Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED CYANOCOBALAMIN INJECTION is supplied in the following dosage forms NDC 51662-1394-1 CYANOCOBALAMIN INJECTION, USP 30000 mcg/30 mL (1000 mcg/mL) 30 mL VIAL NDC 51662-1394-2 Pouch containing a single CYANOCOBALAMIN INJECTION, USP 30000 mcg/30 mL (1000 mcg/mL) 30 mL VIAL NDC 51662-1394-3 Case of 10 pouches - CYANOCOBALAMIN INJECTION, USP 30000 mcg/30 mL (1000 mcg/mL) 30 mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Cyanocobalamin Injection, USP 1000 mcg/mL is available in the following packages: NDC 0143-9621-25 1 mL Vial Boxes of 25 Vials NDC 0143-9620-10 10 mL Multiple Dose Vial Boxes of 10 Vials NDC 0143-9619-10 30 mL Multiple Dose Vial Boxes of 10 Vials Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mό, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: WEST-WARD A HIKMA COMPANY Eatontown, NJ 07724 USA Revised June 2017 PIN350-WES/3; PRINCIPAL DISPLAY PANEL - VIAL LABEL VIAL LABELING; PRINCIPAL DISPLAY PANEL - SERIALIZED LABELING SERIALIZED LABELING; Principal Display Panel - 51662-1394-2 - Pouch Labeling Pouch Labeling; Principal Display Panel - 51662-1394-3 - Case Labeling RFID Label Case Label
- HOW SUPPLIED CYANOCOBALAMIN INJECTION is supplied in the following dosage forms NDC 51662-1394-1 CYANOCOBALAMIN INJECTION, USP 30000 mcg/30 mL (1000 mcg/mL) 30 mL VIAL NDC 51662-1394-2 Pouch containing a single CYANOCOBALAMIN INJECTION, USP 30000 mcg/30 mL (1000 mcg/mL) 30 mL VIAL NDC 51662-1394-3 Case of 10 pouches - CYANOCOBALAMIN INJECTION, USP 30000 mcg/30 mL (1000 mcg/mL) 30 mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Cyanocobalamin Injection, USP 1000 mcg/mL is available in the following packages: NDC 0143-9621-25 1 mL Vial Boxes of 25 Vials NDC 0143-9620-10 10 mL Multiple Dose Vial Boxes of 10 Vials NDC 0143-9619-10 30 mL Multiple Dose Vial Boxes of 10 Vials Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. PROTECT FROM LIGHT. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mό, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: WEST-WARD A HIKMA COMPANY Eatontown, NJ 07724 USA Revised June 2017 PIN350-WES/3
- PRINCIPAL DISPLAY PANEL - VIAL LABEL VIAL LABELING
- PRINCIPAL DISPLAY PANEL - SERIALIZED LABELING SERIALIZED LABELING
- Principal Display Panel - 51662-1394-2 - Pouch Labeling Pouch Labeling
- Principal Display Panel - 51662-1394-3 - Case Labeling RFID Label Case Label
Overview
Cyanocobalamin Injection (vitamin B12) is a sterile solution of Cyanocobalamin. Each mL contains Cyanocobalamin 1000 mcg, sodium chloride 9 mg and benzyl alcohol 0.015 mL in water for injection. Hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH (range 4.5-7.0). Cyanocobalamin appears as dark red crystals or as an amorphous or crystalline red powder. It is very hygroscopic in the anhydrous form, and sparingly soluble in water (1:80). It is stable to autoclaving for short periods at 121°C. The vitamin B12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C63H88CoN14O14P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below. STRUCTURE
Indications & Usage
INDICATIONS & 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 PRECAUTIONS- 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 ( DOSAGE & ADMINISTRATION- Schilling test).
Dosage & Administration
DOSAGE & 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 1000 mcg. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Warnings & Precautions
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 nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Contraindications
Sensitivity to cobalt and/or vitamin B12 is a contraindication.
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
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