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:

Denton Pharma, Inc. dba Northwind Pharmaceuticals

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 yellow, scored, round, standard convex debossed with “B”, “—“ and “01” on one side and plain on the other side supplied in bottles of 30 and 90. 30s NDC 70934-732-30 90s NDC 70934-732-90 Dispense in well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Manufactured for: AIPING PHARMACEUTICAL, INC . Hauppauge, NY 11788 USA By: ANSHI PHARMACEUTICAL (ZHONGSHAN) INC . Zhongshan, Guangdong 528437 P. R. China

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

FOLIC ACID- FOLIC ACID TABLET
DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS
----------
FOLIC ACID TABLETS USP
RX ONLY
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: lactose
monohydrate, microcrystalline cellulose, sodium starch glycolate and
magnesium
stearate.
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
megaloblas