urotoli
urotoli
urotoli
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
preparatis samedicino gamoyenebis instruqcia<br />
<strong>urotoli</strong><br />
saregistracio nomeri: lsr-005815/09<br />
preparatis savaWro dasaxeleba: <strong>urotoli</strong><br />
saerTaSoriso arapatentirebuli dasaxeleba: tolterodini.<br />
samkurnalo forma: apkovani garsiT dafaruli tabletebi.<br />
Semadgenloba<br />
erTi apkovani garsiT dafaruli tableti Seicavs:<br />
aqtiur nivTierebas: tolterodinis hidrotartrats – 1 mg, 2 mg.<br />
damxmare nivTierebebi:<br />
birTvi: mikrokristaluri celuloza, natriumis karboqsimeTilsaxamebeli<br />
(tipi A), koloiduri kremniumis dioqsidi, natriumis stearilfumarati.<br />
garsi:<br />
1 mg tabletebi: hipromeloza 2910/5, makrogoli 6000, titanis dioqsidi, talki,<br />
saRebavi rkinis yviTeli oqsidi.<br />
2 mg tabletebi: hipromeloza 2910/5, makrogoli 6000, titanis dioqsidi, talki.<br />
aRwera<br />
1 mg tabletebi: mrgvali, oradamoburculi yviTeli feris apkovani garsiT<br />
dafaruli tabletebi.<br />
2 mg tabletebi: mrgvali, oradamoburculi TeTri feris apkovani garsiT<br />
dafaruli tabletebi.<br />
farmakoTerapiuli jgufi<br />
m-qolinoblokatori.<br />
aTq kodi: G04BD07.<br />
farmakologiuri Tvisebebi<br />
rogorc tolterodini, iseve misi 5-hidroqsimeTiluri warmoebuli,<br />
maRalspecifiuria muskarinuli receptorebis mimarT, konkurentulad<br />
ablokirebs m-qolinoreceptorebs umaRlesi seleqtiurobiT Sardis buStis<br />
receptorebis mimarT (sanerwyve jirkvlebis receptorebTan SedarebiT).<br />
1
preparati aqveiTebs Sardgamomyofi gzebis gluvi muskulaturis tonuss,<br />
detruzoris kumSvadobis aqtivobas, aseve amcirebs nerwyvdenas.<br />
Terapiulze maRali dozebis miRebisas iwvevs Sardis buStis arasrul<br />
daclas da zrdis darCenili Sardis raodenobas.<br />
tolterodinis Terapiuli efeqti miiRweva 4 kviraSi.<br />
tolterodini ar ainhibirebs CYP2D6, 2C19, 3A4 da 1A2.<br />
farmakokinetika<br />
Sewova<br />
preparatis SigniT miRebisas tolterodini swrafad Seiwoveba kuW-nawlavis<br />
traqtidan (knt). SratSi maqsimaluri koncentracia (C max ) miiRweva 1-2 saaTSi.<br />
Terapiuli dozebis intervaliT (1-4 mg) miRebisas arsebobs xazovani<br />
damokidebuleba sisxlis SratSi C max mniSvnelobasa da preparatis dozas<br />
Soris.<br />
tolterodinis sruli bioSeRwevadoba Seadgens 65%-s CYP2D6 ukmarisobis<br />
mqone pirebSi da 17%-s pacientTa umravlesobaSi.<br />
sakvebi ar moqmedebs preparatis bioSeRwevadobaze, magram tolterodinis<br />
koncentracia izrdeba misi sakvebTan miRebisas.<br />
ganawileba<br />
tolterodini da 5-hidroqsimeTiluri metaboliti ukavSirdeba upiratesad<br />
orozomukoids. SeukavSirebeli fraqciebi Seadgens 3,7% da 36%, Sesabamisad.<br />
tolterodinis ganawilebis moculoba Seadgens 113 l.<br />
tolterodinisa da 5-hidroqsimeTiluri metabolitis cilebTan SekavSirebis<br />
gansxvavebis gamo tolterodinis mrudis qveS farTobi ~koncentracia – dros~<br />
(AUC) CYP2D6 ukmarisobis mqone pirebSi axlosaa tolterodinisa da 5-<br />
hidroqsimeTiluri metabolitis AUC sidideebis jamTan pacientTa<br />
umravlesobaSi dozirebis erTnairi reJimis dros. aqedan gamomdinare,<br />
preparatis usafrTxoeba, amtanoba da klinikuri efeqti ar aris damokidebuli<br />
CYP2D6 aqtivobaze.<br />
metabolizmi<br />
tolterodini ZiriTadad metabolizdeba RviZlSi polimorfuli fermenti<br />
CYP2D6 saSualebiT farmakologiurad aqtiuri 5-hidroqsimeTiluri<br />
metabolitis warmoqmniT, romelic Semdeg metabolizdeba 5-karbonis mJava da<br />
2
N-dezalkilirebul 5-karbonis mJavamde. 5-hidroqsimeTilur metabolits aqvs<br />
tolterodinis msgavsi farmakologiuri Tvisebebi da umravles avadmyofSi<br />
arsebiTad aZlierebs preparatis moqmedebas.<br />
daqveiTebuli metabolizmis (CYP2D6 ukmarisobiT) mqone pirebSi tolterodini<br />
ganicdis dezalkilirebas CYP3A4 izofermentebiT N-dezalkilirebuli<br />
tolterodinis warmoqmniT, romelsac ar gaaCnia farmakologiuri aqtivoba.<br />
gamoyofa<br />
SratSi tolterodinis sistemuri klirensi umravles pacientSi Seadgens<br />
daaxloebiT 30l/sT. preparatis miRebisas tolterodinis naxevradgamoyofis<br />
periodi (T 1/2 ) Seadgens 2-3 saaTs, xolo 5-hidroqsimeTiluri metabolitis T 1/2 –<br />
3-4 saaTs. daqveiTebuli metabolizmis mqone pirebSi T 1/2 daaxloebiT 10 saaTia.<br />
sawyisi SeerTebis klirensis daqveiTeba CYP2D6 ukmarisobis mqone pirebSi<br />
iwvevs tolterodinis koncentraciis gazrdas (daaxloebiT 7 jer) gamovlenas<br />
dauqvemdebarebeli 5-hidroqsimeTiluri metabolitis koncentraciebis fonze.<br />
tolterodinis daaxloebiT 77% gamoiyofa SardTan da 17 % - ganavalTan.<br />
dozis 1%-ze naklebi gamoiyofa Seucvleli saxiT da daaxloebiT 4% - 5-<br />
hidroqsimeTiluri metabolitis saxiT. 5-karbonis mJava da N-<br />
dezalkilirebuli 5-karbonis mJava Seadgens, Sesabamisad, SardTan<br />
gamoyofili raodenobis daaxloebiT 51% da 29%.<br />
farmakokinetika gansakuTrebul klinikur pirobebSi<br />
tolterodinisa da misi aqtiuri 5-hidroqsimeTiluri metabolitis AUC sidide<br />
izrdeba daaxloebiT 2 jer avadmyofebSi RviZlis ciroziT.<br />
tolterodinisa da 5-hidroqsimeTiluri metabolitis AUC saSualo sidide 2<br />
jer maRalia pacientebSi Tirkmelebis funqciis gamoxatuli darRveviT<br />
(gorgolovani filtraciis siCqare
- Sardis buStis hiperrefleqsia (hiperaqtivoba, arastabiluroba), romelic<br />
vlindeba moSardvis xSiri, imperatiuli surviliT da/an Sardis<br />
SeukaveblobiT.<br />
ukuCveneba<br />
- momatebuli mgrZnobeloba preparatis komponentebis mimarT;<br />
- Sardvis Sekaveba;<br />
- mkurnalobas dauqvemdebarebeli daxurulkuTxovani glaukoma;<br />
- miasTenia gravis;<br />
- mZime wylulovani koliti;<br />
- megakoloni;<br />
- 18 wlamde asaki.<br />
preparati sifrTxiliT iniSneba qveda Sardgamomyofi gzebis gamoxatuli<br />
obstruqciis SemTxvevaSi Sardvis Sekavebis riskTan dakavSirebiT, knt<br />
peristaltikis daqveiTebis momatebuli riskis, knt obstruqciuli<br />
daavadebebis (magaliTad, kuWis gasavlis stenozi), Tirkmlis an RviZlis<br />
ukmarisobis (dRe-Ramuri doza ar unda aRematebodes 2 mg-s), nevropaTiis,<br />
diafragmis saylapavis xvrelis Tiaqaris dros.<br />
gamoyeneba orsulobis da ZuZuTi kvebis periodSi<br />
orsulobis periodSi tolterodinis miReba SesaZlebelia mxolod im<br />
SemTxvevaSi, Tu dedisaTvis mosalodneli sargebeli aRemateba nayofisaTvis<br />
potenciur risks.<br />
imis gamo, rom tolterodinis dedis rZeSi gamoyofis Sesaxeb cnobebi ar<br />
arsebobs, laqtaciis periodSi preparatis miReba ar SeiZleba.<br />
Svilosnobis asakis qalebma tolterodiniT Terapiis dros unda gamoiyenon<br />
kontracefpciis saimedo meTodebi.<br />
gamoyenebis wesi da dozebi<br />
preparati miiReba SigniT 2 mg 2 jer dReSi, sakvebis miRebisagan<br />
damoukideblad.<br />
preparatis saerTo doza SeiZleba Semcirdes 2 mg-mde dRe-RameSi, preparatis<br />
individualur amtanobaze damokidebiT.<br />
4
RviZlis da/an Tirkmelebis funqciis darRvevisas, aseve ketokonazolTan an<br />
CYP3A4 sxva Zlier inhibitorebTan erTdroulad miRebisas rekomendebulia<br />
preparatis dozis Semcireba 1 mg-mde 2 jer dRe-RameSi.<br />
Terapiis efeqturoba ganmeorebiT unda Sefasdes mkurnalobis dawyebidan 2-3<br />
TveSi.<br />
gverdiTi moqmedeba<br />
imunuri sistemis mxriv: alergiuli reaqciebi, kvinkes SeSupeba (Zalian<br />
iSviaTad).<br />
nervuli sistemis mxriv: nervozuloba, gonebis dakargva, halucinaciebi,<br />
Tavbrusxveva, Zilianoba, paresTezia, Tavis tkivili.<br />
mxedvelobis organoebis mxriv: Tvalebis simSrale, akomodaciis darRveva.<br />
gul-sisxlZarRvTa sistemis mxriv: taqikardia, momatebuli gulis cema,<br />
ariTmia (iSviaTad).<br />
knt mxriv: simSrale piris RruSi, dispefsia, Sekruloba, muclis tkivili,<br />
meteorizmi, Rebineba, iSviaTad – gastroezofaguri refluqsi.<br />
kanis safaris mxriv: kanis simSrale.<br />
Sardgamomyofi sistemis mxriv: Sardvis Sekaveba.<br />
sxva: momatebuli daRliloba, tkivili gul-mkerdis areSi, periferiuli<br />
SeSupeba, bronqiti, sxeulis masis momateba.<br />
dozis gadaWarbeba<br />
simptomebi: akomodaciis parezi, midriazi, Sardvis mtkivneuli survili,<br />
halucinaciebi, Zlieri agzneba, krunCxva, sunTqvis ukmarisoba, taqikardia, QT<br />
intervalos gaxangrZliveba, Sardis Sekaveba.<br />
mkurnaloba: kuWis gamorecxva, gaaqtivebuli naxSiri. halucinaciebis, Zlieri<br />
agznebis ganviTarebisas – fizostigmini, krunCxvebis an gamoxatuli agznebis<br />
dros – benzodiazepinis struqturis anqsiolitikebi, sunTqvis ganviTarebuli<br />
ukmarisobis dros – filtvebis xelovnuri ventilacia, taqikardiis dros –<br />
beta-adrenoblokatorebi, Sardis Sekavebis dros – Sardis buStis<br />
kateterizacia, midriazis dros – pilokarpini Tvalis wveTebSi da/an<br />
pacientis gadayvana bnel oTaxSi.<br />
5
urTierTqmedeba sxva samkurnalo saSualebebTan<br />
moerideT tolterodinis erTdroulad miRebas CYP3A4 Zlieri inhibitorebTan,<br />
magaliTad, makrolidur antibiotikebTan (eriTromicini, klariTromicini),<br />
sokos sawinaaRmdego saSualebebTan (ketokonazoli, itrakonazoli da<br />
mikonazoli), proteazis inhibitorebTan sisxlis SratSi tolterodinis<br />
koncentraciis momatebis SesaZleblobis gamo, rac zrdis preparatis dozis<br />
gadaWarbebis risks.<br />
muskarinuli qolinerguli receptorebis agonistebi aqveiTebs tolterodinis<br />
efeqturobas.<br />
antiqolinerguli Tvisebebis mqone samkurnalo sasualebebi aZlierebs<br />
gverdiTi movlenebis moqmedebas da zrdis maTi ganviTarebis risks.<br />
preparati asustebs prokinetikebis (metoklopramidi, cizapridi) moqmedebas.<br />
SesaZlebelia farmakokinetikuri urTierTqmedeba preparatebdan, romlebic<br />
metabolizdeba citoqroma P450 CYP2D6 an CYP3A4 izofermentebiT<br />
(induqtorebiT da inhibitorebiT).<br />
fluoqsetinTan (CYP2D6 Zlieri inhibitori - metabolizdeba<br />
norfluoqsetinamde, romelic warmoadgens CYP3A4 inhibitors) erTdroulad<br />
miReba iwvevs tolterodinisa da misi aqtiuri 5-hidroqsimeTiluri<br />
metabolitis saerTo AUC mxolod umniSvnelo momatebas, rac ar iwvevs<br />
klinikurad mniSvnelovan urTierTqmedebas.<br />
ar arsebobs urTierTqmedeba varfarinTan da kombinirebul peroralur<br />
kontraceptivebTan (romlebic Seicavs eTinilestradiols/levonorgestrels).<br />
tolterodini ar warmoadgens CYP2D6, 2C19, 3A4, 1A2 inhibitors, amitom<br />
tolterodinTan kombinaciaSia miRebisas mosalodneli ar aris sisxlis<br />
plazmaSi im preparatebis donis momateba, romlebic metabolizdeba mocemuli<br />
izofermentebiT.<br />
gansakuTrebuli miTiTeba<br />
mkurnalobis dawyebamde saWiroa gamoiricxos moSardvis xSiri da<br />
imperatiuli survilis organuli mizezebi.<br />
reproduqciuli asakis qalebSi mkurnalobis dawyeba SeiZleba mxolod<br />
saimedo kontracepciis gamoyenebis pirobiT.<br />
6
am momentisaTvis bavSvebSi preparatis gamoyenebis usafrTxoeba da efeqturoba<br />
Seswavlili ar aris.<br />
mkurnalobis periodSi saWiroa sifrTxilis dacva avtotransportis marTvisa<br />
da sxva potenciurad saSiSi saqmianobis Sesrulebisas, rac saWiroebs<br />
yuradRebis momatebul koncentracias, fsiqomotoruli reaqciebis siswrafes<br />
da karg mxedvelobas (SeiZleba gamoiwvios akomodaciis darRveva da<br />
fsiqomotoruli reaqciebis siCqaris daqveiTeba).<br />
gamoSvebis forma<br />
1 mg an 2 mg apkovani garsiT dafaruli tabletebi. 14 tableti<br />
pvq/pvdq/aluminis blisterSi. 2 an 4 blisteri da gamoyenebis instruqcia<br />
moTavsebulia muyaos kolofSi.<br />
Senaxvis piroba<br />
sia b. mSral adgilze. preparati SeinaxeT bavSvebisaTvis miuwvdomel<br />
adgilas.<br />
vargisianobis vada<br />
3 weli. ar gamoiyeneba vargisianobis vadis gasvlis Semdeg.<br />
afTiaqidan gacemis piroba<br />
receptiT.<br />
mwarmoebeli<br />
zentiva a.s., CexeTis respublika<br />
u kabelovni 130, 10237 praRa 10, dolni mexolupi, CexeTis respublika.<br />
momxmarebelTa pretenziebi preparatis xarisxTan dakavSirebiT waradgineT<br />
Sps ~zentiva farma~-s misamarTze:<br />
ruseTi, 119017, moskovi, didi ordinkas q. saxli 40, S. 4.<br />
telefoni: (495) 721 16 66/67/68, faqsi: (495) 721 16 69.<br />
Переводчица: Эльмира Арутюнян<br />
mTargmneli: elmira aruTiniani<br />
me, mTargmneli elmira aruTiniani, vadastureb, rom vflob rusul enas, pasuxs vageb<br />
Targmanis sizusteze da viZlevi Targmnis sisworis garantias<br />
Я, переводчица Эльмира Арутюнян владею русским языком и отвечаю за гарантию достоверного<br />
перевода.<br />
7
Change language