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preparatis samedicino gamoyenebis instruqcia ko-reniteki

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nebadarTulia saqarTvelos Sromis,<br />

janmrTelobisa da socialuri dacvis saministros mier<br />

registraciis # ws r 001094<br />

<strong>preparatis</strong> <strong>samedicino</strong> <strong>gamoyenebis</strong> <strong>instruqcia</strong><br />

<strong>ko</strong>-<strong>reniteki</strong><br />

(CO-RENITEC)<br />

savaWro dasaxeleba<br />

<strong>ko</strong>-<strong>reniteki</strong><br />

wamlis forma<br />

tabletebi<br />

Semadgenloba<br />

TiToeuli tableti Seicavs:<br />

aqtiur nivTierebas: enalapril maleati 20 mg da hidroqloroTiazidi 12.5 mg.<br />

damxmare nivTierebebs: natriumis hidrokarbonati (bikarbonati), laqtoza, simindis<br />

saxamebeli, simindis saxamebeli Jelatinizirebuli, rkinis oqsidi yviTeli, magniumis<br />

stearati.<br />

aRweriloba<br />

mrgvali tableti yviTeli feris; erT mxares amotvifrulia MSD 718, meore mxares ki<br />

danayofi.<br />

farma<strong>ko</strong>logiuri jgufi<br />

hipotenziuri <strong>ko</strong>mbinirebuli saSualeba (angiotenzingardamqmneli fermenti (agf)<br />

inhibitori + diurezuli saSualeba).<br />

ATX <strong>ko</strong>di: C09BA02<br />

farma<strong>ko</strong>logiuri Tvisebebi<br />

<strong>ko</strong>-<strong>reniteki</strong> warmoadgens agf inhibitoris (enalapril maleati) da diurezulis<br />

(hidroqloroTiazidi) <strong>ko</strong>mbinacias.<br />

<strong>ko</strong>-<strong>reniteki</strong> arteriuli hipertenziis (ah) samkurnalo maRalefeqturi saSualebaa. misi<br />

ori <strong>ko</strong>mponentis hipotenziuri efeqti avsebs erTmaneTs 24 saaTis ganmavlobaSi.<br />

arteriuli hipertenziiT daavadebul pacientTa umravlesoba ukeT reagirebs <strong>ko</strong><strong>reniteki</strong>T<br />

mkurnalobaze, vidre calkeul mis <strong>ko</strong>mponentze.<br />

farma<strong>ko</strong>dinamika<br />

<strong>ko</strong>mbinirebul preparat <strong>ko</strong>-reniteks gaaCnia antihipertenziuli da diurezuli<br />

moqmedeba. enalaprili warmoadgens agf-s inhibitors, romelic xels uwyobs<br />

angiotenzin I-is gardaqmnas angiotenzin II presorul substanciaSi. Sewovis Semdeg<br />

enalaprili hidrolizis gziT gardaiqmneba enalaprilatad, romelic inhibirebas<br />

ukeTebs agf-s. agf-s inhibireba iwvevs sisxlis plazmaSi angiotenzin II-is<br />

<strong>ko</strong>ncentraciis Semcirebas, ris Sedegadac matulobs sisxlis plazmis reninis<br />

aqtivoba (reninis produqciis Secvlaze ukuqcevadi uaryofiTi reaqciis Tavidan<br />

acilebis Sedegad) da klebulobs aldosteronis sekrecia.<br />

agf ferment kinazin II-s identuria, amitom enalaprili aseve ablokirebs<br />

vazodilatirebadi moqmedebis mqone peptidis – bradikininis daSlas. enalaprilis<br />

Terapiul moqmedebaSi am efeqtis mniSvneloba dasazustebelia. dResdReobiT<br />

iTvleba, rom is meqanizmi, romlis saSualebiTac enalaprili amcirebs arteriul<br />

wnevas (aw), aris renin-angiotenzin-aldosteronuli sistemis aqtivobis daqveiTeba,<br />

rac mniSvnelovan rols TamaSobs arteriuli wnevis regulirebaSi. enalaprili<br />

antihipertenziul moqmedebas axdens im pacientTa SemTxvevaSic ki, romelTac reninis<br />

dabali <strong>ko</strong>ncentracia aqvT. arteriuli wnevis dacemas Tan axlavs saerTo<br />

1


periferiul sisxlZarRvTa winaaRmdegobis Sesusteba, gulis kumSvis umniSvnelo<br />

momateba. enalaprilis miRebis Sedegad imatebs TirkmelSi sisxlis dineba, magram<br />

gorglisebri filtraciis done ucvleli rCeba. Tumca, im pacientTa SemTxvevaSi,<br />

romelTac gorglisebri filtracia Tavidanve Semcirebuli aqvT, misi done, rogorc<br />

wesi, imatebs.<br />

enalapriliT antihipertenziuli Terapia iwvevs marcxena parkuWis mniSvnelovan<br />

regresias da misi disfunqciis progresirebis Senelebas. arteriuli hipertenziiT<br />

daavadebul pacientTaTvis enalaprilis miReba iwvevs arteriuli wnevis dacemas,<br />

rogorc vertikalur, aseve mSvid mdgomareobaSi, gulis SekumSvis sixSiris momatebis<br />

gareSe.<br />

simptomaturi postularuli hipotenzia iSviaTad viTardeba. zogierT pacientTa<br />

SemTxvevaSi, arteriuli wnevis optimaluri dawevis miRwevas sWirdeba Terapia<br />

ramdenime kviris manZilze. enalapriliT Terapiis Sewyveta ar iwvevs arteriuli<br />

wnevis mkveTr momatebas.<br />

agf-s aqtiurobis efeqturi inhibireba, rogorc wesi, viTardeba enalaprilis<br />

erTjeradi dozis SigniT miRebidan 2-4 saaTis Semdeg. antihipertenziuli moqmedeba<br />

iwyeba 1 saaTis manZilze, arteriuli wnevis maqsimaluri daweva xdeba <strong>preparatis</strong><br />

miRebidan 4-6 saaTis Semdeg. moqmedebis xangrZlivoba damokidebulia dozaze. Tumca,<br />

re<strong>ko</strong>mendebuli dozis miRebisas, antihipertenziuli moqmedeba da hemodinamikuri<br />

efeqtebi 24 saaTis manZilze SenarCundeba. enalaprili amcirebs kaliumis ionebis<br />

kargvas, romelsac hidroqloroTiazidis miReba iwvevs. enalaprilsa da<br />

hidroqloroTiazids msgavsi dozirebis reJimi aqvT. amitom, <strong>ko</strong>-<strong>reniteki</strong><br />

enalaprilisa da hidroqloroTiazidis erToblivi miRebis mosaxerxebel wamlis<br />

formas warmoadgens.<br />

hidroqloroTiazidi Sardmdeni da antihipertenziuli saSualebaa, romelic xels<br />

uwyobs reninis aqtivobis momatebas. miuxedavad imisa, rom enalaprilis<br />

antihipertenziuli moqmedeba vrceldeba arteriuli hipertenziis mqone im<br />

pacientebis SemTxvevaSic ki, romelTac reninis dabali <strong>ko</strong>ncentracia aqvT,<br />

hidroqloroTiazidis damatebiTi gamoyeneba aseTi pacientebis SemTxvevaSi<br />

arteriuli wnevis metad gamoxatul dawevas iwvevs.<br />

enalaprilisa da hidroqloroTiazidis <strong>ko</strong>mbinaciis gamoyeneba iwvevs aw-s dawevis<br />

efeqtis gaZlierebas gansxvavebiT Terapiis im sqemisagan, rodesac TiToeuli<br />

preparati cal-calke iniSnebba da inarCunebs preparat <strong>ko</strong>-<strong>reniteki</strong>s antihipertenziul<br />

moqmedebas 24 saaTis manZilze.<br />

farma<strong>ko</strong>kinetika<br />

enalaprili<br />

SigniT miRebis Semdeg enalaprili swrafad Seiwoveba, enalaprilis maqsimaluri<br />

<strong>ko</strong>ncentracia sisxlis SratSi aRiniSneba misi miRebidan 1 saaTis manZilze. SigniT<br />

miRebis Semdeg absorbacia daaxloebiT 60% Seadgens. Sewovis Semdeg xdeba<br />

enalaprilis swrafi hidrolizeba da warmoiqmneba aqtiuri nivTiereba enalaprilati,<br />

agf-s mZlavri inhibitori. enalaprilatis maqsimaluri <strong>ko</strong>ncentracia sisxlis SratSi<br />

aRiniSneba enalaprilis dozis miRebidan 3-4 saaTis Semdeg. enalaprilis gamoyofa<br />

upiratesad Tirkmelebis saSualebiT xdeba. ZiriTadi metabolitebi, romlebic<br />

SardSi ganisazRvreba, aris enalaprilati, romelic dozis daaxloebiT 40% Seadgens<br />

da ucvleli enalaprili. hidrolizisa da enalaprilatis garda, monacemebi<br />

enelaprilis mniSvnelovani metabolizis Sesaxeb ar arsebobs. sisxlis plazmaSi<br />

enalaprilatis <strong>ko</strong>ncentracias xangrZlivi dasrulebis faza aqvs, romelic<br />

ganpirobebulia agf-sTan dakavSirebuli enalaprilatis gamonTavisuflebasTan.<br />

Tirkmlis normaluri funqciis pirebs Soris enalaprilatis stabiluri <strong>ko</strong>ncentracia<br />

miiRweva enalaprilis miRebidan me-4 dRes. enalaprilatis naxevradgamoyofis<br />

(T1/2) periodi <strong>preparatis</strong> <strong>gamoyenebis</strong> mTeli kursis dros 11 saaTs Seadgens. sakvebis<br />

miReba ar axdens gavlenas enalaprilis Sewovaze. enalaprilis Sewovisa da<br />

2


hidrolizis xangrZlivoba msgavsia sxvadasxva re<strong>ko</strong>mendebuli Terapiuli dozebis<br />

dros.<br />

hidroqloroTiazidi<br />

hidroqloroTiazidis T 1/2 5,6-dan 14,8 saaTamde. ar ganicdis metabolizms, magram<br />

swrafad gamoiyofa Tirkmelebis saSualebiT. SigniT miRebuli dozis aranakleb 61%<br />

ucvleli saxiT gamoiyofa 24 saaTis manZilze. hidroqloroTiazidi aRwevs<br />

placentaSi, magram ar aRwevs hematoencefalur barierSi.<br />

enalapril maleatisa da hidroqloroTiazidis <strong>ko</strong>mbinacia<br />

enalaprilisa da hidroqloroTiazidis mravaljeradi miReba ar axdens gavlenas (an<br />

mxolod umniSvnelod) <strong>preparatis</strong> TiToeuli <strong>ko</strong>mponentis bioSeRwevadobaze. preparat<br />

<strong>ko</strong>-<strong>reniteki</strong>s <strong>ko</strong>mbinirebuli tabletis miReba misi ingredientebis calkeuli wamlis<br />

formiT erTdrouli miRebis bioeqvivalenturia.<br />

miRebis Cveneba<br />

arteriuli hipertenzia (pacientTaTvis, romlebisTvisac naCvenebia <strong>ko</strong>mbinirebuli<br />

Terapia).<br />

ukuCveneba<br />

- hipermgrZnobeloba <strong>preparatis</strong> nebismieri <strong>ko</strong>mponentis mimarT;<br />

- hipermgrZnobeloba sulfonamidebis mimarT;<br />

- anamnezSi angionevrozuli SeSupeba, romelic dakavSirebulia agf<br />

inhibitorebis daniSvnasTan, aseve genetikuri an idiopaTuri angionevrozuli<br />

SeSupeba;<br />

- 18 wlamde asakis pacientTaTvis (usafrTxoeba da efeqturoba ar aris<br />

dadgenili);<br />

- anuria;<br />

- hemodializi Tirkmlis ukmarisobis mqone pacientTa SemTxvevaSi.<br />

sifrTxiliT<br />

aortaluri stenozi, cerebrovaskularuli daavadeba (maT Soris Tavis tvinis<br />

sisxlis mimoqcevis ukmarisoba), gulis iSemiuri daavadeba, gulis qronikuli<br />

ukmarisoba, SemaerTebeli qsovilis mwvave autoimunuri sistemuri daavadeba (maT<br />

Soris sistemuri wiTeli mglura, sklerodermiti), Zvlis tvinis sisxlwarmoqmnis<br />

daTrgunva, Saqriani diabeti, hiperkaliemia, Tirkmlis arteriis ormxrivi stenozi,<br />

mdgomareoba Tirkmlis transplantaciis Semdeg, Tirkmlis da/an RviZlis ukmarisoba,<br />

natriumis SemzRudveli dieta, mdgomareoba, romelsac Tan axlavs cirkulirebadi<br />

sisxlis moculobis Semcireba (maT Soris diarea, Rebineba), xandazmuli asaki.<br />

miReba fexmZimobis dros<br />

re<strong>ko</strong>mendebuli ar aris <strong>preparatis</strong> gamoyeneba fexmZimobis dros. fexmZimobis<br />

dadgenisaTanave Sewyvetil unda iqnas preparat <strong>ko</strong>-<strong>reniteki</strong>s miReba. gamonakliss<br />

warmoadgens is SemTxvevebi, rodesac <strong>preparatis</strong> miRebas dedisTvis sasicocxlo<br />

mniSvneloba aqvs. <strong>preparatis</strong> fexmZimobis meore da mesame trimestris dros miRebis<br />

SemTxvevaSi, agf inhibitorebi nayofis an Cvilis daavadebas an sikvdils iwvevs. am<br />

periodis ganmavlobaSi agf inhibitorebis gamoyenebas uaryofiTi gavlena aqvs<br />

nayofsa da Cvilze, kerZod, arteriuli wnevis vardna, Tirkmlis ukmarisoba,<br />

hiperkaliemia da/an Cvilis Tavis qalis hipoplazia. SesaZlebelia oligohidramnionis<br />

Camoyalibeba, rac, rogorc wesi, Tirkmlis funqciis klebis Sedegadaa mosalodneli.<br />

es daavadeba iwvevs kidurebis <strong>ko</strong>ntraqturas, Tavis qalis deformacias, maT Soris,<br />

saxis nawilis, filtvebis hipoplazias.<br />

re<strong>ko</strong>mendebuli ar aris fexmZimobis dros diurezulebis gamoyeneba, rameTu SesaZloa<br />

gamoiwvios nayofisa da axalSobilis siyviTle, Trombocitopenia da, mozrdil<br />

pacientTa msgavsad, sxva gverdiTi efeqtebi. <strong>preparatis</strong> fexmZimobis dros <strong>gamoyenebis</strong><br />

aucileblobis SemTxvevaSi, pacienti gafrTxilebul unda iqnas mosalodneli<br />

safrTxis Sesaxeb. im iSviaT SemTxvevaSi, rodesac <strong>preparatis</strong> daniSvna aucilebeli<br />

3


xdeba fexmZime qalisTvis, mkurnalobis procesSi nayofis mdgomareobis dasadgenad<br />

regularulad ultrabgeriTi gamokvleva unda tardebodes. gamokvleul unda iqnas<br />

aseve intraamnionuri sivrce oligohidramnionis sawyis stadiaSi gamosavlenad.<br />

oligohidramnionis gamovlenisTanave unda Sewydes <strong>ko</strong>-<strong>reniteki</strong>s miReba, garda im<br />

SemTxvevebisa, rodesac <strong>preparatis</strong> miRebas sasicocxlo mniSvneloba aqvs dedisaTvis.<br />

Tumca, rogorc eqimebma, aseve pacientebma unda icodnen, rom oligohidramnioni<br />

SesaZloa ganviTardes, rodesac ukve adgili aqvs nayofis Seuqcevad dazianebas.<br />

axalSobilebi, romelTa dedebi preparats Rebulobdnen, saWiroeben regularul<br />

<strong>ko</strong>ntrols arteriuli wnevis dacemis, oliguriisa da hiperkaliemiis mxriv.<br />

enalaprili, romelic placentaSi aRwevs, SesaZloa gamoyvanil iqnas axalSobilis<br />

sisxlismimoqcevidan peritonealuri dializis saSualebiT. Teoriulad,<br />

SesaZlebelia <strong>preparatis</strong> sisxlidan gamodevna sisxlis cvladi gadasxmis gziT.<br />

dResdReobiT ar arsebobs hidroqloroTiazidis nayofis sisxlismimoqcevidan<br />

gamodevnis klinikuri gamocdileba.<br />

miReba ZuZuTi kvebis dros<br />

rogorc enalaprili, aseve Tiaziduri diurezulebi xvdeba dedis rZeSi. <strong>preparatis</strong><br />

<strong>gamoyenebis</strong> aucileblobis SemTxvevaSi, pacientma ZuZuTi kveba unda Sewyvitos.<br />

miRebis wesi da dozireba<br />

<strong>preparatis</strong> SigniT miRebaze ar moqmedebs sakvebis miReba.<br />

arteriuli hipertenzia:<br />

Cveuli doza Seadgens 1 tablets dRe-RameSi erTxel. saWiroebisamebr, SesaZlebelia<br />

dozirebis gazrda – 2 tableti dRe-RameSi.<br />

adreuli mkurnaloba diurezulebiT:<br />

<strong>ko</strong>-<strong>reniteki</strong>T mkurnalobis dasawyisSi SesaZloa ganviTardes arteriuli wnevis<br />

simptomaturi dacema. es xSirad vlindeba im pacientTa SemTxvevaSi, romlebsac<br />

diurezulebis gamoyenebiT Catarebulma Terapiam daarRvia wyal-eleqtrolituri<br />

balansi. Terapia diurezulebis gamoyenebiT Sewyvetil unda iqnas <strong>ko</strong>-<strong>reniteki</strong>T<br />

mkurnalobis dawyebamde 2-3 dRiT adre.<br />

Tirkmlis ukmarisoba<br />

Tiaziduri diurezulebi xSirad arasakmarisad efeqturia Tirkmlis funqciis<br />

moSlis mqone pacientTa SemTxvevaSi da sruliad araefeqturia kreatininis<br />

klirensis 30ml/wT-mde da qvemoT (zomieri da gamoxatuli Tirkmlis ukmarisoba)<br />

dawevis dros, rac gasaTvaliswinebelia Terapiis SerCevis dros. im pacientTa<br />

SemTxvevaSi, romelTa SemTxvevaSi kreatininis klirensis diapazoni 30-dan 80 ml/wTmde<br />

aRwevs, <strong>ko</strong>-<strong>reniteki</strong> gamoiyeneba mxolod <strong>preparatis</strong> TiToeuli <strong>ko</strong>mponentis dozis<br />

saguldagulo SerCevis Semdeg. enalaprilis re<strong>ko</strong>mendebuli doza zomieri Tirkmlis<br />

ukmarisobis dros 5-10 mg Seadgens.<br />

gverdiTi movlenebi<br />

<strong>ko</strong>-<strong>reniteki</strong>, rogorc wesi, advilad gadasatania. klinikuri gamokvlevebis dros<br />

gverdiTi movlenebi, rogorc wesi, zomieri iyo da umetes SemTxvevaSi, mkurnalobas<br />

ar saWiroebda.<br />

gverdiT movlenebs Soris yvelaze gavrcelebulia Tavbrusxveva da Warbi<br />

moTenTiloba, romlebic, rogorc wesi, swrafad qreboda da iSviaTad saWiroebda<br />

<strong>preparatis</strong> moxsnas.<br />

sxva gverdiTi movlenebi (1-2%): kunTebis krunCxva, Rebineba, asTenia orTostaturi<br />

efeqtebi, maT Soris, orTostaturi hipotenzia, Tavis tkivili, xvela da impotencia.<br />

iSviaTad gvxvdeba Semdegi arasasurveli movlenebi, romlebic aRiniSna an<br />

<strong>ko</strong>ntrolirebadi klinikuri gamokvlevebis, an farTo <strong>gamoyenebis</strong> procesSi:<br />

sisxlismimoqcevis organoTa sistema:<br />

gulyra, arteriuli wnevis gamoxatuli dacema, gulis aCqareba, taqikardia, tkivili<br />

gulis areSi.<br />

4


saWmlis momnelebeli organoTa sistema: pankreatiti, diarea, Rebineba, dispefsia,<br />

tkivili muclis areSi, meteorizmi, yabzoba.<br />

centraluri nervuli sistema:<br />

uZiloba, Zilianoba, paresTeziebi, momatebuli nervuli agznebadoba.<br />

sasunTqi sistema:<br />

qoSini.<br />

kanis safari:<br />

stivens-jonsonis sindromi, kanis gamonayari, qavili, hiperhidrozi.<br />

sxva:<br />

Tirkmlis funqciis moSla, Tirkmlis ukmarisoba, libidos Sesusteba, simSrale piris<br />

RruSi, podagra, Suili yurebSi, arTralgia.<br />

aRweril iqna sindromebis <strong>ko</strong>mpleqsi, romelic Seicavs cxelebas, serozits,<br />

vaskulits, mialgias/miozits, arTralgias/arTrits, dadebiTi testi antinukleur<br />

antisxeulebze, eriTrocitebis dagrovebis siswrafis momateba, eozinofilia da<br />

lei<strong>ko</strong>citozi. SesaZloa gamovlindes fotosensibilizacia.<br />

alergiuli reaqciebi / angionevrozuli SeSupeba:<br />

saxis, kidurebis, tuCebis, enis, xmovani iogebis, kidurebis da/an saylapavis<br />

angionevrozuli SeSupebis SemTxveva Zalze iSviaTad gamovlenila (ix.<br />

gansakuTrbuli miTiTebebi). aseve iSviaTad gamovlenila intersticiuli<br />

angionevrozuli SeSupeba, romelic dakavSirebulia agf inhibitorebis miRebasTan,<br />

maT Soris, enalaprilTan.<br />

laboratoriuli maCveneblebi:<br />

hiperkaliemia, hiperurikemia da hipokaliemia. aRiniSna aseve Sratis kreatininis<br />

<strong>ko</strong>ncentraciis da RviZlis fermentebis aqtivobisa da/an Sratis bilirubinis<br />

momateba. es maCveneblebi, rogorc wesi, normalizdeboda <strong>ko</strong>-<strong>reniteki</strong>T mkurnalobis<br />

dasrulebis Semdeg. aRiniSna hemoglobinisa da hematokritis maCveneblebis daweva.<br />

Warbi doza<br />

simptomebi:<br />

enalapril maleati<br />

arteriuli wnevis gamoxatuli dacema, romelic <strong>preparatis</strong> miRebidan daaxloebiT 6<br />

saaTis Semdeg iwyeba. sisxlis plazmaSi enalaprilatis <strong>ko</strong>ncentracia, romelic 100-<br />

200-jer aRemateba Terapiuli dozis daniSvnis Sedegad Camoyalibebul <strong>ko</strong>ncentracias,<br />

aRiniSna Sesabamisad 300 da 440 mg enalaprilis miRebis Semdeg.<br />

hidroqloroTiazidi<br />

simptomatika, gamowveuli eleqtrolitebis dakargviTa (hipokaliemia, hipoqloremia,<br />

hipoanatriemia) da dehidtrataciiT Warbi diurezis gamo. Tu pacienti adre<br />

digitalisis preparatebs Rebulobda, hipokaliemiam, SesaZloa, ariTmia gamoiwvios.<br />

mkurnaloba<br />

ar arsebobs specifiuri monacemebi <strong>preparatis</strong> Warbi dozis miRebis samkurnalod.<br />

pacienti eqimis mkacri <strong>ko</strong>ntrolis qveS unda imyofebodes, mkurnaloba dauyovnebliv<br />

unda iqnas Sewyvetili. mkurnaloba – simptomaturi. gadaudebel zomad SeiZleba<br />

CaiTvalos kuWis amorecxva, Tuki preparati cota xnis winaa miRebuli, aseve<br />

dehidrataciis, eleqtrolituri balansisa da arteriuli wnevis mkveTri dawevis<br />

<strong>ko</strong>reqcia sayovelTaod gavrcelebuli meTodebis gamoyenebiT: 0.9% natriumis<br />

qloridis xsnaris Sinagani infuzia. efeqturia, aseve, angiotenzin II-s Seyvana.<br />

enalaprilatis gamoyvana sisxlismimoqcevis sistemidan SesaZlebelia hemodializis<br />

saSualebiT (ix. gansakuTrebuli miTiTebebi, hemodializze myofi pacientebi).<br />

urTierTqmedeba sxva samkurnalo saSualebebTan<br />

sxva hipotenziuri saSualebebi<br />

enalaprilis sxva hipotenziur saSualebebTan daniSnvisas SesaZloa aRiniSnos<br />

efeqtis sumireba.<br />

5


Sratis kaliumi<br />

kaliumis dakargva Tiaziduri diurezulebis miRebis fonze, rogorc wesi, sustdeba<br />

enalaprilis moqmedebiT. sisxlis SratSi kaliumis <strong>ko</strong>ncentracia, rogorc wesi,<br />

normis farglebSi rCeba.<br />

kaliumi<br />

kaliumis damatebebis, kaliumis damzogveli diurezulebis an kaliumis Semcveli<br />

marilebis gamoyeneba, gansakuTrebiT, Tirkmlis ukmarisobis mqone pacientTa<br />

SemTxvevaSi, iwvevs SratSi kaliumis Semcvelobis mkveTr momatebas.<br />

liTiumis preparatebi<br />

liTiumis preparatebs, rogorc wesi, ar niSnaven diurezulebs, an agf<br />

inhibitorebTan erTad. diurezulebi da agf inhibitorebi asusteben Tirkmelebis<br />

mier liTiumis gamoyofas, ris Sedegadac imatebs liTiumiT intoqsikaciis riski.<br />

arasteroiduli anTebis sawinaaRmdego preparatebi (aasp)<br />

Tirkmlis funqciis moSlis mqone zogierTi im pacientis SemTxvevaSi, romlebic aasps<br />

Rebuloben, agf inhibitorebis gamoyenebam, SesaZloa, Tirkmlis funqciis gauareseba<br />

gamoiwvios. es cvlilebebi, rogorc wesi, Seqcevadia.<br />

aramadepolarizebeli miorelaqsantebi<br />

Tiaziduri diurezulebis Sedegad imatebs mgrZnobeloba tubokurarinis mimarT.<br />

hipotenziuri efeqtis Semcirebas xels uwyobs aasp, estrogenebi, eTanoli.<br />

imunodepresantebi, alopurinoli, citostaturebis miReba zrdis hematotoqsikurobis<br />

risks.<br />

gansakuTrebuli miTiTebebi<br />

arteriuli hipotenzia da wyal-eleqtrolituri balansis moSla<br />

rogorc nebismieri hipotenziuri Terapiis dros, zogierTi pacientis SemTxvevaSi,<br />

SesaZloa, ganviTardes arteriuli wnevis simptomaturi dacema. savaldebuloa<br />

pacientTa gamokvleva wyal-eleqtrolituri balansis – siTxis ukmarisobis,<br />

hipovolemiis, hipoanatriemiis, hipoqloremiuli alkalozis, hipomagniemiis an<br />

hipokalemiis moSlis klinikuri niSnebis dadgenis mizniT, romlebic, SesaZloa,<br />

diareis an Rebinebis Sedegad gaCndes. aseT pacientebs periodulad unda CautardeT<br />

eleqtrolitebis ganmsazRvreli gamokvleva. gansakuTrebuli yuradReba unda mieqces<br />

gulis iSemiuri daavadebis an cerebrovaskularuli daavadebis mqone pacientebs,<br />

romlebic <strong>ko</strong>-reniteks Rebuloben, rameTu arteriuli wnevis mkveTrma dawevam,<br />

SesaZloa, miokardis infarqti an insulti gamoiwvios.<br />

arteriuli wnevis gamoxatuli dacemis dros pacienti unda dawves loginSi da,<br />

saWiroebisamebr, gamoyenebul unda iqnas 0.9% natriumis qloridis xsnaris Sinagani<br />

infuzia. arteriuli wnevis droebiTi dacema rpeparatis daniSnvis dros ar uSlis<br />

xels mis Semdgom gamoyenebas. arteriul wnevasa da cirkulirebadi sisxlis<br />

moculobis normalizaciis Semdgom SesaZloa aRdgenil iqnas Terapia an<br />

Semcirebuli doziT, an <strong>preparatis</strong> <strong>ko</strong>mponentebis calkeuli <strong>gamoyenebis</strong> gziT.<br />

aortaluri stenozi / hipertrofiuli kardiomiopaTia<br />

rogorc sxva, vazodilatirebadi moqmedebis mqone preparatebi,<br />

agf inhibitorebi didi sifrTxiliT unda daeniSnos im pacientebs, romelTac<br />

garTulebuli aqvT gulis marcxena parkuWSi sisxlis cvla.<br />

Tirkmlis ukmarisoba<br />

Tiaziduri diurezulebi xSirad arasakmarisad efeqturia Tirkmlis funqciis<br />

moSlis mqone pacientTa SemTxvevaSi da sruliad araefeqturia kreatininis<br />

klirensis 30ml/wT-mde da qvemoT (zomieri da gamoxatuli Tirkmlis ukmarisoba)<br />

dawevis dros, rac gasaTvaliswinebelia Terapiis SerCevis dros. preparati ar unda<br />

daeniSnos Tirkmlis ukmarisobis mqone pacients (kreatininis klirensis 80 ml/wT-ze<br />

naklebi), sanam <strong>preparatis</strong> calkeuli <strong>ko</strong>mponentebis SerCevis Sedegad ar dadgindeba,<br />

romeli preparati Seicavs pacientisaTvis saWiro dozas. zogieT pacientTa<br />

SemTxvevaSi, romelTac ar aqvT Tirkmelebis raime daavadeba, mkurnalobis<br />

6


dawyebamde, enalapriliTa da diurezulebiT Terapiis dros aReniSna sisxlSi Sardovanas,<br />

xolo SratSi ki kreatininis umniSvnelo momateba. aseT SemTxvevaSi,<br />

Sewyvetil unda iqnas mkurnaloba. SemdgomSi, SesaZlebelia Terapiis aRdgena<br />

Semcirebuli dozis miRebiT, an <strong>preparatis</strong> calkeuli <strong>ko</strong>mponentebis daniSvniT.<br />

Tirkmlis arteriis ormxrivi stenoziT an cali Tirkmlis arteriis stenoziT<br />

daavadebul zogierT pacientTa SemTxvevaSi, agf inhibitorebiT mkurnalobis Sedegad<br />

aRniSnul iqna sisxlSi Sardovanasa da SratSi kreatininis momateba. es cvlilebebi<br />

Seqcevadi xasiaTisaa da, rogorc wesi, mkuranlobis Sewyvetis Semdeg maCveneblebi<br />

normas ubrundeba.<br />

RviZlis daavadeba<br />

Tiaziduri diurezulebi sifrTxiliT gamoiyeneba RviZlis funqciis moSlis an<br />

RviZlis progresirebadi daavadebis mqone pacientTa SemTxvevaSi, radgan wyaleleqtrolituri<br />

balansis umniSvnelo cvlilebasac ki SeuZlia RviZlis <strong>ko</strong>mis<br />

gamowveva.<br />

qirurgia / zogadi anesTezia<br />

didi qirurgiuli operaciebis an zogadi anesTeziis dros, rodesac gamoiyeneba<br />

hipotenziuri efeqtis mqone preparatebi, enalaprilati blokirebas ukeTebs<br />

angiotenzin II warmoqmnas reninis <strong>ko</strong>mpensatorul gamonTavisuflebasTan mimarTebaSi.<br />

garda amisa, arteriuli wnevis gamoxatuli vardnis ganviTarebis SemTxvevaSi,<br />

SesaZlebeli iqneba misi <strong>ko</strong>reqcia Sesayvani siTxis raodenobis gazrdis gziT.<br />

metaboluri da endokrinuli efeqtebi<br />

Tiaziduri diurezulebi xSirad glu<strong>ko</strong>zis mimarT tolerantobis darRvevs iwvevs.<br />

SesaZloa saWiro gaxdes hipoglikemiur saSualebaTa dozis <strong>ko</strong>reqcia, maT Soris,<br />

insulinis.<br />

Tiaziduri diurezulebi amcirebs SardSi kalciumis eqskrecias, aseve SratSi<br />

kalciumis <strong>ko</strong>ncentraciis umniSvnelo momatebas. gamoxatuli hiperkaliemia, SesaZloa,<br />

faruli hiperparatireozis niSani iyos. Tiaziduri diurezulebis miReba Sewyvetil<br />

unda iqnas farisebri jirkvlis funqciis kvlevis dawyebamde. qolesterinisa da<br />

trigliceridebis <strong>ko</strong>ncentraciis momateba SesaZloa aseve Tiaziduri diurezulebiT<br />

TerapiasTan iyos dakavSirebuli, Tumca, hidroqloroTiazidis 12,5 mg dozis miRebis<br />

dros, romelsac <strong>ko</strong>-<strong>reniteki</strong>s tableti Seicavs, aseTi efeqti an ar gamovlenila, an<br />

mxolod umniSvnelo xasiaTs atarebda. zogierT pacientTa SemTxvevaSi, Tiaziduri<br />

diurezulebiT Terapiam, SesaZloa, gamoiwvios hiperurikemia da/an podagra. Tumca,<br />

enalaprilma SesaZloa xeli Seuwyos SardSi Sardis mJavis momatebas, ris xarjzec<br />

Sesustdeba hidroqloroTiazidis hiperurikemiuri efeqti.<br />

alergiuli reaqciebi / angionevrozuli SeSupeba<br />

agf inhibitorebiT, maT Soris, enalapriliT mkurnalobisas, iSviaTad gamovlenila<br />

saxis, kidurebis, tuCebis, enis, xmovani iogebis, kidurebis da/an saylapavis<br />

angionevrozuli SeSupebis SemTxvevebi. es movlenebi SesaZloa gaCndes mkurnalobis<br />

nebismier dros. aseT SemTxvevaSi, dauyovnebliv unda Sewydes enalaprilis miReba.<br />

msgavsi klinikuri simptomebis <strong>ko</strong>reqciis mizniT, pacienti eqimis <strong>ko</strong>ntrolis qveS<br />

unda imyofebodes. dakvirvebis Sewyveta SesaZlebelia mxolod zemoaRniSnuli<br />

simptomebis gavlis Semdeg. Tuki SeSupeba saxisa da tuCebis areSi vrceldeba,<br />

rogorc wesi, specifiuri mkurnaloba saWiro ar aris, antihistaminuri saSualebebiT<br />

Catarebuli Terapia am SemTxvevaSi sakmaod efeqturia.<br />

saylapavis SeSupebasTan dakavSirebul angionevrozuli SeSupebas zogjer letaluri<br />

dasasruli aqvs. im SemTxvevaSi, rodesac SeSupebis lokalizaciis adgilia ena,<br />

xmovani iogebi da saylapavi, rac sasunTqi gzebis obstruqcias iwvevs, pacients<br />

dauyovnebliv unda SeuyvanoT kanqveS 0.1% (0,3-0,5 ml) epinefrinis xsnari, raTa<br />

SesaZlebeli gaxdes sasunTqi gzebis gaxsna.<br />

negroiduli rasis pacientebs Soris, romlebic agf inhibitorebs Rebuloben,<br />

SeSupeba ufro xSorad aRiniSneba. pacientebi, romelTac anamnezSi aqvT<br />

7


angioSeSupeba, romelic ar aris dakavSirebuli agf inhibitorebis miRebasTan, sxva<br />

pacientebze metad arian agf inhibitorebis miRebis fonze angionevrozuli SeSupebis<br />

warmoqmnis riskis qveS (ix. aseve ukuCveneba). pacientebi, romlebic Tiazidur<br />

diorezulebs Rebuloben, SesaZloa gauCndeT alergiuli reaqciebi alergiuli<br />

anamnezisgan damoukidebladac. aseT pacientebs Soris dafiqsirebula sistemuri<br />

wiTeli mgluras recidivis an garTulebis SemTxvevebi.<br />

sifrifanafrTianebis Sxamisagan damzadebuli alergeniT hiposensibilizaciis<br />

Catarebis dros anafilaqtoiduri reaqciebi<br />

iSviaT SemTxvevebSi, pacientebs, romlebic agf inhibitorebs Rebulobdnen,<br />

uviTardebodaT sicocxlisaTvis saSiSi sifrifanafrTianebis Sxamisagan dazadebuli<br />

alergeniT hiposensibilizaciis Catarebis dros anafilaqtoiduri reaqciebi.<br />

SesaZlebelia msgavsi reaqciebis Tavidan acileba, Tu hiposensibilizaciis<br />

dawyebamde droebiT iqneba Sewyvetil agf inhibitorebis miReba.<br />

hemodializze myofi pacientebi<br />

<strong>ko</strong>-<strong>reniteki</strong>s daniSvna ukunaCvenebia Tirkmlis ukmarisobis mqone pacientTaTvis,<br />

romlebic hemodializze imyofebian (ix. ukuCveneba). anafilaqtoiduri reaqciebis<br />

SemTxvevebi dafiqsirebula im pacientTa Soris, romlebic imyofebodnen dializze<br />

maRalgamtariani membranebis gamoyenebiT (mag. AN 69) da Rebulobdnen agf<br />

inhibitorebs. aseTi pacientebis SemTxvevaSi gamoyenebul unda iqnas sxva tipis<br />

dializuri membranebi an sxva jgufis hipotenziuri saSualebebi.<br />

xvela<br />

agf inhibitorebis miRebis fonze zogjer vlindeba xvelis SemTxvevebi. rogorc wesi,<br />

xvela araproduqtiuli, Zlieri xasiaTisaa da wydeba mxolod Terapiis dasrulebis<br />

Semdeg. agf inhibitorebis miRebasTan dakavSirebuli xvela warmoadgens xvelis<br />

diagnostikis diferencialur nawils.<br />

gamoyeneba xandazmuli pacientebis SemTxvevaSi<br />

enalaprilisa da hidroqloroTiazidis erTdrouli miRebis efeqturobisa da<br />

amtanobis klinikuri gamokvlevebis Sedegebi erTnairia axalgazrda da xandazmul<br />

pacientebs Soris.<br />

gamoyeneba pediatriaSi<br />

dadgenili ar aris <strong>preparatis</strong> bavSvebis samkurnalod <strong>gamoyenebis</strong> usafrTxoeba da<br />

efeqturoba.<br />

gamoSvebis forma<br />

blisterSi moTavsebulia 7 tableti an 56 tableti fla<strong>ko</strong>nSi. muyaos <strong>ko</strong>lofSi 1,2 an<br />

4 blisteri an 1 fla<strong>ko</strong>ni, <strong>gamoyenebis</strong> <strong>instruqcia</strong>sTan erTad.<br />

Senaxvis pirobebi<br />

sia B<br />

30 0 -ze nakleb temperaturaze, bavSvebisaTvis miuwvdomel adgilas.<br />

vargisianobis vada<br />

tabletebisTvis, romlebic moTavsebulia 7 tableti blisterSi, 1, 2 an 4 blisteri<br />

muyaos <strong>ko</strong>lofSi, miRebis <strong>instruqcia</strong>sTan erTad – 36 Tve<br />

tabletebisaTvis, romlebic moTavsebulia 56 tableti maRali simkvrivis fla<strong>ko</strong>nSi, 1<br />

fla<strong>ko</strong>ni miRebis <strong>instruqcia</strong>sTan erTad – 24 Tve.<br />

dauSvebelia <strong>preparatis</strong> gamoyeneba SefuTvaze miTiTebuli vargisianobis vadis<br />

amowurvis Semdeg.<br />

afTiaqidan gacemis pirobebi<br />

gaicema eqimis receptiT.<br />

mwarmoebeli firma<br />

“Merck Sharp & Dohme, B.V.”, haarlemi, niderlandebi<br />

8

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