NIFEREX®-PN FORTE Tablets contain ingredients of the following classes: vitamins and minerals. Each white, film-coated tablet for oral administration contains:
Iron (elemental) ........................................................ 60 mg
(polysaccharide-iron complex, as cell-contracted akaganéite)
Vitamin A ............................................................ 5000 IU
Vitamin D ............................................................... 400 IU
Vitamin E (as dl-alpha-tocopheryl acetate) ................ 30 IU
Vitamin C (ascorbic acid) ......................................... 80 mg
Folic acid ................................................................... 1 mg
Vitamin B 1 (as thiamine mononitrate) .......................... 3 mg
Vitamin B 2 (riboflavin) ........................................... 3.4 mg
Vitamin B 6 (as pyridoxine hydrochloride) ................... 4 mg
Niacinamide ............................................................. 20 mg
Vitamin B 12 (cyanocobalamin) ............................... 12 mcg
Calcium (as calcium carbonate) .............................. 250 mg
Iodine (as potassium iodide) ................................. 200 mcg
Magnesium (as magnesium oxide) ............................. 10 mg
Copper (as cupric oxide) ............................................ 2 mg
Zinc (as zinc sulfate) ................................................. 25 mg
Each tablet also contains the following inactive ingredients: castor oil, corn starch, ethyl cellulose, flavor, gelatin, hydrogenated vegetable oil, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyethylene glycol, povidone, propylene glycol, silicon dioxide, sodium benzoate, sorbic acid and titanium 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.
This product is formulated to meet the vitamin and mineral needs of the pregnant or lactating patient with special consideration given to adequate amounts of the hematopoietic factors: iron, folic acid and cyanocobalamin. Calcium is included in the formula to help supply the increased requirements of this mineral. Sixty (60) mg of elemental iron is available in the form of NIFEREX® (polysaccharide-iron complex, as cell-contracted akaganéite). A radioisotope tracer study in man demonstrated that absorption of NIFEREX® Elixir is comparable to ferrous sulfate elixir. In addition, folic acid and cyanocobalamin are included to prevent or treat pregnancy-related megaloblastic anemia.
NIFEREX®-PN FORTE is indicated for the prevention and/or treatment of dietary vitamin and mineral deficiencies associated with pregnancy and lactation.
NIFEREX®-PN 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:
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Vitamin A, in high doses, may be associated with birth defects.
Information for Patients:
As with all oral iron preparations, NIFEREX®-PN FORTE should be stored out of the reach of children to guard against accidental 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 tablet daily or as directed by a physician.
NIFEREX®-PN FORTE Tablets are white, capsule shaped, scored, film-coated tablets debossed with "SP2309" on the unscored side and 1/0 on the scored side. They are supplied as follows:
Unit Dose 100 NDC 0131-2309-09
Store at controlled room temperature 15°-30°C (59°-86°F).
PC2623C Rev. 5/98
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