Bioron

• Approved Indications:
• Treatment of iron deficiency anemia due to inadequate dietary intake, chronic blood loss, or increased iron requirements (e.g., pregnancy, growth).
• Prevention of iron deficiency in high-risk populations, including pregnant women and infants.
• Adjunct therapy in anemia secondary to chronic diseases where iron deficiency is present.
• Treatment of sideroblastic anemia.
• Off-label / Clinically Accepted Uses:
• Supportive therapy in anemia of chronic kidney disease with concurrent iron deficiency.
• Management of iron deficiency in gastrointestinal disorders impairing absorption.
• Perioperative and postoperative anemia management.

• Route: Oral.
• Adults:
• Treatment dose: Typically 325 mg ferrous sulfate tablets (containing approximately 65 mg elemental iron) taken 1 to 3 times daily.
• Prevention dose: 1 tablet daily or as recommended.
• Pediatrics:
• Dose based on elemental iron content: 3-6 mg/kg/day divided into 2-3 doses.
• Use pediatric formulations as appropriate.
• Elderly:
• Same dosing as adults; monitor for tolerance and adverse effects.
• Special Populations:
• Renal impairment: Use cautiously; no standard dose adjustment but monitor iron status and toxicity.
• Hepatic impairment: Use with caution.
• Administration:
• Preferably taken on an empty stomach to enhance absorption.
• If gastrointestinal upset occurs, may be taken with food.
• Avoid concurrent intake with calcium, antacids, or dairy products.
• Duration:
• Continue treatment for at least 3-6 months to replenish iron stores after anemia correction.

Ferrous sulfate supplies elemental iron essential for hemoglobin synthesis within erythrocytes. Upon oral administration, ferrous iron (Fe²⁺) is absorbed primarily in the duodenum and proximal jejunum via active transport. Inside enterocytes, iron is either stored as ferritin or transported into the bloodstream bound to transferrin. Circulating iron is delivered to the bone marrow for incorporation into hemoglobin, facilitating oxygen transport. By correcting iron deficiency, ferrous sulfate restores erythropoiesis and alleviates symptoms of anemia.

• Absorption:
• Approximately 10-15% of orally administered elemental iron from ferrous sulfate is absorbed, depending on the individual's iron status and gastric pH.
• Absorption enhanced by acidic gastric environment; inhibited by food and some medications.
• Distribution:
• Iron binds plasma transferrin, delivered primarily to bone marrow and storage sites (liver, spleen).
• Metabolism:
• Iron is not metabolized but incorporated into hemoglobin or stored as ferritin and hemosiderin.
• Excretion:
• Iron elimination is minimal; losses occur via sloughing of intestinal mucosal cells, bleeding, menstruation.
• Half-life:
• Reflects red blood cell turnover (~120 days) rather than direct drug elimination.

• Pregnancy Category: Generally considered Category A for iron supplementation; recommended for prevention and treatment of iron deficiency anemia in pregnancy.
• Lactation: Iron is excreted into breast milk in small amounts and is safe during breastfeeding. Supplementation supports maternal and infant iron status.

• Primary therapeutic class: Hematinic agent.
• Subclass: Oral iron supplement.

• Known hypersensitivity to ferrous sulfate or formulation excipients.
• Hemochromatosis or other iron overload disorders.
• Hemosiderosis.
• Anemias not due to iron deficiency (e.g., hemolytic anemia, thalassemia major).
• Severe hepatic impairment.

• Use caution in patients with peptic ulcer disease or inflammatory bowel disease.
• Monitor iron status to avoid iron overload and toxicity.
• Overdose can be fatal, especially in children—store safely.
• Iron supplementation may mask symptoms of vitamin B12 deficiency; monitor accordingly.
• May cause gastrointestinal irritation; dosage adjustment may be needed.

• Common:
• Gastrointestinal upset: nausea, epigastric discomfort, constipation, diarrhea.
• Dark stools (benign effect of unabsorbed iron).
• Serious/Rare:
• Hypersensitivity reactions (rash, pruritus).
• Iron overload toxicity.
• Gastrointestinal bleeding or ulceration (rare).

• Decreased absorption with concurrent use of:
• Antacids, calcium supplements.
• Proton pump inhibitors and H2 blockers (due to increased gastric pH).
• Tetracyclines and quinolone antibiotics.
• Iron may reduce absorption of levothyroxine and certain antibiotics.
• No major CYP450 enzyme interactions.

• WHO and multiple national guidelines continue to endorse ferrous sulfate as first-line oral iron therapy for iron deficiency anemia.
• Recent emphasis on lower doses to improve adherence and reduce gastrointestinal side effects.
• No new black box warnings or major safety alerts recently.

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