1. Clinical Overview
A fixed-dose combination oral hematinic agent containing 100mg of elemental iron as ferrous ascorbate and 1.5mg of folic acid. It is a first-line therapy for the treatment and prevention of iron deficiency anemia (IDA) and folate deficiency anemia, particularly in high-risk populations like pregnant women in India. The ascorbate moiety enhances iron absorption and reduces gastric irritation.
| Onset | Duration | Bioavailability |
|---|---|---|
| Reticulocyte response begins in 3-5 days, with a peak in 7-10 days. Hemoglobin levels typically start rising within 2-3 weeks of therapy. | The hematinic effect is sustained with daily dosing. Iron stores are replenished over 3-6 months of continuous therapy. | Ferrous Ascorbate: 15-35% (enhanced by ascorbic acid). Folic Acid: 90-98% when taken orally on an empty stomach. |
2. Mechanism of Action
Ferrous Ascorbate provides elemental iron, a critical component of hemoglobin, myoglobin, and various enzymes. Folic Acid acts as a cofactor in one-carbon transfer reactions essential for DNA synthesis, cell division, and amino acid metabolism. The combination corrects deficiencies in both, synergistically supporting erythropoiesis.
3. Indications & Uses
- Iron Deficiency Anemia (IDA)
- Megaloblastic Anemia due to Folic Acid deficiency
- Prophylaxis of nutritional anemias in pregnancy (as per Indian guidelines)
4. Dosage & Administration
Adult Dosage: One tablet once daily, preferably on an empty stomach (1 hour before or 2 hours after food). For severe anemia, one tablet twice daily as directed by physician.
Administration: Swallow whole with a full glass of water. Do not crush or chew. To enhance absorption and reduce gastric upset, take on an empty stomach. If GI intolerance occurs, may be taken with a small amount of food, avoiding dairy, tea, coffee, and high-fiber foods concurrently.
5. Side Effects
Common side effects may include:
- Nausea, epigastric pain
- Constipation or diarrhea
- Darkening of stools (harmless)
- Mild abdominal cramping
6. Drug Interactions
| Drug | Effect | Severity |
|---|---|---|
| Antacids, Proton Pump Inhibitors (e.g., Omeprazole), H2 Blockers (e.g., Ranitidine) | Reduce gastric acidity, impairing iron absorption. | Moderate |
| Tetracyclines, Quinolones (e.g., Ciprofloxacin), Bisphosphonates (e.g., Alendronate) | Iron binds to these drugs in the GI tract, reducing absorption of both. Administer at least 2-3 hours apart. | Major |
| Levothyroxine | Iron can decrease its absorption, reducing efficacy. | Major |
| Chloramphenicol | May delay the hematinic response to iron therapy. | Moderate |
| Methotrexate, Trimethoprim, Pyrimethamine | Folic acid can interfere with the therapeutic effect of these folate antagonists. | Major |
| Phenytoin, Phenobarbital, Primidone | Folic acid may decrease serum levels of these anticonvulsants, potentially reducing seizure control. | Major |
7. Patient Counselling
- DO take on an empty stomach for best absorption.
- DO store in a cool, dry place, away from children (risk of fatal iron poisoning in toddlers).
- DO continue therapy for the full prescribed duration (often 3-6 months) even after feeling better.
- DON'T take with antacids, milk, tea, or coffee. Separate by 1-2 hours.
- DON'T lie down immediately after taking the tablet.
8. Toxicology & Storage
Overdose: Primarily iron toxicity: Early Phase (within 6 hrs): Nausea, vomiting (often bloody), diarrhea, abdominal pain, lethargy. Late Phase (12-48 hrs): Apparent recovery followed by metabolic acidosis, hypoglycemia, coagulopathy, shock, hepatic necrosis, and multi-organ failure. Folic acid is generally non-toxic even at high doses.
Storage: Store below 30°C in a cool, dry place. Protect from light and moisture. Keep the bottle tightly closed. Keep out of reach of children. Do not use after the expiry date printed on the pack.