Deferasirox dispersible tablets 100,250,400,500 mg Tab

Product Details
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Name Of Product(Genric Name) :

Deferasirox dispersible tablets 100,250,400,500 mg Tab

Product Description :

DEFERASIROX DISPERSIBLE TABLETS

100 mg, 250 mg, 400 mg & 500 mg

1. COMPOSITION

Each dispersible tablet contains:

Deferasirox 100 mg / 250 mg / 400 mg / 500 mg
Excipients: q.s.
Colour: As approved.

2. PHARMACEUTICAL FORM

Dispersible Tablets

3. THERAPEUTIC CLASS

Iron Chelating Agent

4. INDICATIONS

Deferasirox is indicated for the treatment of chronic iron overload associated with:

  • Transfusion-dependent anaemias requiring frequent blood transfusions.

  • Non-transfusion-dependent thalassaemia syndromes with chronic iron overload, when clinically appropriate.

Treatment should be initiated and monitored by a physician experienced in the management of iron overload.

5. CONTRAINDICATIONS

  • Hypersensitivity to deferasirox or any component of the formulation.

  • Severe renal impairment.

  • Severe hepatic impairment.

  • Concomitant use with other iron-chelating therapy unless specifically prescribed by a specialist.

  • Patients with clinical conditions in which deferasirox treatment is considered inappropriate.

6. DRUG INTERACTIONS

Deferasirox may interact with:

  • CYP3A4 substrates.

  • CYP2C8 substrates, including repaglinide.

  • CYP1A2 substrates, including theophylline.

  • Aluminium-containing antacids.

  • Other iron-chelating agents.

  • Medicines that increase the risk of gastrointestinal ulceration or bleeding.

  • Medicines affecting renal or hepatic function.

Inform the physician about all prescription medicines, over-the-counter medicines, supplements, and herbal products being taken.

7. ADMINISTRATION

For oral use only.

The dose should be individualized according to iron burden, transfusion requirements, renal and hepatic function, and clinical response.

Disperse the tablet completely in water, orange juice, or apple juice by stirring until a fine suspension is obtained. Drink immediately. Rinse the glass with a small amount of liquid and drink the rinse to ensure the entire dose is taken.

Do not swallow, chew, or crush the tablet whole.

Regular monitoring of serum ferritin, renal function, hepatic function, blood counts, and other relevant parameters is recommended during treatment.

8. STORAGE

Store below 30°C, protected from moisture.

Keep the container tightly closed and out of reach of children.

Do not use after the expiry date printed on the package.


Market : international export

Private Label : Avilable

Registration Support : Available

Regulatory documents : Available on request

TABLETS