Strength
DEFRATAJ 100 mg - Deferasirox
Dispersible Tablet · Oral (after dispersion)
DEFRATAJ 100 mg
Deferasirox Dispersible Tablet
| Product Name | Deferasirox Dispersible Tablet 100 mg |
|---|---|
| Brand Name | DEFRATAJ |
| Strength | 100 mg |
| Dosage Form | Dispersible Tablet |
| Route of Administration | Oral (after dispersion) |
| Packing | 10 x 10 PVC/PVDC-Aluminium blisters; HDPE bottles available; custom pack sizes for tenders |
| Shelf Life | 24-36 months (market-specific) |
| Therapeutic Use | Iron chelator (ATC: V03AC03) for chronic transfusional iron overload |
| Indication | Treatment of chronic iron overload due to frequent blood transfusions in pediatric and adult patients with beta-thalassemia major, sickle-cell disease and other transfusion-dependent anemias. The 100 mg strength supports fine-grained weight-based dose titration, particularly in pediatric patients. |
| Storage | Store below 30 degrees C. Protect from moisture. Keep in original blister. |
| Composition | Each dispersible tablet contains: Deferasirox 100 mg. Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K30, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate. |
| Tablet Description | Off-white to pale yellow, round, flat, uncoated tablet with break-line on one face; disperses in water or juice within ~3 minutes. |
Full Excipient Breakdown
| Excipient | Function |
|---|---|
| Lactose monohydrate | Diluent |
| Microcrystalline cellulose | Diluent / binder |
| Crospovidone | Disintegrant |
| Povidone K30 | Binder |
| Sodium lauryl sulfate | Wetting agent |
| Colloidal silicon dioxide | Glidant |
| Magnesium stearate | Lubricant |
Dosage Instructions
Disperse tablet(s) in 100-200 ml of water, orange juice or apple juice; stir until fully dispersed; drink immediately. Rinse glass with additional liquid and drink. Take on an empty stomach, 30 minutes before food, at the same time each day. Dose calculated per body weight; refer to locally approved prescribing information.
Caution & Warning
Schedule H drug. Sold by prescription only.
Monitor renal and hepatic function before initiation and at regular intervals.
Discontinue immediately if signs of severe cutaneous adverse reactions (SJS / TEN / DRESS), GI haemorrhage, renal failure or hepatic failure occur.
Not for use when CrCl < 60 mL/min.
Monitor renal and hepatic function before initiation and at regular intervals.
Discontinue immediately if signs of severe cutaneous adverse reactions (SJS / TEN / DRESS), GI haemorrhage, renal failure or hepatic failure occur.
Not for use when CrCl < 60 mL/min.
Overdose
No specific antidote. Limited data; doses up to 80 mg/kg tolerated with GI side effects. Supportive management - monitor renal/hepatic function. Dialysis unlikely effective due to high protein binding.
Disposal
Dispose in accordance with local regulations for pharmaceutical waste. Do not dispose via wastewater or household refuse.
The 100 mg strength is most often used as part of a pediatric or fine-titration regimen, allowing accurate dose adjustments in 5 mg/kg/day increments below the 250 mg starting unit.
Schedule H: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Not all pack sizes may be marketed.