FOLIC ACID tablet

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

NuCare Pharmaceuticals,Inc.

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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.

Produkt oversigt:

Folic acid tablets, USP, 1 mg are Light Yellow, round, biconvex tablets debossed CE on the top of the functional score and 21 on the bottom on one side and plain on other side. Tablets are supplied in bottles of 100 (NDC 68071-2204-1) Dispense in a well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F). [see USP Controlled Room Temperature].

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

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: 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