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Aquamephyton Side Effects, and Drug Interactions - Aqueous Colloidal Solution of Vitamin K1

Aquamephyton Side Effects, and Drug Interactions - Aqueous Colloidal Solution of Vitamin K1

SIDE EFFECTS

Severe hypersensitivity reactions, including anaphylactoid reactions and deaths have been reported following parenteral administration. The majority of these reported events occurred following intravenous administration (see Box Warning.)

The possibility of allergic sensitivity, including an anaphylactoid reaction, should be kept in mind following parenteral administration.

Transient "flushing sensations" and "peculiar" sensations of taste have been observed, as well as rare instances of dizziness, rapid and weak pulse, profuse sweating, brief hypotension, dyspnea, and cyanosis.

Pain, swelling, and tenderness at the injection site may occur.

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 phytonadione. This has occurred rarely and primarily with doses above those recommended. (See PRECAUTIONS, Pediatric Use.)

DRUG INTERACTIONS

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.

Laboratory Tests

Prothrombin time should be checked regularly as clinical conditions indicate.

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