Benzyl alcohol as a preservative in Bacteriostatic Sodium Chloride Injection has been associated with toxicity in newborns. Data are unavailable on the toxicity of other preservatives in this age group. There is no evidence to suggest that the small amount of benzyl alcohol contained in AquaMEPHYTON, when used as recommended, is associated with toxicity.
An immediate coagulant effect should not be expected after administration of phytonadione. It takes a minimum of 1 to 2 hours for measurable improvement in the prothrombin time. Whole blood or component therapy may also be necessary if bleeding is severe.
Phytonadione will not counteract the anticoagulant action of heparin.
When vitamin K1 is used to correct excessive anticoagulant-induced hypoprothrombinemia, anticoagulant therapy still being indicated, the patient is again faced with the clotting hazards existing prior to starting the anticoagulant therapy. Phytonadione is not a clotting agent, but overzealous therapy with vitamin K1 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.
Vitamin K1 is fairly rapidly degraded by light; therefore, always protect AquaMEPHYTON from light. Store AquaMEPHYTON in closed original carton until contents have been used. (See also HOW SUPPLIED, Storage.)
Temporary resistance to prothrombin-depressing anticoagulants may result, especially when larger doses of phytonadione are used. If relatively large doses have been employed, it may be necessary when reinstituting anticoagulant therapy to use somewhat larger doses of the prothrombin-depressing anticoagulant, or to use one which acts on a different principle, such as heparin sodium.
Prothrombin time should be checked regularly as clinical conditions indicate.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Studies of carcinogenicity, mutagenesis or impairment of fertility have not been conducted with AquaMEPHYTON.
Pregnancy Categtory C: Animal reproduction studies have not been conducted with AquaMEPHYTON. It is also not known whether AquaMEPHYTON can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. AquaMEPHYTON should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AquaMEPHYTON is administered to a nursing woman.
Hemolysis, jaundice, and hyperbilirubinemia in newborns, particularly in premature infants, may be related to the dose of AquaMEPHYTON. Therefore, the recommended dose should not be exceeded (see ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).