Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)
PD-Rx Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
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.
Folic Acid Tablets, USP 1 mg, are round, yellow tablets debossed “N8”on one side and bisected on other side and supplied in bottles of 30 (NDC 43063-791-30), 90 (NDC 43063-791-90). Dispense in well-closed container with child-resistant closure. Store at controlled room temperature 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Rev. October 2021
Abbreviated New Drug Application
FOLIC ACID- FOLIC ACID TABLET PD-RX PHARMACEUTICALS, INC. ---------- FOLIC ACID TABLETS, USP RX ONLY DESCRIPTION Folic acid, USP, 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, 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: C H N O M.W. 441.40 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 19 19 7 6 deoxyribonucleic acid (DNA) synthesis Olvassa el a teljes dokumentumot