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- ANABREZ ANASTROZOLE FILM COATED TABLET USP 1MG [SIN16144P]
ANABREZ ANASTROZOLE FILM COATED TABLET USP 1MG [SIN16144P]
Active ingredients: ANABREZ ANASTROZOLE FILM COATED TABLET USP 1MG
Product Info
ANABREZ ANASTROZOLE FILM COATED TABLET USP 1MG
[SIN16144P]
Product information
Active Ingredient and Strength | ANASTROZOLE - 1 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | SUN PHARMACEUTICAL INDUSTRIES LIMITED - INDIA |
Registration Number | SIN16144P |
Licence Holder | RANBAXY (MALAYSIA) SDN. BHD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | L02BG03 |
INDICATIONS
ANABREZ 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.
DOSE AND METHOD OF ADMINISTRATION
Adults including elderly: One 1mg tablet to be taken orally once a day
Special Populations
Children: 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.
For early disease, the recommended duration of treatment should be 5 years.
Method of Administration
For oral use
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
Oestrogen-containing therapies should not be co-administered with anastrozole as they would negate its pharmacological action.
Concurrent tamoxifen therapy (see DRUG INTERACTIONS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
