive blood loss, the use of whole blood or component therapy is indicated. Hypoprothrombinemia Due to Other Causes in Adults A dosage of 2.5 to 25 mg or more (rarely up to 50 mg) is recommended, the amount and route of administration depending upon the severity of the condition and response obtained. If possible, discontinuation or reduction of the dosage of drugs interfering with coagulation mechanisms (such as salicylates; antibiotics) is suggested as an alternative to administering concurrent phytonadione injectable emulsion, USP. The severity of the coagulation disorder should determine whether the immediate administration of phytonadione injectable emulsion, USP is required in addition to discontinuation or reduction of interfering drugs. Contraindications Hypersensitivity to any