FOLIC ACID tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Cadila Pharmaceuticals Limited

INN (nemzetközi neve):

FOLIC ACID

Összetétel:

FOLIC ACID 1 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Folic acid, USP 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, USP is contraindicated in patients who have shown previous intolerance to the drug.

Termék összefoglaló:

Folic Acid Tablets, USP 1 mg are supplied as yellow, round, biconvex uncoated tablets, debossed with "C3" on one side and breakline on other side and supplied in bottles of 100 and 1000. Folic Acid Tablets, USP 1 mg is having functional scoring. They are available as follows: Bottles of 100s: NDC 71209-007-05 Bottles of 1000s: NDC 71209-007-11  Dispense in well-closed container with child-resistant closure. Store at 20°to 25°C (68°to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Cadila Pharmaceuticals Limited, 1389, Trasad Road, Dholka-382225 Dist.: Ahmedabad, Gujarat, INDIA Revised: March 2023

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

FOLIC ACID - FOLIC ACID TABLET
CADILA PHARMACEUTICALS LIMITED
----------
RX ONLY
DESCRIPTION
Folic acid, USP, N-[_p_-[[(2-amino-4- hydroxy-6-pteridinyl methyl]-
amino] benzoyl]-
Lglutamic acid, is a B complex vitamin containing apteridine 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 pre
pared 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
19
19
7
6
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 megalo