Fero TR

• Approved Indications:
• Treatment and prevention of iron deficiency anemia.
• Treatment and prevention of folate deficiency anemia.
• Anemia associated with pregnancy and lactation.
• Anemia related to chronic blood loss or nutritional deficiency.
• Supportive therapy in megaloblastic anemia due to folate deficiency.
• Prevention of neural tube defects in pregnancy through folic acid supplementation.
• Off-label / Clinically Accepted Uses:
• As a nutritional supplement in populations at risk of combined iron and folate deficiencies.
• Adjunct therapy in anemia of chronic disease when iron and folate deficiencies coexist.
• Support during periods of increased physiological demand (e.g., adolescence, menstruation).

• Route: Oral.
• Adults:
• Typical dose: 1 tablet daily containing approximately 200 mg ferrous fumarate (equivalent to ~65 mg elemental iron) and 1 mg folic acid.
• Taken preferably on an empty stomach for better absorption; may be taken with food to reduce gastrointestinal discomfort.
• Pediatrics:
• Use pediatric formulations or adjust dosage based on age and weight, as per physician’s recommendation.
• Elderly:
• Same dosing as adults, with monitoring for tolerance.
• Special Populations:
• Renal or Hepatic Impairment: No established dose adjustment; use cautiously with monitoring.
• Duration:
• Continue therapy until hematologic parameters normalize and iron/folate stores replenish, usually 3 to 6 months.

Ferrous fumarate acts as a source of elemental iron, essential for the synthesis of hemoglobin within red blood cells. Iron is absorbed primarily in the duodenum and upper jejunum where it is transported across the intestinal mucosa, entering the bloodstream bound to transferrin. It then participates in oxygen transport and cellular respiration. Folic acid (vitamin B9) is required for DNA synthesis and cell division, critical in the formation and maturation of erythrocytes. Folic acid facilitates the production of tetrahydrofolate, a coenzyme essential for purine and thymidylate synthesis, thereby preventing megaloblastic changes and promoting normal red blood cell formation. Together, these agents correct nutritional anemias by replenishing essential substrates for erythropoiesis.

• Absorption:
• Ferrous fumarate is absorbed in the small intestine, with an approximate bioavailability of 20-30% of elemental iron, enhanced by gastric acidity.
• Folic acid is absorbed primarily in the proximal small intestine by active transport mechanisms.
• Distribution:
• Iron binds plasma transferrin for delivery to the bone marrow and storage in ferritin.
• Folic acid is distributed to rapidly dividing tissues.
• Metabolism:
• Iron is incorporated into hemoglobin or stored.
• Folic acid is converted intracellularly to tetrahydrofolate, the biologically active form.
• Excretion:
• Iron loss is minimal, regulated mainly via mucosal turnover and menstruation.
• Folic acid metabolites are excreted primarily in urine.
• Half-life:
• Folic acid plasma half-life is approximately 3-4 hours.
• Iron elimination corresponds to red blood cell lifespan (~120 days).

• Pregnancy Category: Generally classified as FDA Pregnancy Category A (folic acid) and Category C (iron); both are considered safe and essential during pregnancy.
• Lactation: Both components are excreted in breast milk in small amounts and are considered safe for nursing infants. Supplementation benefits the mother and infant.

• Primary therapeutic class: Hematinic agent.
• Subclass: Oral iron supplement and vitamin supplement.

• Known hypersensitivity to ferrous fumarate, folic acid, or any excipients.
• Hemochromatosis or other iron overload conditions.
• Megaloblastic anemia caused by vitamin B12 deficiency (without B12).
• Severe liver disease.
• Conditions with risk of iron accumulation or inability to handle excess iron.

• Use caution in patients with hepatic or renal impairment.
• Monitor iron status to avoid iron overload.
• Overdose can be fatal, especially in children; keep out of reach.
• Folic acid may mask symptoms of vitamin B12 deficiency; monitor hematologic and neurologic status.
• Gastrointestinal irritation is common; dose adjustment or administration with food may help.
• Use with caution in patients with active peptic ulcer or inflammatory bowel disease.

• Common:
• Gastrointestinal disturbances: nausea, abdominal pain, constipation, diarrhea.
• Dark or black stools (due to unabsorbed iron).
• Rare/Serious:
• Allergic reactions (rash, pruritus, anaphylaxis).
• Iron overload with chronic excessive use.
• Masking of vitamin B12 deficiency leading to neurological damage if uncorrected.

• Absorption of iron decreased by antacids, calcium, tetracyclines, and quinolone antibiotics.
• Folic acid may decrease efficacy of anticonvulsants (phenytoin, phenobarbital).
• Iron can reduce absorption of levodopa and levothyroxine.
• No significant CYP450 interactions reported.

• WHO and other health bodies continue to recommend combined iron and folic acid supplementation during pregnancy for prevention of anemia and neural tube defects.
• Updated dosing regimens emphasize lower doses to reduce side effects and improve compliance.
• No recent major safety warnings or regulatory changes.

• Store at controlled room temperature: 20°C to 25°C (68°F to 77°F).
• Protect from moisture, heat, and light.
• Keep tightly closed in original container.
• Keep out of reach of children.
• No refrigeration or reconstitution needed.