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warnings
WARNINGS Patients with early Leber's disease (hereditary optic nerve atrophy) who were treated with cyanocobalamin suffered severe and swift optic atrophy. Hypokalemia and sudden death may occur in severe megaloblastic anemia which is treated intensely. Anaphylactic shock and death have been reported after parenteral vitamin B12 administration. An intradermal test dose is recommended before Cyanocobalamin Injection, USP is administered to patients suspected of being sensitive to this drug. This product contains Benzyl Alcohol. Benzyl Alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants. 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 require 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 nervoussystem and bone toxicity. Tissue loading may occur at even lower rates of administration.
ADVERSE REACTIONS Generalized : Anaphylactic shock and death have been reported with administration of parenteral vitamin B12 (see WARNINGS). Cardiovascular : Pulmonary edema and congestive heart failure early in treatment; peripheral vascular thrombosis. Hematological : Polycythemia vera Gastrointestinal : Mild transient diarrhea Dermatological: Itching; transitory exanthema Miscellaneous : Feeling of swelling of entire body