- Approval Id
- c3d09d27bfd6b5dc
- Drug Name
- ANASOMA 1 FILM-COATED TABLETS 1MG
- Product Name
- ANASOMA 1 FILM-COATED TABLETS 1MG
- Approval Number
- SIN16621P
- Approval Date
- 2022-10-05
- Registrant
- APOTHECA MARKETING PTE LTD
- Licence Holder
- APOTHECA MARKETING PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **POSOLOGY AND METHOD OF ADMINISTRATION**
_Posology_
The recommended dose of Anastrozole for adults including the elderly is one 1 mg tablet once a day.
Special populations
Paediatric population
Anastrozole is not recommended for use in children and adolescents.
Renal impairment
No dose change is recommended in patients with mild or moderate renal impairment.
Hepatic impairment
No dose change is recommended in patients with mild hepatic disease.
Method of administration
Anastrozole should be taken orally.
- Route Of Administration
- ORAL
- Indication Info
- **Therapeutic indications**
Anastrozole is indicated for the:
Treatment of advanced breast cancer in postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. Efficacy has not been demonstrated in oestrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen.
- Contraindications
- **CONTRAINDICATIONS**
Anastrozole is contraindicated in:
- premenopausal women.
- pregnant or lactating women.
- patients with severe renal impairment (creatinine clearance less than 20ml/min).
- patients with moderate or severe hepatic disease.
- patients with known hypersensitivity to anastrozole or to any of the excipients as listed under “List of excipients”.
Oestrogen-containing therapies should not be co-administered with Anastrozole as they would negate its pharmacological action.
Concurrent tamoxifen therapy.
- Atc Code
- L02BG03
- Atc Item Name
- anastrozole
- Pharma Manufacturer Name
- APOTHECA MARKETING PTE LTD
- Company Detail Path
- /organization/apotheca-marketing-pte-ltd