Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**4.2 Posology and method of administration** Adults including elderly : One 1 mg tablet to be taken orally once a day Children :Anastrozole Tablets is not recommended for use in children 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.
ORAL
Medical Information
**4.1 Therapeutic indications** Anastrozole is indicated for adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer. 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.
**4.3 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 referenced on the carton. Oestrogen-containing therapies should not be co-administered with Anastrozole as they would negate its pharmacological action. Concurrent tamoxifen therapy.
L02BG03
anastrozole
Manufacturer Information
ACCORD HEALTHCARE PRIVATE LIMITED
Intas Pharmaceutical Limited
Active Ingredients
Documents
Package Inserts
ANAST 1 Tab PI - Clean.pdf
Approved: February 6, 2023