马尿酸乌洛托品片说明书(英文)

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1、Urex™(methenaminehippurate)Toreducethedevelopmentofdrug-resistantbacteriaandmaintaintheeffectivenessofUREXtabletsandotherantibacterialdrugs,UREXtabletsshouldbeusedonlytotreatorpreventinfectionsthatareprovenorstronglysuspectedtobecausedbybacteria.DESCRIPTIONUREX(methen

2、aminehippurate)isaurinarytractantisepticdrug.Eachwhite,scoredUREXtabletcontainsmethenaminehippurate1g(seeHOWSUPPLIED).UREXtabletsalsocontain:magnesiumstearate,povidoneandsaccharinsodium.Chemically,methenaminehippurateisthehippuricacidsaltofmethenamine(hexamethylenetet

3、ramine).Structuralformula:C15H21N5O3MolecularWeight319.37CLINICALPHARMACOLOGYUREXisreadilyabsorbedfromtheGItract.Methenaminedistributeswidelyintobodyfluids,butverylittleishydrolyzedpriortoexcretioninthekidneyandthushasminimalsystemictoxicpotential.Withinone-halfhouraf

4、terasingle1gdoseofUREX,anti-bacterialactivityisdemonstrableintheurine.UrineshowscontinuousantibacterialactivitywhenUREXisadministeredattherecommendeddosagescheduleof1gtwicedaily.Over90%ofthemethenaminemoietyisexcretedintheurinewithintwenty-fourhoursafteradministration

5、ofasingle1gdose.Similarly,thehippuratemoietyisrapidlyabsorbedandexcreted,anditreachestheurinebybothtubularsecretionandglomerularfiltration.Thismaybeofimportanceinolderpatientsorthosewithsomedegreeofrenalimpairment.Methenamineisplacentallytransferredtothefetusduringpre

6、gnancy.1Microbiology.UREXexertsitsactivitybecausethemethenaminecomponentishydrolyzedtoformaldehydeinacidurine.Hippuricacid,theothercomponent,actstokeeptheurineacid.Theminimalinhibitoryconcentrationsaresignificantlylowerinmoreacidicmedia;therefore,theefficacyofUREXcanb

7、eincreasedbyacidificationofurine(seeDOSAGEANDADMINISTRATION).Microorganismsdonotdevelopresistancetoformaldehyde;howeverurea-splittingmicroorganisms(e.g.Proteusspecies)tendtoraisethepHoftheurinethusinhibitingthereleaseofformaldehyde.WhentheurinepHis6andthedailyurinevol

8、umeis1000–1500mLa2gdoseofUREXdailywillyieldaurinaryconcentrationof18to60ug/mLofformaldehyde,thisbeingmorethantheminimalinhib