FOLIC ACID tablet

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Physicians Total Care, Inc.

SNN (starptautisko nepatentēto nosaukumu):

FOLIC ACID

Kompozīcija:

FOLIC ACID 1 mg

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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.

Produktu pārskats:

Folic Acid Tablets, USP 1 mg are scored, round, yellow tablets imprinted “AN” and “361” on one side and supplied in: bottles of 30    NDC 54868-2314-2 bottles of 60    NDC 54868-2314-3 bottles of 90    NDC 54868-2314-4 bottles of 100  NDC 54868-2314-0 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 by: Amneal Pharmaceuticals Paterson, NJ 07504 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 5-2009 Repackaging and Relabeling by: Physicians Total Care, Inc. Tulsa, OK    74146

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

FOLIC ACID - FOLIC ACID TABLET
PHYSICIANS TOTAL CARE, INC.
----------
RX ONLY
DESCRIPTION
Folic acid, 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 are present in a wide
variety of foods, particularly liver, kidneys, yeast, and leafy green
vegetables. Commercially available
folic acid is pre pared 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:
C
H N O M.W. 441.40
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 deoxyribonu cleic acid (DNA) synthesis that leads to
megaloblast formation and
megaloblastic and macrocytic anemias.