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:

Cardinal Health 107, LLC

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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.

Ringkasan produk:

Folic Acid Tablets USP, 1 mg, are supplied as light yellow colored, round convex tablet debossed "AN 361" on one side and bisected on the other side. They are available as follows: Overbagged with 10 tablets per bag, NDC 55154-4306-0 Dispense contents with a child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Packaged and Distributed By: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number Distributed By: Cardinal Health Dublin, OH 43017 L58117570124 Rev. 07-2021-00

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

FOLIC ACID- FOLIC ACID TABLET
CARDINAL HEALTH 107, LLC
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FOLIC ACID TABLETS, USP
(1 MG)
RX ONLY
DESCRIPTION
Folic acid, 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 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, USP occurs as a yellow or yellowish-orange, odorless,
crystalline powder.
It 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 (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, USP.
Folic acid tablets, USP 1 mg contain the following inactive
ingredients: lactose
monohydrate, microcrystalline cellulose, sodium starch glycolate, Type
A 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
19
19
7
6
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 l