CYANOCOBALAMINE- cyanocobalamine injection injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)

Available from:

Henry Schein, Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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). Sensitivity to cobalt and/or vitamin B12 is a contraindication.

Product summary:

Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows: 10 mL Multiple Dose Vial, NDC 67457-399-10 Box of 1 vial. 10 mL Multiple Dose Vial, NDC 67457-399-25 Box of 25 vials. 30 mL Multiple Dose Vial, NDC 67457-400-31 Box of 1 vial. 30 mL Multiple Dose Vial, NDC 67457-400-05 Box of 5 vials. Store at 20o to 25oC (68o to 77oF). [See USP Controlled Room Temperature.] PROTECT FROM LIGHT. Manufactured for: Mylan Institutional LLC Rockford, IL 61130 U.S.A. Manufactured by: Mylan Laboratories Limited Bangalore, India Code No.: KR/DRUGS/KTK/28/384/2009 1028190 MAY 2016

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYANOCOBALAMINE- CYANOCOBALAMINE INJECTION INJECTION
HENRY SCHEIN, INC.
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CYANOCOBALAMINE
DESCRIPTION
Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin
for intramuscular or subcutaneous
injection.
Each mL contains 1,000 mcg cyanocobalamin, Sodium Chloride 0.9%.
Benzyl Alcohol 1.5% is present as a
preservative. Sodium acetate and Glacial acetic acid are present as
buffers. Hydrochloric acid and/or sodium
hydroxide may have been added during manufacture to adjust the pH
(range 4.5 to 7.0).
Cyanocobalamin appears as dark red crystals or as an amorphous or
crystalline red powder or purplish
crystalline powder. Sparingly soluble in water and soluble in alcohol,
practically insoluble in acetone, in
chloroform and in either. It is stable to autoclaving for short
periods at 121°C. The vitamin B12coenzymes 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
1355.4.
The structural formula is represented below.
CLINICAL PHARMACOLOGY
Vitamin B
is essential to growth, cell reproduction, hematopoiesis, and
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 1
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 factor and calcium
ions. Intrinsic factor deficiency causes pernicious anemia, which may