FOLIC ACID tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Rising Pharma Holdings, Inc.

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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.

Ringkasan produk:

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 16571-881-01 Bottles of 1000:              NDC 16571-881-10 Dispense in well-closed container with child-resistant closure. Store 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 00816 Iss. 06/2022

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

FOLIC ACID- FOLIC ACID TABLET
RISING PHARMA HOLDINGS, INC.
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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, 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:
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
patients with folic acid deficiency is thought to account for the
defective
deoxyribonucleic acid (DNA) synthesis that leads to megaloblast
formation and
megalobl