Feofol

• Approved Indications:
• Treatment and prevention of iron deficiency anemia due to iron and folate deficiency.
• Prevention of neural tube defects in pregnancy through folic acid supplementation.
• Anemia associated with pregnancy, lactation, menstruation, or nutritional deficiencies.
• Supportive treatment in conditions with increased folate and iron requirements such as chronic blood loss, growth spurts in children, and chronic illnesses.
• Off-label / Clinically Accepted Uses:
• Adjunct therapy in anemia of chronic disease with combined iron and folate deficiency.
• Perioperative anemia management to optimize hemoglobin levels.

• Route: Oral.
• Adults:
• Typical dosage: 1 to 2 tablets daily containing approximately 65 mg elemental iron (from ferrous sulfate) and 0.4 to 1 mg folic acid.
• Dose may be adjusted based on severity of anemia and physician discretion.
• Pediatrics:
• Dose calculated based on elemental iron and folic acid requirements, often lower strength formulations.
• Typically 3-6 mg/kg/day of elemental iron and 0.1-0.5 mg folic acid daily in divided doses.
• Elderly:
• Same as adults; monitor tolerance and hematologic response.
• Special Populations:
• Renal/Hepatic impairment: Use with caution, monitor blood counts and iron levels; no specific dose adjustments established.
• Pregnant women: Usually higher doses may be required for prophylaxis and treatment, especially in the second and third trimesters.
• Administration Notes:
• Preferably taken on an empty stomach for better absorption, but can be taken with food to reduce gastrointestinal discomfort.
• Avoid simultaneous intake with calcium supplements, antacids, or dairy products.
• Duration:
• Continue treatment for at least 3-6 months after normalization of hemoglobin to replenish iron and folate stores.

Ferrous sulfate provides elemental iron essential for hemoglobin synthesis by supplying bioavailable iron that is absorbed in the proximal small intestine and transported via transferrin to the bone marrow. Folic acid, a water-soluble B vitamin, is vital for DNA synthesis and erythropoiesis by facilitating the conversion of deoxyuridylate to thymidylate during nucleotide synthesis. Combined, they address deficiencies that impair red blood cell production, resulting in correction of anemia and improvement of oxygen-carrying capacity in the blood.

• Absorption:
• Ferrous sulfate: 10-15% absorption of elemental iron, enhanced in acidic gastric environment; inhibited by food and certain drugs.
• Folic acid: Rapidly absorbed in the proximal small intestine; absorption unaffected significantly by food.
• Distribution:
• Iron binds transferrin in plasma; folic acid distributed to tissues including liver and red blood cells.
• Metabolism:
• Iron incorporated into hemoglobin or stored as ferritin; no metabolic transformation.
• Folic acid converted intracellularly to tetrahydrofolate, active metabolite involved in one-carbon transfer reactions.
• Elimination:
• Iron losses minimal, mainly via sloughing of mucosal cells, menstruation, and bleeding.
• Folic acid eliminated primarily via renal excretion.
• Half-life:
• Iron reflects red blood cell turnover (~120 days).
• Folic acid plasma half-life approximately 3 to 4 hours.

• Pregnancy: Considered safe and recommended during pregnancy to prevent and treat iron and folate deficiency anemia. Folic acid is specifically indicated to reduce the risk of neural tube defects.
• Lactation: Both iron and folic acid are considered safe during breastfeeding. Small amounts are secreted into breast milk and support infant nutritional needs.

• Primary class: Hematinic agent.
• Subclasses: Oral iron supplement + Vitamin B9 (folic acid) supplement.

• Known hypersensitivity to ferrous sulfate, folic acid, or any excipients.
• Iron overload disorders (e.g., hemochromatosis, hemosiderosis).
• Anemias not due to iron or folate deficiency (e.g., pernicious anemia without B12 supplementation).
• Severe hepatic impairment without medical supervision.

• Use cautiously in patients with peptic ulcer disease or gastrointestinal inflammation.
• Monitor for signs of iron overload, especially with prolonged use.
• High doses of folic acid may mask symptoms of vitamin B12 deficiency; ensure vitamin B12 status is adequate.
• Overdose of iron-containing products is a leading cause of fatal poisoning in children; store out of reach.
• Monitor hematologic parameters periodically to assess efficacy and toxicity.

• Common:
• Gastrointestinal: nausea, abdominal pain, constipation, diarrhea, dark stools.
• Mild headache or dizziness.
• Serious/Rare:
• Hypersensitivity reactions: rash, pruritus, anaphylaxis (rare).
• Iron toxicity in overdose.
• Allergic reactions to folic acid are rare.

• Decreased absorption of iron when coadministered with:
• Antacids, calcium, magnesium-containing products.
• Proton pump inhibitors and H2 blockers.
• Certain antibiotics such as tetracyclines and quinolones.
• Folic acid may decrease the efficacy of methotrexate.
• Iron may reduce absorption of levothyroxine.
• No major CYP450 metabolism involvement.

• Guidelines from WHO and various hematology associations continue to recommend ferrous sulfate + folic acid as first-line therapy for iron and folate deficiency anemia, especially in pregnancy.
• Recent recommendations focus on tailored dosing to improve tolerability and adherence.
• No new black box warnings or major safety alerts.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and direct light.
• Keep container tightly closed.
• Keep out of reach of children.
• No refrigeration required.