Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
Anastrozole
Eris Pharmaceuticals (Australia) Pty Ltd
Anastrozole
AZASTROLE™ CONSUMER MEDICINE INFORMATION Anastrozole 1 mg film-coated tablets What is in this leaflet_ _ This leaflet answers some of the common questions about AZASTROLE. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of taking AZASTROLE against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. What AZASTROLE is used for AZASTROLE is used to treat breast cancer in women who no longer have their menstrual periods either naturally, due to their age or after surgery, radiotherapy or chemotherapy. AZASTROLE is a non-steroidal aromatase inhibitor, which reduces the amount of oestrogen (female sex hormone) made by the body. In some types of breast cancer, oestrogen can help the cancer cells grow. By blocking oestrogen, AZASTROLE may slow or stop the growth of cancer. FOLLOW ALL DIRECTIONS GIVEN TO YOU BY YOUR DOCTOR. They may differ from the information contained in this leaflet. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY AZASTROLE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed AZASTROLE for another reason. AZASTROLE is only available with a doctor's prescription. AZASTROLE is not addictive Before you take AZASTROLE _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE AZASTROLE IF YOU ARE PREGNANT OR INTEND TO BECOME PREGNANT. AZASTROLE may affect your developing baby if you take it during pregnancy. DO NOT BREASTFEED WHILE TAKING AZASTROLE. Your baby can take in AZASTROLE from breast milk if you are breastfeeding. DO NOT TAKE AZASTROLE IF YOU HAVE AN ALLERGY TO: Anastrozole, the active ingredient of AZASTROLE;. Any of the other ingredients of AZASTROLE listed at the end of this leaflet; or Other anti-oestrogen medicines. Symptoms of an allergic reaction may include shortness of breath, wheezing or diffi Les hele dokumentet
Page 1 of 17 PRODUCT INFORMATION AZASTROLE FILM-COATED TABLETS _ _ NAME OF THE MEDICINE The active ingredient in AZASTROLE Tablets is anastrozole. The structural formula is: CAS: 120511-73-1 Chemical name: , , ’, ’-tetramethyl-5-(1_H_-1,2,4-triazol-1-ylmethyl)-_m-_ benzenediacetonitrile. _ _ DESCRIPTION Anastrozole is a fine white to off white powder. It is freely soluble in most organic solvents slightly soluble in water (0.707 mg/mL at 25ºC) and insoluble in n-hexane. Inactive ingredients: hypromellose, lactose, macrogol 400, magnesium stearate, povidone, sodium starch glycollate, titanium dioxide, Opadry White Y1-7000 PHARMACOLOGY Anastrozole is a potent and highly selective nonsteroidal aromatase inhibitor. It significantly lowers serum oestradiol concentrations and has no detectable effect on formation of adrenal corticosteroids or aldosterone. Many breast cancers have oestrogen receptors and growth of these tumours can be stimulated by oestrogen. In post-menopausal women, oestradiol is produced primarily from the conversion of androstenedione to oestrone through the aromatase enzyme complex in peripheral tissues. Oestrone is subsequently converted to oestradiol. Many breast cancers also contain aromatase; the importance of tumour generated oestrogens is uncertain. Page 2 of 17 Reducing circulating estradiol levels has been shown to produce a beneficial effect in women with breast cancer. In postmenopausal women, anastrozole at a daily dose of 1 mg produced estradiol suppression of greater than 80% using a highly sensitive assay. Anastrozole does not possess any progestogenic, androgenic or oestrogenic activity. Daily doses of anastrozole up to 10 mg do not have any effect on cortisol or aldosterone secretion, measured before or after standard ACTH challenge testing. Corticoid supplements are therefore, not needed. In a phase III/IV study, there was a neutral effect on plasma lipids in those patients treated with anastrozole. PHARMACOKINETICS: _ABSORPTION_ Absorption of anastrozole is ra Les hele dokumentet