CYANOCOBALAMIN injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Regent, Inc.

INN (International Name):

CYANOCOBALAMIN

Composition:

CYANOCOBALAMIN 1000 ug in 1 mL

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

Product summary:

Cyanocobalamin Injection, USP 1,000 mcg/mL NDC 0517-0031-25           1 mL Multiple-Dose Vial             Boxes of 25 NDC 0517-0032-25           10 mL Multiple-Dose Vial           Boxes of 25 NDC 0517-0130-01           30 mL Multiple-Dose Vial           Boxes of 1 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 THE PRODUCT FROM LIGHT. IN0031 Rev. 01/2021 MG #10565

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYANOCOBALAMIN- CYANOCOBALAMIN INJECTION, SOLUTION
AMERICAN REGENT, INC.
----------
CYANOCOBALAMIN
INJECTION, USP
RX ONLY
DESCRIPTION:
Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin
for intramuscular
or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin.
Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%,
is present as a
preservative. Hydrochloric acid and/or sodium hydroxide may have been
added during
manufacture 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
coenzymes
are very unstable in light.
The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the
molecular formula
is C
H
CoN
O
P. The cobalt content is 4.34%. The molecular weight is 1355.39.
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.
12
63
88
14
14
12
12
12
12
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
be associated with subacute combined degeneration o