overzealous therapy with phytonadione injectable emulsion may restore conditions which originally permitted thromboembolic phenomena. dosage should be kept as low as possible, and prothrombin time should be checked regularly as clinical conditions indicate.repeated large doses of vitamin k are not warranted in liver disease if the response to initial use of the vitamin is unsatisfactory. failure to respond to vitamin k may indicate that the condition being treated is inherently unresponsive to vitamin k. benzyl alcohol has been reported to be associated with a fatal “gasping syndrome” in premature infants. warning: this product contains aluminum that may be toxic. aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. premature neonates are particularly at risk because their kidneys are immature, and they required large amounts of calcium and phosphate solutions, which contain aluminum. research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. tissue loading may occur at even lower rates of administration.

ded, as well as unused contents of the ampule. prophylaxis of hemorrhagic diseas e of the newborn the american academy of pediatrics recommends that phytonadione be given to the newborn. a single intramuscular dose of phytonadione injectable emulsion 0.5 to 1 mg within one hour of birth is recommended. treatment of hemorrhagic diseas e 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 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 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 it (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 ormore (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. the severity of the coagulation disorder should determine whether the immediate administration of phytonadione injectable emulsion is required in addition to discontinuation or reduction of interfering drugs.