FOLIC ACID- folic acid tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

West-ward Pharmaceutical Corp

INN (International Name):

FOLIC ACID

Composition:

FOLIC ACID 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Folic acid is effective in the treatment of megaloblastic anemias due to 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.

Product summary:

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 the bisect on one side and "210 " on other; supplied in bottles of 100 (NDC 0143-9717-01) and 1000 (NDC 0143-9717-10). New Tablet ID Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Dispense in well-closed container with child-resistant closure. Store at controlled room temperature 20°-25°C (68-77°F)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOLIC ACID- FOLIC ACID TABLET
WEST-WARD PHARMACEUTICAL CORP
----------
FOLIC ACID TABLETS, USP
RX ONLY
REV. 01/11
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 dry place protected from light.
The structural formula is as follows:
Each tablet for oral administration contains 1 mg folic acid and the
following inactive
ingredients: colloidal silicon dioxide, lactose monohydrate,
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 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 macrocytic anemias.
Folic acid