CYANOCOBALAMIN injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hikma Pharmaceuticals USA 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: 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 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 is available in the following packages: NDC 0143-9621-25            1 mL Vial                                      Boxes of 25 Vials NDC 0143-9620-10           10 mL Multiple Dose Vial            Boxes of 10 Vials NDC 0143-9619-10            30 mL Multiple Dose Vial            Boxes of 10 Vials 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 FROM LIGHT. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mό, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised December 2022 PIN350-WES/5

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYANOCOBALAMIN- CYANOCOBALAMIN INJECTION
HIKMA PHARMACEUTICALS USA INC.
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CYANOCOBALAMIN INJECTION, USP
RX ONLY
DESCRIPTION
Cyanocobalamin Injection (vitamin B
) is a sterile solution of Cyanocobalamin. Each mL
contains Cyanocobalamin 1000 mcg, sodium chloride 9 mg and benzyl
alcohol 0.015 mL
in water for injection. Hydrochloric acid and/or sodium hydroxide may
have been added
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
12
12
63
88
14
14
12
12
12
12
12
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 vitamin B
prevents progre