FOLIC ACID tablet

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Bryant Ranch Prepack

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

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. NDC: 71335-9628-1: 30 Tablets in a BOTTLE NDC: 71335-9628-2: 100 Tablets in a BOTTLE NDC: 71335-9628-3: 120 Tablets in a BOTTLE NDC: 71335-9628-4: 50 Tablets in a BOTTLE NDC: 71335-9628-5: 90 Tablets in a BOTTLE NDC: 71335-9628-6: 60 Tablets in a BOTTLE NDC: 71335-9628-7: 10 Tablets in a BOTTLE Dispense in well-closed container with child-resistant closure. Store 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

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, 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
megaloblastic an