Cyanocobalamin (B₁₂)Injection, USP

CONTRAINDICATIONS
Sensitivity to cobalt and/or vitamin B₁₂ is a contraindication.

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.

PRECAUTIONS
Doses of cyanocobalamin exceeding 10 mcg daily may produce hematologic response in patients with folate deficiency.

Laboratory Tests
During the initial treatment of patients with pernicious anemia, serum potassium must be observed closely the first 48 hours and potassium replaced if necessary.

Hematocrit, reticulocyte count, vitamin B₁₂, folate, and iron levels should be obtained prior to treatment. Hematocrit and reticulocyte counts should be repeated daily from the fifth to seventh days of therapy, and then frequently until the hematocrit is normal.

Patients with pernicious anemia have about three times the incidence of carcinoma of the stomach as the general population, so appropriate tests for this condition should be carried out when indicated.

Drug/Laboratory Test Interactions
Persons taking most antibiotics, methotrexate, and pyrimethamine invalidate folic acid and vitamin B₁₂ diagnostic blood assays.

Colchicine para-aminosalicylic acid and heavy alcohol intake for longer than 2 weeks may produce malabsorption of vitamin B₁₂.

Pregnancy
Pregnancy Category C
Adequate and well-controlled studies have not been done in pregnant women. However, vitamin B₁₂ is an essential vitamin and requirements are increased during pregnancy.

Nursing Mothers: Vitamin B₁₂ is known to be excreted in human milk.

ADVERSE REACTIONS
Generalized: Anaphylactic shock and death have been reported with administration of parenteral vitamin B₁₂.
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.

INDICATIONS AND USAGE
Cyanocobalamin is indicated for vitamin B₁₂ deficiencies due to malabsorption, which may be associated with the following conditions:

• Addisonian (pernicious) anemia
• Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy
• Fish tapeworm infestation
• Malignancy of pancreas or bowel
• Folic acid deficiency

Cyanocobalamin Injection, USP is also suitable for the vitamin B₁₂ absorption test (Schilling test).

Use of this product intravenously will result in almost all of the vitamin being lost in the urine.

For additional safety information, please see Full Prescribing Information.

You are encouraged to report Adverse Drug Events to American Regent, Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

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