CYANOCOBALAMIN injection

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

SOLA Pharmaceuticals

Antoreitti:

INTRAMUSCULAR

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 suppleme

Tuoteyhteenveto:

Cyanocobalamin Injection, USP 1,000 mcg/mL 70512-840-01 1 mL Multiple-Dose Vial 70512-840-25 Box of 25 Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) (See USP Controlled Room Temperature). PROTECT THE PRODUCT FROM LIGHT. Rev 10/2022 Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA Made in India TN/DRUGS/616/1996 US/LF/047 V01 PLF 169

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

CYANOCOBALAMIN- CYANOCOBALAMIN INJECTION
SOLA PHARMACEUTICALS
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CYANOCOBALAMIN INJECTION, USP
DESCRIPTION
Cyanocobalamin Injection, USP is a sterile solution of cyanocobalamin
for intramuscular
or subcutaneous injection. Each mL contains 1,000 mcg cyanocobalamin.
Each vial also contains Sodium Chloride, 0.9%. Benzyl Alcohol, 1.5%,
is present as a
preservative. Hydrochloric acid and/or sodium hydroxide may have been
added during
manufacture 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 PHAMRACOLOGY
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 organfor vitamin B12 storage. Within 48 hours after injection
of 100 or 1,000
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 parente