Cyanocobalamin (B₁₂)Injection, USP

• 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.

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.

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 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 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.

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.

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