Dodex Injection

Generic name:cyanocobalamin
Dosage form: injection

Medically reviewed by Drugs.com. Last updated on May 1, 2022.

DESCRIPTION:

Dodex ® Injectable (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, 0.4% and Sodium Acetate, 0.04%. Benzyl Alcohol, 1.5%, is present as a preservative and Water for Injection q.s. Glacial acetic acid may has 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 12 coenzymes are very unstable in light.

The chemical name is 5,6-dimethyl-benzimidazolyl cyanocobamide; the molecular formula is C 63H 88CoN 14O 14P. The cobalt content is 4.34%. The molecular weight is 1355.39.

The structural formula is represented below.

CLINICAL PHARMACOLOGY:

Vitamin B 12 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 12 is transported via specific B 12 binding proteins, transcobalamin I and II to the various tissues. The liver is the main organ for vitamin B 12 storage.

Within 48 hours after injection of 100 or 1000 mcg of vitamin B 12, 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 12 depends on the presence of sufficient intrinsic factor and calcium ions. Intrinsic factor defi...