Repliva 21 7 tablets

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 B 12 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 B 12 from the gastrointestinal tract.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron therapy.

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.

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.

Repliva 21/7™ Tablets are available in a TheraPak blister dispenser ( NDC 64011-165-34) 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 "155" with a partial bisect on the other side. The purple film-coated tablets are debossed "Ther-Rx" on one side with a partial bisect on the other side.

Store at controlled room temperature 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.

* 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.

Mktd. by Ther-Rx Corp., St. Louis, MO 63044

U.S. Patent Nos.: 4,599,152; 4,822,816; 4,830,716; 5,070,085; 6,716,814. Other U.S. patents pending.

P4865  04/05

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis.