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1、NDA21-748Page1RxOnlyGLUMETZA™(metforminhydrochlorideextendedreleasetablets)DESCRIPTIONGLUMETZA(metforminhydrochloride)extendedreleasetabletisanoralantihyperglycemicdrugusedinthemanagementoftype2diabetes.Metforminhydrochloride(N,N-dimethylimidodicarbon
2、imidicdiamidehydrochloride)isnotchemicallyorpharmacologicallyrelatedtoanyotherclassesoforalantihyperglycemicagents.Thestructuralformulaofmetforminhydrochloride(metforminHCl)isasshown:MetforminHClisawhitetooff-whitecrystallinecompoundwithamolecularform
3、ulaofC4H11N5•HClandamolecularweightof165.63.MetforminHClisfreelysolubleinwaterandispracticallyinsolubleinacetone,ether,andchloroform.ThepKaofmetforminis12.4.ThepHofa1%aqueoussolutionofmetforminhydrochlorideis6.68.GLUMETZAtabletsaremodifiedreleasedosag
4、eformsthatcontain500mgor1000mgofmetforminHCl.Each500mgtabletcontainscoloring,hypromellose,magnesiumstearate,microcrystallinecelluloseandpolyethyleneoxide.Each1000mgtabletcontainscrospovidone,dibutylsebacate,ethylcellulose,glycerylbehenate,polyvinylalc
5、ohol,polyvinylpyrrolidone,andsilicondioxide.GLUMETZA500and1000mgtabletsbothutilizepolymer-based,oraldrugdeliverysystems,whichallowdeliveryofmetforminHCltotheuppergastrointestinal(GI)tract.CLINICALPHARMACOLOGYMechanismofActionMetforminisanantihyperglyc
6、emicagent,whichimprovesglucosetoleranceinpatientswithtype2diabetes,loweringbothbasalandpostprandialplasmaglucose.Itspharmacologicmechanismsofactionaredifferentfromotherclassesoforalantihyperglycemicagents.Metformindecreaseshepaticglucoseproduction,dec
7、reasesintestinalabsorptionofglucose,andimprovesinsulinsensitivitybyincreasingperipheralglucoseuptakeandutilization.Unlikesulfonylureas,metformindoesnotproducehypoglycemiaineitherpatientswithtype2diabetesornormalsubjects(exceptinspecialcircumstances,se
8、ePRECAUTIONS)anddoesnotcausehyperinsulinemia.Withmetformintherapy,insulinsecretionremainsunchangedwhilefastinginsulinlevelsanddaylongplasmainsulinresponsemayactuallydecrease.PharmacokineticsAbsorptionandBioavailabilityFollowingasingleoraldoseo
