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Polysaccharide Iron Complex (Capsules)
NIFEREX® 150 FORTE Each bead-filled capsule for oral administration contains:
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 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.
NIFEREX®-150 FORTE is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.
Adults: 1 capsule daily or as directed by a physician. HOW SUPPLIED NIFEREX®-150 FORTE Capsules are red and clear capsules containing brown beads. The capsules are imprinted "SP" and "4330". They are supplied as follows:
Storage: Store at controlled room temperature 15°-30°C
(59°-86°F).
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.
No information provided.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 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 See PATIENT INFORMATION section.
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