CYANOCOBALAMIN injection, solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Fresenius Kabi USA, LLC

INN (Tên quốc tế):

CYANOCOBALAMIN

Thành phần:

CYANOCOBALAMIN 1000 ug in 1 mL

Tuyến hành chính:

INTRAMUSCULAR

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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, ma

Tóm tắt sản phẩm:

Cyanocobalamin Injection, USP is supplied as follows: 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.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

CYANOCOBALAMIN - CYANOCOBALAMIN INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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CYANOCOBALAMIN INJECTION, USP
DESCRIPTION
Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin
for intramuscular or
subcutaneous use.
Each mL contains 1000 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 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
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 progression of neurologic damage.
The average diet supplies about 5 to 15 mcg/day of Vitamin B
in a p