Country: United States
Language: English
Source: NLM (National Library of Medicine)
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)
Somerset Therapeutics, LLC
CYANOCOBALAMIN
CYANOCOBALAMIN 1000 ug in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
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 bacterial 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/Laboratory Test 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 is also suitable for the Vitamin B12 absorption test (Schilling test). Sensitivity to cobalt and/or Vitamin B12 is a contraindication.
1 mL multiple dose vial, packaged 25 vials per tray. 10 mL multiple dose vial, packaged as; - 10 vials per tray and - 25 vials per tray. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT Use only if solution is clear and seal intact. For Product Inquiry call 1-800-417-9175 Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024 Made in India Code No.: KR/DRUGS/KTK/28/289/97 ST-CYC/P/05 Revised: 09/2020 Made in India Made in India Neutral Code No: TN/DRUGS/616/1996 ST-CYC-MPPL/P/00 Revised: 10/2022
Abbreviated New Drug Application
CYANOCOBALAMIN- CYANOCOBALAMIN INJECTION SOMERSET THERAPEUTICS, LLC ---------- CYANOCOBALAMIN INJECTION USP 1000 MCG/ML DESCRIPTION Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin for intramuscular or subcutaneous use. Each mL contains 1,000 mcg cyanocobalamin; sodium chloride 0.9%; benzyl alcohol 1.5%; Water for Injection q.s.; Hydrochloric acid and/or sodium hydroxide for pH adjustment if necessary (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 coenzymes are very unstable in light. The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide. The cobalt content is 4.34%. The structural formula is represented below: CLINICAL PHARMACOLOGY Vitamin B is essential to growth, cell reproduction, hematopoiesis, nucleoprotein and myelin synthesis. Cyanocobalamin is quantitatively and rapidly absorbed from intramuscular and subcutaneous sites of injection; the plasma level of the compound reaches its peak within one hour after intramuscular injection. Absorbed Vitamin B is transported via specific B binding proteins, transcobalamin I and II to the various tissues. The liver is the main organ for Vitamin B storage. Within 48 hours after injection of 100 or 1,000 mcg of Vitamin B , 50 to 98% of the injected dose may appear in the urine. The major portion is excreted within the first eight hours. Intravenous administration results in even more rapid excretion with little opportunity for liver storage. Gastrointestinal absorption of Vitamin B depends on the presence of sufficient intrinsic 12 12 12 12 12 12 12 factor and calcium ions. Intrinsic factor deficiency causes pernicious anemia, which may be associated with subacute combined degeneration of the spinal cord. Prompt parenteral administration of Vitamin B prevents progression of neurologic damage. The average diet supplies about 5 to 15 Read the complete document