CYANOCOBALAMIN injection

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

General Injectables and Vaccines, Inc.

Uygulama yolu:

INTRAMUSCULAR

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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 supp

Ürün özeti:

Cyanocobalamin Injection, USP 1,000 mcg/mL is supplied as follows: 10 mL Multiple Dose Vial, NDC 67457-399-10  Box of 1 vial. 10 mL Multiple Dose Vial, NDC 67457-399-25  Box of 25 vials. 30 mL Multiple Dose Vial, NDC 67457-400-31  Box of 1 vial. 30 mL Multiple Dose Vial, NDC 67457-400-05  Box of 5 vials. Store at 20o to 25oC (68o to 77oF). [See USP Controlled Room Temperature.] PROTECT FROM LIGHT.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

CYANOCOBALAMIN- CYANOCOBALAMIN INJECTION
GENERAL INJECTABLES AND VACCINES, INC.
----------
CYANOCOBALAMIN INJECTION, USP
(1,000 MCG/ML)
RX ONLY
DESCRIPTION
Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin
for intramuscular or
subcutaneous injection.
Each mL contains 1,000 mcg cyanocobalamin, Sodium Chloride 0.9%.
Benzyl Alcohol 1.5% is present
as a preservative. Sodium acetate and Glacial acetic acid are present
as buffer. Hydrochloric acid
and/or sodium hydroxide may have been added during manufacture to
adjust the pH (range 4.5 to 7.0).
Cyanocobalamin appears as dark red crystals or as an amorphous or
crystalline red powder or purplish
crystalline powder. Sparingly soluble in water and soluble in alcohol,
practically insoluble in acetone,
in chloroform and in either. 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
1355.4.
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.
12
63
88
14
14
12
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 factor and
calcium ions. Intrins