Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 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 NDC 0143-9619-01 30 mL Multiple Dose Vial Box of 1 Vial 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 Hikma Pharmaceuticals USA Inc. 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: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised December 2022 PIN350-WES/5; PRINCIPAL DISPLAY PANEL NDC 0143- 9621 -01 1 mL Vial Cyanocobalamin Injection, USP Rx only 1,000 mcg/mL For IM or SC use ONLY Protect from light Contains Benzyl Alcohol NDC 0143- 9621 -25 Rx only Cyanocobalamin Injection, USP 1,000 mcg/mL For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative 25 x 1 mL Vials 1000 vial 1000 shelfpack; PRINCIPAL DISPLAY PANEL NDC 0143- 9620 -01 10 mL Multiple Dose Vial Cyanocobalamin Injection, USP Rx only 10,000 mcg per 10 mL (1,000 mcg/mL) For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative NDC 0143- 9620 -10 Rx only Cyanocobalamin Injection, USP 10,000 mcg per 10 mL (1,000 mcg/mL) For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative 10 x 10 mL Multiple Dose Vials 10000 vial 10000 mcg per 10 mL; PRINCIPAL DISPLAY PANEL NDC 0143- 9619 -01 30 mL Multiple Dose Vial Cyanocobalamin Injection, USP Rx only 30,000 mcg per 30 mL (1,000 mcg/mL) For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative NDC 0143- 9619 -10 Rx only Cyanocobalamin Injection, USP 30,000 mcg per 30 mL (1,000 mcg/mL) For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative 10 x 30 mL Multiple Dose Vials NDC 0143- 9619 -01 Rx only Cyanocobalamin Injection, USP 30,000 mcg per 30 mL (1,000 mcg/mL) For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative 1 x 30 mL Multiple Dose Vials 30000 vial 30000 shelfpack carton
- HOW SUPPLIED 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 NDC 0143-9619-01 30 mL Multiple Dose Vial Box of 1 Vial 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 Hikma Pharmaceuticals USA Inc. 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: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised December 2022 PIN350-WES/5
- PRINCIPAL DISPLAY PANEL NDC 0143- 9621 -01 1 mL Vial Cyanocobalamin Injection, USP Rx only 1,000 mcg/mL For IM or SC use ONLY Protect from light Contains Benzyl Alcohol NDC 0143- 9621 -25 Rx only Cyanocobalamin Injection, USP 1,000 mcg/mL For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative 25 x 1 mL Vials 1000 vial 1000 shelfpack
- PRINCIPAL DISPLAY PANEL NDC 0143- 9620 -01 10 mL Multiple Dose Vial Cyanocobalamin Injection, USP Rx only 10,000 mcg per 10 mL (1,000 mcg/mL) For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative NDC 0143- 9620 -10 Rx only Cyanocobalamin Injection, USP 10,000 mcg per 10 mL (1,000 mcg/mL) For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative 10 x 10 mL Multiple Dose Vials 10000 vial 10000 mcg per 10 mL
- PRINCIPAL DISPLAY PANEL NDC 0143- 9619 -01 30 mL Multiple Dose Vial Cyanocobalamin Injection, USP Rx only 30,000 mcg per 30 mL (1,000 mcg/mL) For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative NDC 0143- 9619 -10 Rx only Cyanocobalamin Injection, USP 30,000 mcg per 30 mL (1,000 mcg/mL) For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative 10 x 30 mL Multiple Dose Vials NDC 0143- 9619 -01 Rx only Cyanocobalamin Injection, USP 30,000 mcg per 30 mL (1,000 mcg/mL) For Intramuscular or Subcutaneous use ONLY Contains Benzyl Alcohol as a Preservative 1 x 30 mL Multiple Dose Vials 30000 vial 30000 shelfpack carton
Overview
Cyanocobalamin Injection (vitamin B 12 ) 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 B 12 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C 63 H 88 CoN 14 O 14 P. The cobalt content is 4.34%. The molecular weight is 1355.39. The structural formula is represented below. Structural Formula
Indications & Usage
Cyanocobalamin is indicated for vitamin B 12 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 B 12 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 B 12 absorption test ( Schilling test ).
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 B 12 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 B 12 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 B 12 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 B 12 is a contraindication.
Adverse Reactions
Generalized Anaphylactic shock and death have been reported with administration of parenteral vitamin B 12 (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
Storage & Handling
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 Hikma Pharmaceuticals USA Inc. 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: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised December 2022 PIN350-WES/5
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