Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)
Quality Care Products, LLC
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 yellow to orange color, round, bisected compressed tablets, debossed “EP” above bisect and “127” below the bisect on one side and plain on the other side. 55700-698-30 Dispense in a well-closed container as defined in the USP, using a child-resistant closure. Store at 20°-25° C (68°-77° F). [See USP controlled room temperature.] Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 Rev. 02 04/17
Abbreviated New Drug Application
FOLIC ACID- FOLIC ACID TABLET QUALITY CARE PRODUCTS, LLC ---------- 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 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: corn starch, microcrystalline cellulose, sodium starch glycolate and stearic acid. CLINICAL PHARMACOLOGY Folic acid acts on megaloblastic bone marrow to produce a normoblastic marrow. In man, 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 macrocytic anemias. Folic acid is absorbe Lesen Sie das vollständige Dokument