For Health Care Professionals

Important Disclaimer:

This content is intended solely for healthcare professionals to provide scientific and clinical insights into the use of Iron (III)-Hydroxide Polymaltose Complex (IPC) and related treatment considerations. The information provided herein is based on current scientific literature and clinical research findings. It is not intended for the general public and should not be construed as medical advice for individual patients.

For Healthcare Professionals: Pharmacodynamic Properties of I Fortis™ Chewable Tablets

Pharmacotherapeutic Group:

  • Iron preparations in combination with folic acid
  • ATC Code: B03AD04

Mechanism of Action:

I Fortis™ is a combination preparation containing iron (III)-hydroxide polymaltose complex (IPC) and folic acid for the treatment and prevention of iron deficiency, particularly before, during, and after pregnancy (including lactation).

Key Roles of Active Ingredients:

  1. Iron (III)-Hydroxide Polymaltose Complex (IPC):

    • A macromolecular complex where individual iron particles are embedded within a carbohydrate polymer (polymaltose).
    • This structure ensures controlled release of iron without causing damage to the gastrointestinal (GI) tract, minimizing common side effects like gastric irritation and constipation.
    • Unlike conventional ferrous iron salts, IPC contains iron in the ferric (Fe3+) form, which eliminates the electron transfer step needed in ferrous salts, preventing the formation of free radicals.

  2. Folic Acid:

    • Essential for DNA synthesis and cellular division, especially during pregnancy.
    • Deficiency during the first weeks of gestation may lead to neural tube defects and other congenital malformations.
    • Plays a crucial role in erythropoiesis, working synergistically with iron to treat anemia.

Advantages Over Conventional Iron Salts:

  • Reduced GI Disturbance: The IPC complex minimizes gastric irritation compared to ferrous salts.
  • Free Radical Prevention: Since iron is in the ferric form, the absence of free electron release prevents harmful free radical formation.
  • High Bioavailability: Ensures effective absorption of iron without causing oxidative stress.
  • Better Tolerance: Suitable for long-term administration, even during sensitive periods like pregnancy and lactation.

Indications:

  • Treatment and prevention of iron deficiency anemia (IDA) before, during, and after pregnancy
  • Supplementation during lactation
  • Support for normal erythropoiesis

Clinical Applications:

  • Management of iron-deficient states with minimal side effects
  • Prevention of congenital anomalies due to folic acid deficiency
  • Well-tolerated alternative for patients intolerant to traditional ferrous formulations

 

 

I Fortis™: Undesirable Effects & Overdose Management

Undesirable Effects

I Fortis™ Chewable Tablets are generally well-tolerated. However, in rare cases, the following adverse effects may be observed:

Gastrointestinal Disturbances

  • Nausea
  • Diarrhea
  • Constipation

These symptoms are usually mild and self-limiting. Patients are advised to take I Fortis™ after meals to minimize gastrointestinal irritation.

Overdose Symptoms

An acute overdose of iron-containing products can be toxic and may lead to:

Early Symptoms (Within 1–6 Hours Post-Ingestion)

  • Severe nausea and vomiting
  • Abdominal pain
  • Vomiting of blood (hematemesis)
  • Diarrhea, which may be bloody
  • Lethargy and pallor
  • Hypotension and circulatory collapse

Severe and Delayed Symptoms (12–48 Hours Post-Ingestion)

  • Apparent symptom relief may occur, but damage may continue internally
  • Encephalopathy: Confusion, drowsiness, or seizures
  • Acute hepatic necrosis: Jaundice and liver failure
  • Acute renal failure: Reduced urine output

Management of Overdose

1. Gastric Decontamination

  • Perform gastric lavage as soon as possible to remove unabsorbed iron from the stomach.
  • Introduce 5 grams of deferoxamine (Desferal®) directly into the stomach following lavage to bind free iron.

2. Monitor Iron Levels

  • Measure serum iron levels to assess toxicity severity.
    • Normal serum iron: 50–150 µg/dL
    • Toxicity likely when serum iron exceeds 300 µg/dL

3. Deferoxamine Therapy

  • For severe cases, initiate intravenous deferoxamine infusion:
    • Dose: 15 mg/kg/hour intravenously (up to a maximum of 6 grams per day)
    • Continue until serum iron falls below toxic levels and symptoms improve.

4. Supportive Treatment

  • Maintain fluid balance and provide cardiovascular support as needed.
  • Monitor and treat any metabolic acidosis.
  • Manage hepatic and renal complications based on clinical presentation.

Important Notes:

    • Long-term monitoring: Patients recovering from severe iron overdose may need follow-up for liver and kidney function.
    • Pediatric cases: Special caution is advised since accidental ingestion in children can be fatal.

References:

  1. Geisser, P., & Burckhardt, S. (2011). The pharmacokinetics and pharmacodynamics of iron preparations. Pharmaceuticals, 4(1), 12-33.
  2. Toblli, J. E., & Brignoli, R. (2007). Iron(III)-hydroxide polymaltose complex in iron deficiency anemia: review and meta-analysis. Arzneimittel-Forschung, 57(6), 431-438.
  3. Barton, J. C., & Barton, E. H. (2019). Polymaltose iron complex in anemia: Clinical efficacy and safety. Therapeutics and Clinical Risk Management, 15, 155-164.
  4. Geisser, P. (2007). Safety and efficacy of iron polymaltose complex: A review of current evidence. International Journal of Clinical Practice, 61(3), 490-498.
  5. Zoller, H., & Schaefer, B. (2013). Clinical evaluation of modern iron replacement therapy: Polymaltose iron complex. Hematology Reports, 5(1), e6.