Data from FDA - Curated by EPG Health - Last updated 28 July 2017

Indication(s)

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 It may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see Drug Interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. Such measures remove the need for long-term administration of cyanocobalamin. Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. Cyanocobalamin Injection, USP is also suitable for the vitamin B12 absorption test (Schilling test).

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Advisory information

contraindications
CONTRAINDICATIONS Sensitivity to cobalt and/or vitamin B12 is a contraindication.
Special warnings and precautions
PRECAUTIONS General Precautions: Vitamin B12 deficiency that is allowed to progress for longer than 3 months may produce permanent degenerative lesions of the spinal cord. Doses of folic acid greater than 0.1 mg per day may result in hematologic remission in patients with vitamin B12 deficiency. Neurologic manifestations will not be prevented with folic acid, and if not treated with vitamin B12, irreversible damage will result. Doses of cyanocobalamin exceeding 10 mcg daily may produce hematologic response in patients with folate deficiency. Indiscriminate administration may mask the true diagnosis. Information for Patients: Patients with pernicious anemia should be informed that they will require monthly injections of vitamin B12 for the remainder of their lives. Failure to do so will result in return of the anemia and in development of incapacitating and irreversible damage to the nerves of the spinal cord. Also, patients should be warned about the danger of taking folic acid in place of vitamin B12, because the former may prevent anemia but allow progression of subacute combined degeneration. A vegetarian diet which contains no animal products (including milk products or eggs) does not supply any vitamin B12. Patients following such a diet should be advised to take oral vitamin B12 regularly. The need for vitamin B12 is increased by pregnancy and lactation. Deficiency has been recognized in infants of vegetarian mothers who were breast fed, even though the mothers had no symptoms of deficiency at the time. 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. If folate levels are low, folic acid should also be administered. If reticulocytes have not increased after treatment or if reticulocyte counts do not continue at least twice normal as long as the hematocrit is less than 35%, diagnosis or treatment should be reevaluated. Repeat determinations of iron and folic acid may reveal a complicating illness that might inhibit the response of the marrow. Patients with pernicious anemia have about 3 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. Carcinogenesis, Mutagenesis, Impairment of Fertility: Long term studies in animals to evaluate carcinogenic potential have not been done. There is no evidence from long-term use in patients with pernicious anemia that cyanocobalamin is carcinogenic. Pernicious anemia is associated with an increased incidence of carcinoma of the stomach, but this is believed to be related to the underlying pathology and not to treatment with cyanocobalamin. Pregnancy: Teratogenic Effects. 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. Amounts of vitamin B12 that are recommended by the Food and Nutrition Board, National Academy of Science-National Research Council for pregnant women (4 mcg daily) should be consumed during pregnancy. Nursing Mothers: Vitamin B12 is known to be excreted in human milk. Amounts of vitamin B12 that are recommended by the Food and Nutrition Board, National Academy of Science National Research Council for lactating women (4 mcg daily) should be consumed during lactation. Pediatric Use: Intake in children should be in the amount (0.5 to 3 mcg daily) recommended by the Food and Nutrition Board, National Academy of Science-National Research Council.
Adverse reactions
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 To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1 877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION Avoid using the intravenous route. Use of this product intravenously will result in almost all of the vitamin being lost in the urine. Pernicious Anemia: Parenteral vitamin B12 is the recommended treatment and will be required for the remainder of the patient's life. The oral form is not dependable. A dose of 100 mcg daily for 6 or 7 days should be administered by intramuscular or deep subcutaneous injection. If there is clinical improvement and if a reticulocyte response is observed, the same amount may be given on alternate days for seven doses, then every 3 to 4 days for another 2 to 3 weeks. By this time hematologic values should have become normal. This regimen should be followed by 100 mcg monthly for life. Folic acid should be administered concomitantly if needed. Patients with Normal Intestinal Absorption: Where the oral route is not deemed adequate, initial treatment similar to that for patients with pernicious anemia may be indicated depending on the severity of the deficiency. Chronic treatment should be with an oral B12 preparation. If other vitamin deficiencies are present, they should be treated. Schilling Test: The flushing dose is 1,000 mcg. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

More information

Category Value
Authorisation number ANDA204829
Agency product number P6YC3EG204
Orphan designation No
Product NDC 67457-400,67457-399
Date Last Revised 06-07-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 309594
Marketing authorisation holder Mylan Institutional LLC