Zeefol-CI

Approved and Clinically Accepted Uses:

A. Iron-Deficiency States

• Iron Deficiency Anemia (IDA): Treatment and prevention of iron-deficiency anemia due to chronic blood loss, nutritional deficiency, or increased physiological demand.
• Anemia in Pregnancy and Lactation: Indicated to correct iron and folate deficiency in pregnant or breastfeeding women, preventing maternal anemia and supporting fetal development.

B. Nutritional Supplementation

• Pregnancy and Preconceptional Use: To prevent neural tube defects, support maternal health, and enhance fetal growth.
• Post-Surgical or Chronic Illness Recovery: Used for nutritional support in patients recovering from surgery or with chronic illnesses leading to micronutrient depletion.

C. Pediatric and Adolescent Use

• For treating or preventing iron and zinc deficiency in children and adolescents with poor dietary intake or increased requirements due to rapid growth.

Route of Administration: Oral

Usual Dosage Formulation:

• Carbonyl Iron 100 mg
• Folic Acid 1.5 mg
• Zinc Sulfate Monohydrate 61.8 mg (equivalent to elemental Zinc 22.5 mg)

Recommended Doses:

A. Adults:

• Prophylactic use: 1 tablet or capsule daily.
• Therapeutic use: 1 tablet or capsule 1–2 times daily, based on severity and physician guidance.

B. Pregnant and Lactating Women:

• 1 capsule or tablet daily, continued throughout pregnancy and lactation or as advised.

C. Children >12 years:

• 1 tablet daily (if age-appropriate formulation is available), under medical supervision.

D. Geriatric Use:

• Same as adult dosage; monitor for gastrointestinal effects like constipation or intolerance.

E. Renal or Hepatic Impairment:

• Use with caution. Monitor iron and zinc levels to avoid accumulation and toxicity.

Administration Instructions:

• Take on an empty stomach with water for optimal absorption.
• If gastrointestinal upset occurs, it may be taken with meals.
• Avoid concurrent use with antacids, calcium, tea, milk, or high-fiber food.

Carbonyl Iron is a purified, finely divided elemental iron with controlled release, allowing gradual absorption in the small intestine. Once absorbed, it contributes to hemoglobin and myoglobin synthesis, enhancing oxygen transport and correcting anemia. Folic Acid functions as a coenzyme in DNA synthesis, red blood cell maturation, and fetal neural tube development. Zinc Sulfate provides elemental zinc, essential for immune modulation, wound healing, DNA synthesis, and growth. Together, these components replenish deficient micronutrients, restore hematologic function, and support maternal-fetal health.

Absorption:

• Carbonyl Iron: Slowly absorbed in the duodenum; less gastrointestinal irritation than ferrous salts.
• Folic Acid: Rapidly absorbed in the proximal small intestine.
• Zinc Sulfate: Absorbed in the jejunum; absorption may be reduced by phytates and dairy.

Bioavailability:

• Carbonyl Iron: Approximately 69%
• Folic Acid: Around 76%
• Zinc: 20%–30%

Distribution:

• Iron: Circulates bound to transferrin; stored in liver, spleen, and bone marrow.
• Folic Acid: Widely distributed, especially to liver and bone marrow.
• Zinc: Binds to plasma proteins (e.g., albumin) and distributes systemically.

Metabolism:

• Iron and Zinc: Not metabolized enzymatically; utilized directly in physiological processes.
• Folic Acid: Hepatically converted to active tetrahydrofolate derivatives.

Elimination:

• Iron: Primarily fecal excretion of unabsorbed iron; negligible renal elimination.
• Folic Acid: Excreted in urine.
• Zinc: Eliminated mainly via feces; minor renal and sweat excretion.

Half-life:

• Iron: Variable, dependent on iron stores.
• Folic Acid: ~3–4 hours.
• Zinc: ~12–24 hours.

Pregnancy:

• Folic Acid: FDA Pregnancy Category A – Safe and recommended for use during pregnancy.
• Carbonyl Iron and Zinc Sulfate: Widely used and considered safe when used in therapeutic doses.

Lactation:

• Safe during breastfeeding.
• Minimal drug transfer into breast milk; no significant adverse effects reported in infants.

Caution:

• Avoid overdosing; excess iron or zinc may cause gastrointestinal or systemic toxicity.
• Folic acid supplementation should not replace B12 evaluation in macrocytic anemia.

• Primary Class: Hematinic and Nutritional Supplement
• Subclass: Iron–Folic Acid–Zinc Combination Therapy

• Known hypersensitivity to carbonyl iron, folic acid, zinc sulfate, or formulation excipients.
• Hemochromatosis or hemosiderosis (iron overload disorders).
• Hemolytic anemia not caused by iron deficiency.
• Wilson’s disease or other disorders of copper/zinc metabolism.
• Megaloblastic anemia due to Vitamin B12 deficiency (folate may mask the condition).

• Use cautiously in patients with:
• Peptic ulcer, ulcerative colitis, or inflammatory bowel disease.
• Liver disorders or chronic alcoholism (increased iron accumulation risk).
• Renal impairment (risk of zinc accumulation).
• Monitor:
• Hemoglobin, hematocrit, ferritin, and zinc levels during prolonged therapy.
• Folic acid may mask symptoms of Vitamin B12 deficiency, delaying diagnosis.
• Risk of accidental overdose in children – a leading cause of fatal poisoning in pediatric populations.
• Report early signs of iron toxicity: vomiting, diarrhea, abdominal pain.

Common:

• Gastrointestinal: Constipation, darkened stools, nausea, vomiting, abdominal discomfort, flatulence.
• Systemic: Metallic taste (zinc-related), headache.

Less Common:

• Allergic rash, pruritus, dizziness.

Serious/Rare:

• Iron toxicity (especially in pediatric overdose): metabolic acidosis, shock, hepatic failure.
• Prolonged high-dose zinc: Immune dysfunction, copper deficiency, anemia.

Onset & Severity:

• GI symptoms often appear within the first few days of use.
• Severity is usually dose-dependent and reduced by taking with food.

Iron-related Interactions:

• ↓ Absorption with antacids, calcium, dairy, tea, and coffee.
• ↓ Absorption of drugs such as tetracycline, doxycycline, ciprofloxacin, and levodopa.

Folic Acid Interactions:

• Antagonized by methotrexate, phenytoin, sulfasalazine, and trimethoprim.

Zinc-related Interactions:

• ↓ Absorption of tetracyclines, fluoroquinolones, and penicillamine.
• High zinc intake may interfere with copper absorption.

Enzyme Involvement:

• No significant CYP450 involvement; interactions primarily affect absorption rather than metabolism.

• WHO: Recommends daily iron and folic acid supplementation during pregnancy to reduce anemia and birth defects.
• NICE (UK): Continues to endorse folic acid supplementation during preconception and first trimester.
• Recent Formulation Updates: Some combination supplements now include Vitamin B12 to prevent masking of B12 deficiency.

• Temperature: Store below 25°C.
• Humidity: Keep in a dry place, protected from excessive moisture.
• Light: Store in original packaging to protect from light.
• Handling: Do not crush or chew. Shake suspensions well before use (if applicable).
• Safety: Keep out of reach of children to prevent accidental ingestion and iron toxicity.