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Niferex-150 Forte (Polysaccharide-Iron Complex Capsules): Side Effects, Uses, Dosage, Interactions, Warnings

Niferex-150 Forte

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 7/18/2022

Drug Summary

What Is Niferex-150 Forte?

Niferex-150 Forte (polysaccharide-iron complex capsules) is an iron supplement used for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.

What Are Side Effects of Niferex-150 Forte?

Common side effects of Niferex-150 Forte include:

  • constipation,
  • diarrhea,
  • nausea,
  • vomiting,
  • upset stomach,
  • abdominal pain, or
  • dark stools

Niferex-150 Forte may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • rash,
  • itching, and
  • severe dizziness

Get medical help right away, if you have any of the symptoms listed above.

Most side effects of Niferex-150 Forte are temporary.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Niferex-150 Forte

The recommended dosage of Niferex-150 Forte is 1 capsule daily taken orally. Tell your doctor all prescription, over-the-counter, and herbal medications you use.

What Drugs, Substances, or Supplements Interact with Niferex-150 Forte?

Niferex-150 Forte may interact with bisphosphonates, levodopa, penicillamine, antibiotics, and thyroid medications. Talk to your doctor about your complete medical history, including a use/abuse of alcohol, stomach/intestinal problems, or vitamin B12 deficiency (pernicious anemia).

Niferex-150 Forte During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or breastfeeding.

Additional Information

Our Niferex-150 Forte (polysaccharide-iron complex capsules) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

Description for Niferex-150 Forte

Each powder-filled capsule for oral administration contains:

Iron
  Sumalate™* (elemental iron)............................. 50 mg
  Polysaccharide iron (elemental iron)...................100 mg
Succinic acid ....................................................... 50 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 B12 (cyanocobalamin).............................. 25 mcg

* Sumalate™ (ferrous asparto glycinate) is a trademark of Albion International, Inc., Clearfield, Utah. U.S. patent pending.
† Ester-C® is a patented pharmaceutical grade material consisting of calcium ascorbate and calcium threonate. Ester-C® is a licensed trademark of Zila Nutraceuticals, Inc.

Inactive Ingredients: citric acid, D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, malic acid, modified food starch, pharmaceutical glaze, silicon dioxide, sodium benzoate, sodium citrate, sorbic acid, and titanium dioxide.

Uses for Niferex-150 Forte

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

Dosage for Niferex-150 Forte

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 "164" on the body, in bottles of 90 capsules (NDC 64011-164-26).

Store at 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. 05/06. FDA rev date: n/a

Side Effects for Niferex-150 Forte

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 for Niferex-150 Forte

No information provided.

Warnings for Niferex-150 Forte

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

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.

Precautions for Niferex-150 Forte

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.

Overdose Information for Niferex-150 Forte

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 LD50 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.

Contraindications for Niferex-150 Forte

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.

Clinical Pharmacology for Niferex-150 Forte

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 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..

Patient Information for Niferex-150 Forte

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

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