CYANOCOBALAMIN injection, solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Asclemed USA, Inc.

Administreringsrute:

INTRAMUSCULAR

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 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 B 12 in excess of normal (due to pregnancy, thyrotoxi

Produkt oppsummering:

Cyanocobalamin Injection, USP is supplied as follows: NDC NDC 76420-111-25 (relabeled from NDC 63323-044-01) Unit of 25 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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CYANOCOBALAMIN- CYANOCOBALAMIN INJECTION, SOLUTION
ASCLEMED USA, INC.
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CYANOCOBALAMIN INJECTION, USP
DESCRIPTION
Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin
for intramuscular
or subcutaneous use.
Each mL contains 1000 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 1000 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
12
12
12
12
12
12
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 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 mcg/day of Vita