Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
cilostazol
Otsuka Australia Pharmaceutical Pty Ltd
Cilostazol
Registered
PLETAL ® _Cilostazol (sil-OS-tah-zol)_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using PLETAL. This leaflet answers some common questions about PLETAL. 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 PLETAL 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 PLETAL IS USED FOR PLETAL is used to treat intermittent claudication. Blockage of the blood vessels to the legs, causes a distinctive type of pain called intermittent claudication. In this condition, which usually affects the calves, you experience muscle pain or cramping whenever you walk some distance, but the pain disappears when you rest. The pain occurs because the calf muscles are not receiving enough oxygen. PLETAL is only recommended for patients whose symptoms have not improved sufficiently after making life-style modifications (such as stopping smoking and increasing exercise) and after other appropriate interventions. It is important that you continue the modifications you have made to your life-style whilst taking cilostazol. PLETAL belongs to a group of medicines called phosphodiesterase inhibitors. This medicine works by preventing blood clots and widening blood vessels. 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. There is not enough information to recommend the use of this medicine for children under the age of 18 years. BEFORE YOU TAKE PLETAL _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE PLETAL IF YOU HAVE AN ALLERGY TO: • any medicine containing cilostazol • any of the ingredients listed at the end of Đọc toàn bộ tài liệu
PRODUCT INFORMATION PLETAL ® (CILOSTAZOL) NAME OF THE MEDICINE Pletal (cilostazol) is a quinolinone derivative which inhibits cellular phosphodiesterase (more specific for phosphodiesterase 3). Molecular formula C 20 H 27 N 5 O 2 Molecular wt 369.47 CAS 73963-72-1 The IUPAC name for cilostazol is 6-[4-(1-cyclohexyl-1_H-_tetrazol-5-yl)butoxy]-3,4-dihydro-2(1_H_)- quinolinone. DESCRIPTION Cilostazol is slightly soluble in methanol and ethanol and practically insoluble in water, 0.1N HCl, and 0.1N NaOH. The tablets are an immediate release formulation containing maize starch, microcrystalline cellulose, carmellose calcium, hypromellose and magnesium stearate. PHARMACOLOGY PHARMACODYNAMICS Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitor Animal studies have shown Pletal to have vasodilator effects and this has been demonstrated in small studies in man where ankle blood flow was measured by strain gauge plethysmography. Pletal also inhibits smooth muscle cell proliferation in rat and human smooth muscle cells in vitro, and inhibits the release of platelet-derived growth factor and PF-4 from human platelets. Studies in animals (in vivo and ex vivo) have shown that Pletal causes inhibition of platelet aggregation. The inhibition is effective against a range of aggregants (including shear stress, arachidonic acid, collagen, ADP and adrenaline); in man the inhibition lasts for up to 12 hours, and on cessation of administration of Pletal recovery of aggregation occurs within 48-96 hours, without rebound hyperaggregability. PHARMACOKINETICS _ABSORPTION: _ Following multiple doses of Pletal 100 mg twice daily in patients with peripheral vascular disease, steady state is achieved within 4 days. The Cmax of Pletal and its two active metabolites increase less than proportionally with increasing doses. However, the AUC for Pletal and its metabolites increase approximately proportionately with dose. _Pletal (cilostazol 50 mg and 100 mg tablets) _ _Product Information _ Page 2 of 12 Compared to the Đọc toàn bộ tài liệu