FOLIC ACID tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

American Health Packaging

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

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: Unit dose packages of 100 (10 x 10) NDC 60687-681-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken. 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

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

FOLIC ACID- FOLIC ACID TABLET
AMERICAN HEALTH PACKAGING
----------
FOLIC ACID TABLETS, USP
8468101/0322
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:
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
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
fo