资源描述：
《SIMCOR说明书(美国,原研,英文)》由会员上传分享，免费在线阅读，更多相关内容在行业资料-天天文库。
1、DN1744V1-Simcor-ADRChange-clean-041508HIGHLIGHTSOFPRESCRIBINGINFORMATION—————CONTRAINDICATIONS—————Thesehighlightsdonotincludealltheinformationneededtouse•Activeliverdisease,whichmayincludeunexplainedpersistentSimcorsafelyandeffectively.Seefullprescribinginfor
2、mationforelevationsinhepatictransaminaselevels(4,5.2)Simcor.•Activepepticulcerdisease(4)Simcor(simvastatin/niacinextended-release)Tablet,FilmCoated,•Arterialbleeding(4)ExtendedReleaseforOraluse•Womenwhoarepregnantormaybecomepregnant(4,8.1)InitialU.S.Approval:2
3、008•Nursingmothers(4,8.3)—————INDICATIONSANDUSAGE—————•Knownhypersensitivitytoproductcomponents(4,6.1)SIMCORisacombinationofsimvastatin,anHMG-Co-Areductaseinhibitor,andextended-releaseniacin(Niaspan),nicotinicacid.SIMCORisindicatedto:•Reduceelevatedtotal–C,LDL
4、-C,ApoB,non-HDL-C,TG,orto—————WARNINGSANDPRECAUTIONS—————increaseHDL-Cinpatientswithprimaryhypercholesterolemiaand•Skeletalmuscleeffects(e.g.,myopathyandrhabdomyolysis):Risksmixeddyslipidemiawhentreatmentwithsimvastatinmonotherapyorniacinextended-releasemonoth
5、erapyisconsideredinadequate.(1.1)increasewithhigherdoses,advancedage(≥65),hypothyroidism,renal•ReduceTGinpatientswithhypertriglyceridemia(Fredricksontypeimpairment,andconcomitantuseofcyclosporine,danazol,IVhyperlipidemia)whentreatmentwithsimvastatinmonotherapy
6、orgemfibrozil,amiodarone,andverapamilandpotentCYP3A4niacinextended-releasemonotherapyisconsideredinadequate.(1.1)inhibitors.(5.1)•Liverenzymeabnormalitiesandmonitoring:Persistentelevationsinhepatictransaminasecanoccur.MonitorliverenzymesbeforeandLimitationsofu
7、se:duringtreatment.(5.2)NoincrementalbenefitofSIMCORoncardiovascularmorbidityandmortalityoverandabovethatdemonstratedforsimvastatinmonotherapy•Severehepatictoxicityhasoccurredinpatientssubstitutingsustained-andniacinmonotherapyhasbeenestablished.(1.1)releaseni
8、acinforimmediate-releaseniacinatequivalentdoses.Ifswitchingfromotherniacinpreparations,initiatewithlowestSIMCORdose;niacinextended-releasecanbeconvertedatequivalentdoses.—————DOSAG
