Each bead-filled capsule for oral administration contains:
Iron (elemental) ...................................................... 150 mg
(polysaccharide-iron complex, as cell-contracted akaganéite)
Folic Acid .................................................................. 1 mg
Vitamin B
12
(cyanocobalamin) ................................ 25 mcg
Each capsule also contains the following inactive ingredients: corn starch, D&C Red #7, D&C Red #28, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, hydrogenated castor oil, pharmaceutical glaze, povidone, sodium lauryl sulfate, sucrose, and titanium dioxide. It may contain: silicon dioxide.
NIFEREX® (polysaccharide-iron complex, as cell-contracted akaganéite) is the product of ferric iron complexed to a low molecular weight polysaccharide. This polysaccharide is produced by the extensive hydrolysis of starch. NIFEREX® is a dark brown powder which dissolves in water to form a very dark brown solution. It is virtually tasteless and odorless. Because it is an organic complex, it contains no free ions.
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. A radioisotope tracer study in man demonstrated that absorption of NIFEREX® Elixir is comparable to ferrous sulfate elixir. Clinical studies demonstrate that NIFEREX® produces good hematopoietic response as shown by increases in hemoglobin and hematocrit in pediatric and elderly patients. NIFEREX® is effective in maintaining the hematopoietic status in end-stage renal disease patients receiving epoetin alfa therapy.
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.
NIFEREX®-150 FORTE is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.
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.
| 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. |
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient.
General:
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 in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.
Information for Patients:
As with all oral iron preparations, NIFEREX®-150 FORTE should be stored out of the reach of children to guard against accidental iron poisoning. Patients should not exceed the recommended dosage unless directed by the physician. Patients should be informed that iron therapy can cause black or dark stools.
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.
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.
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.
Adults: 1 capsule daily or as directed by a physician.
NIFEREX®-150 FORTE Capsules are red and clear capsules containing brown beads. The capsules are imprinted "SP" and "4330". They are supplied as follows:
Unit Dose 100 NDC 0131-4330-86
Store at controlled room temperature 15°-30°C (59°-86°F).
PC2621C Rev. 7/99
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