FOLIC ACID tablet

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)

Fáanlegur frá:

Exelan Pharmaceuticals, Inc.

INN (Alþjóðlegt nafn):

FOLIC ACID

Samsetning:

FOLIC ACID 1 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Folic acid is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood. Folic acid is contraindicated in patients who have shown previous intolerance to the drug.

Vörulýsing:

Folic Acid Tablets USP, 1 mg are Light Yellow, Round, biconvex tablets debossed “I” on the left side of the bisect and “G” on the right side of bisect on one side and “210” on other; supplied in bottles of 100 (NDC 76282-210-01) and 1000 (NDC 76282-210-10). Dispense in a well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature]. Manufactured by: InvaGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Exelan Pharmaceuticals, Inc. Lawrenceville, GA 30046 Rev: 06/12

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

FOLIC ACID - FOLIC ACID TABLET
EXELAN PHARMACEUTICALS, INC.
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FOLIC ACID TABLET USP
DESCRIPTION
Folic acid,
N-[_p_-[[(2-amino-4-hydroxy-6-pteridinyl)methyl]-amino]benzoyl]L-
glutamic acid, is a B
complex vitamin containing a pteridine moiety linked by a methylene
bridge to _para_-aminobenzoic acid,
which is joined by a peptide linkage to glutamic acid. Conjugates of
folic acid are present in a wide
variety of foods, particularly liver, kidneys, yeast, and leafy green
vegetables. Commercially available
folic acid is prepared synthetically. Folic acid occurs as a yellow or
yellowish-orange crystalline
powder and is very slightly soluble in water and insoluble in alcohol.
Folic acid is readily soluble in
dilute solutions of alkali hydroxides and carbonates, and solutions of
the drug may be prepared with the
aid of sodium hydroxide or sodium carbonate, thereby forming the
soluble sodium salt of folic acid
(sodium folate). Aqueous solutions of folic acid are heat sensitive
and rapidly decompose in the
presence of light and/or riboflavin; solutions should be stored in a
cool place protected from light.
The structural formula of folic acid is as follows:
Each tablet, for oral administration, contains 1 mg folic acid.
Folic Acid Tablets USP 1 mg contain the following inactive
ingredients: microcrystalline cellulose,
colloidal silicon dioxide, lactose monohydrate, sodium starch
glycolate and stearic acid.
CLINICAL PHARMACOLOGY
Folic acid acts on megaloblastic bone marrow to produce a normoblastic
marrow.
In man, an exogenous source of folate is required for nucleoprotein
synthesis and the maintenance of
normal erythropoiesis. Folic acid is the precursor of tetrahydrofolic
acid, which is involved as a
cofactor for transformylation reactions in the biosynthesis of purines
and thymidylates of nucleic acids.
Impairment of thymidylate synthesis in patients with folic acid
deficiency is thought to account for the
defective deoxyribonucleic acid (DNA) synthesis that leads to
megaloblast formation and megaloblastic
and m