B12 INJECT KIT cyanocobalamin

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Oaklock, LLC

INN (International Name):

CYANOCOBALAMIN

Composition:

CYANOCOBALAMIN 1000 ug in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

B12 INJECT KIT- CYANOCOBALAMIN
OAKLOCK, LLC
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B12 INJECT KIT
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.
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.
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 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 progres