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:

Bryant Ranch Prepack

INN (International Name):

FOLIC ACID

Composition:

FOLIC ACID 1 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Folic acid, USP is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid, USP (as may be seen in tropical or nontropical sprue) and in anemias of nutritional origin, pregnancy, infancy, or childhood. Folic acid, USP is contraindicated in patients who have shown previous intolerance to the drug.

Product summary:

Product: 63629-2816 NDC: 63629-2816-4 50 TABLET in a BOTTLE NDC: 63629-2816-1 30 TABLET in a BOTTLE NDC: 63629-2816-2 100 TABLET in a BOTTLE NDC: 63629-2816-3 120 TABLET in a BOTTLE NDC: 63629-2816-5 90 TABLET in a BOTTLE NDC: 63629-2816-6 60 TABLET in a BOTTLE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOLIC ACID- FOLIC ACID TABLET
BRYANT RANCH PREPACK
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FOLIC ACID TABLETS, USP
DESCRIPTION
Folic acid, USP, N-[_p_-[[(2-amino-4- hydroxy-6-pteridinyl) methyl]-
amino] benzoyl]-Lglutamic 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, USP are present in
a wide variety of foods, particularly liver, kidneys, yeast, and leafy
green vegetables. Commercially
available folic acid, USP is prepared synthetically. Folic acid, USP
occurs as a yellow or yellowish-
orange crystalline powder and is very slightly soluble in water and
insoluble in alcohol. Folic acid,
USP 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, USP (sodium folate). Aqueous solutions of
folic acid, USP 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, USP is as follows:
C
H N O M.W. 441.40
Each tablet, for oral administration, contains 1 mg folic acid, USP.
Folic acid tablets, USP 1 mg contain the following inactive
ingredients: 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, 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 deoxyribonu cleic acid (DNA) synthesis that leads to
megalobl