Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
Cyproterone acetate
Bayer Australia Ltd
Medicine Registered
1209 CYPROSTAT ® -100 CMI Page 1 of 4 CYPROSTAT ® -100 (SIGH·PRO·STAT) _cyproterone acetate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Cyprostat-100. 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 you taking Cyprostat-100 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 THE MEDICINE. You may need to read it again. WHAT CYPROSTAT- 100 IS USED FOR Cyprostat-100 is an anti-androgen medicine. Androgens such as testosterone are natural male sex hormones. In some types of prostate cancer, androgens may help the cancer cells to grow. By blocking these hormones, Cyprostat-100 may slow or stop the growth of cancer. Cyprostat-100 may be used in combination with other medicines or following surgical removal of the testes to treat side effects such as “hot flushes” or “sweats” and to prevent any initial worsening of the disease. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor’s prescription. BEFORE YOU TAKE CYPROSTAT-100 _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE CYPROSTAT-100 IF YOU HAVE AN ALLERGY TO: • cyproterone acetate, the active ingredient in Cyprostat-100 • any of the ingredients listed at the end of this leaflet _ _ Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or d Soma hati kamili
101109 CYPROSTAT-100 PI Page 1 of 9 CYPROSTAT ® 100MG PRODUCT INFORMATION NAME OF THE MEDICINE Cyprostat 100mg Each pack contains tablets with 100mg cyproterone acetate. Cyproterone acetate: CH 3 CH 3 H H H O O CH 3 O Cl O Chemical Name: 6-chloro-17 α hydroxy-1α,2α-methylene-pregna-4,6-diene-3,20-dione actetate Molecular Formula: C 24 H 29 CIO 4 Molecular Mass: 416.96 CAS No.: 427-51-0 DESCRIPTION Cyproterone acetate is a white to pale yellow crystalline powder. M.P. 206-213 °C. Cyproterone acetate is very soluble in chloroform and dioxane, freely soluble in acetone and benzene, soluble in ethanol, methanol and ethyl acetate, sparingly soluble in solvent hexane, and almost insoluble in water. PHARMACOLOGY Cyprostat is an antiandrogenic hormone preparation. Cyproterone acetate inhibits competitively the effect of androgens at androgen- dependent target organs, e.g. it shields the prostate from the effect of androgens originating from the gonads and/or the adrenal cortex. Prostatic carcinoma and its metastases are in general androgen-dependent, cyproterone acetate therefore exerts a direct antiandrogenic action on the tumour and its metastases. Cyproterone acetate in addition has a progestogenic action exerting a negative feedback effect centrally on the hypothalamic receptors, so leading to a reduction in gonadotropin release, and hence to diminished production of testicular androgens. Treatment with cyproterone acetate in men results in a reduction of sexual drive and potency and inhibition of gonadal function. These changes are reversible following discontinuation of the therapy. The antigonadotropic effect of cyproterone acetate is also exerted when the substance is combined with LHRH agonists. The initi Soma hati kamili