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ციპროფლოქსაცინი 500 მგ + ლაქტულოზა ანჰიდრო 600 მგ #10

ekocifoli

® Ekocifol®

preparatis savaWro dasaxeleba: ekocifoli

saerTaSoriso arapatentirebuli dasaxeleba: ciprofloqsacini

wamlis forma: apkiT dafaruli tabletebi

Semadgenloba:

erTi tableti Seicavs:

aqtiuri nivTiereba: ciprofloqsacinis hidroqloridis monohidrati (ciprofloqsacinis saxiT) 500mg

damxmare nivTirebebi: laqtuloza 600,0mg

dabalmolekuluri povidoni 28,0mg

natriumis kroskarmeloza 65,0mg

mikrokristaluri celuloza 60,0mg

magniumis stearati 10,0mg

simindis saxamebeli

saWiro raodenobiT ugarso tabletis miRebamde, romelic iwonis 1400,0mg-s

garsis Semadgeneli damxmare nivTierebebi:

hipromeloza 19,04mg

makrogoli-4000 8,32mg

talki 2,2mg

titanis dioqsidi 10,44mg

aRweriloba:

apkiT dafaruli, TeTri an TiTqmis TeTri feris, kafsulis formis, ormxriv amobruculi tabletebi. gamyofi xazi TeTri feris.

farmakoTerapiuli jgufi: antimikrobuli saSualeba, ftorqinoloni

aTq kodi: J01MA02

farmakologiuri Tvisebebi:

farmakodinamika:

moqmedebis farTo speqtris mqone antimikrobuli saSualeba, qinlonis warmoebuli, iwvevs baqteriis dnm-hirazas inhibirebas (topoizomerazebi II da IV, romlebic uzrunvelyofen qromosomuli dnm-is superspiralizacias birTvuli rnm-is irgvliv, rac aucilebelia genetikuri informaciis wasakiTxad), arRvevs dnm-is sinTezs, baqteriebis zrdas da gayofas; iwvevs gamoxatul morfologiur cvlilebebs (maT Soris ujreduli kedlis da membranis) da baqteriuli ujredis swraf sikvdils.

moqmedebs baqtericidulad gramuaryofiT organizmebze umoqmedobis da gayofis fazaSi(radgan gavlenas axdebs ara mxolod dnm-hirazaze, aramed aseve iwvevs ujreduli kedlis darRvevas), gramdadebiT mikroorganizmebzemxolod gayofis periodSi.

makroorganizmebis ujredebisaTvis dabali toqsikuroba aixsneba maTSi dnmhirazas ararsebobiT. ciprofloqsacinis miRebisas ar viTardeba parareluri mdgradoba sxva antibiotikebis mimarT, romlebic ar miekuTvnebian dnm-hirazas inhibitorebis jgufs, rac mas ufro efeqturs xdis baqteriebTan mimarTebaSi, romlebic rezistentulebi arian magaliTad aminoglikozidebis, penicilinebis, cefalosporinebis, tetraciklinebis mimarT.

ciprofloqsacinis mimarT mgrZnobiareni arian Semdegi gramuaryofiTi aerobuli baqteriebi: enterobaqteriebi(Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Hafnia alvei, Edwardsiella tarda, Providencia spp., Morganella morganii, Vibrio spp., Yersinia spp.), sxva gramuaryofiTi baqteriebi (Haemophilus spp., Pseudomona aeruginosa, Moraxella catarrhalis, Aeromonas spp., Pasteurella multocida, Plesiomonas shigelloides, Campylobacter jejuni, Neisseria spp.); zogierTi Sidaujreduli organizmebi: Legionella pneumophila, Brucella spp., Listeria monocytogenes, Mucobacterium tuberculosis, Mycobacterium kansasii.

ciprofloqsacinis mimarT aseve mgrZnobiarea gramdadebiTi aerobuli baqteriebi: Staphylococcus spp.,(Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus), Streptococcus spp.(Streptococcus pyogenes, Streptococcu agalactiae).

aqtiuria Bacillus anthracis-Tan mimarTebaSi.

stafilokokebis umetesoba, romlebic rezistentulni arian meticilinis mimarT, aseve rezistentulni arian ciprofloqsacinis mimarTac. mgrZnobeloba zomieria Streptococcus pneumonia, Enterococcus faecalis, Mycobacterium avium(mdebareoben ujredis SigniT) mimarT (maTi inhibirebisaTvis saWiroa maRali koncentracia).

preparatis mimarT rezistentulni arian: Bacteroides fragilis, Pseudomonas capacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroids. araefeqturia Treponema pallidum mimarT.

rezistentuloba viTardeba Zalian nela, ramdenadac erTis mxriv ciprofloqsacinis moqmedebis Semdeg persistentuli mikroorganizmebi praqtikulad ar rCeba, xolo meores mxriv baqteriul ujredebSi ar aris fermentebi, romlebic mis inaqciavacias moaxdenen.

farmakokinetika:

peroraluri miRebis Semdeg preparati swrafad da sakmaod srulad Seiwoveba kuW-nawlavis traqtidan (ZiriTadad 12-goja da msxvili nawlavidan). sakvebi anlebs Sewovis process, magram ar cvlis maqsimalur koncentracias(Cmax) da bioSeRwevadobas. bioSeRwevadoba-50/85%, ganawilebis moculoba-2-3,5l/kg, plazmis cilebTan SekavSireba-20-40%, maqsimaluri koncentraciis (TCmax) miRwevis dro-60-90wT, maqsimaluri koncentracia pirdapir damokidebulia miRebul dozaze da Seadgens dozebis 250, 500, 750 da 1000mg Sesabamisad 1,2,2,4,4,3 da 5,4mkg/ml-s. 250, 500 da 750mg dozebis proralurad miRebidan 12sT-Si preparatis koncentracia plazmaSi mcirdeba Sesabamisad 0,1, 0,2 da 0,4mkg/ml-mde. kargad nawildeba organizmis qsovilebSi (garda qsovilisa, romelSic Warboben cximebi, magaliTad nervuli qsovilebi). koncentracia qsovilebSi 2-12-jer maRalia vidre plazmaSi. Terapiuli koncentracia miiRweva nerwyvSi, nuSisebr jirkvlebSi, RviZlSi, naRvlis buStSi, naRvelSi, nawlavebSi, muclis Rrus da mcire menjis organoebSi(endometriumi, falopis milebi da sakvercxeebi, saSvilosno), saTesle siTxe, prostatis jirkvlebis qsovilebi, Tirkmelebi da Sardgamomyofi organoebi, filtvis qsovilebi, bronquli sekreti, Zvlis qsovilebi, kunTebi, sinovialuri siTxe da saxsrebis xrtilebi, peritonluri siTxe, kani. mcire raodenobiT aRwevs zurgistvinis siTxeSi, sadac misi koncentracia tvinis garsis anTebis ararsebobis SemTxvevaSi Seadgens 6-10%-s sisxlis SratSi, xolo anTebis dros-14-37%-s. ciprofloqsacini kargad aRwevs aseve Tvalis siTxeSi, plevraSi, peritoneumSi, limfaSi, placentaSi. ciprofloqsacinis koncentracia sisxlis neitrofilebSi 2-7-jer metia vidre sisxlis SratSi. metabolizdeba RviZlSi(16-30%) naklebad aqtiuri metabolitebis warmoqmniT (dieTilciprofloqsacini, sulfociprofloqsacini, oqsociprofloqacini, formilciprofloqsacini).

naxevargamoyofis periodi Seadgens daaxloebiT 4sT-s, Tirkmlis qronikuli ukmarisobis dros 12sT-mde. gamoiyofa ucvleli formiT ZiriTadad TirkmelebiT tubularuli filtraciis da sekreciis gziT (40-50%) da metabolitebis saxiT (15%), danarCeni nawili ki kuW-nawlavis traqtidan. mcire raodenoba gamoiyofa rZiT.

Tirkmlismieri klirensi-3-5ml/wT/kg; saerTo klirensi-8-10ml/wT/kg.

Tirkmlis qronikuli ukmarisobis dros (kreatininis klirensi >20ml/wT) Tirkmis mier gamoyofili ciprofloqsacinis raodenoba mcirdeba, Tumca organizmSi ar kumulirdeba, rac ganpirobebulia ciprofloqsacinis metabolizmis kompensatoruli zrdiT, rac gamoiyofa kuW-nawlavis traqtidan.

Cvenebebi:

mgrZnobiare mikoorganizmebiT gamowveuli infeqciur-anTebiTi daavadebebi:  qveda sasunTqi gzebis daavadebebi (mwvave da qronikuli (gamwvavebis

· stadiaSi) bronqiti, pnevmonia, bronqieqtazi, kistozuri fibrozis infeqciuri garTulebebi);  yel-yur-cxviris infeqciebi (mwvave sinusiti);

· Tirkmlis da saSarde gzebis infeqciebi (cistiti, pielonefriti);

· intraabdominluri infeqciebis garTulebebi (metronidazolTan

· erTad);  qronikuli baqteriuli prostatiti;

· gaurTulebeli gonorea;

· muclis tifi, kampilobaqteriozi, Sigelozi, “mogzaurTa” diarea;

· kanis da rbili qsovilis infeqciebi (infeqciuri wyluli, Wrilobebi,· damwvrobebi, abscesebi, flegmona);  Zvlebis da saxrebis infeqciebi(osteomieliti, septikuri arTriti);

· imunodeficitis fonze ganviTarebuli infeqciebi (viTardeba

· imunodepresantebiT mkurnalobis dros an neitropeniis mqone pacientebSi);  inhalaciuri cimbiris wylulis profilqtika da mkurnaloba.

bavSvebSi:

· Pseudomonas aeruginosa-s mier gamowveuli garTulebebis mkurnaloba 5-17

· wlis bavSvebSi, romelTac aReniSnebaT filtvis kistozuri fibrozi  inhalaciuri cimbiris wylulis prevencia da mkurnaloba(cimbiris

· wylulis CxiriT gamowveuli infeqcia)

ukuCvenebebi:

hipermgrZnobeloba, tizanidinTan erTad miReba (arteriuli wnevis gamoxatuli dawevis, Zilianobis riski), 18 wlamde asaki (ConCxis Camoyalibebis procesis dasrulebamde, garda Pseudomonas auruginosa-s mier gamowveuli garTulebebisa 5-17 wlis bavSvebSi, romelTac aReniSnebaT filtvis kistozuri fibrozi, inhalaciuri cimbiris wylulis prevencia da mkurnaloba), orsuloba, laqtaciis periodi.

sifrTxiliT:

Tavis tvinis sisxlZarRvebis gamoxatuli aTerosklerozi, Tavis tvinSi sisxlis mimoqcevis darRveva, fsiqiatriuli daavadebebi, epilefsia, Tirkmlis da/an RviZlis gamoxatuli ukmarisoba, xandazmuli asaki.

miRebis wesi da dozebi:

miiReba peroralurad. tabletebi kvebis Semdeg mTlianad unda gadaiylapos mcire raodenobis siTxesTan erTad. preparatis uzmoze miRebisas aqtiuri nivTiereba swrafad Seiwoveba.

qveda sasunTqi gzebis msubuqi da saSualo formis infeqciebis dros-0,5g dResi 2-jer, rTuli mimdinareobisas-0,75g dReSi 2-jer. mkurnalobis kursi- 7-14 dRe.

mwvave sinusitis dros- 0,5g dReSi 2-jer . mkurnalobis kursi-10 dRe. kanis da rbili qsovilis msubuqi da saSualo formis infeqciebis dros-0,5g dReSi 2-jer, rTuli mimdinareobis dros-0,75g dReSi 2-jer. mkurnalobis kursi 7-14 dRe. Zvlebis da saxsrebis infeqciebis msubuqi da saSualo formis infeqciebis dros-0,5g dReSi 2-jer. rTuli mimdinareobis dros-0,75g dReSi 2-jer. mkurnalobis kursi 4-6 kvira.

Sardgamomyofi gzebis infeqciebis dros-0,25-0,5g dReS 2-jer; mkurnalobis kursi-7-14 dRe, qalebSi gaurTulebeli cistitis dros-3 dRe.

qronikuli bqteriuli prostatitis dros-0,5g dReSi 2-jer, mkurnalobis kursi-28 dRe. gaurTulebeli gonoreis dros-0,25-0,5g erTjeradad.

nawlavTan mwvave infeqciebis(salmonelozi, Sigelozi, kampilobaqteriozi da sxva) dros-0,5g dReSi 2-jer, mkurnalobis kursi-5-7 dRe.

muclis tifis dros-0,5g dReSi 2-jer; mkurnalobis kursi-10 dRe.

garTulebuli intraabdominaluri infeqciebis dros-0,5g yovel 12sT-Si 7-14 dRis ganmavlobaSi.

inhalaciuri cimbiris wylulis profilqtikis da mkurnalobis dros-0,5g dReSi 2-jer 60 dRis ganmavlobaSi.

imunodeficitis mqone pacientebSi mkurnaloba iniSneba infeqciis sirTulis da gamomwvevis mixedviT. antibiotikoTerapia grZeldeba neitropeniis mimdinareobis bolomde.

pediatriul pacientebSi:

Pseudomonas aeruginosa-iT gamowveuli garTulebebis mkurnalobisas 5-17 wlis bavSvebSi filtvis kistozuri fibroziT-20mg/kg dReSi 2-jer(maqsimaluri doza 1,5g). mkurnalobis xangrZlivoba-10-14 dRe.

inhalaciuri cimbiris wylulis(profilaqtika da mkurnaloba)-15mg/kg dReSi 2-jer. maqsimaluri erTjeradi doza-0,5g, dRiuri-1g. ciprofloqsaciniT mkurnalobis xangrZlivoba-60 dRe.

Tirkmlis qronikuli ukmarisoba: rodesac kreatininis klirensi(kk) aWarbebs 50ml/wT-s dozis dakoreqtireba ar aris saWiro; kk 30-50ml/wT-0,25-0,5 yofel 12sT-Si; kk 5-29ml/wT-0,25-0,5g yovel 18 sT-Si. hemodializze an peritonealur dializze myof pacientebSi iniSneba 0,25-0,5g/dReSi, preparati miiReba hemodializis Semdeg.

gverdiTi moqmedeba:

· saWmlis momnelebeli sistemis mxriv: gulisreva, faRaraTi, Rebineba, muclis tkivili, meteorizmi, anoreqsia, qolestazuri siyviTle (gansakuTrebiT pacientebSi, romelTac gadatanili aqvT RviZlis daavadebebi), hepatiti, hepatonekrozi.

· centraluri nervuli sistemis mxriv: Tavbrusxveva, Tavis tkivili, Zlieri daRliloba, SiSis SegrZneba, kankali, uZiloba, “koSmaruli” sizmrebi, periferiuli paralgezia(tkivilis SegrZnebis anomalia), oflianoba, qalasSida wnevis momateba, gonebis areva, depresia, halucinaciebi, aseve fsiqozuri reaqciebis sxva gamovlinebebi (iSviaTad iseTi SemTxvevebi, rodesac pacienti midis im mdgomareobamde, rom SesaZlebelia Tavs avnos), Sakiki, gulis wasvla, cerebraluri arteriebis Trombozi.

· grZnobi organoebis mxriv: gemos da ynosvis, mxedvelobis darRveva(diplopia, ferebis aRqmis darRveva), yurebSi Suili, smenis daqveiTeba.

· gul-sisxlZarRvTa sistemis mxriv: taqikardia, gulis riTmis darRvva, arteriuli wnevis daweva.

· sisxlmbadi sistemis mxriv: leikopenia, granulocitopenia, anemia, Trombocitopenia, leikocitozi, Trombocitozi, hmolizuri anemia.

· laboratoriuli maCveneblebi: hipoproTrombinemia ”RviZlis” transaminazebis da tute fosfatazebis aqtivobis momateba, hiperkreatininemia, hiperbilirubinemia, hperglikemia.

·Sardgamomyofi sistemis mxriv: hemturia, kristaluria(pirvel rigSi SardSi tutis da dabali diurezis dros), glomerulonefriti, dizuria, poliuria, Sardis Sekaveba, albuminuria, uretraluri sisxldena, Tirkmlis funqciis daqveiTeba, romelic uzrunvelyofs azotis gamoyofas, intersticialuri nefriti.

· alergiuli reaqciebi: gamonayari kanze, WinWris cieba, buStukebis warmoqmna, rasac Tan axlavs sisxldena, patara kvanZebi, romelTac qmnian fufxs, wamlismieri cxeleba, wertilovani sisxlCaqcevebi kanze(petexia), saxis an saylapavis SeSupeba, sunTqvis ukmarisoba, eozinofilia, vaskuliti, kvanZovani eriTema, eqsudaciuri multiformuli eriTema, stivens-jonsonis sindromi(avTvisebiani eqsudaciuri eriTema), toqsikuri epidermuli nekrolizi(laielis sindromi).

· sayrden-mamoZravebeli aparatis mxriv: arTralgia, arTriti, tendovaginiti, myesebis gagleja, mialgia.  sxva: saerTo sisuste, sinaTlis mimarT momatebuli mgrZnobeloba, superinfeqciebi (kandidozi, fsevdomembranuli koliti), saxis “wamoxureba”.

Warbi dozireba:

specifikuri antidoti ar arsebobs. saWiroa pacientis mdgomareobis regularulad gakontroleba, kuWis amorecxva, gadaudebeli daxmarebis saWiro zomebis miReba, sakmarisi raodenobiT siTxis miReba. hemo- an periotonealuri dializiT SesaZloa gamoiyos preparatis umniSvnelo raodenoba ((<10%).

sxva preparatebTan urTierTqmedeba:

hepatocitebSi mikrosomaluri Jangvis procesis aqtivobis Semcirebis Sedegad izrdeba Teofilinis (da sxva qsantinebis, magaliTad kofeinis), peroraluri hipoglikemiuri samkurnalo saSualebebis, proTrombinis indeqsis Sesamcirebeli arapirdapiri moqmedebis antikoagulantebis koncentracia da xangrZlivdeba naxevargamoyofis periodi.

sxva antimikrobul samkurnalo saSualebebTan (beta-laqtamuri antibiotikebi, aminoglikozidebi, klindamicini, metronidazoli) erTad gamoyenebisas Cveulebriv aRiniSneba sinergizmi; SesaZloa efeqturad dainiSnos azlocilinTan da ceftazidinTan erTad PSeudomonas spp-s mier gamowveuli infeqciebis dros; mezlocilinTan, azlocilinTan da sxva beta laqtamur antibiotikebTan erTad streptokokuri infeqciebis dros; izoqsazolilpenicilinTan da vankomicinTan erTad- stafilokokuri infeqciebis SemTxvevaSi; metronidazolTan da klindamicinTan-anaerobuli infeqciebis dros.

aZlierebs ciklosporinis nefrotoqsikur moqmedebas, aRiniSneba Sratismieri kreatininis momateba, aseT pacientebSi saWiroa mocemuli maCveneblebis gakontroleba kviraSi 2-jer.

erToblivi gamoyenebisas Zlierdeba arapirdapiri moqmedebis antikoagulantebis moqmedeba.

erToblivad gamoyenebisisa rkinis Semcvel preparatebTan, sukralfatTan da antacidur samkurnalo saSualebebTan, romlebic Seicaven magniumis, kaliumis da aluminis marils, iwvevs ciprofloqsacinis Sewovis Semcirebas, Sesabamisad igi iniSneba zemoT mocemuli preparatis miRebamde 1-2sT-iT adre an maTi miRebidan 4 sT-Si. anTebis sawinaaRmdego arasteroiduli preparatebi(acetilsalicilis mJavis garda) zrdian krunCxvebis ganviTarebis risks. ftorqinolonebi qmnian qelatur naerTebs magniumis da aluminis ionebTan preparat didanozinis buferuli sistemidan, ris gamoc swrafad mcirdeba antibiotikebis Sewova, Sesabamisad ciprofloqsacini iniSneba didanozinis miRebamde 2sT-iT adre an misi miRebidan 2sT-Si. metoklopramidi aCqarebs absorbcias, rac iwvevs maqsimaluri koncentraciis miRwevis drois Semcirebas. Sardis mJavis gamomyof saSualebebTan erTad miReba anelebs ciprofloqsacinis gamoyofas(50%) da zrdis plazmaSi mis koncentracias. zrdis tizanidinis maqsimalur koncentracias 7-jer(4-21 jer), xolo mrudis qveS arsebuli sivrcis Sefardebas “koncentracia-dro” 10-jer(6-24-jer), ris gamoc izrdeba gamoxatuli arteriuli wnevis dawevis da Zilianobis riski.

gansakuTrebuli miTiTebebi:

ciprofloqsacinze ar keTdeba arCevani Streptococcus pneumonia-iT gamowveuli saeWvo an dadgenili pnevmoniis dros. kristaluris Tavidan aridebis mizniT dauSvebelia rekomendirebuli dRiuri dozebis gadaWarbeba, aseve aucilebelia saWiro raodenobiT siTxis miReba da Sardis mJavuri reaqciis SenarCuneba.

mkurnalobis dros unda moeridoT potenciurad saSiSi qmedebebis Sesrulebas, rac moiTxovs maqsimalur yuradRebas da swraf fsiqikur da mamoZravebel reaqciebs.

epilefsiis mqone pacientebSi, romelTac anamnezSi aReniSnebaT krunCxvebi, sisxlZarRvebis daavadebebi da Tavis tvinis organuli dazianebebi, ramac SesaZloa gamoiwvios centraluri nervuli sistemis mxriv gverdiTi reaqciebis ganviTarebis riski ciprofloqsacini iniSneba mxolod “sasicocxlod mniSvnelovani” Cvenebebis dro.

ciprofloqsaciniT mkurnalobis periodSi an Semdeg mwvave an xangrZlivi faRaraTis SemTxvevaSi saWiroa fsevdomembranuli kolitis diagnozis gamoricxva, romelic preparatis dauyovnebliv moxsnas da Sesabamisi mkurnalobis daniSvnas moiTxovs.

myesebis tkivilis SemTxvevaSi an tendovaginitis pirveli niSnebis gamovlenisas mkurnaloba unda Sewydes, radgan aRwerilia fTorqinolonebiT mkurnalobis dros myesebis anTebis da gaglejis calkeuli SemTxvevebi. ciprofloqsaciniT mkurnalobis periodSi unda moeridoT ultraiisfer dasxivebas (maT Soris mzis sxivebi).

gamoSvebis forma:

apkiT dafaruli tabletebi 500mg.

5 tableti polivinilqloridis da aluminis folgis konturul ujredul SefuTvaSi.

10 tableti flakonSi xraxniani plastmasis xufiT an polimerul flakonSi. TiTo flakoni, 2 konturuli ujreduli SefuTva gamoyenebis instruqciasTan erTad moTavsebulia muyaos kolofSi.

Senaxvis pirobebi:

inaxeba mSral, sinaTlisagan dacul adgilas ara umetes 25º C temperaturaze. moarideT bavSvebs.

vargisobis vada:

2 weli. ar gamoiyeneba vargisianobis vadis gasvlis Semdeg.

afTiaqidan gacemis wesi:

ფარმაცევტული პროდუქტის ჯგუფი - II (გაიცემა ფორმა 3 რეცეპტით)

mwarmoeblis/organizaciis misamarTi, romlebic Rebuloben pretenziebs: Rss “avva rus”, ruseTi, 121614 q.moskovi, krilatskie xolmis q, b.30, korp.9     (495) 956-75-74

www.avva-rus.ru

www.ecoantibiotic.ru