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toradoli - GPC

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<strong>toradoli</strong>ketorolak trometamolianalgeziuri saSualebaSemadgenloba da gamoSvebis formaerTi tableti Seicavs:ketorolak trometaminis 10 mgerTi ampula xsnaris 1 ml-iT i/m an i/v gamoyenebisaTvis Seicavs:ketorolak trometaminis 30 mgfarmakologiuri moqmedeba<strong>toradoli</strong> – Zliermoqmedi analgetikia, romelic miekuTvneba anTebis sawinaaRmdegoarasteroidul saSualebebs (asas) da romelsac gaaCnia tkivilgamayuCebeli, anTebissawinaaRmdego da sicxis damwevi Tvisebebi. <strong>toradoli</strong> Trgunavs ciklooqsigenazasfermentul sistemas da Sesabamisad prostaglandinebis sinTezs. preparati ar miekuTvnebaopiatebs da ar moqmedebs centralur opiatur receptorebze. igi ar axdens zegavlenassunTqvaze da ar aZlierebs opiatebiT gamowveul sunTqvis daTrgunvas an sedacias.farmakokinetikaSewovaaxalgazrda janmrTel moxaliseebSi ketorolak trometamini i/m Seyvanis Semdeg swrafadda mTlianad Seiwoveba. 30 mg erTjeradi Seyvanis Semdeg plazmaSi maqsimalurikoncentracia – 2.2-3.0 μg/ml miiRweva 50 wuTSi.zrdasrul janmrTel moxaliseebSi ketorolak trometaminis 10 mg erTjeradi i/v nakaduriSeyvanis Semdeg saSualo maqsimaluri koncentracia plazmaSi – 2.4 μg/ml – miiRweva,saSualod, Seyvanidan 5.4 wuTSi.axalgazrda janmrTel moxaliseebSi 30 mgiani dozis i/v infuziis Semdeg plazmaSimaqsimaluri koncentracia miiRweva 5 wuTSi. amis Semdgom uwyveti infuzia siCqariT 5 mg/sTinarCunebs koncentracias plazmaSi imave doneze, rac aRiniSneba yovel 6 saaTSi 30 mg i/mSeyvanis Semdeg.axalgazrda janmrTel moxaliseebSi ketorolak trometaminis 10 mg uzmoze peroralurimiRebis Semdeg preparati swrafad da mTlianad Seiwoveba, da maqsimaluri koncentraciaplazmaSi – 0.7-1.1 μg/ml miiRweva 44 wuTSi.ganawilebaketorolak trometaminis farmakokinetika zrdasrul janmrTel moxaliseebSi erTjeradi damravaljeradi i/m/ i/v da p/o miRebis Semdeg xazovan xasiaTs atarebs.RviZlis funqciis darRvevis mqone avadmyofebSi ketorolakis farmakokinetikis raimemniSvnelovani klinikuri cvlilebebi ar aRiniSneba.Cvenebebizomieri da Zlieri tkivilis xanmokle kupireba, romelic saWiroebs opiatebiT analogiuriintensivobis gautkivarebas. <strong>toradoli</strong> ar aris naCvenebi qronikuli tkivilis sindromebissamkurnalod.miRebis reJimimkurnalobis xangrZlivobamozrdilebSi <strong>toradoli</strong>s mravaljeradi i/m an nakaduri i/v gamoyenebis jamurixangrZlivoba ar unda aRematebodes 5 dRes, vinaidan ufro xangrZlivi gamoyenebisasizrdeba gverdiTi movlenebis sixSire. mozrdilebSi <strong>toradoli</strong>s i/v infuziis maqsimalurixangrZlvoba ar unda aRematebodes 24 saaTs. bavSvebSi <strong>toradoli</strong>s parenteruli gamoyenebisjamuri xangrZlivoba ar unda aRematebodes 2 dRes.mozrdilebSi <strong>toradoli</strong>s tabletebis miReba rekomendebulia araxangrZlivi droisganmavlobaSi (7 dRemde); misi xangrZlivi miReba ar aris naCvenebi.xsnari ineqciisaTvispreparati unda dainiSnos minimalur efeqtian dozaSi. mas arCeven tkivilis intensivobisada avadmyofis reaqciis mixedviT. saWiroebisas SesaZlebelia damatebiT dainiSnos opiatebidabal dozebSi, Tu ar arsebobs ukuCvenebebi maT mimarT. <strong>toradoli</strong>s erTdrouliparenteruli daniSvnisas opiatebis dozebi SeiZleba Cveulebrivze naklebi iyos.


kreatinini > 442 mkmol/l) <strong>toradoli</strong> ukunaCvenebia. Tirkmlis msubuqi ukmarisobisaspreparati unda dainiSnos sifrTxiliT da naklebi doziT, Tirkmlis funqciissaguldagulo kontrolis fonze. aseT SemTxvevebSi sadReRamiso dozas amcirebennaxevramde (ara umetes 60 mg/dReRameSi). dializiT ver xerxdeba ketorolakis mniSvnelovanigamoyvana sisxlis mimoqcevidan.ukuCvenebebikuWisa da Tirmetgoja nawlavis wylulovani daavadeba, sisxldena kuW-nawlavis traqtidanda perforacia (maT Soris anamnezSi). Tirkmlis zomieri da mZime ukmarisoba. Tirkmlisukmarisobis riski hipovolemiisas da dehidrataciisas. orsuloba da mSobiaroba.momatebuli mgrZnobeloba <strong>toradoli</strong>sadmi da sxva asas, alergiuli reaqciebi aspirinze daprostaglandinebis sinTezis sxva inhibitorebze (aseT avadmyofebSi aRiniSna mZimeanafilaqtoiduri reaqciebi). profilaqtikuri gautkivareba operaciis win daintraoeperaciuli gamoyeneba (arsebobs Trombocitebis agregaciis daTrgunvisSesaZlebloba da sisxldenis riski). hemoragiuli insulti, sisxldenis ganviTarebismaRali riskis an arasruli hemostazis mdgomareobebi. acetilsalicilis mJavis da sxvaasas, pentoqsifilinis erTdrouli miReba.<strong>toradoli</strong>s Seyvana epi- an subduralurad dauSvebelia, radgan xsnari Seicavs spirts.gverdiTi movlenebi<strong>toradoli</strong>s gamoyenebisas mosalodnelia Semdegi gverdiTi movlenebis ganviTareba:kuW-nawlavis traqti: tkivili da diskomforti muclis areSi, anoreqsia, Sekruloba, diarea,dispepsia, amoqarveba, meteorizmi, simZimis SegrZena, tkivilebi mucelSi, gastriti,gulisreva, pirRebineba, stomatiti, ezofagiti, sisxldenebi kuW-nawlavis traqtidan,pankreatiti, kuWisa da Tormetgoja nawlavis wylulovani daavadeba, perforaciebi,sisxldena swori nawlavidan, melena.centraluri nervuli da Zval-kunTovani sistemebi: Zilisa da azrovnebis darRvevebi,SfoTva, aseptiuri meningiti, krunCxvebi, depresia, sistemuri da arasistemuri Tavbrusxveva,Zilianoba, piris simSrale, eiforia, wyurvilis SegrZneba, halucinaciebi, Tavis tkivili,hiperkineziebi, koncentraciis darRveva, uZiloba, tkivili kunTebSi, nervozuloba,paresTeziebi, fsiqiuri reaqciebi, oflianoba.saSarde gzebi: Tirkmlis mwvave ukmarisoba, tkivili ferdebSi (hematuriis da azoTemiisTanxlebiT an maT gareSe), hemolizuri uremiuli sindromi, hiperkaliemia, hiponatriemia,Sardvis gaxSireba, Sardis Sekaveba, intersticiuli nefriti, nefrozuli sindromi,oliguria, Sardovanas da kreatininis donis momateba SratSi.iseve rogorc prostaglandinebis damTrgunveli sxva preparatebiT mkurnalobisas,<strong>toradoli</strong>s erTjeradi miRebis Semdeg SeiZleba gamovlindes Turkmlis funqciis darRvevisniSnebi (magaliTad, kreatininisa da kaliumis donis momateba SratSi)gulsisxlZarRvTa sistema: bradikardia, simxurvalis SegrZneba saxis areSi, arteriulihipertenzia da hipotenzia, kanis siferkmrTale, guliscemis SegrZneba, tkivili mkerdisareSi.sunTqvis sistema: asTma, qoSini, filtvebis SeSupeba.RviZli da sanaRvle gzebi: RviZlis funqciuri testebis cvlilebebi, hepatiti,qolestazuri siyviTle, RviZlis ukmarisoba.kani: eqsfoliaciuri dermatiti, laielis sindromi, makulo-papulozuri gamonayari, qavili,stivens-jonsonis sindromi, WinWris cieba.hipemgrZnobelobis reaqciebi: bronqospazmi, gamonayari, hipotonia, xorxis SeSupeba,angionevrozuli SeSupeba, anafilaqtoiduri reaqciebi, anafilaqsia.sisxlis sistema: purpura, Trombocitopenia, sisxldena cxviridan, hematomebi,postoperaciuli sisxldenebi, sisxldenis drois gaxangrZliveba.grZnobis organoebi: gemovnebiTi SegrZnebebis darRvevebi, mxedvelobis darRvevebi,Tavbrusxveva, smenis daqveiTeba.sxva: asTenia, SeSupeba, reaqcia Seyvanis adgilze, sxeuli wonis momateba, cxeleba.sifrTxilis zomebiwylulovani daavadeba, sisxldena kuWnawlavis traqtidan, kuW-nawlavis traqtisperforaciebi.toradolma SeiZleba gamoiwvios kuW-nawlavis traqtis lorwovani garsis dazianeba.avadmyofebi, romlebic Rebuloben asas, maT Soris toradols nebismier dros SeiZlebaganuviTardeT mZime gverdiTi movlenebi kuW-nawlavis traqtis mxriv (kuWisa da nawlavebisgaRizianeba, sisxldenebi, wylulebis ganviTareba, perforaciebi da a.S.), maT Soriswinamorbedi simpomatikis gareSe. asas preparatebze Catarebulma kvlevebma ver gamoavlinespaceintebis romelime jgufi, romelSic ar iqneboda wylulis ganviTarebis an sisxldenis


iski. am reaqciebisadmi ufro metad mgrZnobiarenni arian da ufro cudad itanenxandazmuli da dauZlurebulo pacientebi; swored am jgufSi aRiniSneba kuW-nawlavistraqtis reaqciebis yvelaze meti ricxvi letaluri dasasruliT.iseve rogorc sxva asas mkurnalobisas, gverdiTi movlenebis sixSire da simZimis xarisximatulobs <strong>toradoli</strong>s dozisa da Terapiis xangrZlivobis matebasTan erTad. kuW-nawlavistraqtidan mZime sisxldenebis riski damokidebulia dozaze da izrdeba xandazmuli asakispacientebSi, romlebic dReRameSi <strong>toradoli</strong>s 60 mg-ze mets Rebuloben. anamnezSiwylulovani daavadebis arseboba zrdis kuW-nawlavis mxriv mZime garTulebebisganviTarebis albaTobas.zegavlena Tirkmlebze<strong>toradoli</strong>s, iseve rogorc sxva asas, daniSvna anamnezSi Tirkmlis funqciis darRvevebismqone avadmyofebisaTvis unda ganxorcieldes sifrTxiliT, vinaidan igi prostaglandinebissinTezis Zlieri inhibitoria. sifrTxilis dacvaa agreTve saWiro mocirkulire sisxlisSemcirebuli moculobis da/an Tirkmlis Semcirebuli sisxlmomaragaebis mqone pacientebSi<strong>toradoli</strong>s daniSvnisas, rameTu TirkmlebSi warmoqmnili prostaglandinebi xels uwyobenTirkmlis perfuziis SenarCunebas. am pacientebSi asas gamoyenebam SeiZleba gamoiwviosTirkmlebSi prostaglandinebis warmoqmnis dozaze damokidebuli Semcireba da migviyvanosTirkmlis manifestirebul ukmarisobamde. amis riski yvelaze metadaa gamoxatulimocirkulire sisxlis moculobis Semcirebis, gulis ukmarisobis da RviZlis funqciisdarRvevebis mqone pacientebSi, agreTve xandazmuli asakis pirebSi da avadmyofebSi,romlebic diuretikebs Rebuloben. asas miRebis Sewyvetis Semdeg avadmyofis mdgomareoba,Cveulebriv, sawyiss ubrundeba.anafilaqsiuri (anafilaqtoiduri) reaqciebiavadmyofebs, romelTac anamnezSi aReniSnebaT asTma da bronqospazmi, cxviris polipozi,angionevrozuli SeSupebebi, toradols uniSnaven sifrTxiliT.sisxlis sistema<strong>toradoli</strong> Trgunavs Trombocitebis agregacias, amcirebs Tromboqsanis koncentracias dazrdis sisxldenis xangrZlivobas. aspirinisgan gansxvavebiT toradol xanmokle droiTmoqmedebs Trombocitebis funqciaze, romelic normalizdeba preparatis gauqmebidan 24-48saaTSi.avadmyofebs Sededebis darRvevebiT <strong>toradoli</strong> gansakuTrebuli sifrTxiliT iniSneba, maTimdgomareoba saguldagulo kontrolis fonze. Tumca klinikuri kvlevebiT ar gamovlindamniSvnelovani urTierTqmedeba toradolsa da varfarins an heparins Soris, <strong>toradoli</strong>sa dahemostazze moqmedi preparatebis, maT Soris antikoagulantebis (varfarini,heparinoprofilaqtika dabal dozebSi – 2500-5000 erTeuli 2-jer dRe-RameSi) dadeqstranebis, erTdroulma gamoyenebam SeiZleba gazardos sisxldenebis riski. <strong>toradoli</strong>sdaniSvna msgavs situaciebSi unda ganxorcieldes gansakuTrebuli sifrTxiliT,avadmyofebis saguldagulo kontrolis fonze.aRwerilia postoperaciuli hematomebis da operaciuli Wrilobis sxva garTulbebisganviTarebis SemTxvevebi <strong>toradoli</strong>s parenterulad perioperaciuli gamoyenebisas.sifrTxilis gamoCenaa saWiro <strong>toradoli</strong>s daniSvnisas postoperaciul avadmyofebSi,romlebic gansakuTrebulad saguldagolo hemostazs saWiroeben, magaliTad winamdebarejirkvlis rezeqciis, tonzileqtomiisa an kosmetikuri operaciis Semdeg.xandazmuli asakis avadmyofebies avadmyofebi ufro mgrZnobiarenni arian gverdiTi movlenebisadmi, vidre axalgazrdebi.riskis gazrda asakis parakelurad yvela asas aris damaxiasaTebeli. xandazmuli asakispacientebSi naxevradgamoyofis periodi izrdeba, xolo ketorolakis plazmuri klirensiSeiZleba Semcirdes.siTxis Sekaveba da SeSupebebi<strong>toradoli</strong>s gamoyenebisas aRwerilia siTxis Sekavebisa da SeSupebebis SemTxvevebi, amitompreparatis daniSvnisas sifrTxilis gamoCenaa saWiro gulis dekompensirebuli ukmarisobis,arteriuli hipertenziisa da analogiuri mdgomareobebebis mqone avadmyofebSi.sifrTxilea saWiro <strong>toradoli</strong>sa da probenecidis erTdrouli daniSvnisas, vinaidan amukanasknelma SeiZleba Secvalos ketorolakis farmakokinetika.sifrTxiles moiTxovs <strong>toradoli</strong>s da metotreqsatis erTdrouli gamoyeneba, vinaidanprostaglandinebis inhibitorebi metotreqsatis klirens amcireben da amiT zrdian misSesaZlo toqsiurobas.transportis marTva da manqana-danadgarebTan muSaoba<strong>toradoli</strong>T mkurnalobisas zogierT avadmyofs SeiZleba ganuviTardes Zilianoba,Tavbrusxveva, uZiloba an depresia. aseT SemTxvevebSi gansakuTrebuli sifrTxilea saWiroim saxis samuSaos Sesrulebisas, romelic yuradRebis srul daZabvas moiTxovs.orsuloba da ZuZuTi kveba


orsulobisas <strong>toradoli</strong> SeiZleba dainiSnos mxolod im SemTxvevaSi, roca potenciurisargebeli gadawonis nayofisTvis arsebul SesaZlo risks.mSobiarobis pirvel da meore periodSi <strong>toradoli</strong> ukunaCvenebia, vinaidanprostaglandinebis inhibiciiT man SeiZleba uaryofiTi zegavlena iqonios nayofis sisxlismimoqcevaze da Seasustos saSvilosnos kumSvadoba, rac zrdis saSvilosnodansisxldenebis risks.ZuZuTi kvebisas <strong>toradoli</strong> SeiZleba dainiSnos mxolod im SemTxvevaSi, roca potenciurisargebeli gadawonis nayofisTvis arsebul SesaZlo risks.bocvrebsa da virTxebze Catarebuli kvlevebiT, rodesac ketorolak trometaminisgamoyenebuli dozebi toqsiur zemoqmdbas axdendnen dedlebze, preparatis teratogenobisniSnebi ar gamovlenila. virTxebSi aRiniSna orsulobis periodis gaxangrZliveba da gvianimSobiaroba. ketorolakis daaxloebiT 10% gadis placentarul bariers. mcirekoncentraciebSi igi aRmoCenilia dedis rZeSi.^urTierTqmedeba wamlebTanerTdrouli daniSvna aspirinTan an sxva asas zrdis am jgufis preparatebTandakavSirebuli mZime garTulebebis risks.pentooqsifilinTan erTad daniSvnisas izrdeba sisxldenebisadmi tendecia.probenecidi amcirebs ketorolakis plazmur klirensa da ganawilebis moculobas, zrdismis koncentracias plazmaSi da axangrZlivebs naxevradgamoyofis periods.prostaglandinebis zogierTi inhibitori amicrebs metotreqsatis klirenss da amiTSeiZleba gaaZlieros misi toqsiuroba. prostaglandinebis zogierTi inhibitori TrgunavenliTiumis klirenss Tirkmlebidan, riTac zrdian mis koncentracias SratSi. aRweriliaSratSi liTiumis koncentraciis momatebis SemTxvevebi <strong>toradoli</strong>T mkurnalobis fonze.ketorolak trometamini ar moqmedebs digoqsinis cilebTan SekavSirebaze. salicilatebisTerapevtuli koncentracibis arsebobisas (300 mkg/ml) <strong>toradoli</strong>s SekavSireba cilebTan invitro mcirdeboda 99.2%-dan 97.5%-mde, ris Sedegadac plazmaSi Tavisufali ketorolakiskoncentracia orjer gaizarda. diqoqsinis, vafarinis, ibuprofenis, naproqsenis,piroqsimakis, acetaminofenis, fentoinis da tolbutamidis Terapevtulma koncentraciebmaar iqonies zegavlena <strong>toradoli</strong>s cilebTan SekavSirebis xarisxze.marTalia klinikurma kvlevebma ar gamoavlines mniSvnelovani urTierTqmedeba toradolsda varfarins an heparins Soris, <strong>toradoli</strong>sa da hemostasze moqmedi sxva preparatebis, maTSoris antikoagulantebis (varfarini, heparinoprofilaqtika dabal dozebSi – 2500-5000erTeuli 2-jer dRe-RameSi) da deqstranebis, erTdroulma daniSvnam SeiZleba sisxldenisriski gazardos.janmrTel moxaliseebSi normovolemiiT <strong>toradoli</strong> furosemidis Sardmden moqmedebasamcirebs daaxloebiT 29%-iT, amitom sifrTxilis gamoCenaa saWiro preparatis gulisukmarisobis mqone avadmyoebSi gamoyenebisas.sxva asas zrdian Tirkmlis funqiis darRvevis risks agf inhibitorebTan erTdrouligamoyenebisas. ketorolakma SeiZleba gamoavlinos msgavsi efeqti analogiuri meqanizmiT.Tu <strong>toradoli</strong> iniSneba postoperaciuli tkivilebis kuprebisaTvis, igi amcirebsmoTxovnilebas opiatebSi.<strong>toradoli</strong>s tabletebis miRebas cximebiT mdidari sakvebis Semdeg Tan axlda maqsimalurikoncentracis Semcireba da misi miRwevis Seferxeba daaxloebiT 1 saaTiT. antacidebi armoqmedeben <strong>toradoli</strong>s Sewovaze.borotad gamoyeneba/damokidebulebatoradols ara aqvs damokidebulebis Camoyalibebis potenciali. prepratis swrafi moxsnisSemdeg, moxsnis simptomebi ar vlindeba.SeuTavseblobaar ariis rekomendebuli <strong>toradoli</strong>s saineqcio xsnaris Sereva morfinis sulfatTan,petidinis hidroqloridTan, prometazinTan an hidroqsizinTan patara moculobisWurWelSi (magaliTad, erT SpricSi), vinaidan am dros ketorolaki SeiZleba daileqos.<strong>toradoli</strong>s xsnari SeTavsebadia natriumis qloridis fiziologiur xsnarTan, glukozis5% xsnarTan, ringerisa da ringer-laktatis xsnarebTan, agreTve xsnar “plazmalitTan”.<strong>toradoli</strong> SeTavsebadia infuziur xsnarebTan, romlebic Sicaven aminogilins, lidokainishidroqlorids, morfinis sulfats, meperidin hidroqlorids, dopaminis hidroqlorids,xanmokle moqmedebis adamianis insulisns da heparinis natriumis marils.dozis gadaWarbeba<strong>toradoli</strong>s dozis gadaWarbebas erTjeradi Seyvanisas Tan axlavs tkivili mucelSi,gulisreva, pirRebineba, hiperventilacia, peptiuri wylulebis da/an eroziuli gastritisganviTareba, Tirmklis funqciis darRveva, romlebic qreba preparatis miRebis SewyvetisSemdeg.


dializiT ketorolakis mniSvnelovani gamoyofa sisxlis mimoqcevidan ver xerxdeba.Senaxvis vada2 weli (ampulebi) da 3 weli (tabletebi). ar SeiZleba preparatis gamoyeneba kolofzemiTiTebuli Senaxvis vadis gasvlis Semdeg.SefuTvaampulebi 5tabletebi 20unda iqnes Senaxuli bavSvebisTvis miuwvdomel adgilze 30°С-mde temperaturaze,sinaTlisgan dacul adgilas. tabletebi daculi unda iyos nestis zemoqmedebisgan.gaicema eqimis receptiT.

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