国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
cyproterone acetate
Amneal Pharma Australia Pty Ltd
cyproterone acetate
Registered
_Cyproterone AN tablets – Consumer Medicine Information _ _ _ _Cyproterone AN CMI v2 _ _ _ _ _ _Page 1 _ CYPROTERONE AN 50 MG TABLETS _Cyproterone acetate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CYPROTERONE AN. 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 CYPROTERONE AN 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 CYPROTERONE AN IS USED FOR CYPROTERONE AN is an antiandrogenic hormone medication which has several different uses. Androgens such as testosterone are natural male sex hormones which are also produced, to a slight extent, in females. MEN In men, androgens may help cancer cells to grow in some types of prostate cancer. By blocking these hormones, CYPROTERONE AN may slow or stop the growth of cancer. CYPROTERONE AN may also 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. CYPROTERONE AN is also used to reduce abnormal sex drive in men. WOMEN In women, androgens may increase hair growth, loss of scalp hair and secretion of oil from the sweat glands. By blocking these hormones, CYPROTERONE AN may slow or stop excessive hairiness, loss of scalp hair, acne, oily skin and dandruff. 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 CYPROTERONE AN _WHEN YOU MUST NOT TAKE _ _IT _ _ _ Do not take CYPROTERONE AN if you have an allergy to: • cyproterone acetate, the active ingredient in CYPROTE 阅读完整的文件
_ _ _ _ _Cyproterone AN 50 mg tablets Product Information _ _ _ _Amneal Pharma Australia Pty Ltd _ Cyproterone AN PI v3 Page 1 CYPROTERONE AN 50 MG TABLETS _ _ _(CYPROTERONE ACETATE TABLETS) _ _ _ PRODUCT INFORMATION NAME OF THE MEDICINE The name of this medicine is cyproterone acetate. _ _ _Structural formula:_ The chemical name is 6-chloro-17 -hydroxy-1 α, 2 α-methylene-pregna-4,6- diene-3,20- dione acetate. _ _ MOLECULAR FORMULA : C 24 H 29 ClO 4 . MOLECULAR WEIGHT_: _ 416.95. _CAS Number: _ 427-51-0. DESCRIPTION White circular flat bevelled tablets, with breakline on one side and plain on the other. Each Cyproterone AN 50 mg tablet contains cyproterone acetate 50 mg. CYPROTERONE AN contains the active ingredient cyproterone acetate 50 mg and the following excipients: lactose monohydrate, povidone, magnesium stearate, croscarmellose sodium .and microcrystalline cellulose PHARMACOLOGY Following oral administration, cyproterone acetate is absorbed slowly. Its bio-availability is unknown. The maximum plasma level is reached 3 to 4 hours after ingestion. Cyproterone acetate is eliminated with a half-life of 38 ± 5 h. After 10 days, 33 ± 6 of the dose can be demonstrated in the urine and 60 ± 8% in the faeces. Cyproterone acetate is eliminated _ _ _ _ _Cyproterone AN 50 mg tablets Product Information _ _ _ _Amneal Pharma Australia Pty Ltd _ Cyproterone AN PI v3 Page 2 with the urine mainly in the form of unconjugated metabolites and with the bile in the form of glucuronidized metabolites, the main one being 15 β-hydroxy-cyproterone acetate. Radioimmunoassays show that about 0.2% of the dose is eliminated with the breast milk. CYPROTERONE AN is an antiandrogenic hormone preparation. Cyproterone acetate is believed to prevent the effect of endogenously produced and exogenously administered androgens at the target organs by means of competitive inhibition. The stimulating effect of male sex hormones on androgen-dependent structures and functions is weakened or counteracted by cyproterone acetate. Cyproterone ace 阅读完整的文件