CYANOCOBALAMIN injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, 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: 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 NDC 54868-0762-1           1 mL Vial                                       Tray of 25 NDC 54868-0762-0           30 mL Multiple Dose Vial           Boxes of 1 NDC 54868-0762-2           30 mL Multiple Dose Vial           Boxes of 5 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. 11/05 MG #10565 AMERICAN REGENT, INC. SHIRLEY, NY 11967 Relabeling of "Additional Barcode"  by: Physicians Total Care, Inc. Tulsa, OK     74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYANOCOBALAMIN - CYANOCOBALAMIN INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
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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 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