CYANOCOBALAMIN injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

HF Acquisition Co LLC, DBA HealthFirst

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 PRECAUTIONS-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

Product summary:

CYANOCOBALAMIN INJECTION, USP is supplied in the following dosage forms. NDC 51662-1440-1 CYANOCOBALAMIN INJECTION, USP 10,000mcg/10mL (1,000mcg/mL) 10mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Cyanocobalamin Injection, USP 1000 mcg/mL NDC 0517-0031-25 1 mL Fill in a 2 mL 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°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature). PROTECT THE PRODUCT FROM LIGHT. IN0031 Rev. 10/18 MG #10565 AMERICAN REGENT, INC. SHIRLEY, NY 11967

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYANOCOBALAMIN- CYANOCOBALAMIN INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
CYANOCOBALAMIN INJECTION, USP 10,000MCG/10ML (1,000MCG/ML) 10ML VIAL
SPL UNCLASSIFIED
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.
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
C63H88CoN14O14P. 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 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
calcium ions. Intrinsic factor deficiency causes pernicious anemia,
wh