FOLIC ACID tablet

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Aphena Pharma Solutions - Tennessee, LLC

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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.

Каталог на резюме:

Folic Acid Tablets, USP 1 mg are yellow, functionally scored, round, standard convex debossed with “ET breakline 28” debossed on one side and plain on the other side supplied in bottles of 1000. 1000s NDC 63629-9258-1 Dispense in well-closed container with child-resistant closure. Store 20°-25°C (68°-77°F). [See USP controlled room temperature.]

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

FOLIC ACID- FOLIC ACID TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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
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
deoxyribonucleic acid (DNA) synthesis that leads to megaloblast
formation and
megaloblastic and macrocyt