- Approval Id
- 4f2cedc6d1bfe4fe
- Drug Name
- ANABREZ ANASTROZOLE FILM COATED TABLET USP 1MG
- Product Name
- ANABREZ ANASTROZOLE FILM COATED TABLET USP 1MG
- Approval Number
- SIN16144P
- Approval Date
- 2021-04-05
- Registrant
- RANBAXY (MALAYSIA) SDN. BHD.
- Licence Holder
- RANBAXY (MALAYSIA) SDN. BHD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- **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
- Route Of Administration
- ORAL
- Indication Info
- **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.
- 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
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_)
- Atc Code
- L02BG03
- Atc Item Name
- anastrozole
- Pharma Manufacturer Name
- RANBAXY (MALAYSIA) SDN. BHD.
- Company Detail Path
- /organization/5e0de622414edf8b/ranbaxy-malaysia-sdn-bhd
