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augmentini BD tabletebi
amoqsicilinis trihidrati - kaliumis klavulanati
augmentini 1 g tabletebi: TeTri an moTeTro feris, ovaluri formis, apkiani garsiT dafaruli
tabletebi, gravirebiT “AC” da gamyofi xaziT cal mxares, meore mxare - sada.
klinikuri informacia
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: recidiuli
tonziliti, sinusiti, Sua yuris anTeba.
qveda respiratoruli gzebis infeqciebi, rogoricaa: filtvebis qronikuli obstruqciuli
daavadebis gamwvaveba (AECOPD)/ qronikuli bronqitis gamwvaveba (AECB), 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.
dentaluriinfeqciebi, 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.
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gastro-intestinuri autanlobis Sesamcireblad iniSneba Wamis dawyebisas. augmentinis
Sewova optimaluria, roca misi miReba xdeba kvebis dawyebasTan erTad.
Terapiis xangrZlivobam ar unda gadaaWarbos 14 dRes ganxilvis gareSe.
Terapia SeiZleba daiwyos parenteralurad da gagrZeldes SigniT misaRebi preparatiT.
tabletebi unda gadaiylapos mTlianad, daReWvis gareSe. saWiroebis SemTxvevaSi,
tabletebi SeiZleba gaiyos orad da gadaiylapos daReWvis gareSe.
augmentinistabletebi ar aris rekomendebuli 12 wlis da naklebi asakis bavSvebisaTvis.
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 mqonepacientebSi.
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.
orsuloba da laqtacia
cxovelebze (Tagvebsa da virTagvebSi, dozebze, romlebic 10-jer aWarbebs adamianis
dozas) 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
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mkurnaloba SeiZleba dakavSirebuli yofiliyo nekrozuli enterokolitis gazrdil riskTan
axalSobilSi. yvela sxva medikamentis msgavsad, orsulobis 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 aris cnobili raime
saziano gavlena ZuZuTi kvebaze myof Cvilze.
gverdiTi reaqciebi
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 darRvevebi
iSviaTi: Seqcevadi leikopenia (maT Soris neitropenia) da Trombocitopenia
Zalian iSviaTi: Seqcevadi agranulocitozi da hemolizuri anemia. sisxldenis drois da
proTrombinis droisgaxangrZliveba
imunuri sistemis darRvevebi
Zalian iSviaTi: angionevrozuli SeSupeba, anafilaqsia, Sratismieri daavadebis msgavsi
sindromi, hipermgrZnobelobiTi vaskuliti
nervuli sistemis 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.
kardialuri darRvevebi
Zalian iSviaTi: kunisis sindromi (ix. gafrTxilebebi da sifrTxilis zomebi)
gastrointestinuri 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.
hepatobiliaruli darRvevebi:
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araxSiri: ast da/an altdonis zomieri momateba aRiniSna pacientebSi, romlebic
mkurnalobdnen beta-laqtamuri jgufis antibiotikebiT, Tumca am maCveneblebis
mniSvneloba ucnobia.
Zalian iSviaTi: hepatitida 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 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 darRvevebi
Zalian iSviaTi: intersticiuli nefriti, kristaluria (ix. dozis gadaWarbeba).
dozis gadaWarbeba
SeiZleba ganviTardes gastrointestinuri simptomebi da siTxisa da eleqtrolitebis balansis
darRveva. gastrointestinuri simptomebis mkurnaloba unda moxdes simptomurad, wylis/
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
aTq kodi: J01CR02
farmakoTerapiuli jgufi: penicilinebis kombinaciebi, beta-laqtamazas inhibitorebis CaTvliT
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.
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ZiriTadi mgrZnobiare saxeobebi
gramdadebiTi aerobebi:
Bacillius anthracis
Enterococcus faecalis
Listeria monocytogenes
Nocardia asteroids
Streptococcus pyogenes*†
Streptococcus agalactiae*†
Streptococcus spp. (sxva beta-hemolizuri) *†
Staphylococcus aureus (meticilinmgrZnobiare)*
Staphylococcus saprophyticus(meticilinmgrZnobiare)
koagulazauaryofiTi stafilokokebi (meticilinmgrZnobiare)
gramuaryofiTi aerobebi:
Bordetella pertussis
Haemophilus influenzae*
Haemophilus parainfluenzae
Helicobacter pylori
Moraxella catarrhalis*
Neisseria gonorrhoeae
Pasteurella multocida
Vibrio cholerae
sxva:
Borrelia burgdorferi
Leptospira ictterohaemorrhagiae
Treponema pallidum
gramdadebiTi anaerobebi:
Clostridium spp.
Peptococcus niger
Peptostreptococcus magnus
Peptostreptococcus micros
Peptostreptococcus spp.
gramuaryofiTi anaerobebi:
Bacteroides fragilis
Bacteroides spp.
Capnocytophaga spp.
Eikenella corrodens
Fusobacterium nucleatum
Fusobacterium spp.
Porphyromonas spp.
Prevotella spp.
saxeobebi, romlebisTvisac SeZenili rezistentoba SeiZleba problemuri iyos
gramuaryofiTi aerobebi:
Escherichia coli*
Klebsiella oxytoca
Klebsiella pneumoniae*
Klebsiella spp.
Proteus mirabilis
Proteus vulgaris
Proteus spp.
Salmonella spp.
Shigella spp.
gramdadebiTi aerobebi:
Corynebacterium spp.
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Enterococcus faecium
Streptococcus pneumoniae*†
Viridans group streptococcus
bunebrivad rezistentuli organizmebi
gramuaryofiTi aerobebi:
Acinetobacter spp.
Citrobacter freundii
Enterobacter spp.
Hafnia alvei
Legionella pneumophila
Morganella morganii
Providencia spp.
Pseudomonas spp.
Serratia spp.
Stenotrophomas maltophilia
Yersinia enterolitica
sxva:
Chlamydia pneumoniae
Chlamydia psittaci
Chlamydia spp.
Coxiella burnetti
Mycoplasma spp.
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.
araklinikuri informacia
ar aris damatebiTi informacia.
farmacevtuli informacia
damxmare nivTierebebis CamonaTvali
augmentinis tabletebi Seicaven: natriumis saxameblis glikolati, magniumis stearati (E572),
koloiduri siliciumis dioqsidi, mikrokristaluri celuloza, titanis dioqsidi (E171),
hidroqsipropilmeTilceluloza, polieTilenglikoli, dimeTikoni (silikonis zeTi).
Senaxvis vada
Senaxvis vada miTiTebulia SefuTvaze.
gamoyeneba da moxmareba
paketi blisteriT Seicavs desikantis saSets, romlis amoReba an Wama dauSvebelia.
nebismieri gaxsnili an gamouyenebeli tableti Senaxvis Semdeg gadagdebul unda iqnas
SefuTvaze miTiTebulis Sesabamisad.
nebismieri gamouyenebeli samkurnalo produqti an narCeni masala unda ganadgurdes
adgilobrivi moTxovnebis Sesabamisad.
yvela SefuTvis forma xelmisawvdomi ar aris yvela qveyanaSi.
გაცემის რეჟიმი:
ფარმაცევტული პროდუქტის ჯგუფი - II, გაიცემა ფორმა №3 რეცეპტით
warmoebulia:
SmithKline Beecham Limited*
Clarendon Road
Worthing
West Sussex, BN14 8QH
United Kingdom
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