阿司匹林双嘧达莫缓释胶囊

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1、阿司匹林双嘧达莫缓释胶囊说明书【药品名称】通用名称：阿司匹林双嘧达莫缓释胶囊商品名称：斯纳格英文名称：AspirinandDipyridamoleSustained-releaseCapsules汉语拼音：AsipilinshuangmidamoHuanshijiaonang【成份】本品为复方制剂，每粒含双嘧达莫100mg和阿司匹林12.5mg。【性状】本品为胶囊剂，内容物为白色薄膜衣片和黄色微丸。【适应症】本品适用于已有短暂脑缺血发作或血栓形成所致缺血性脑卒中患者，降低脑卒中或脑卒中再发的危险。【规格】每粒含双嘧

2、达莫100mg、阿司匹林12.5mg。【用法用量】□服，成人每次2粒(阿司匹林25mg和双嘧达莫200mg)，每日二次，早晚各服一次。可与食物同服，也可分开。本品应整粒吞服，不能咀嚼。【不良反应】在国外进行的为期24个月的多中心双盲、随机对照的临床研究中观察了本品的安全性。其中发生率在1%以上的不良事件如下：表1临床不良事件  分组不良事件阿司匹林双嘧达莫缓释胶囊缓释双嘧达莫阿司匹林安慰剂总人数1650165416491649至少发生一种不良事件的病人1319(79.9%)1305(78.9%)1323(80.2%

3、)1304(79.1%)中枢、外周神经系统异常 头痛647(39.2%)634(38.3%)558(33.8%)543(32.96%)惊厥28(1.7%)15(0.9%)28(1.7%)26(1.6%)消化系统异常 消化不良303(18.4%)288(17.4%)299(18.1%)275(16.7%)腹痛289(17.5%)255(15.4%)262(15.9%)239(14.5%)恶心264(16.0%)254(15.4%)210(12.7%)232(14.1%)腹泻210(12.7%)257(15.5%)11

4、2(6.8%)161(9.8%)呕吐138(8.4%)129(7.8%)101(6.1%)118(7.2%)直肠出血26(1.6%)22(1.3%)16(1.0%)13(0.8%)黑便31(1.9%)10(0.6%)20(1.2%)13(0.8%)痔疮16(1.0%)13(0.8%)10(0.6%)10(0.6%)胃肠道出血20(1.2%)5(0.3%)15(0.9%)7(0.4%)全身性异常 疼痛105(6.4%)88(5.3%)103(6.2%)99(6.0%)疲倦95(5.9%)93(5.6%)97(5.9%

5、)90(5.5%)背痛76(4.6%)77(4.7%)74(4.5%)65(3.9%)意外损伤42(2.5%)24(1.5%)51(3.1%)37(2.2%)不适感27(1.6%)23(1.4%)26(16%)22(1.3%)虚弱29(1.8%)19(1.1%)17(1.0%)18(1.1%)晕厥17(1.0%)13(0.8%)16(1.0%)8(0.5%)精神系统异常 健忘症39(2.4%)40(2.4%)57(3.5%)24(2.1%)精神错乱18(1.1%)9(0.5%)22(1.3%)15(0.9%)厌食1

6、9(1.2%)17(1.0%)10(0.6%)15(0.9%)嗜睡20(1.2%)13(0.8%)18(1.1%)9(0.5%)骨骼肌肉系统异常 关节痛91(5.5%)75(4.5%)91(5.5%)76(4.6%)关节炎34(2.1%)25(1.5%)17(1.0%)19(1.2%)关节病18(1.1%)22(1.3%)13(0.8%)14(0.81%)肌痛20(1.2%)16(1.0%)11(0.7%)11(0.7%)呼吸系统异常 咳嗽25(1.5%)18(1.1%)32(1.9%)21(1.3%)上呼吸道感染

7、16(1.0%)9(0.5%)16(1.0%)14(1.8%)心血管系统 心衰26(1.6%)17(1.0%)30(1.8%)25(1.5%)血小板、出凝血系统异常 出血52(3.2%)24(1.5%)46(2.8%)24(1.5%)鼻出血39(2.4%)16(1.0%)45(2.7%)25(1.5%)紫癜23(1.4%)8(0.5%)9(0.5%)7(1.4%)肿瘤28(1.7%)16(0.5%)23(1.4%)20(1.2%)红细胞异常 贫血27(1.6%)16(1.0%)19(1.2%)9(0.5%) 表2引

8、起用药中断的不良事件  分组 不良事件阿司匹林双嘧达莫缓释胶囊缓释双嘧达莫阿司匹林安慰剂总人数1650165416491649至少发生一种不良事件的病人417(25%)419(25%)318(19%)352(21%)头痛165(10%)166(10%)57(3%)69(4%)      眩晕85(5%)97(6%)69(4%)68(4%)恶心91(6%)95