Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
letrozole
Southern Cross Pharma Pty Ltd
Letrozole
Registered
LETROZOLE FBM/NOVEMBER2013/CMI-2 1 LETROZOLE FBM _contains the active ingredient letrozole _ CONSUMER MEDICINE INFORMATION What is in this leaflet This leaflet answers some common questions about LETROZOLE FBM. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking LETROZOLE FBM against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. Keep this leaflet with your medicine. You may need to read it again. What LETROZOLE FBM is used for LETROZOLE FBM is used to treat breast cancer in women who are post-menopausal that is, women who no longer have periods, either naturally due to their age or after surgery or chemotherapy. LETROZOLE FBM belongs to a group of medicines called aromatase inhibitors also called ‘antioestrogens’. These medicines work by reducing the production of oestrogen in your body. Oestrogen stimulates the growth of certain types of breast cancer. These cancers are called "oestrogen-dependent." Reducing the production of oestrogen may help to keep the cancer from growing. This may be the first time you are taking an "antioestrogen" such as LETROZOLE FBM or you may have taken another "antioestrogen" such as femara or tamoxifen in the past. Your doctor may have prescribed LETROZOLE FBM for another reason. Ask your doctor if you have any questions about why LETROZOLE FBM has been prescribed for you. LETROZOLE FBM is available only with a doctor's prescription. There is no evidence that LETROZOLE FBM is addictive. Before you take LETROZOLE FBM _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE LETROZOLE FBM IF YOU ARE ALLERGIC TO MEDICINES CONTAINING LETROZOLE OR AROMATASE INHIBITORS (CLASS) MEDICINE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some of the symptoms of an allergic reaction may include skin rash, itching or hives, swelling of the face, lips or t Прочитать полный документ
Letrozole FBM_PI_11032016 Page 1 of 19 LETROZOLE FBM LETROZOLE 2.5 MG TABLETS NAME OF THE MEDICINE Letrozole Chemical Structure: Molecular formula: C 17 H 11 N 5 Chemical name: 4, 4'-[(1 _H_ -1, 2, 4-triazol-1-yl)-methylene]bis-benzonitrile Molecular weight: 285.303 CAS number: 112809-51-5 DESCRIPTION Letrozole is a white or yellowish crystalline powder. It is practically insoluble in water, freely soluble in methylene chloride and sparingly soluble in methanol. Each film-coated tablet of LETROZOLE FBM contains letrozole 2.5 mg and the inactive ingredients: lactose, maize starch, hypromellose, microcrystalline cellulose, sodium starch glycollate, colloidal anhydrous silica, magnesium stearate, macrogol 6000, titanium dioxide, purified talc and iron oxide yellow CI77492. PHARMACOLOGY PHARMACODYNAMICS The elimination of oestrogen-mediated stimulatory effects is a prerequisite for tumour response in cases where the growth of tumour tissue depends on the presence of oestrogens. Letrozole FBM_PI_11032016 Page 2 of 19 In postmenopausal women, oestrogens are mainly derived from the action of the aromatase enzyme, which converts adrenal androgens - primarily androstenedione and testosterone - to oestrone (E1) and oestradiol (E2). The suppression of oestrogen biosynthesis in peripheral tissues and the cancer tissue itself can, therefore, be achieved by specifically inhibiting the aromatase enzyme. Letrozole is a non-steroidal aromatase inhibitor. Data suggest that it inhibits the aromatase enzyme by competitively binding to the haem of the cytochrome P450 subunit of the enzyme, resulting in a reduction of oestrogen biosynthesis in all tissues. In healthy post-menopausal women, single doses of 0.1, 0.5 and 2.5 mg letrozole suppressed serum oestrone and oestradiol by 75-78% and 78% from baseline, respectively. Maximum suppression was achieved in 48-78 h. In post-menopausal patients with advanced breast cancer, daily doses of 0.1 to 5 mg letrozole suppressed plasma concentrations of oestradiol, oestrone, and oestrone sulphat Прочитать полный документ