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:

MUTUAL PHARMACEUTICAL COMPANY, INC.

INN (International Name):

folic acid

Pharmaceutical form:

TABLET

Composition:

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 round, yellow, debossed MP 727 on the upper side, bisected on the other side. Bottles of 30            NDC 53489-580-07 Bottles of 60            NDC 53489-580-06 Bottles of 100          NDC 53489-580-01 Bottles of 250          NDC 53489-580-03 Bottles of 500          NDC 53489-580-05 Bottles of 1000        NDC 53489-580-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Summary of Product characteristics

FOLIC ACID- FOLIC ACID TABLET
MUTUAL PHARMACEUTICAL COMPANY, INC.
----------
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:
C H N O M.W. 4 4 1.4 0
Each tablet, for oral administration, contains 1 mg folic acid.
Folic acid tablets, USP 1 mg contain the following inactive
ingredients: corn starch, crospovidone,
magnesium stearate, microcrystalline cellulose, povidone, silicon
dioxide.
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