Prescription Drugs

CLINICAL PHARMACOLOGY Iron is an essential component in the formation of hemoglobin. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes that are involved in electron transport. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is converted in the liver and plasma to its metabolically active form, tetrahydrofolic acid, by dihydrofolate reductase. Vitamin B12 is required for the maintenance of normal erythropoiesis, nucleoprotein and myelin synthesis, cell reproduction and normal growth. Intrinsic factor, a glycoprotein secreted by the gastric mucosa, is required for active absorption of Vitamin B12 from the gastrointestinal tract.

Niferex® GOLD Tablets (ferrous bis-glycinate chelate and polysaccharide) Iron Complex DESCRIPTION Each orange film-coated tablet for oral administration contains: Iron Ferrochel®* (elemental iron)................................. 50 mg Polysaccharide iron complex (elemental iron) ......... 150 mg Succinic acid......................................................... 50 mg Vitamin C as Ester-C®† Ascorbic acid (as calcium ascorbate)...................... 60 mg Threonic acid (as calcium threonate)..................... 0.8 mg Folic acid, USP...................................................... 1 mg Vitamin B12 (cyanocobalamin)................................. 25 mcg Zinc (zinc oxide).................................................... 10 mg Docusate sodium.................................................. 50 mg * Ferrochel® (ferrous bis-glycinate chelate) is a registered trademark of Albion International, Inc., Clearfield, Utah, and is protected under U.S. Patent Nos. 4,599,152; 4,830,716 and 6,716,814. †Ester-C® is a patented pharmaceutical grade material consisting of calcium ascorbate and calcium threonate. Ester-C® is a licensed trademark of Zila Nutraceuticals, Inc. Inactive ingredients: carnauba wax, citric acid, croscarmellose sodium, FD&C Blue No. 2 aluminum lake, FD&C Red No. 40 aluminum lake, FD&C Yellow No. 6 aluminum lake, fumed silica, hypromellose, lactose monohydrate, magnesium stearate, maltodextrin, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silicon dioxide, sodium benzoate, sodium citrate, sorbic acid, starch, stearic acid, titanium dioxide, and triacetin..

INDICATIONS For the treatment of all anemias responsive to oral iron therapy, such as hypochromic anemia associated with pregnancy, chronic or acute blood loss, dietary restriction, metabolic disease and post-surgical convalescence. DOSAGE AND ADMINISTRATION Usual adult dose is 1 tablet daily, or as directed by a physician. HOW SUPPLIED Niferex® Gold Tablets (ferrous bis-glycinate chelate and polysaccharide iron complex) are supplied as oval, orange film-coated tablets, debossed "Ther-Rx" on one side and "162" with a partial bisect on the other side, in bottles of 90 tablets (NDC 64011162-26).. Store at controlled room temperature 15°- 30°C (59°- 86°F). Mktd. by Ther-Rx Corp. St. Louis, MO 63044. .05/05. FDA rev date: n/a

PATIENT INFORMATION No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

OVERDOSE The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma. The oral LD50 of polysaccharide iron complex was estimated to be greater than 5000 mg iron/kg in the rat. Chronic toxicity studies in rats and dogs administered polysaccharide iron complex showed that a daily dosage of 250 mg iron/kg for three months had no adverse effects. CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron therapy.

SIDE EFFECTS Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid. DRUG INTERACTIONS No information provided.

WARNINGS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately. PRECAUTIONS General. Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with Niferex® Gold. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible. Folic Acid Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia. Pediatric Use Safety and effectiveness in pediatric patients have not been established.. Geriatric Use Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy..