CYANOCOBALAMIN injection

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 be met with oral supplementation. Cyanocobalamin Injection, USP is also suitable for the vitamin B12 absorption test ( DOSAGE & ADMINISTRATION-Schilling test). Sensitivity to cobalt and/or vitamin B12 is a contraindication.

Product summary:

CYANOCOBALAMIN INJECTION is supplied in the following dosage forms NDC 51662-1394-1 CYANOCOBALAMIN INJECTION, USP 30000 mcg/30 mL (1000 mcg/mL) 30 mL VIAL NDC 51662-1394-2 Pouch containing a single CYANOCOBALAMIN INJECTION, USP 30000 mcg/30 mL (1000 mcg/mL) 30 mL VIAL NDC 51662-1394-3 Case of 10 pouches - CYANOCOBALAMIN INJECTION, USP 30000 mcg/30 mL (1000 mcg/mL) 30 mL 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 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 Storage 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 West-Ward Pharmaceuticals Corp. 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: WEST-WARD A HIKMA COMPANY Eatontown, NJ 07724 USA Revised June 2017 PIN350-WES/3

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYANOCOBALAMIN- CYANOCOBALAMIN INJECTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
CYANOCOBALAMIN INJECTION, USP 30000 MCG/30 ML (1000 MCG/ML) 30 ML
VIAL
SPL UNCLASSIFIED
Rx only
DESCRIPTION
Cyanocobalamin Injection (vitamin B12) 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 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,
which may be associated with subacute combined degeneration of the
spinal cord.
Prompt par