farmakologiuri maxasiaTeblebi:

farmakodinamika:

levocetirizini, cetirizinis (R) enantiomeri, aris periferiuli H1 receptorebis Zlieri da seleqciuri antagonisti. kavSiris kvlevebma gamoavlina, rom levocetirizins gaaCnia maRali afinoba adamianis H1-receptorebisadmi (Ki=3.2 nmol/l). levocetirizins gaaCnia cetirizinze 2 -ჯერ maRali afinoba (Ki=6.3 nmol/l). levocetirizini H1-receptorebidan disocirebs naxevargamoyofis periodiT-115±38 wT. erTjeradi miRebis Semdeg levocetirizini receptorebis 90%-ian dakavebas aCvenebs 4 saaTis Semdeg da 57%-iT 12 saaTis Semdeg. janmrTeli moxaliseebis farmakodinamiuri kvlevebi aCvenebs rom naxevari doziT levocetirizins gaaCnia Sedarebadi aqtivoba cetirizinis mimarT kanSi da cxvirSi.

levocetirizini ainhibirebs alergiuli reaqciis histaminiT mediatirebul adreul fazas da agreTve amcirebs garkveuli tipis anTebiTi ujredebis migracias da dagvianebul alergiul pasuxTan dakavSirebul garkveuli mediatorebis gamoTavisuflebas.

ფarmakokinetika:

levocetirizinis farmakokinetika xazovania, doza da dro-damoukidebelia da mcired varirebs subieqtebs Soris. farmakokinetikuri profili igivea erTjeradi enantiomeris da cetirizinis saxiT gamoyenebisas. kiraluri inversia ar aRiniSneba absorbciis da eliminaciis procesis dros.

absorbcia: levocetirizini swrafad da eqstensiurad Seiwoveba oraluri miRebis Semdeg. plazmaSi koncentraciis piki miiRweva dozirebidan 0.9 saaTis Semdeg. myari mdgomareoba miiRweva ori dRis ganmavlobaSi. koncentraciis piki Cveulebriv Seadgens 270 ng/ml-s da 308 ng/ml-s erTjeradi da 5 mg-s ganmeorebiTi dReSi erTxel dozirebis Semdeg. absorbciis masStabi doza-damoukidebelia da masze ar moqmedebs sakvebi, magram qveiTdeba da gviandeba koncentraciis pikis miRweva.

ganawileba: qsovilebSi ganawilebis monacemebi cnobili ar aris adamianebSi, igive exeba levocetirizinis hematoencefalur barierSi SeRwevas. levocetirizini 90%-iT ukaSirdeba plazmis cilebs. levocetirizinis ganawileba SezRudulia, radgan ganawilebis moculoba Seadgens 0.4 l/kg-s.

biotransformacia: adamianebSi levocetirizinis metabolizmis masStabi Seadgens dozis 14%-ze naklebs da aqedan gamomdinare, savaraudod, umniSvneloa genetikuri polimorfizmiT an enzimebis inhibitorebis miRebisgan gamowveuli gansxvaveba. metaboluri gzebi moicavs aromatul daJangvas, N da O–dealkilirebas da taurinTan koniugacias. dealkilirebis gzebis mediators ZiriTadad warmoadgens CYP3A4, xolo aromatuli daJangva moicavs mravlobiT da/an araidentificirebul CYP izoformebs. levocetirizini ar moqmedebs CYP izoenzimebis 1A2, 2C9, 2C19, 2D6, 2E1, 3A4 izoformebis aqtivobaze koncentraciis pikze maRali maCveneblisas, romelic miiRweva 5 mg-is oraluri dozirebis Semdeg.

dabali metabolizmis da metabolizmis inhibirebis potencialis ararsebobis gamo levocetirizinis sxva nivTierebebTan urTierTqmedeba naklebsavaraudoa.

eliminacia: plazmaSi naxevardaSlis periodi mozrilebSi Seadgens 7.9±1.9 saaTs. mTeli organizmidan klirensi saSualod Seadgens 0.63 ml/wT/kg-s. levocetirizinis da misi metabolitebi ZiriTadad eliminirdeba Sardis saSualebiT, rac dozis daaxloebiT 85.4%-s Seadgens. fekaluri masebiT gamoiyofa dozis mxolod 12.9%. levocetirizini gamoiyofa gorglovani filtraciis da aqtiuri milakovani sekreciis gziT.

Terapiuli Cveneba:

levocetirizini naCvenebia Semdeg SemTxvevebSi:

• cxviris da Tvalis simptomebis moxsna sezonuri da mTeli wlis ganmavlobaSi mimdinare alergiuli rinitis dros
• qronikuli idiopaTiuri urtikariis simptomebis SemsubuqebisTvis

dozireba da miRebis wesi

mozrdilebi, 12 wlis da ufrosi asakis mozardebi: sadReRamiso rekomendebuli dozaa 5 mg dReSi erTxel.

6-12 wlis bavSvebi: sadReRamiso rekomendebuli dozaa 5 mg dReSi. usafrTxoebis da efeqturobis arasakmarisi monacemebis arsebobis gamo 6 wlamde asakis bavSvebSi levocetirizinis gamoyeneba rekomendebuli ar aris.

xandazmulebi: am droisTvis ar arsebobs monacemebi, romlebic miuTiTebs, rom Tirkmlis normaluri funqciis SemTxvevaSi xandazmul adamianebSi saWiroa dozis Semcireba.

pacientebi RviZlis funqciis darRveviT: dozis cvlileba saWiro ar aris mxolod RviZlis dazianebis mqone pirebSi.

pacientebi RviZlis da Tirkmlis funqciis darRveviT: rekomendebulia dozis cvlileba.

miRebis wesi

oraluri dezintegrirebadi stripi unda miiRon oralurad, gadaiylapos mTlianad siTxesTan erTad, sakvebis miRebis dros an mis Semdeg.

ukuCveneba

momatebuli mgrZnobeloba levocetirizinis, formulaSi gamoyenebuli romelime Semavseblis mimarT.

Tirkmlis mwvave ukmarisobiT daavadebuli pacientebi, romelTa kreatininis klirensic wuTSi 10 ml-ze naklebia.

iSviaTi memkvidruli problemebis mqone pacientebma, romlebsac aReniSnebaT saqarozas autanloba, levocetirizinis oraluri dezintegrirebadi stripi ar unda miiRos.

gansakuTrebuli gafrTxilebebi da usafrTxoebis zomebi gamoyenebisTvis:

• ar gadaaWarboT miTiTebul dozas.
• levocetirizinis dihidroqloridis gamoyeneba rekomendebuli ar aris 6 welamde asakis bavSvebSi
• Terapiul dozebSi aRwerili ar aris alkoholTan klinikurad mniSvnelovani urTierTqmedeba (sisxlSi alkoholis donisas-0.5 g/l). miuxedavad amisa, alkoholis miRebisas saWiroa sifrTxile.
• sifrTxilea saWiro epilefsiiT daavadebul pacientebSi da im pirebSi, romlebsac aReniSnebaT gulyrebis riski.

gavlena avtomobilis marTvis da meqanizmebis gamoyenebis unarze:

avtomobilis marTvis unaris, Zilis xangrZlivobis da swor xazze siarulis obieqturma gazomvebma ar gamoavlina klinikurad mniSvnelovani efeqtebi rekomendebuli 5 mg dozis gamoyenebisas. pacientebma romlebic gegmaven avtomobilis marTvas, potenciurad saxifaTo moqmedebebs an meqanizmebTan muSaobas, ar unda gadaaWarbon rekomendebul dozas da unda gaiTvaliswinon samedicino produqtze maTi pasuxi. am mgrZnobiare pacientebSi alkoholis da cns-is damTrgunveli sxva saSualebebis gamoyenebam SeiZleba gamoiwvios sifxizlis damatebiT Semcireba da moqmedebis darRveva.

arasasurveli efeqtebi:

arasasurveli efeqtebis sixSire gansazRvrulia Semdegnairad: Zalian xSiri (≥1/10); xSiri (≥1/100-<1/10); naklebad xSiri (≥1/1,000-<1/100); iSviaTi (≥1/10,000-<1/1,000), Zalian iSviaTi (<1/10,000) ucnobia (Sefaseba SeuZlebelia arsebuli monacemebis mixedviT).

xSiri: Zilianoba, Tavbrusxveva, Tavis tkivili, faringiti, riniti*, muclis tkivili, piris simSrale, gulisreva, daRliloba.

naklebad xSiri: aJitireba, paresTezia, diarea, qavili, gamonayari, asTenia, sisuste.

iSviaTi: momatebuli mgrZnobeloba, agresia, konfuzia, depresia, halucinaciebi, uZiloba, konvulsiebi, moZraobis darRvevebi, taqikardia, edema, RviZlis funqciuri anomaliebi (transaminazebis, tutefosfatazas, Y-GT-s da bilirubinismomateba, urtikaria, wonaSi mateba).

Zalian iSviaTi: Trombocitopenia, anafilaqsiuri Soki, tikebi, disgevzia, sinkope, tremori, distonia, diskinezia, akomodaciis darRvevebi, mxedvelobis dabindva, okulogiracia, angionevrozuli SeSupeba, preparatebis fiqsirebuli erupcia, dizuria, enurezi.

urTierTqmedeba sxva samedicino produqtebTan da urTierTqmedebis sxva formebi

• levocetirizinis farmakokinetikuri, farmakodinamiuri da tolerantobis profilis gamo mosalodneli ar aris am antihistaminTan urTierTqmedeba. kerZod arc farmakodinamiuri da arc mniSvnelovani farmakokinetikuri urTierTqmedeba ar iyo aRwerili wamalTaSorisi urTierTqmedebis kvlevebSi, umetesad fsevdoefedriniT an TeofiliniT (400mg/dReSi).
• levocetirizinis absorbciis masStabi ar mcirdeba sakvebiT, Tumca qveiTdeba absorbciis siswrafe.

fertiloba, orsuloba da laqtacia:

eqspozirebuli orsulobebis Sesaxeb arsebobs Zalian iSviaTi klinikuri monacemebi. cxovelebis kvlevebi ar aCvenebs pirdapir an arapirdapir damazianebel efeqts orsulobaze, embrionalur/fetalur ganviTarebaze, mSobiarobaze da postnatalur ganviTarebaze. sifrTxilea saWiro orsul da meZuZur qalebSi daniSvnisas, radgan levocetirizini gadadis laqtatSi.

Warbi dozireba:

simptomebi: levocetirizinis dozis gadaWarbebis Semdgom aRniSnuli efeqtebi ZiriTadad dakavSirebulia cns efeqtebTan an efeqtebTan, romlebic SeiZlreba antiqolinergul movlenebze miuTiTebdes.

rekomendebul sadReRamiso dozaze minimum 5-jer meti preparatis miRebis dros aRniSnuli gverdiTi movlenebi:

konfuzia, diarea, Tavbrusxveva, daRliloba, Tavis tkivili, sisuste, midriazi, qavili, mousvenroba, sedacia, Zilianoba, stupori, taqikardia, tremori da Sardis Sekaveba.

dozis gadaWarbebis menejmenti: ar arsebobs levocetirizinis specifiuri antidoti. dozis gadaWarbebis SemTxvevaSi rekomendebulia simptomuri da damxmare Terapia. Tu SigniT miRebis Semdeg mcire droa gasuli unda gaiTvaliswinon kuWis amorecxva. levocetirizini efeqturad ar gamoiyofa dializiT.

klinikamdeli usafrTxoebis monacemebi

usafrTxoebis farmakologiis, ganmeorebiTi dozis toqsiurobis, genotoqsiurobis, karcinogenuri potencialis, reproduqciuli toqsiurobis kvlevebis safuZvelze ar gamovlinda adamianisTvis klinikurad mniSvnelovani safrTxis maCveneblebi.

SeuTavsebloba: ucnobia

gamoSvebis forma da SefuTva

10 x1 stripi.

Senaxvis vada

3 weli.

gansakuTrebuli usafrTxoebis zomebi SenaxvisTvis

inaxeba araumetes 25°C temperaturaze, sinaTlisgan da nestisgan dacul adgilas.

afTiaqidan gacemis pirobebi: 

ფარმაცევტული პროდუქტის ჯგუფი II, გაიცემა ფორმა №3 რეცეპტით

warmoebulia

ZIM LABORATORIES LIMITED-s mier (zim laboratoris limited)

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nagpuri 441 501, maharaStras Stati

indoeTi

damzadebulia Tinoralis^® teqnologiis gamoyenebiT.