Repliva 21/7 Tablets (Ther-Rx)

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DESCRIPTION

Repliva 21/7™ Tablets for oral administration to provide 28-day iron supplement therapy.

Each red film-coated tablet contains:

Iron

   Ferrochel® ^* (elemental iron)   70 mg

   Ferrous fumarate (elemental iron)   81 mg

Succinic acid    150 mg

Vitamin C (ascorbic acid)   140 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 B ₁₂ (cyanocobalamin)   10 mcg

Inactive Ingredients:    citric acid, croscarmellose sodium, FD&C Red No. 40 aluminum lake, FD&C Yellow No. 6 aluminum lake, fumed silica, hypromellose, lactose monohydrate, lecithin, magnesium stearate, maltodextrin, 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 inert ingredients:   croscarmellose sodium, D&C Red No. 27 aluminum lake, FD&C Blue No. 1 aluminum lake, 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 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.

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 B ₁₂ is deficient.

PRECAUTIONS

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 inactive 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 64011-165-34) 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.

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

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