Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)
Exelan Pharmaceuticals, Inc.
FOLIC ACID
FOLIC ACID 1 mg
ORAL
PRESCRIPTION DRUG
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.
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. Lawrenceville, GA 30046 Rev: 06/12
Abbreviated New Drug Application
FOLIC ACID - FOLIC ACID TABLET EXELAN PHARMACEUTICALS, INC. ---------- 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: 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 defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic and m Prečítajte si celý dokument