Professional Documents
Culture Documents
farmacevtuli forma
augmentini 625 mg tabletebi: TeTri an moTeTro feris, ovaluri formis, apkiani garsiT
dafaruli tableti, gravirebiT «AC» da gamyofi xaziT erT mxares da meore mxare - sada.
augmentini 1 g tabletebi: TeTri an moTeTro feris, kafsulis formis, apkiani garsiT dafaruli
tableti, gravirebiT «AC» orive mxares da gamyofi xaziT cal mxares.
klinikuri maxasiaTeblebi
Cvenebebi
augmentini aris antibiotiki gamoxatuli farTo speqtris aqtivobiT ZiriTadad gavrcelebuli
baqteriuli paTogenebis winaaRmdeg da gamoiyeneba zogad praqtikaSi da hospitaluri
mkurnalobisaTvis. klavulanatis β-laqtamazuri mainhibirebeli moqmedeba afarToebs
amoqsicilinis speqtrs organizmebis ufro farTo speqtris winaaRmdeg, maT Soris moicavs
bevr β-laqtamuri antibiotikebis mimarT rezistentul mikroorganizms.
augmentini gamoyenebul unda iqnas antibiotikebis gamoyenebis adgilobrivi oficialuri
gaidlainebis da mgrZnobelobis monacemebis mixedviT.
augmentinis SigniT misaRebi forma orjer dReSi naCvenebia Semdegi baqteriuli
infeqciebis xanmokle mkurnalobisaTvis:
zeda respiratoruli gzebis infeqciebi (maT Soris yel-yur-cxviris), rogoricaa tonziliti,
sinusiti, Sua yuris anTeba.
qveda respiratoruli gzebis infeqciebi, rogoricaa qronikuli bronqitis gamwvaveba,
wilovani da bronqopnevmonia.
Sard-sasqeso gzebis infeqciebi, rogoricaa cistiti, ureTriti, pielonefriti.
kanisa da rbili qsovilebis infeqciebi: rogoricaa furunkuli, abscesi, celuliti, Wrilobis
infeqciebi.
Zvlisa da saxsrebis infeqciebi, rogoricaa osteomieliti.
dentaluri infeqciebi, rogoricaa dentoalveolaruli abscesi.
sxva infeqciebi: rogoricaa septikuri aborti, mSobiarobis Semdgomi sefsisi, intra-
abdominaluri sefsisi.
augmentinisadmi mgrZnobeloba icvleba geografiulad da drois mixedviT (damatebiTi
informaciisaTvis ix. farmakologiuri Tvisebebi, farmakodinamika). Tu xelmisawvdomia,
ganxilul unda iqnas adgilobrivi mgrZnobelobis monacemebi da saWiroebis SemTxvevaSi
gakeTdes mikrobiologiuri nimuSebis da mgrZnobelobis analizi.
RviZlis dazianeba
doza iniSneba sifrTxiliT; RviZlis funqciis monitoringi unda Catardes regularuli
intervalebiT.
ukuCvenebebi
augmentini ukunaCvenebia pacientebSi beta-laqtamuri hipermgrZnobelobiT anamnezSi,
mag. penicilinebis da cefalosporinebis mimarT.
augmentini ukunaCvenebia augmentinTan asocirebuli siyviTlis/RviZlis disfunqciis
anamnezis mqone pacientebSi.
urTierTqmedebebi
ar aris rekomendebuli probenecidis erTdrouli gamoyeneba. probenecidi aqveiTebs
amoqsicilinis Tirkmelebis milakovan sekrecias. augmentinTan erTdroulma miRebam
SeiZleba gamoiwvios amoqsicilinis, magram ara klavulanis mJavas donis gazrda sisxlSi.
alopurinolis miRebam amoqsiciliniT Terapiis dros SeiZleba gazardos kanis alergiuli
reaqciebis riski. ar aris monacemebi augmentinis da alopurinolis erTdrouli gamoyenebis
Sesaxeb.
rogorc wesi, sxva antibiotikebis msgavsad, augmentinma SeiZleba gavlena iqonios
nawlavebis floraze, rac iwvevs estrogenis dabal reabsorbcias da kombinirebuli oraluri
kontraceptivebis daqveiTebul efeqturobas.
literaturaSi aRwerilia iSviaTi SemTxvevebi, roca izrdeba saerTaSoriso normalizebuli
Sefardebis maCvenebeli pacientebSi, romlebic iReben acenokumarols an varfarins da
amave dros itareben amoqsicilinis kurss. Tu aucilebelia erTdrouli daniSvna, augmentinis
damatebis an moxsnis dros saWiroa proTrombinis drois an saerTaSoriso normalizebuli
maCveneblis monitoringi.
pacientebSi, romlebic iReben mikofenolatis mofetils, mikofenolis mJavas aqtiuri
metabolitis koncentracia sisxlSi Semdegi dozis miRebamde (predozis koncentracia)
Semcirda daaxloebiT 50%-iT oraluri amoqsicilinis da klavulanis mJavas miRebis Semdeg.
predozis donis cvlileba SeiZleba zustad ar aCvenebdes mfa-s eqspoziciis saerTo
cvlilebas.
fexmZimoba da laqtacia
cxovelebze (Tagvebsa da virTagvebSi) reproduqciulma kvlevebma oraluri da
parenteraluri augmentinis miRebisas ar gamoavlina raime teratogenuli efeqti. erTjerad
kvlevaSi qalSi, naadrevi mSobiarobiT, sanayofe garsis naadrevi rupturiT (pPROM)
aRiniSna, rom augmentiniT profilaqtikuri mkurnaloba SeiZleba dakavSirebuli yofiliyo
nekrozuli enterokolitis gazrdil riskTan axalSobilSi. yvela sxva medikamentis msgavsad,
fexmZimobis dros, gansakuTrebiT pirvel trimestrSi, ar unda dainiSnos, garda im
SemTxvevisa Tu eqimi ar CaTvlis mas aucileblobad.
augmentini SeiZleba dainiSnos laqtaciis dros. mgrZnobelobis riskis garda, romelic
dakavSirebulia narCeni raodenobis gamoyofasTan dedis rZeSi, ar aRiniSneba saziano
gavlena Cvilze.
gavlena avtomobilis marTvis da sxva meqanizmebTan muSaobis unarze
gverdiTi efeqtebi avtomobilisa da sxva meqanizmebis marTvis unarze ar gamovlenila.
gverdiTi movlenebi
monacemebi farTo klinikuri kvlevebidan gamoyenebul iqna, raTa gansazRvruliyo gverdiTi
efeqtebis sixSire Zalian xSiridan iSviaTamde. sxva gverdiTi movlenebis sixSire (rogoricaa
<1/10.000 sixSiriT ganviTareba) ZiriTadad ganisazRvra postmarketinguli monacemebis
mixedviT da miuTiTebs ufro Setyobinebis sixSires, vidre WeSmarit sixSires.
qvemoT mocemuli SeTanxmeba gamoyenebulia sixSiris klasifikaciisaTvis:
Zalian xSiri ≥1/10
xSiri ≥1/100-dan <1/10-mde
araxSiri ≥1/1.000-dan <1/100-mde
iSviaTi ≥1/10.000-dan <1/1.000-mde
Zalian iSviaTi <1/10.000
infeqciebi da invaziebi
xSiri: kan-lorwovanis kandidozi
sisxlisa da limfuri sistemis mxriv darRvevebi
iSviaTi: Seqcevadi leikopenia (maT Soris neitropenia) da Trombocitopenia
Zalian iSviaTi: Seqcevadi agranulocitozi da hemolizuri anemia. sisxldenis drois da
proTrombinis drois gaxangrZliveba
imunuri sistemis mxriv darRvevebi
Zalian iSviaTi: angionevrozuli SeSupeba, anafilaqsia, Sratismieri daavadebis msgavsi
sindromi, hipermgrZnobelobiTi vaskuliti
nervuli sistemis mxriv darRvevebi
araxSiri: Tavbrusxveva, Tavis tkivili
Zalian iSviaTi: Seqcevadi hiperaqtiuroba, aseptikuri meningiti, krunCxvebi. krunCxvebi
SeiZleba ganviTardes pacientebSi, romlebsac aReniSnebaT daqveiTebuli Tirkmlis funqcia
an romlebic iReben maRal dozebs.
gastro-intestinuri darRvevebi
mozrdilebi:
Zalian xSiri: diarea
xSiri: gulisreva, Rebineba
bavSvebi:
xSiri: diarea, gulisreva, Rebineba
yvela populacia:
gulisreva xSirad dakavSirebulia maRal oralur dozebTan. Tu gastro-intestinuri reaqciebi
vlindeba, maTi Semcireba SesaZlebelia augmentinis miRebiT kvebis dasawyisSi.
araxSiri: dispefsia
Zalian iSviaTi: antibiotikTan asocirebuli koliti (maT Soris fsevdomembranozuli koliti da
hemoragiuli koliti – ix. gafrTxilebebi da sifrTxilis zomebi), Savi bususebiani ena.
hepato-biliaruli darRvevebi:
araxSiri: ast da/an alt donis zomieri momateba aRiniSna pacientebSi, romlebic
mkurnalobdnen beta-laqtamuri jgufis antibiotikebiT, Tumca am maCveneblebis
mniSvneloba ucnobia.
Zalian iSviaTi: hepatiti da qolestazuri siyviTle. es movlenebi aRiniSna sxva penicilinebis
da cefalosporinebis miRebis dros.
RviZlismieri movlenebi upiratesad aRiniSna mamakacebSi da xandazmul pacientebSi da
SeiZleba dakavSirebuli iyos gaxangrZlivebul mkurnalobasTan. es movlenebi Zalian
iSviaTad aRiniSna bavSvebSi. niSnebi da simptomebi Cveulebriv viTardeba mkurnalobis
dros an mkurnalobidan xanmokle periodis Semdeg, magram zogierT SemTxvevaSi
SeiZleba ar gamovlindes mkurnalobis Sewyvetidan ramdenime kviris ganmavlobaSi. es
simptomebi Cveulebriv Seqcevadi xasiaTisaa. RviZlismieri movlenebi SeiZleba iyos
mZime xasiaTis da ukiduresad iSviaT SemTxvevebSi aRiniSna sikvdili. TiTqmis yvela
SemTxvevaSi pacientebs aReniSnebodaT mZime Tanmxlebi daavadeba an iRebdnen
Tanmxleb medikamentebs, romlebsac aqvT potenciuri efeqti RviZlze.
kanisa da kanqveSa qsovilis mxriv darRvevebi
araxSiri: gamonayari kanze, qavili, WinWris cieba
iSviaTi: multiformuli eriTema
Zalian iSviaTi: stivens-jonsonis sindromi, toqsikuri epidermuli nekrolizi, bulozuri
eqsfoliaciuri dermatiti, mwvave generalizebuli egzanTematozuri pustulozi (AGEP) da
wamlismieri reaqcia eozinofiliiTa da sistemuri simptomebiT (DRESS).
Tu aRiniSneba hipermgrZnobelobiTi dermatitis reaqcia, mkurnaloba unda Sewydes.
Tirkmlisa da saSarde gzebis mxriv darRvevebi
Zalian iSviaTi: intersticiuli nefriti, kristaluria (ix. dozis gadaWarbeba).
dozis gadaWarbeba
SeiZleba ganviTardes gastro-intestinuri simptomebi da siTxisa da eleqtrolitebis balansis
darRveva.
gastro-intestinuri simptomebis mkurnaloba unda moxdes simptomurad wylisa da
eleqtrolitebis balansze yuradRebis miqceviT.
aRiniSna amoqsicilinis kristaluria, romelmac zogierT SemTxvevebSi gamoiwvia Tirkmlis
ukmarisoba (ix. gafrTxilebebi da sifrTxilis zomebi).
augmentinis gamoyofa SesaZlebelia hemodializis saSualebiT.
farmakologiuri Tvisebebi
farmakodinamika
bevri antibiotikis mimarT rezistentoba gamowveulia baqteriuli fermentebiT, romlebic
Slian antibiotiks, sanam is daiwyebs paTogenze zemoqmedebas. augmentinSi Semavali
klavulanati ewinaaRmdegeba am damcvelobiT meqanizms beta-laqtamazas fermentis
blokirebiT, rac organizmebs mgrZnobiares xdis amoqsicilinis swrafi baqteriociduli efeqtis
mimarT im koncentraciiT, romelic advilad miiRweva organizmSi. klavulanats TavisTavad
susti antibaqteriuli moqmedeba gaaCnia, Tumca amoqsicilinTan erTad, rogorc es
warmodgenilia augmentinSi, is warmoqmnis farTo speqtris antibiotiks, romelic farTod
gamoiyeneba hospitaluri mkurnalobisaTvis da zogad praqtikaSi.
qvemoT CamoTvlili organizmebi kategorizebulia augmentinis mimarT maTi in vitro
mgrZnobelobis mixedviT.
farmakokinetika
augmentinis ori komponentis farmakokinetika Zalian hgavs erTmaneTs. plazmaSi pikur
dones orive aRwevs daaxloebiT 1 saaTis Semdeg SigniT miRebisas. augmentinis Sewova
optimaluria Wamis dawyebisas.
augmentinis dozis gaormageba iwvevs plazmaSi misi donis daaxloebiT gaormagebas.
klavulanats da amoqsicilins plazmaSi dakavSirebis dabali done axasiaTebs;
daaxloebiT 70% Tavisufali rCeba plazmaSi.
farmacevtuli maxasiaTeblebi
damxmare nivTierebebis CamonaTvali
augmentinis tabletebi Seicaven: natriumis saxameblis glikolati, magniumis stearati
(E572), koloiduri siliciumis dioqsidi, mikrokristaluri celuloza, titanis dioqsidi (E171),
hidroqsipropil meTilceluloza, polieTilenglikoli, dimeTikoni (silikonis zeTi).
SeuTavsebloba
ar aris cnobili.
Senaxvis vada
Senaxvis vada miTiTebulia SefuTvaze.
გაცემის წესი:
ფარმაცევტული პროდუქტის ჯგუფი - II , გაიცემა ფორმა №3 რეცეპტით
warmoebulia:
SmithKline Beecham Limited*
Clarendon Road
Worthing
West Sussex, BN14 8QH
United Kingdom