Strength
DEFRATAJ 500 mg - Deferasirox
Dispersible Tablet · Oral (after dispersion)
DEFRATAJ 500 mg
Deferasirox Dispersible Tablet
| Product Name | Deferasirox Dispersible Tablet 500 mg |
|---|---|
| Brand Name | DEFRATAJ |
| Strength | 500 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 in adult patients with beta-thalassemia major, sickle-cell disease and MDS where 30-40 mg/kg/day regimens are clinically appropriate. |
| Storage | Store below 30 degrees C. Protect from moisture. |
| Composition | Each dispersible tablet contains: Deferasirox 500 mg. Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K30, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate. |
| Tablet Description | Off-white to pale yellow, oblong, flat, uncoated tablet with break-line; 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 in 100-200 ml water/juice; drink immediately. Once daily, empty stomach, same time daily. The 500 mg unit minimises tablet count in high-dose adult therapy.
Caution & Warning
Schedule H drug. Sold by prescription only. Monitor renal/hepatic function with extra vigilance at higher daily doses. Discontinue on signs of SJS/TEN/DRESS, GI haemorrhage or organ failure. Not for use when CrCl < 60 mL/min.
Overdose
No specific antidote. Supportive management. Dialysis unlikely effective.
Disposal
Dispose per local pharmaceutical-waste regulations.
The 500 mg strength is the highest single-tablet unit in the DEFRATAJ range, designed for adult patients on the upper end of weight-based dosing.
Schedule H: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Not all pack sizes may be marketed.