CYANOCOBALAMIN injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Somerset Therapeutics, LLC

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: Addisonian (pernicious) anemia Gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacterial 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/Laboratory Test 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 is also suitable for the Vitamin B12 absorption test (Schilling test). Sensitivity to cobalt and/or Vitamin B12 is a contraindication.

Product summary:

1 mL multiple dose vial, packaged 25 vials per tray. 10 mL multiple dose vial, packaged as; - 10 vials per tray and - 25 vials per tray. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. PROTECT FROM LIGHT Use only if solution is clear and seal intact. For Product Inquiry call 1-800-417-9175 Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024 Made in India Code No.: KR/DRUGS/KTK/28/289/97 ST-CYC/P/05 Revised: 09/2020 Made in India Made in India Neutral Code No: TN/DRUGS/616/1996 ST-CYC-MPPL/P/00 Revised: 10/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYANOCOBALAMIN- CYANOCOBALAMIN INJECTION
SOMERSET THERAPEUTICS, LLC
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CYANOCOBALAMIN INJECTION USP 1000 MCG/ML
DESCRIPTION
Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin
for intramuscular
or subcutaneous use.
Each mL contains 1,000 mcg cyanocobalamin; sodium chloride 0.9%;
benzyl alcohol
1.5%; Water for Injection q.s.; Hydrochloric acid and/or sodium
hydroxide for pH
adjustment if necessary (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
cobalt content is
4.34%. The structural formula is represented below:
CLINICAL PHARMACOLOGY
Vitamin B
is essential to growth, cell reproduction, hematopoiesis,
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 one 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
12
12
12
12
12
12
12
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 progression of neurologic damage.
The average diet supplies about 5 to 15