Iron Polymaltose Complex

• Iron Deficiency Anemia: Treatment and prevention of iron deficiency anemia due to blood loss, dietary insufficiency, pregnancy, or chronic diseases such as chronic kidney disease (CKD).
• Iron Deficiency without Anemia: For patients with low iron stores but normal hemoglobin, to replenish iron reserves.
• Anemia of Chronic Disease (adjunctive): Where iron supplementation is indicated alongside other therapies.
• Prevention of Iron Deficiency: In high-risk groups such as pregnant and lactating women, infants, adolescents, and elderly.
• Post-Surgical or Trauma Patients: To restore iron stores depleted by blood loss.
• Chronic Kidney Disease (CKD): For non-dialysis and dialysis patients requiring iron supplementation.

• Route: Oral administration (tablets, capsules, or oral solution).
• Adults:
• Usual dose is 100-200 mg elemental iron daily, typically administered as 1-2 tablets/capsules of Iron Polymaltose Complex once or twice daily.
• Dosage may be adjusted based on severity and response.
• Pediatrics:
• Dose depends on age and weight; usually 3-6 mg/kg/day elemental iron in divided doses.
• Use pediatric formulations (oral solution or syrup) as appropriate.
• Elderly:
• Same as adults; monitor for tolerance.
• Special Populations:
• Renal or hepatic impairment: Use with caution; monitor iron parameters and clinical response.
• Pregnant and lactating women: Dose typically 1 tablet daily (100 mg elemental iron) to meet increased requirements.
• Administration Instructions:
• Take orally, preferably on an empty stomach to improve absorption but may be taken with food if gastrointestinal upset occurs.
• Avoid simultaneous intake with antacids, calcium supplements, dairy products, or certain antibiotics to prevent reduced iron absorption.
• Separate doses of interacting medications by at least 2 hours.

Iron Polymaltose Complex provides bioavailable iron in a stable, non-ionic complex that releases iron slowly in the gastrointestinal tract, minimizing free ionic iron and reducing gastrointestinal side effects. The absorbed iron binds to transferrin and is transported to the bone marrow where it is incorporated into hemoglobin for erythropoiesis. Iron is essential for oxygen transport in red blood cells and for various enzymatic processes in cellular metabolism. The complexed form allows gradual release and effective replenishment of iron stores with improved tolerability.

• Absorption:
  Iron Polymaltose Complex is absorbed slowly and steadily in the duodenum and upper jejunum. Its bioavailability is approximately 10-15%, influenced by gastric pH and food intake.
• Distribution:
  Absorbed iron binds to transferrin and is transported to tissues, primarily bone marrow for hemoglobin synthesis and liver/spleen for storage as ferritin.
• Metabolism:
  Iron itself is not metabolized; the polymaltose carrier is metabolized by intestinal enzymes.
• Elimination:
  Iron is primarily lost through sloughing of intestinal mucosal cells, menstruation, and minor bleeding. The half-life of circulating iron bound to transferrin varies but is typically hours; storage iron turnover is slower.

• Pregnancy:
  Iron Polymaltose Complex is considered safe and is classified as FDA Pregnancy Category A or B (depending on regional labeling). It is routinely recommended to prevent and treat iron deficiency anemia during pregnancy.
• Lactation:
  Iron is excreted in breast milk in small amounts, considered safe for breastfeeding infants. No adverse effects reported with appropriate maternal dosing.
• Note: Iron supplementation during pregnancy should be supervised to avoid excess iron.

• Hematinic
• Oral Iron Preparation
• Nutritional Supplement

• Known hypersensitivity to iron polymaltose or any component of the formulation
• Hemochromatosis or other iron overload syndromes
• Hemosiderosis
• Severe hepatic impairment
• Anemia not due to iron deficiency (e.g., hemolytic anemia, thalassemia major)
• Conditions with uncorrected iron metabolism disorders

• Avoid iron overload; monitor serum ferritin and transferrin saturation during prolonged therapy
• Use cautiously in patients with liver disease or inflammation
• Iron may cause gastrointestinal irritation; dose adjustment may be necessary
• May mask symptoms of other underlying hematologic conditions
• Keep out of reach of children to prevent accidental overdose and toxicity (iron poisoning is potentially fatal)
• Monitor for hypersensitivity reactions

Common:

• Gastrointestinal: nausea, constipation, diarrhea, abdominal pain, metallic taste, dark stools (benign)

Uncommon:

• Headache, dizziness
• Allergic skin reactions such as rash or pruritus

Rare but Serious:

• Anaphylactic or hypersensitivity reactions (rare)
• Iron overload toxicity (with excessive dosing)

• Antacids, Calcium Supplements, Dairy Products: Decrease iron absorption
• Tetracyclines and Quinolone Antibiotics: Reduced absorption of both iron and antibiotics when given concurrently
• Levothyroxine: Reduced absorption with iron; separate dosing by 2-4 hours
• Ascorbic Acid (Vitamin C): Increases iron absorption; may be co-administered to enhance efficacy
• No significant involvement of cytochrome P450 enzymes; minimal CYP-mediated interactions.

• Updated WHO guidelines emphasize the importance of iron supplementation in pregnancy and young children for anemia prevention.
• Recent recommendations favor iron polymaltose complex for better gastrointestinal tolerability compared to ferrous salts.
• Emphasis on monitoring iron status during long-term therapy to avoid overload.
• Pediatric formulations have been improved for palatability and dosing accuracy.

• Store at 20°C to 25°C (68°F to 77°F)
• Protect from moisture, heat, and direct sunlight
• Keep tablets in original packaging until use
• Keep out of reach of children
• Do not freeze or refrigerate