CYANOCOBALAMIN- cyanocobalamin_injection, solution

Vitamin B 12 Cyanocobalamin is quantitatively and rapidly absorbed from intramuscular and subcutaneous sites of injection; the plasma level of the compound reaches its peak within 1 hour after intramuscular injection. Absorbed vitamin B 12 12 12 Within 48 hours after injection of 100 or 1,000 mcg of vitamin B 12 Gastrointestinal absorption of vitamin B 12 12 The average diet supplies about 5 to 15 mcg/day of vitamin B 12 12 Vitamin B 12 12 12 Cyanocobalamin is the most widely used form of vitamin B 12

Cyanocobalamin is indicated for vitamin B 12 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 Requirements of vitamin B 12 Cyanocobalamin Injection, USP is also suitable for the vitamin B 12

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: 12 Patients with Normal Intestinal Absorption: 12 Schilling Test: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Generalized: 12 Warnings Cardiovascular: Hematological: Gastrointestinal: Dermatological: Miscellaneous: To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Sensitivity to cobalt and/or vitamin B 12

OVERDOSAGE
No overdosage has been reported with this drug.">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 B 12 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 nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
OVERDOSAGE
No overdosage has been reported with this drug.

BluePoint Laboratories

CYANOCOBALAMIN- cyanocobalamin_injection, solution Product manual source documgent