Ferrous Ascorbate + Folic Acid + Zinc Sulfate

• Approved Indications:
• Prevention and treatment of iron deficiency anemia and iron deficiency without anemia, especially in:
• Pregnancy and lactation.
• Nutritional iron deficiency states.
• Menstrual blood loss.
• Chronic blood loss.
• Treatment and prevention of folate deficiency anemia and support of normal hematopoiesis.
• Correction of zinc deficiency, which may occur in malnutrition, chronic illnesses, or increased physiological needs.
• Used as a multinutrient supplement in populations at risk of combined micronutrient deficiencies (iron, folate, zinc).
• Off-label/Clinically Accepted Uses:
• Adjunctive therapy in anemia of chronic disease with documented iron and folate deficiency.
• Supportive therapy during pregnancy to reduce risks of neural tube defects and improve fetal development.
• General nutritional supplementation in malnourished individuals.

• Route: Oral administration.
• Adults & Adolescents:
• Typical dose: 1 tablet daily, providing approximately:
• 100 mg elemental iron (ferrous ascorbate),
• 1 mg to 5 mg folic acid (dose varies by formulation),
• 10 mg to 22.5 mg elemental zinc (zinc sulfate).
• Taken preferably on an empty stomach to maximize absorption, but may be taken with food to reduce gastrointestinal irritation.
• Pediatrics:
• Use formulations specifically for children or adjust dose based on age and weight; consult pediatrician.
• Elderly:
• Same as adult dose; monitor tolerance and nutritional status.
• Special Populations:
• Renal or hepatic impairment: No specific dosage adjustment, but use with caution and monitor serum levels of iron, folate, and zinc.
• Duration:
• Continued until anemia or deficiency is corrected, typically 3 to 6 months or as advised by a healthcare professional.

This combination preparation provides essential micronutrients necessary for hematopoiesis and metabolic functions. Ferrous ascorbate supplies bioavailable ferrous iron, which is absorbed in the small intestine with the aid of ascorbic acid that maintains iron in its reduced, absorbable form, promoting hemoglobin synthesis. Folic acid (vitamin B9) acts as a coenzyme in the synthesis of nucleic acids (DNA/RNA), crucial for the production and maturation of red blood cells, thus preventing megaloblastic anemia. Zinc sulfate provides zinc ions essential for numerous enzymatic reactions involved in cellular replication, immune function, and tissue repair. Together, these agents synergistically correct micronutrient deficiencies leading to improved erythropoiesis and overall health.

• Absorption:
• Ferrous iron is absorbed primarily in the duodenum and upper jejunum; ascorbic acid enhances absorption.
• Folic acid is absorbed mainly in the proximal small intestine by active transport.
• Zinc sulfate is absorbed in the small intestine via carrier-mediated mechanisms.
• Distribution:
• Iron binds to plasma transferrin and is distributed to bone marrow and storage sites.
• Folic acid is transported to tissues requiring rapid cell division.
• Zinc is distributed to all body tissues, with high concentrations in muscle, bone, liver, and skin.
• Metabolism:
• Iron is incorporated into hemoglobin and stored as ferritin.
• Folic acid is converted intracellularly to tetrahydrofolate, its active form.
• Zinc is not metabolized but utilized as a cofactor in numerous enzymes.
• Excretion:
• Iron loss is minimal and regulated mostly through absorption.
• Folic acid is metabolized and excreted via urine.
• Zinc is excreted primarily via feces and urine.
• Half-life:
• Iron half-life corresponds to red blood cell lifespan (~120 days) once incorporated.
• Folic acid has a plasma half-life of approximately 3 to 4 hours.
• Zinc half-life varies but typically around 280 days in the body.

• Pregnancy Category: FDA Category A for folic acid and iron supplements; considered safe and recommended during pregnancy to prevent and treat anemia and support fetal development.
• Lactation: Considered safe; small amounts of iron, folic acid, and zinc pass into breast milk and are beneficial to the nursing infant.
• Data support routine supplementation in pregnant and lactating women to prevent deficiencies.

• Primary class: Hematopoietic agent and micronutrient supplement
• Subclasses: Oral iron supplement, vitamin supplement (folic acid), mineral supplement (zinc)

• Known hypersensitivity or allergy to ferrous ascorbate, folic acid, zinc sulfate, or any excipients.
• Hemochromatosis or other iron overload conditions.
• Megaloblastic anemia due to Vitamin B12 deficiency (without B12 supplementation).
• Severe hepatic or renal impairment without specialist supervision.
• Conditions where oral iron therapy is contraindicated (e.g., peptic ulcer, active gastrointestinal bleeding).

• Monitor patients with chronic diseases, liver or kidney dysfunction.
• Avoid use in iron overload disorders.
• Overdose can cause severe toxicity, especially in children – keep out of reach.
• Use caution in patients with known malabsorption syndromes.
• May mask symptoms of vitamin B12 deficiency; monitor carefully.
• Watch for gastrointestinal irritation and allergic reactions.

• Common:
• Gastrointestinal upset (nausea, abdominal pain, constipation, diarrhea).
• Dark stools (due to iron).
• Serious (rare):
• Hypersensitivity reactions (rash, urticaria, anaphylaxis).
• Iron overload with excessive or prolonged use.
• Zinc overdose causing nausea, vomiting, and copper deficiency if used long term.

• Absorption of iron reduced by antacids, calcium, tetracyclines, quinolones.
• Folic acid may reduce the efficacy of anticonvulsants.
• Zinc absorption decreased by penicillamine and high-calcium diets.
• Iron may reduce absorption of levodopa and some antibiotics.
• No major CYP450 enzyme involvement noted.

• Current guidelines by WHO and other health authorities recommend combined iron and folic acid supplementation during pregnancy for anemia prevention.
• Zinc supplementation is endorsed in populations at risk of deficiency, particularly in malnutrition or chronic diseases.
• Dosage regimens optimized to reduce side effects and improve adherence.
• No recent black box warnings or significant regulatory changes.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and direct light.
• Keep tablets in original tightly closed containers.
• Keep out of reach of children.
• No special refrigeration or reconstitution needed.