- Home
- Automated
- List of product information
- ANAST 1 FILM COATED TABLET 1 MG [SIN15633P]
ANAST 1 FILM COATED TABLET 1 MG [SIN15633P]
Active ingredients: ANAST 1 FILM COATED TABLET 1 MG
Product Info
ANAST 1 FILM COATED TABLET 1 MG
[SIN15633P]
Product information
Active Ingredient and Strength | ANASTROZOLE - 1 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | INTAS PHARMACEUTICAL LIMITED - INDIA |
Registration Number | SIN15633P |
Licence Holder | ACCORD HEALTHCARE PRIVATE LIMITED |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | L02BG03 |
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.
4.2 Posology and method of administration
Table caption
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. |
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.
