Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**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.
ORAL
Medical Information
**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** 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.
L02BG03
anastrozole
Manufacturer Information
APOTHECA MARKETING PTE LTD
EUGIA PHARMA SPECIALITIES LIMITED
Active Ingredients
Documents
Package Inserts
ANASOMA FILM-COATED TABLETS_PI.pdf
Approved: October 5, 2022