Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7), FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8), CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)
Mission Pharmacal Company
ORAL
PRESCRIPTION DRUG
Ferralet ® 90 is indicated for the treatment of all anemias that are responsive to oral iron therapy. These include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, postsurgical convalescence, and dietary needs. Hypersensitivity to any of the ingredients. Hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy.
Ferralet ® 90 (NDC 0178-0089-90) is a green, modified rectangle shaped, film-coated tablet, debossed with "F6" on one side and blank on the other, and packaged in bottles of 90. Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). (See USP Controlled Room Temperature.)
unapproved drug other
FERRALET 90- IRON, FOLIC ACID, CYANOCOBALAMIN, ASCORBIC ACID, AND DOCUSATE SODIUM TABLET, FILM COATED MISSION PHARMACAL COMPANY _Disclaimer: This drug has not been found by FDA to be safe and effective, and this_ _labeling has not been approved by FDA. For further information about unapproved_ _drugs, click here._ ---------- FERRALET 90 90 MG DUAL-IRON DELIVERY DESCRIPTION Each green film-coated tablet for oral administration contains: Iron (Carbonyl iron, ferrous gluconate) 90 mg Folic Acid 1 1 mg Vitamin B (Cyanocobalamin) 12 mcg Vitamin C (Ascorbic acid) 120 mg Docusate sodium 50 50 mg INACTIVE INGREDIENTS:Povidone, croscarmellose sodium, acrylic resin, color added, magnesium stearate, FD&C Yellow No. 5, magnesium silicate, FD&C Blue No. 1, polyethylene glycol, vitamin A palmitate, ethyl vanillin. CLINICAL PHARMACOLOGY Oral iron is absorbed most efficiently when administered between meals. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport energy production and proper function of cells. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes, which are involved in electron transport. Folic acid is required for ® 12 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. Deficiency of folic acid may account for the defective deoxyribonucleic acid (DNA) synthesis that leads to megaloblast formation and megaloblastic macrocytic anemias. Vitamin B is essential to growth, cell reproduction, hematopoiesis, nucleic acid, and myelin synthesis. Deficiency may result in megaloblastic anemia or pernicious anemia. INDICATIONS AND USAGE Ferralet 90 is indicated for the treatment of all anemias that are responsive to oral iron therapy. These include: hypochromic anemia associated with pregnancy, chronic and/or Прочитать полный документ