Folic Acid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Method Pharmaceuticals, LLC

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 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.

Product summary:

Folic Acid Tablets, USP 1 mg are yellow, functionally scored, round, standard convex debossed with “B”, “-“ and “01” on one side and plain on the other side supplied in bottles of 100 and 1000.  100s     NDC 58657-150-01 1000s  NDC 58657-150-10 Dispense in well-closed container with child-resistant closure. Store 20°-25°C (68°-77°F). [See USP controlled room temperature.] Manufactured by: ANSHI PHARMACEUTICAL ( ZHONGSHAN ) INC. Zhongshan, Guangdong 528437 P.R. China Manufactured for: Method Pharmaceuticals, LLC Arlington, TX 76006 Rev Date: 2/15

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOLIC ACID- FOLIC ACID TABLET
METHOD PHARMACEUTICALS, LLC
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FOLIC ACID
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: 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 megaloblastic
and macrocytic ane