FOLIC ACID tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

NuCare Pharmaceuticals, Inc.

INN (Nome Internazionale):

FOLIC ACID

Composizione:

FOLIC ACID 1 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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 anemia of nutritional origin, pregnancy, infancy, or childhood. Folic acid is contraindicated in patients who have shown previous intolerance to the drug.

Dettagli prodotto:

Folic Acid Tablets, USP 1 mg are 5/16, scored, round, yellow to orange color tablets Debossed EP 127 and supplied in bottles of 30 (NDC 66267-217-30) and 90. (NDC 66267-217-90) Dispense in well-closed container with child-resistant closure. Store at controlled room temperature 20°-25°C (68°-77°F).

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

FOLIC ACID- FOLIC ACID TABLET
NUCARE PHARMACEUTICALS, INC.
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FOLIC ACID
TABLETS, 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: corn starch, microcrystalline
cellulose, sodium starch glycolate and
stearic acid.
CLINICAL PHARMACOLOGY
Folic acid acts on megaloblastic bone marrow to produce a normoblastic
marrow.
In man, exogenous source of folate is required for nucleoprotein
synthesis and the maintenance of
normal erythropoiesis. Folic acid is a 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 deficiency
is thought to account for the
defective deoxyribonucleic acid (DNA) synthesis that leads to
megaloblast formation and megaloblastic
and macrocytic anemia.
Folic acid is absorbed rapidl