FOLIC ACID tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Aphena Pharma Solutions - Tennessee, LLC

INN (Kansainvälinen yleisnimi):

FOLIC ACID

Koostumus:

FOLIC ACID 1 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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.

Tuoteyhteenveto:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Folic Acid Tablets USP, 1 mg are Light Yellow, Round, biconvex tablets debossed “I” on the left side of the bisect and “G” on the right side of bisect on one side and “210” on other; supplied in bottles of 100 (NDC 76282-210-01) and 1000 (NDC 76282-210-10). Dispense in a well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Manufactured by: InvaGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Exelan Pharmaceuticals, Inc. Peachtree City, GA 30269 Rev: 12/11

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

FOLIC ACID - FOLIC ACID TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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FOLIC ACID TABLET 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:
C
H N O M.W. 441.40
Each tablet, for oral administration, contains 1 mg folic acid.
Folic Acid Tablets USP 1 mg contain the following inactive
ingredients: microcrystalline cellulose,
colloidal silicon dioxide, lactose monohydrate, 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
19
19
7
6
defective deoxyribonucleic acid (DNA) synthesis that leads to
megalob