Biron Plus

• Approved Indications:
• Treatment and prevention of iron deficiency anemia and folate deficiency anemia, especially in populations at risk of nutritional deficiencies.
• Prevention of anemia during pregnancy and lactation.
• Supportive therapy in chronic blood loss anemia, nutritional deficiencies, and growth spurts in children.
• Zinc sulfate addition supports treatment of zinc deficiency, enhancing immune function and wound healing.
• Off-label / Clinically Accepted Uses:
• Adjunct in anemia of chronic disease with combined iron, folate, and zinc deficiencies.
• Supplementation in malabsorption syndromes and chronic illnesses with concurrent micronutrient deficiencies.
• Supportive nutritional therapy in elderly or debilitated patients.

• Route: Oral.
• Adults:
• Common dosage: 1-2 tablets daily containing approximately 65 mg elemental iron (ferrous sulfate), 0.4-1 mg folic acid, and 10-22 mg elemental zinc (from zinc sulfate).
• Taken preferably on an empty stomach or with food if gastrointestinal irritation occurs.
• Pediatrics:
• Dose individualized based on age, weight, and severity of deficiency.
• Pediatric formulations with adjusted doses of iron, folic acid, and zinc are used.
• Elderly:
• Same as adults with monitoring for tolerance and therapeutic response.
• Special Populations:
• Renal or hepatic impairment: Use with caution; no established dose adjustment.
• Pregnancy: Often requires higher folic acid and iron dosing; zinc dosing must be monitored carefully.
• Duration:
• Typically continued for 3-6 months after correction of anemia to replenish stores.
• Administration Tips:
• Avoid concurrent intake with calcium supplements, antacids, or dairy products due to reduced absorption.
• Separate from antibiotics like tetracyclines and fluoroquinolones by 2-3 hours.

Ferrous sulfate provides elemental iron critical for hemoglobin synthesis by supplying bioavailable iron absorbed in the duodenum and proximal jejunum, transported by transferrin to erythroid precursors in bone marrow. Folic acid acts as a coenzyme in DNA synthesis and cell division, promoting erythropoiesis and neural tube development. Zinc sulfate replenishes zinc, a trace element vital for numerous enzymatic reactions, immune function, and cellular repair. Combined, these agents restore deficient micronutrients, improving red blood cell production, oxygen delivery, and overall cellular metabolism.

• Absorption:
• Ferrous sulfate: 10-15% elemental iron absorption; enhanced in acidic environment; inhibited by food and certain drugs.
• Folic acid: Rapid absorption in the small intestine; bioavailability near 100%.
• Zinc sulfate: Absorbed primarily in the small intestine; absorption influenced by dietary phytates.
• Distribution:
• Iron bound to transferrin and stored in ferritin.
• Folic acid distributed to liver, red blood cells, and tissues.
• Zinc distributed widely, concentrated in muscle and bone.
• Metabolism:
• Iron incorporated into hemoglobin; no metabolism.
• Folic acid converted intracellularly to tetrahydrofolate.
• Zinc utilized in metalloenzymes; not metabolized.
• Elimination:
• Iron lost via sloughed intestinal mucosa, menstruation, bleeding.
• Folic acid eliminated renally.
• Zinc excreted primarily in feces and urine.
• Half-life:
• Iron: Dependent on red cell turnover (~120 days).
• Folic acid plasma half-life ~3-4 hours.
• Zinc plasma half-life ~280 days due to body stores.

• Pregnancy:
• Ferrous sulfate + folic acid are recommended and widely used to prevent and treat anemia and folate deficiency; folic acid reduces risk of neural tube defects.
• Zinc sulfate considered safe within recommended doses during pregnancy; excess zinc avoided.
• Lactation:
• Iron, folic acid, and zinc are excreted in breast milk in small amounts; considered safe for breastfeeding infants.

• Hematinic agent (iron supplement).
• Vitamin supplement (folic acid).
• Mineral supplement (zinc).

• Known hypersensitivity to ferrous sulfate, folic acid, zinc sulfate, or excipients.
• Iron overload conditions (e.g., hemochromatosis).
• Pernicious anemia without concurrent vitamin B12 therapy.
• Severe hepatic impairment without medical supervision.

• Monitor for gastrointestinal irritation and iron overload.
• High folic acid doses can mask vitamin B12 deficiency symptoms.
• Zinc overdose may cause copper deficiency and immunosuppression.
• Use cautiously in patients with peptic ulcer disease.
• Keep out of reach of children due to risk of fatal iron overdose.
• Regular monitoring of hematologic parameters recommended.

• Common:
• Gastrointestinal discomfort, nausea, constipation, diarrhea.
• Dark stools (due to iron).
• Metallic taste.
• Serious/Rare:
• Hypersensitivity reactions: rash, angioedema, anaphylaxis.
• Iron toxicity from overdose.
• Zinc-related side effects: nausea, vomiting, abdominal cramps.

• Absorption of iron decreased by antacids, calcium, proton pump inhibitors, and some antibiotics (tetracyclines, quinolones).
• Folic acid reduces efficacy of methotrexate.
• Zinc may interfere with absorption of tetracyclines and fluoroquinolones.
• Iron may reduce absorption of levothyroxine and penicillamine.
• No major involvement of CYP450 enzymes.

• Continued endorsement by WHO, CDC, and obstetric guidelines for iron-folic acid supplementation during pregnancy.
• Recent emphasis on combined micronutrient supplements including zinc for broader maternal and child health benefits.
• No new major safety warnings.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep container tightly closed.
• Do not freeze.
• Keep out of reach of children.