Niferex-150 Forte Capsules (Ther-Rx)

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DESCRIPTION

Each powder-filled capsule for oral administration contains:

Iron

   Ferrochel® * (elemental iron) 80 mg

   Polysaccharide iron (elemental iron) 70 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) 25 mcg

Inactive Ingredients:    Magnesium stearate, silicon dioxide, gelatin, titanium dioxide, FD&C Red No. 40, D&C Red No. 28, FD&C Blue No. 1, pharmaceutical glaze.

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

Niferex®-150 Forte is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.

CONTRAINDICATIONS

Niferex®-150 Forte is contraindicated in patients with a known hypersensitivity to any of the components of this product. 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 Niferex®-150 Forte. 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.

The oral LD ₅₀ 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.

DOSAGE AND ADMINISTRATION

Usual adult dose is 1 capsule daily, or as directed by a physician.

HOW SUPPLIED

Niferex®-150 Forte Capsules are red and clear capsules filled with brown powder, imprinted in white ink with "THX" on the cap and "0136" on the body in child-resistant, unit-dose packages of 100 capsules (10 × 10 Unit Dose Packs) (NDC 64011-136-11).

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.

P4206-1 12/04

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