Abiraterone tablets 250 mg Tab

Product Details
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Name Of Product(Genric Name) :

Abiraterone tablets 250 mg Tab

Product Description :

ABIRATERONE TABLETS 250 MG

1. COMPOSITION

Each tablet contains:

Abiraterone Acetate 250 mg
Excipients: q.s.
Colour: As approved.

2. PHARMACEUTICAL FORM

Tablets

3. THERAPEUTIC CLASS

Androgen Biosynthesis Inhibitor / Antineoplastic Agent

4. INDICATIONS

Abiraterone acetate, in combination with prednisone or prednisolone, is indicated for the treatment of advanced prostate cancer, including:

  • Metastatic castration-resistant prostate cancer.

  • Metastatic high-risk castration-sensitive prostate cancer, in appropriate patients.

Treatment should be initiated and monitored by a physician experienced in the management of prostate cancer.

5. CONTRAINDICATIONS

  • Hypersensitivity to abiraterone acetate or any component of the formulation.

  • Pregnancy or potential for pregnancy in the patient receiving treatment.

  • Severe hepatic impairment.

  • Women who are or may become pregnant should not handle the tablets without appropriate protective precautions.

6. DRUG INTERACTIONS

Abiraterone may interact with:

  • CYP3A4 substrates and inhibitors/inducers.

  • Medicines metabolized by CYP2D6.

  • Medicines associated with QT prolongation.

  • Other medicines that may affect liver function.

  • Mineralocorticoid-related medicines or treatments affecting potassium and blood pressure.

Patients should inform their physician about all prescription, non-prescription, and herbal medicines being taken.

7. ADMINISTRATION

For oral use only.

The usual recommended dose of abiraterone acetate is 1,000 mg once daily, administered in combination with prednisone or prednisolone as prescribed by the physician.

The tablets should be taken on an empty stomach. Do not eat food for at least 2 hours before and 1 hour after taking abiraterone.

Swallow the tablets whole with water. Do not crush, chew, or break the tablets.

Blood pressure, serum potassium, liver function, and signs of fluid retention should be monitored regularly during treatment.

8. STORAGE

Store below 30°C, protected from moisture and excessive heat.

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

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


Market : international export

Private Label : Available

Registration Support : Available

Regulatory documents : Available on request

TABLETS