CYANOCOBALAMIN injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)

Available from:

Vitruvias Therapeutics

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 1000 mcg/mL 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYANOCOBALAMIN- CYANOCOBALAMIN INJECTION, SOLUTION
VITRUVIAS THERAPEUTICS
----------
CYANOCOBALAMIN INJECTION USP 1000 MCG/ML
Rx Only
DESCRIPTION
Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin
for intramuscular
or subcutaneous injection. Each mL contains 1000 mcg cyanocobalamin.
Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%,
is present as a
preservative and Water for Injection q.s. 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 B12 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 B12 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 B12 is
transported via
specific B12 binding proteins, transcobalamin I and II to the various
tissues. The liver is
63
88
14
14
specific B12 binding proteins, transcobalamin I and II to the various
tissues. The liver is
the main organ for vitamin B12 storage.
Within 48 hours after injection of 100 or 1000 mcg of vitamin B12, 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 B12 depends on the presence of
sufficient
intrinsic factor and cal