Hemofix

• Approved Indications:
• Treatment and prevention of iron deficiency anemia, especially iron deficiency due to dietary insufficiency, pregnancy, or chronic blood loss.
• Used in cases of iron deficiency with or without anemia.
• Often prescribed during pregnancy and lactation to meet increased iron requirements.
• Off-label/Clinically Accepted Uses:
• Supportive therapy in anemia associated with chronic diseases where iron deficiency coexists.
• Adjunctive treatment to improve iron stores before elective surgery or in malabsorption syndromes.

• Route: Oral administration.
• Adults:
• Typical dose: 100 to 200 mg of elemental iron daily, divided into 1 to 3 doses.
• Common tablet strength: Ferrous ascorbate equivalent to 100 mg elemental iron per tablet.
• Pediatrics:
• Dosage adjusted by weight; generally 3 to 6 mg/kg/day of elemental iron divided into 2 or 3 doses.
• Pediatric formulations or syrups preferred.
• Elderly:
• Same as adults, with attention to tolerance and comorbidities.
• Special Populations:
• Renal or hepatic impairment: No specific dose adjustment but monitor iron status carefully.
• Administration Tips:
• Best absorbed on an empty stomach but may be taken with food to reduce gastrointestinal discomfort.
• Avoid co-administration with antacids, calcium, or dairy products that impair absorption.
• Duration:
• Continued until anemia is corrected and iron stores replenished, typically 3 to 6 months or as directed by physician.

Ferrous ascorbate is an oral iron supplement composed of ferrous (Fe2+) iron and ascorbic acid (vitamin C). The ferrous ion is readily absorbed in the duodenum and upper jejunum via active transport. Ascorbic acid acts as a reducing agent, maintaining iron in its ferrous (Fe2+) form which enhances solubility and absorption in the gastrointestinal tract. Once absorbed, iron binds to transferrin in plasma and is transported to bone marrow, where it is incorporated into hemoglobin for erythropoiesis, thereby correcting iron deficiency anemia.

• Absorption: Approximately 10-15% of oral ferrous iron is absorbed, enhanced by ascorbic acid.
• Distribution: Iron binds plasma transferrin and is distributed primarily to erythroid precursors and iron storage sites (ferritin in liver, spleen).
• Metabolism: Iron itself is not metabolized but incorporated into hemoglobin or stored; ascorbic acid is metabolized by normal vitamin C pathways.
• Excretion: Iron is minimally excreted; homeostasis maintained primarily via absorption regulation. Excess iron stored in tissues.
• Onset: Hematologic improvement generally observed within 1 to 2 weeks of therapy; complete correction may take months.
• Half-life: Iron half-life corresponds to red cell lifespan (~120 days) once incorporated into hemoglobin.

• Pregnancy Category: FDA Category A – considered safe and recommended for prevention and treatment of iron deficiency anemia during pregnancy.
• Lactation: Ferrous ascorbate is considered compatible with breastfeeding; iron is essential for infant development, and small amounts excreted in breast milk are not harmful.

• Primary therapeutic class: Iron supplement
• Subclass: Oral iron preparation

• Known hypersensitivity to ferrous ascorbate or any excipients.
• Hemochromatosis or other iron overload disorders.
• Hemolytic anemia or other non-iron deficiency anemias.
• Severe gastrointestinal diseases where oral iron is contraindicated (e.g., active peptic ulcer, esophagitis).

• Use with caution in patients with:
• History of gastrointestinal disorders due to risk of irritation.
• Inflammatory bowel disease.
• Iron overload conditions or predisposition.
• Monitor iron levels regularly to avoid iron toxicity.
• Overdose can cause severe toxicity, especially in children — keep out of reach.
• Patients should be monitored for signs of anaphylaxis or hypersensitivity.
• Avoid use with agents that reduce absorption (antacids, calcium, tetracyclines).

• Common:
• Gastrointestinal discomfort (nausea, epigastric pain).
• Constipation or diarrhea.
• Dark stools (benign).
• Serious (rare):
• Allergic reactions (rash, pruritus, anaphylaxis).
• Iron overload with prolonged high-dose use.
• Side effects are often dose-dependent and may reduce with dose adjustment or taking with food.

• Decreased absorption with:
• Antacids, proton pump inhibitors, calcium supplements, tetracyclines, and quinolones.
• Vitamin C (ascorbic acid) enhances iron absorption.
• Iron may impair absorption of levodopa, penicillamine, and certain antibiotics.
• No significant CYP450 involvement.

• Continued recommendation by WHO and major health bodies for iron supplementation in prevention and treatment of iron deficiency anemia.
• Recent guidelines emphasize adherence to dosing schedules and duration for complete iron store replenishment.
• Newer formulations combining iron with ascorbic acid improve absorption and tolerability.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep in a tightly closed container.
• Keep out of reach of children.
• Oral solution/syrups should be shaken well before use and discarded after expiration.