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:

AvPAK

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:

Folic Acid Tablets, USP 1 mg , are supplied as round, yellow tablets imprinted “AN” and “361” on one side and scored on the other side. They are available in the following:  10 tablets per card, 5 cards per carton. NDC 50268-345-15 Dispensed in Blister Punch Material.  For Institutional Use Only. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FOLIC ACID- FOLIC ACID TABLET
AVPAK
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FOLIC ACID TABLETS, USP
Rx only
DESCRIPTION
Folic acid, USP, N- [ _p_-[[(2-amino-4- hydroxy-6-pteridinly)
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 peptide linkage
to a 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 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
maybe prepared with the aid of sodium hydroxide or sodium carbonate,
thereby
forming the soluble 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 structure formula of folic acid, USP is as follows:
C
H
N
O
M.W.441.40
Each tablet, for oral administration, contains 1mg folic acid, USP.
Folic acid tablets, USP 1mg 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 or 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 tymidylates
synthesis in
patients with folic acid deficiency is thought to account for the
defective
deoxyribonucleic acid (DNA) synthesis that leads to megaloblast
information and
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