FOLIC ACID tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Athem

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

Folic Acid Tablets, USP, 1 mg, are supplied as Yellow colored round shaped biconvex uncoated tablet with “ET break line 28” debossed on one side & plain on other side. They are available as follows: Bottles of 100:                            NDC 73152-141-01 Bottles of 500:                            NDC 73152-141-05 Bottles of 1000:                          NDC 73152-141-10 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 for: Athem LLC East Brunswick, NJ 08816 Rev. 12/2020

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

FOLIC ACID- FOLIC ACID TABLET
ATHEM
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FOLIC ACID TABLETS
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.
structure.jpg
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 megaloblast