国家: 台湾
语言: 中文
来源: 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)
IRBESARTAN;;HYDROCHLOROTHIAZIDE (EQ TO 3,4-DIHYDROCHLOROTHIAZIDE)
賽諾菲股份有限公司 台北市信義區松仁路3號7樓 (97168356)
C09DA04
膜衣錠
HYDROCHLOROTHIAZIDE (EQ TO 3,4-DIHYDROCHLOROTHIAZIDE) (4028100600) MG; IRBESARTAN (9200038400) MG
鋁箔盒裝
製 劑
須由醫師處方使用
Sanofi Clir 54 Avenue de la Boetie, 75008, Paris, France FR
irbesartan and diuretics
本態性高血壓。
註銷日期: 2017/11/29; 註銷理由: 自請註銷; 有效日期: 2017/11/12; 英文品名: Coaprovel Film-Coated Tablets 300mg/25mg
已註銷
2007-11-12
1 1. NAME OF THE MEDICINAL PRODUCT CoAprovel 150 mg/12.5 mg film-coated tablets. CoAprovel 300 mg/12.5 mg film-coated tablets. CoAprovel 300 mg/25 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CoAprovel 150 mg/12.5 mg: Each film-coated tablet contains 150 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Excipient: Each film-coated tablet contains 38.5 mg of lactose (as lactose monohydrate). CoAprovel 300 mg/12.5 mg: Each film-coated tablet contains 300 mg of irbesartan and 12.5 mg of hydrochlorothiazide. Excipient: Each film-coated tablet contains 89.5 mg of lactose (as lactose monohydrate). CoAprovel 300 mg/25 mg: Each film-coated tablet contains 300 mg of irbesartan and 25 mg of hydrochlorothiazide. Excipient: Each film-coated tablet contains 53.3 mg of lactose (as lactose monohydrate). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. CoAprovel 150 mg/12.5 mg: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2875 engraved on the other side. CoAprovel 300 mg/12.5 mg: Peach, biconvex, oval-shaped, with a heart debossed on one side and the number 2876 engraved on the other side. CoAprovel 300 mg/25 mg: Pink, biconvex, oval-shaped, with a heart debossed on one side and the number 2788 engraved on the other side. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment of essential hypertension. This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1). 4.2 Posology and method of administration CoAprovel can be taken once daily, with or without food. Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommended. When clinically appropriate direct change from monotherapy to the fixed combinations may be considered: CoAprovel 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 阅读完整的文件