Corvite FE

PRESCRIBING INFORMATION DESCRIPTION Red, oval bisected tablets embossed "VP042".

WARNINGS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.

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.

HOW SUPPLIED CORVITE(R) FE available in carton unit dose pack of 30 (6 child resistant blister cards of 5 tablets per card).

US Patent No. 5,516,925 US Patent No. 6,716,814 US Patent No. 7,838,042 US Patent No. 6,706,901 Other Patents Pending

ADVERSE REACTIONS 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.

OVERDOSAGE 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, cyanossi, lassitude, seizures, shock and coma.

CLINICAL PHARMCOLOGY 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.

DOSAGE AND ADMINISTRATION Usual adult dose is 1 tablet daily, or as prescribed by a physician.

INDICATIONS AND USAGE CORVITE(R) FE is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.

CONTRAINDICATIONS CORVITE(R) FE is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to iron therapy.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE 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 CORVITE(R) FE. Since the anemia may be a result of a sytemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Geriatric Use Clinical studies on this product have not been performed in 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.

CFELB021101

STORAGE Store at controlled room temperature 15(0)-30(0)C (59(0)-86(0)F) [See USP]. Protect from light, moisture and excessive heat. Dispense in a tight, light resistant container as defined in the USP using a child-resistant closure.

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Rx Only.

DimaCal and TRAACS are registered trademarks of Albion Laboratories, Inc. Malates covered by U.S. Patent 6,706,904, chelate covered by U.S. Patent 7,838,042; and patents pending.

Sumalate (ferrous asparto glycinate) is a trademark of Albion International, Inc., Clearfield, Utah.