farmakologiuri Tvisebebi:

farmakodinamika

omeprazoli protonuli tumbos specifikuri inhibitoria. omeprazoli aris susti tute. igi advilad aRwevs kuWis lorwovani garsis parietalur ujredebSi, grovdeba maTSi da kuWSi mJavianobis momatebisas aqtiurdeba. igi ainhibirebs H⁺-K⁺-atf-azas _ protonuli tumbos. igi blokavs marilmJavas sekreciis terminalur stadias, dozadamokidebulad amcirebs bazaluri da stimulirebuli sekreciis dones. omeprazoli dReSi erTxel peroraluri miRebisas Trgunavs rogorc Ramis, ise dRis sekrecias, baqtericidulad moqmedebs Helicobacter pylori-ze.

farmakokinetika:

omeprazoli swrafad Seiwoveba. igi maqsimalur koncentracias plazmaSi 1–2 sT-Si aRwevs. omeprazolis bioSeRwevadoba aris daaxloebiT 40%. preparatis ganmeorebiTi miRebisas bioSeRwevadoba 60%-mde izrdeba. misi 97% plazmis cilebs ukavSirdeba. omeprazoli metabolizdeba citoqromi P450 sistemis (CYP) meSveobiT. omeprazolis naxevargamoyofis periodi Seadgens 0.5 sT-ze naklebs, rogorc erTjeradi, ise ganmoreobiTi miRebisas. peroraluri dozis daaxloebiT 80% gamoiyofa organizmidan SardiT metabolitebis saxiT, danarCeni nawili – ganavliT.

Cvenebebi:

• kuWisa da Tormetgoja nawlavis wylulovani daavadeba gamwvavebis fazaSi;
• Helicobacter pylori- sTan asocirebuli kuWisa da Tormetgoja nawlavis eroziul-wylulovani dazianeba (Sesabamis antibiotikebTan kombinaciaSi);
• anTebis sawinaaRmdego arasteroiduli preparatebiT gamowveuli kuWisa da Tormetgoja nawlavis eroziul-wylulovani dazianeba;
• refluqs-ezofagiti;
• gastroezofaguri refluqsi
• paTologiuri hipersekreciuli mdgomareobebi (mag., zolinger-elisonis sindromi, poliendokrinuli adenomatozi);
• funqciuri (arawylulovani) dispefsia.

ukuCvenebebi:

momatebuli mgrZnobeloba omeprazolis, benzomidazolis warmoebulebis an preparatis romelime komponentis mimarT. preparati ar iniSneba nelfinavirTan erTad.

gansakuTrebuli miTiTebebi da usafrTxoebis zomebi:

sasignalo simptomebis (sxeulis masis gamoxatuli daqveiTeba, gulisreva, disfagia, hematemezisi, melena) arsebobisas, kuWis diagnostirebuli wylulis an masze eWvis SemTxvevaSi, saWiroa gamoiricxos daavadebis avTvisebiani xasiaTi, radgan omeprazolis miRebam SeiZleba gamoiwvios simtomebis SeniRbva da xeli SeuSalos swori diagnozis dasmas. pacientebi, romlebic gamoiyeneben preparats xangrZlivi drois ganmavlobaSi (gansakuTrebiT erT welze met xans), unda imyofebodnen regularuli samedicino meTvalyureobis qveS.

Helicobacter руlori-s eradikaciis mizniT daniSvnisas gasaTvaliswinebelia sammagi Terapiis yvela komponentis urTierTqmedebis SesaZlebloba.

klaritromicini CYP3А4-s Zlieri inhibitoria, ris gamoc gasaTvaliswinebelia misi ukuCvenebebi da urTierTqmedeba (sammagi Terapiis dros, rodesac omeprazolTan erTad daniSnulia sxva samkurnalo saSualebebi, mag., cizapridi).

protonuli tumbos inhibitorebiT mkurnaloba zrdis kuW-nawlavuri infeqciis ganviTarebis risks, mag., romelic gamowveulia Salmonella-s an Campilobacter-is mier. erTdrouli daniSvna gardauvalia, klinikuri monitoringis pirobebSi rekomendebulia Semdegi kombinacia _ 400 mg atazanaviri, 100 mg ritonaviri, omeprazolis doza ar unda aRematebodes 20 mg-s.

dozireba da miRebis wesi:

Tormetgoja nawlavis wylulovani daavadebis dros gamwvavebis fazaSi omeprazoli iniSneba doziT 20 mg erTxel dReSi 4 kviris ganmavlobaSi; iSviaTad mkurnalobis xangrZlivoba SeiZleba gaizardos 6_8 kviramde. zogjer iniSneba 20 mg 2-jer dReSi.

kuWis wylulovani daavadebis gamwvavebisas iniSneba 20–40 mg erTxel dReSi 4–8 kviris ganmavlobaSi; kuWisa da Tormetgoja nawlavis wylulovani daavadebis recidivebis profilaqtikisaTvis iniSneba 20 mg erTxel dReSi; aucileblobis SemTxvevaSi sadReRamiso doza SeiZleba gaizardos 40 mg-mde; refluqs-ezofagitis dros iniSneba 20–40 mg erTxel dReSi 4–12 kviris ganmavlobaSi;

zolinger-elisonis sindromis dros doza SeirCeva individualurad. preparatis sawyisi dozaa 20–60 mg erTxel dReSi; aucileblobis SemTxvevaSi sadReRamiso doza izrdeba 120 mg-mde. Tu sadReRamiso doza 80 mg-s aRemateba, saWiroa misi gayofa da 2-jer dReSi miReba. mkurnalobis xangrZlivoba 2–8 kviraa.

Helicobacter pylori-s eradikaciis mizniT iniSneba 20 mg 2-jer dReSi 7 dRis ganmavlobaSi antimikrobul saSualebebTan erTad;

anTebis sawinaaRmdego arasteroiduli preparatebiT gamowveuli kuWisa da Tormetgoja nawlavis eroziul-wylulovani dazianebis dros iniSneba 20 mg erTxel dReSi 4–8 kviris ganmavlobaSi.

gverdiTi movlenebi:

qvemoT moyvanilia omeprazolis klinikuri kvlevebis dros da postmarketingul periodSi dafiqsirebuli an mosalodneli gverdiTi efeqtebi. gverdiTi efeqtebis ganviTareba ar aris damokidebuli preparatis dozaze. es reaqciebi klasificirdeba sixSiris Sesabamisad _ xSiri (>1/100, <1/10); naklebad xSiri (>1/1000, <1/100); iSviaTi (>1/10 000, <1/1000); Zalian iSviaTi (<1/10 000).

sisxlisa da limfuri sistemis darRvevebi:

iSviaTi: leikopenia, Trombocitopenia;

Zalian iSviaTi: agranulocitozi, pancitopenia.

imunuri sistemis darRvevebi:

iSviaTi: momatebuli mgrZnobelobis reaqciebi, mag., cxeleba, angionevrozuli SeSupeba da anafilaqsiuri reaqcia/Soki.

metabolizmisa da kvebis darRvevebi:

naklebad xSiri: periferiuli SeSupeba;

iSviaTi: hiponatremia;

Zalian iSviaTi: hipomagniemia.

fsiqikuri darRvevebi:

naklebad xSiri: uZiloba;

iSviaTi: aRgzneba, depresia, cnobierebis darRveva;

Zalian iSviaTi: agresia, halucinaciebi.

nervuli sistemis darRvevebi:

xSiri: Tavis tkivili;

naklebad xSiri: Tavbruxveva, paresTezia, Zilianoba;

iSviaTi: gemos SegrZnebis darRveva.

mxedvelobis darRvevebi:

iSviaTi: mxedvelobis dabindva.

smenisa da labirinTuli darRvevebi:

naklebad xSiri: Tavbrusxveva.

respiratoruli, gulmkerdisa da mediastinuri darRvevebi:

iSviaTi: bronqospazmi.

kuW-nawalavis sistemis darRvevebi:

xSiri: muclis tkivili, yabzoba, diarea, Seberiloba, gulisreva/Rebineba;

naklebad xSiri: piris simSrale;

iSviaTi: stomatiti, kuW-nawlavis traqtis kandidozi.

hepatobiliaruli darRvevebi:

naklebad xSiri: RviZlis fermentebis aqtivobis gazrda;

iSviaTi: hepatiti siyviTliT an mis gareSe;

Zalian iSviaTi: RviZlis ukmarisoba, encefalopaTia pacientebSi adre gadatanili RviZlis daavadebiT.

kanisa da kanqveSa qsovilis dazianeba:

naklebad xSiri: dermatiti, qavili, gamonayari, WinWris cieba;

iSviaTi: alopecia, fotosensibilizacia;

Zalian iSviaTi: eqsudaciuri multiformuli eriTema, stivens-jonsonis sindromi, toqsikuri epidemuri nekrolizi (TEN).

ConCx-kunTovani, SemaerTebeli qsovilisa da Zvlebis dazineba:

iSviaTi: arTralgia, mialgia;

Zalian iSviaTi: kunTebis sisuste.

Tirkmlebisa da saSarde sistemis darRveva:

Zalian iSviaTi: intersticiuli nefriti.

reproduqciuli sistemis dazianeba:

Zalian iSviaTi: ginekomastia.

zogadi darRvevebi da gamoyenebis Taviseburebebi:

Zalian iSviaTi: zogadi sisuste, momatebuli oflianoba.

orsuloba da laqtacia:

sakmarisi klinikuri monacemebi orsulobis dros omeprazol gamoyenebis Sesaxeb ar moipoveba. omeprazolis racemuli narevis gamoyenebiT Catarebulma epidemiologiurma kvlevebma ar gamoavlina fetotoqsikuri moqmedeba an nayofis ganviTarebis darRveva.

cxovelebSi omeprazolis miRebisas ar aRiniSneboda raime saxis pirdapiri an arapirdapiri uaryofiTi zemoqmedeba embrionis an nayofis ganviTarebaze. preparatis racemuli narevis cxovelebSi Seyvanisas ar aRiniSneboda raime saxis uaryofiTi zegavlena orsulobisa da mSobiarobis mimdinareobaze, aseve postnataluri ganviTarebis periodSi. orsulebis dros preparati iniSneba didi sifrTxiliT. ar aris cnobili, gamoiyofa Tu ara omeprazoli dedis rZesTan erTad. meZuZur dedebSi kvleva ar Catarebula. ZuZuTi kvebis periodSi omeprazoli ar iniSneba.

urTierTqmedeba:

omeprazoliT mkurnalobisas kuWis wvenis mJavianobis daqveiTebam SeiZleba gamoiwvios samkurnalo saSualebebis absorbciis gazrda an Semcireba, Tu Sewovis meqanizmi damokidebulia kuWis wvenis mJavianobaze. mJavas sekreciis sxva inhibitorebis an antacidebis msgavsad, omeprazoliT mkurnalobisas ketokonazolis da itrakonazolis absorbcia qveiTdeba. omeprazoli amcirebs SratSi atazanavirisa da nelfinaviris koncentracias, ris gamoc omeprazolTan erTad maTi gamoyeneba rekomendebuli ar aris.

yoveldRiurad 20 mg omeprazolis gamoyeneba ar cvlis darunaviris (ritonavirTan erTad) da amprenaviris (ritonavirTan erTad) eqspozicias. omeprazoli ainhibirebs CYP2C19-s _ ZiriTad ferments, romelic mis metabolizms axdens. amis gamo omeprazolis erTdrouli gamoyenebisas iseT preparatebTan, romelTa metabolizmSic monawileobs CYP2C19 (diazepami, citaloprami, imipramini, klomipramini, fenitoini), iwvevs maTi koncentraciis momatebas sisxlis plazmaSi da moiTxovs dozis Semcirebas.

omeprazolisa da varfarinis an kumarinis sxva warmoebulebis erTdrouli mkurnalobis dasawyisSi da mkurnalobis dasrulebisas rekomendebulia monitoringis Catareba. omeprazolisa da CYP3A4-s inhibitoris _ klaritromicinis (500 mg 2-jer dReSi) erTdrouli gamoyeneba iwvevs omeprazolis eqspoziciis (AUC) gaormagebas.

Warbi dozirebis simptomebi da misi mkurnaloba:

Warbi dozirebis Sesaxeb Zalze iSviaTi monacemebi moipoveba. 80 mg preparatis erTjeradi miRebisas gverdiTi efeqtebi ar aRiniSneboda. Warbi dozirebis SemTxvevaSi aucilebelia simptomuri da SemanarCunebeli Terapiis Catareba.

zemoqmedeba avtomobilisa da manqana-danadgarebis marTvis unarze:

omeprazoli ar moqmedebs avtomobilisa da danadgarebis marTvis unarze.

SefuTva:

20 mg kafsulebi. 10 kafsula blisterSi. 20 blisteri gamoyenebis

instruqciasTan erTad muyaos kolofSi.

Senaxvis pirobebi:

inaxeba ara umetes 25°C temperaturaze.

SeinaxeT bavSvebisaTvis miuwvdomel adgilas.

vargisobis vada:

3 weli.

SefuTvaze aRniSnuli vadis gasvlis Semdeg preparatis gamoyeneba

dauSvebelia.

gacemis wesi:

ფარმაცევტული პროდუქტის ჯგუფი III, გაიცემა რეცეპტის გარეშე.         

mwarmoebeli:

“ZEE LABORATORIES”

uCani, j. t. roudi, karnali-132001, indoeTi

www.zeelaboratories.com