FOLIC ACID tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Bryant Ranch Prepack

INN（国際名）:

FOLIC ACID

構図:

FOLIC ACID 1 mg

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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.

製品概要:

Folic acid tablets, USP 1 mg are yellow to orange color, round, bisected compressed tablets, debossed “EP” above bisect and “127” below the bisect on one side and plain on the other side. Product: 71335-0766 NDC: 71335-0766-1 30 TABLET in a BOTTLE NDC: 71335-0766-2 100 TABLET in a BOTTLE NDC: 71335-0766-3 120 TABLET in a BOTTLE NDC: 71335-0766-4 50 TABLET in a BOTTLE NDC: 71335-0766-5 90 TABLET in a BOTTLE NDC: 71335-0766-6 60 TABLET in a BOTTLE NDC: 71335-0766-7 10 TABLET in a BOTTLE Dispense in a well-closed container as defined in the USP, using a child-resistant closure. Store at 20°-25° C (68°-77° F). [See USP controlled room temperature.] Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

認証ステータス:

Abbreviated New Drug Application

製品の特徴

FOLIC ACID- FOLIC ACID TABLET
BRYANT RANCH PREPACK
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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: corn starch,
microcrystalline cellulose, sodium starch glycolate and stearic acid.
CLINICAL PHARMACOLOGY
Folic acid acts on megaloblastic bone marrow to produce a normoblastic
marrow.
In man, 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 macrocytic anemias.
Folic acid is absorbed rapi