Zeefol M

Approved Indications:

• Iron Deficiency Anemia: Treatment and prevention of iron deficiency anemia in adults and children, especially during periods of increased iron demand (e.g., growth spurts, menstruation).
• Pregnancy-related Anemia: Management of iron and folate deficiency during pregnancy and lactation.
• Post-surgical or Chronic Blood Loss: To replenish iron stores and prevent folate deficiency.
• Nutritional Deficiencies: Treatment of combined deficiency states involving iron, folic acid, and zinc.

Clinically Accepted Off-label Uses:

• Pre-operative Hematologic Optimization: For patients undergoing surgery with high risk of blood loss.
• Adjunct in Malnutrition: For improving micronutrient status in patients with protein-energy malnutrition.
• Immune Support: Zinc and folate support immunity in patients with recurrent infections due to nutritional deficiencies.

Adults (including pregnant/lactating women):

• Oral: 1 tablet once daily, preferably with food to reduce gastrointestinal discomfort.
• In severe deficiency: May increase to 2 tablets daily, in divided doses, under medical supervision.

Pediatrics (above 12 years):

• 1 tablet once daily, with food. Not recommended for children under 12 without physician consultation.

Elderly:

• Same as adult dosing. Monitor renal function and gastrointestinal tolerance.

Renal or Hepatic Impairment:

• Use with caution. Monitor serum iron, zinc, and folate levels periodically. Adjust dosing or discontinue if iron overload or toxicity symptoms appear.

Route of Administration: Oral, swallow whole with water.

Duration:

• Prophylaxis: 3–6 months.
• Treatment: Continue until iron and folate levels normalize plus an additional 1–2 months to replenish stores.

Iron Polymaltose Complex provides non-ionic iron (ferric form) bound to polymaltose, enabling gradual and controlled release of iron in the small intestine, minimizing oxidative damage and GI irritation. Once absorbed, iron replenishes hemoglobin and myoglobin stores, supporting oxygen transport and cellular respiration.

Folic Acid is a B-vitamin essential for DNA synthesis, cellular replication, and erythropoiesis. It corrects megaloblastic anemia by enabling normal red blood cell formation.

Zinc Sulfate delivers elemental zinc, a critical trace element involved in over 300 enzymatic reactions, supporting immune function, wound healing, and cellular metabolism. Zinc also promotes mucosal integrity and may synergize with folate in DNA repair and cell proliferation.

Iron Polymaltose Complex:

• Absorption: Slowly absorbed in the duodenum and upper jejunum; food reduces but does not significantly impair absorption.
• Bioavailability: ~10–20%, depending on iron status.
• Distribution: Binds to transferrin and stored in ferritin.
• Metabolism: Not metabolized; incorporated into hemoglobin or stored.
• Elimination: Very little excreted; iron loss via desquamation, sweat, urine, and feces.

Folic Acid:

• Absorption: Rapidly absorbed from the proximal small intestine.
• Bioavailability: >85% orally.
• Metabolism: Converted to tetrahydrofolate in the liver.
• Elimination: Primarily via urine.

Zinc Sulfate:

• Absorption: Occurs in the small intestine; phytates and fiber may reduce absorption.
• Bioavailability: ~20–40%.
• Distribution: Found in all tissues, especially muscle and bone.
• Elimination: Primarily via feces; minimal renal excretion.

Pregnancy:

• Folic Acid is classified as Pregnancy Category A (safe).
• Iron Polymaltose Complex and Zinc Sulfate are considered Category B – no evidence of harm in animal studies; widely used safely in human pregnancy for decades.

Lactation:

• All components are excreted in breast milk in small, safe amounts. No adverse effects expected in breastfed infants at therapeutic maternal doses.

Caution:

• Avoid overdose; monitor iron status during long-term use.

• Iron Polymaltose Complex: Oral Iron Preparation (Non-ionic iron complex)
• Folic Acid: Water-Soluble Vitamin (Vitamin B9)
• Zinc Sulfate: Essential Mineral Supplement

• Known hypersensitivity to iron, folic acid, zinc, or any excipients
• Hemochromatosis or other iron overload syndromes
• Hemosiderosis
• Hemolytic anemia not caused by iron deficiency
• Severe renal impairment with oliguria or anuria (relative contraindication for zinc)
• Megaloblastic anemia due to vitamin B12 deficiency

• Iron overload risk with prolonged or high-dose use.
• Monitor serum iron and ferritin in long-term therapy.
• Folic acid may mask vitamin B12 deficiency, leading to neurologic damage if undiagnosed.
• Use caution in patients with GI disorders (e.g., ulcerative colitis, peptic ulcers).
• Zinc may interfere with copper absorption during prolonged use.
• Avoid concurrent iron injection while on oral iron due to risk of iron toxicity.

Common (≥1%):

• Gastrointestinal: Nausea, constipation, diarrhea, metallic taste, epigastric pain
• Stool: Dark-colored stool (harmless)

Less Common:

• Headache
• Dizziness
• Vomiting

Rare but Serious:

• Allergic reactions (rash, urticaria, anaphylaxis)
• Iron overload (hemochromatosis-like symptoms)
• Folic acid hypersensitivity (very rare)

Note: GI side effects are typically dose-related and may subside with continued use or when taken with meals.

• Iron: Decreased absorption with antacids, tetracyclines, calcium, magnesium, and certain foods (tea, coffee, dairy). Space doses by at least 2 hours.
• Folic Acid: Reduced efficacy with methotrexate, phenytoin, and sulfasalazine.
• Zinc: Absorption inhibited by penicillamine, tetracyclines, and quinolones. Zinc reduces absorption of copper and some antibiotics. Take antibiotics and zinc at least 2 hours apart.

Enzyme Systems Involved:

• Folic acid is metabolized in the liver but does not significantly induce/inhibit cytochrome P450 enzymes.

• Updated WHO antenatal care guidelines reaffirm the daily use of iron and folic acid supplementation in pregnancy.
• Zinc supplementation included in updated nutritional guidelines for immune support in deficient populations.
• New labeling in some regions advises clear separation of iron and calcium intake to optimize iron absorption.
• Pediatric use caution emphasized due to accidental overdose risks—child-resistant packaging recommended.

• Store below 25°C (77°F).
• Protect from moisture and direct sunlight.
• Do not refrigerate or freeze.
• Keep in original blister pack or tightly closed container.
• Keep out of reach of children to prevent accidental overdose.