Bariatric Times - January 2009 - (Page 7b)

Clinically proven efficacy through maximum absorption Formulated for maximum iron absorption For more information about Repliva 21/7®, call us at 877-567-7676 or visit www.repliva.com or www.ther-rx.com. References: 1. Data on file, Ther-Rx Corporation. 2. IMS Data (06/08). 3. Repliva 21/7® prescribing information, Ther-Rx Corporation, July 2008. 4. Brise H, Hallberg L. Effect of succinic acid on iron absorption. Acta Med Scand. 1962;171(suppl 376):59-73. *Based on the results of a prospective, randomized, multicenter trial in iron-deficient women (N=150) undergoing 12 weeks of therapy with once-daily Repliva 21/7 or ferrous sulfate (65 mg elemental iron three times daily).1 PRESCRIBED BRANDED ORAL IRON2 #1 Hemochromatosis and hemosiderosis are contraindications to iron therapy. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. 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. 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. PRECAUTIONS Rx Only DESCRIPTION Repliva 21/7® Tablets for oral administration to provide 28-day iron supplement therapy. Each red film-coated tablet contains: Iron (elemental iron) Sumalate®* iron 70 mg Ferrous fumarate 81 mg Succinic acid 150 mg Vitamin C Ascorbic acid 140 mg Ester-C ®† supplement 60 mg Folic acid, USP 1 mg Vitamin B12 (cyanocobalamin) 10 mcg Inactive Ingredients: aluminum hydrate, citric acid, croscarmellose sodium, FD&C Red No. 40 aluminum lake, FD&C Yellow No. 6 aluminum lake, hypromellose, lactose monohydrate, lecithin, magnesium stearate, malic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium benzoate, sodium citrate, sorbic acid, starch, talc, titanium dioxide, triacetin. Each purple film-coated tablet contains 150 mg of succinic acid and the following inactive ingredients: croscarmellose sodium, D&C Red No. 27 aluminum lake, FD&C Blue No. 1 aluminum lake, hydrated alumina, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide. 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. INDICATIONS AND USAGE: 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. CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron therapy. WARNINGS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. General: Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with Repliva 21/7® Tablets. 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. 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, cyanosis, lassitude, seizures, shock and coma. DOSAGE AND ADMINISTRATION: Usual adult dose is 1 tablet daily, or as directed by a physician. The Repliva 21/7® TheraPak supplies a 28-day course of iron therapy that consists of 21 red active tablets and 7 purple absorption period tablets. Take 1 red tablet daily for 21 days, followed by 1 purple tablet daily for 7 days. After 28 tablets have been taken, a new course may be started if prescribed. HOW SUPPLIED: Repliva 21/7® Tablets are available in a TheraPak blister dispenser (NDC 64011-207-34) containing 28 oval shaped tablets (21 red tablets and 7 purple tablets). The red film-coated tablets are debossed “Ther-Rx” on one side and “201” with a partial bisect on the other side. The purple film-coated tablets are debossed “Ther-Rx” on one side and “206” with a partial bisect on the other side. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Avoid excessive heat 40°C (104°F). Avoid freezing. *Sumalate® is a registered trademark of Albion International, Inc., Clearfield, Utah and the product is protected under U.S. Patent Nos. 5,516,925 and 6,716,814, licensed exclusively to KV Pharmaceutical Co. for iron products. Other U.S. patents pending. †Ester-C ® is a licensed trademark of The Ester C Company. Mktd. by Ther-Rx Corp., St. Louis, MO 63044 U.S. Patent Nos.: 5,516,925; 6,716,814. Other U.S. patents pending. P5497-1 07/08 Marketed by Ther-Rx Corporation, St. Louis, MO 63044 © 2008 Ther-Rx Corporation 08-180 08/08 http://www.repliva.com http://www.ther-rx.com http://www.repliva.com

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Bariatric Times - January 2009

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