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1、1PRODUCTINFORMATION2CEPTAZ®3(ceftazidimeforinjection)4L-arginineformulation56ForIntravenousorIntramuscularUse78DESCRIPTION:Ceftazidimeisasemisynthetic,broad-spectrum,beta-lactamantibioticfor9parenteraladministration.Itisthepentahydrateofpyridinium,1-[[7-[[(2-amino
2、-4-thiazolyl)[(1-10carboxy-1-methylethoxy)imino]acetyl]amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-11en-3-yl]methyl]-,hydroxide,innersalt,[6R-[6α,7β(Z)]].Ithasthefollowingstructure:12131415TheempiricalformulaisC22H32N6O12S2,representingamolecularweighto
3、f636.6.16CEPTAZisasterile,drymixtureofceftazidimepentahydrateandL-arginine.TheL-arginine17isataconcentrationof349mg/gofceftazidimeactivity.CEPTAZdissolveswithoutthe18evolutionofgas.Theproductcontainsnosodiumion.SolutionsofCEPTAZrangeincolorfrom19lightyellowtoamber
4、,dependingonthediluentandvolumeused.ThepHoffreshlyconstituted20solutionsusuallyrangesfrom5to7.5.2122CLINICALPHARMACOLOGY:Afterintravenous(IV)administrationof500-mgand1-g23dosesofceftazidimeover5minutestonormaladultmalevolunteers,meanpeakserum24concentrationsof45an
5、d90mcg/mL,respectively,wereachieved.AfterIVinfusionof500-mg,251-g,and2-gdosesofceftazidimeover20to30minutestonormaladultmalevolunteers,mean26peakserumconcentrationsof42,69,and170mcg/mL,respectively,wereachieved.Theaverage27serumconcentrationsfollowingIVinfusionof5
6、00-mg,1-g,and2-gdosestothesevolunteersCEPTAZ®(ceftazidimeforinjection)L-arginineformulation28overan8-hourintervalaregiveninTable1.2930Table1CeftazidimeSerumConcentrations(mcg/mL)IVDose0.5h1h2h4h8h500mg422512621g6039231132g12975421353132Theabsorptionandeliminationo
7、fceftazidimeweredirectlyproportionaltothesizeofthe33dose.Thehalf-lifefollowingIVadministrationwasapproximately1.9hours.Lessthan10%of34ceftazidimewasproteinbound.Thedegreeofproteinbindingwasindependentofconcentration.35Therewasnoevidenceofaccumulationofceftazidimei
8、ntheseruminindividualswithnormal36renalfunctionfollowingmultipleIVdosesof1and2gevery8hoursfor10days.37Followingintramuscular(IM)administrationof500-mgan
