Description

1. Product Overview: Bulex® is a tablet formulation of Bicalutamide, a non-steroidal antiandrogen used in the treatment of prostate cancer.

2. Composition: Active Ingredient: Bicalutamide | Dosage Form: Tablet

3. Pharmacological Class: Non-Steroidal Antiandrogen

4. Mechanism of Action: Bicalutamide competitively inhibits androgen receptors, blocking the effects of testosterone and dihydrotestosterone (DHT), thereby reducing the growth and survival of prostate cancer cells.

5. Indications: Prostate cancer (locally advanced or metastatic), often used in combination with LHRH analog therapy

6. Dosage & Administration: As prescribed by physician | Oral use | Usually taken once daily | Swallow tablet whole

7. Clinical Benefits: Blocks androgen-driven cancer growth | Helps control disease progression | Used in combination therapy | Improves treatment outcomes

8. Contraindications: Hypersensitivity to Bicalutamide or any component | Not indicated for use in women or children

9. Precautions: Monitor liver function tests | Risk of gynecomastia and breast tenderness | Monitor prostate-specific antigen (PSA) levels | Use under specialist supervision

10. Drug Interactions: May interact with warfarin and other CYP3A4 substrates

11. Special Populations: Contraindicated in pregnancy | Not recommended during lactation | Not for pediatric use | Use cautiously in hepatic impairment

12. Adverse Effects: Hot flashes | Breast tenderness | Gynecomastia | Fatigue | Liver enzyme elevation

13. Storage Conditions: Store below 30°C | Protect from light and moisture | Keep out of reach of children

14. Packaging: Tablet in blister pack

15. Manufacturer: Everest Pharmaceutical Ltd.