Polysaccharide Iron Complex (Tablets)

DESCRIPTION

NIFEREX^® PN Forte
(polysaccharide-iron complex, as cell-contracted akaganéite)
Extended-Release Tablets

NIFEREX^®-PN FORTE Tablets contain ingredients of the following classes: vitamins and minerals. Each white, film-coated tablet for oral administration contains:

• Iron (elemental) (polysaccharide-iron complex, as cell-contracted akaganéite) 60 mg
• 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 B₁ (as thiamine mononitrate) 3 mg
• Vitamin B₂ (riboflavin) 3.4 mg
• Vitamin B₆ (as pyridoxine hydrochloride) 4 mg
• Niacinamide 20 mg
• Vitamin B₁₂ (cyanocobalamin) 12 µg
• Calcium (as calcium carbonate) 250 mg
• Iodine (as potassium iodide) 200 µg
• Magnesium (as magnesium oxide) 10 mg
• Copper (as cupric oxide) 2 mg
• Zinc (as zinc sulfate) 25 mg

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.

CLINICAL PHARMACOLOGY

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.

INDICATIONS

NIFEREX^®-PN FORTE is indicated for the prevention and/or treatment of dietary vitamin and mineral deficiencies associated with pregnancy and lactation.

DOSAGE AND ADMINISTRATION

Adults: 1 tablet daily or as directed by a physician.

HOW SUPPLIED

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:

Storage: Store at controlled room temperature 15°-30°C (59°-86°F).

SIDE EFFECTS

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.

DRUG INTERACTIONS

No information provided.

WARNINGS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B₁₂ is deficient.

PRECAUTIONS

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

See PATIENT INFORMATION section.