DEFRATAJ 125 mg

Deferasirox Dispersible Tablet

Tablet manufacturing line producing DEFRATAJ 125 mg dispersible tablets
Tablet manufacturing line, Taj Pharma WHO-GMP facility (Sarigam).
Product NameDeferasirox Dispersible Tablet 125 mg
Brand NameDEFRATAJ
Strength125 mg
Dosage FormDispersible Tablet
Route of AdministrationOral (after dispersion)
Packing10 x 10 PVC/PVDC-Aluminium blisters; HDPE bottles available; custom pack sizes for tenders
Shelf Life24-36 months (market-specific)
Therapeutic UseIron chelator (ATC: V03AC03) for chronic transfusional iron overload
IndicationTreatment 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. Useful for intermediate pediatric titration steps.
StorageStore below 30 degrees C. Protect from moisture.
CompositionEach dispersible tablet contains: Deferasirox 125 mg.
Excipients: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone K30, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate.
Tablet DescriptionOff-white to pale yellow, round, flat, uncoated tablet with break-line; disperses rapidly in water or juice.

Full Excipient Breakdown

ExcipientFunction
Lactose monohydrateDiluent
Microcrystalline celluloseDiluent / binder
CrospovidoneDisintegrant
Povidone K30Binder
Sodium lauryl sulfateWetting agent
Colloidal silicon dioxideGlidant
Magnesium stearateLubricant

Dosage Instructions

Disperse in 100-200 ml of water, orange juice or apple juice; drink immediately. Once daily, on empty stomach, at the same time daily.

Caution & Warning

Schedule H drug. Sold by prescription only. Monitor renal/hepatic function. Discontinue on signs of SJS/TEN/DRESS or organ failure. Not for use when CrCl < 60 mL/min.

Overdose

No specific antidote. Doses up to 80 mg/kg tolerated. Supportive management. Dialysis unlikely effective.

Disposal

Dispose per local pharmaceutical-waste regulations. Not via wastewater or household refuse.


The 125 mg strength complements the 100 mg unit for fine pediatric dose titration and provides flexibility when patient weight does not align cleanly with 100 mg increments.

Schedule H: To be sold by retail on the prescription of a Registered Medical Practitioner only. Not all pack sizes may be marketed.