FOLIC ACID tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Preferred Pharmaceuticals Inc.

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 samenvatting:

Folic Acid Tablets, USP 1 mg, are round, yellow tablets debossed “N8”on one side and bisected on other side and supplied in bottles; bottles of 30 (NDC 68788-7053-3) bottles of 60 (NDC 68788-7053-6) bottles of 90 (NDC 68788-7053-9) bottles of 100 (NDC 68788-7053-1) Dispense in well-closed container with child-resistant closure. Store at controlled room temperature 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Manufactured & Distributed by: Sunrise Pharmaceutical, Inc Rahway, NJ 07065 Repackaged By: Preferred Pharmaceuticals Inc. 5357/00 Rev. October 2021

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

FOLIC ACID- FOLIC ACID TABLET
PREFERRED PHARMACEUTICALS INC.
----------
FOLIC ACID TABLETS, USP
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 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.
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
19
19
7
6
patients with folic acid deficiency is thought to account for the
defective
deoxyribonucleic acid (DNA) synthe