- Approval Id
- 091c6476cff5398a
- Drug Name
- EXACCORD 25 FILM COATED TABLET 25 MG
- Product Name
- EXACCORD 25 FILM COATED TABLET 25 MG
- Approval Number
- SIN16062P
- Approval Date
- 2020-12-18
- Registrant
- ACCORD HEALTHCARE PRIVATE LIMITED
- Licence Holder
- ACCORD HEALTHCARE PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **4.2 Posology and method of administration**
Posology
Adult and elderly patients
The recommended dose of Exemestane is one 25 mg tablet to be taken once a daily, preferably after a meal.
In patients with early breast cancer, treatment with Exemestane should continue until completion of five years of combined sequential adjuvant hormonal therapy (tamoxifen followed by Exemestane), or earlier if tumour relapse occurs.
In patients with advanced breast cancer, treatment with Exemestane should continue until tumour progression is evident.
No dose adjustments are required for patients with hepatic or renal insufficiency (see 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
Paediatric population
Not recommended for use in children.
- Route Of Administration
- ORAL
- Indication Info
- **4.1 Therapeutic indications**
Exemestane is indicated for the adjuvant treatment of postmenopausal women with oestrogen receptor-positive invasive early breast cancer (EBC), following 2 – 3 years of initial adjuvant tamoxifen therapy.
Exemestane is indicated for the treatment of advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-oestrogen therapy. Efficacy has not been demonstrated in patients with oestrogen receptor-negative status.
- Contraindications
- **4.3 Contra-indications**
Exemestane tablets are contraindicated in patients with a known hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.
- Atc Code
- L02BG06
- Atc Item Name
- exemestane
- Pharma Manufacturer Name
- ACCORD HEALTHCARE PRIVATE LIMITED
- Company Detail Path
- /organization/7b2062edde9ff0f1/accord-healthcare-private-limited
