CYANOCOBALAMIN injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Northstar Rx LLC.

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

Product summary:

Cyanocobalamin Injection, USP 1,000 mcg/mL 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Please address medical inquiries to Northstar Rx LLC at 1-800-206-7821. Manufactured for: Northstar Rx LLC Memphis, TN 38141 Distributed by: Zydus Lifesciences Ltd. India. Iss.: 06/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYANOCOBALAMIN - CYANOCOBALAMIN INJECTION, SOLUTION
NORTHSTAR RX LLC.
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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 USP, 0.9%. Benzyl Alcohol NF,
1.5%, is present
as a preservative. Dibasic Sodium Phosphate (Heptahydrate) USP 0.05%
is present as a
buffering agent. Hydrochloric acid NF and/or sodium hydroxide NF may
have been
added during manufacture to adjust the pH (range 4.5-7.0).
Cyanocobalamin appears as crystals or deep red colored, odorless
crystalline 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 4.35%. The molecular weight is 1355.4.
The structural formula is represented below.
12
63
88
14
14
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 pernici