preparatis gamoyenebis instruqcia azoqsini (AZOXIN ...

preparatis gamoyenebis instruqcia
azoqsini
pediatriuli(200mg/5ml)
(AZOXIN)
(aziTromicini)
danarTi #
Ddamtkicebulia
saqarTvelos Sromis, janmrTelobisa da
socialuri dacvis saministros
wamlis saagentos ufrosis
2008 wlis _________________
# --------------- brZanebiT
(AZITROMICIN)
wamlis forma: peroraluri suspenziis damzadebeli mSrali fxvnili.
Semadgenloba:
homogenuri fxvnili, romelic xasiaTdeba TeTri feris Taviseburi, banani_ marwyvis
aromatiT. suspenzia mzaddeba wyliT, romlis yoveli 5ml 200mg aziTromicinis
eqvivalentur aziTromicinis dihidrats Seicavs
damxmare nivTirebebi: saqaroza, natriumis saqarini, bananis da marwyvis aromatizori.
ATK kodi: J01FA10.
farmakologiuri Tvisebebi:
farmakodinamika. aziTromicini miekuTvneba makrolidebis jgufis azalidebis
warmomadgenlebs, romlis molekulis laqtonis me-15 rgolSi, naxSirbadis atomis
magivrad Canacvlebulia meTilis jgufi, romelic dakavSirebulia azotis atomTan.
aziTromicini qvemoT moyvanili TvisebebiT gamoirCeva: advilad gadis histo-hematologiur
bariers da aRwevs qsovilebSi, makrofagebis da neitrofilebis saSualebiT
tansportirdeba infeqciis keramde, mJavianobis regulirebaSi maRali stabilurobiT da
farTo antibaqteriuli speqtriT gamoirCeva.
aziTromicini, rogorc yvela makroliduri antibiotiki, baqteriis 50S ribosomis
doneze Trgunavs mikroorganizmebis cilis biosinTezs. nukleinuri mJavebis sinTezze
gavlenas ar axdens.
aziTromicini efeqturia
gramdadebiTi aerobebi:
Staphylococcus aureus
Streptococcus pyogenes
Streptococcus pneumonaie
streptococcus agalacticae
(Enterococcus faecalis da meticilinis mimarT mdgradi Staphylococcus Stamebi
aziTromicinis mimarT mdgradia)
gramuaryofiTi aerobebi:
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Haemophilus ducreyi
Haemophilus influenzae
Helicobacter pylori
Moraxella (Branhamella) catarrhalis
Neisseria gonorrhoeae
sxva mikroorganizmebi
Chlamydia pneumoniae
Chlamydia trachomatis
Mycoplasma pneumoniae
beta-laqtamazebi ar amcireben aziTromicinis efeturobas.
aziTromicini axdens in vitro zemoqmedebas qvemoT mocemuli mikroorganizmebis mimarT:
gramdadebiTi aerobebi:
streptokokebi (C, F, G jgufebi)
Viridans-s jgufis streptokokebi
gramuaryofiTi aerobebi:
Bordatella pertussis
Legionella pneumophilea
anaerobuli mikroorganizmebi:
Peptostreptococcus Stamebi
Prevotella bivia
sxva mikroorganizmebi:
Ureaplasma urealiticum
Borrelia burgdorferi (laimis daavadebis gamomwvevi)
Mycobacterium avium intracellulare (MAC), Campylobacter and Listeria monocytogenes.
farmakokinetika:
aziTromicini swrafad ixsneba sisxlSi da Semdeg gadadis qsovilebSi. nivTierebis
bioSeRwevadobis maCvenebeli erTjeradi miRebis SemTxvevaSi Seadgens 34%-s. sakvebTan
erTad miRebisas maCvenebeli Cmax matulobs 23%-iT. erTjeradad miRebuli 500mg-is,
xolo SemdgomSi 250 mg 2-5 dReebSi farmakokinetikuri parametrebia.
pirveli dRe mexuTe dRe
plazmaSi maqsimaluri koncentracia (Cmax mcg/ml) 0,41 0,24
maqsimalur koncentraciis miRwevis xangrZlivoba (Tmax/saaTSi 2,5 3,2
zRvars qvemoT arsebuli maCvenebeli (AUC 0-24 ng/ml/h) 2,6 2,1
sisxlis plazmaSi minimaluri koncentracia (Cmin mcg/ml) 0,05 0,05
SardTan gamoyofa(Seyvanili dozis %) 4,5 6,5
aziTromocini xanmokle droSi sisxlidan gadadis qsovilSi. qsovilSi arsebuli
koncentracia ufro maRalia, plazmaSi arsebulTan SedarebiT. aziTromicini grovdeba
fagocitebSi da fibroblastebSi. gadanawilebis savaraudo moculoba Seadgens 31,1l/kg.
plazmis cilebTan SekavSireba sisxlSi arsebuli koncentraciis ukuproporciulia -
0,02mkg/ml _51%, xolo 2mkg/ml _7%. aziTromicini ucvleli saxiT gamoiyofa naRvelTan
erTad. ereTjeradi dozis miRebisas naxevargamoyofis periodi Seadgens 68 saaTs.
aziTromicinis farmakokinetika bavSvebsa da xandazmulebSi ar icvleba. Tirkmelebisa da
RviZlis funqciebis darRvevis dros mimdinare farmakokinetika sakmarisad Seswavlili ar
aris.
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farmakokinetika bavSvebSi
aziTromicinis suspenziis miRebisas pirveli dRis doza ganisazRvreba 10mk/kg. Semdgomi 2-
5 dReebis ganmavlobaSi doza mcirdeba 5mk/kg-mde misi kinetikuri parametrebi aris
Semdegnairi:
1-5 w bavSvTa jgufSi 5-15w.bavSvTa jgufSi
plazmaSi maqsimaluri koncentracia (Cmax mcg/ml 0,216 0,383
maqsimalur koncentraciis miRwevis xangrZlivoba
(Tmax/saaTS
zRvars qvemoT arsebuli maCvenebeli (AUC 0-24
mkq X s/ml)
1-3 2-4
1,822 3,109
Cvenebebi
azoqsini gamoiyeneba saSualo da mZime infeqciur anTebiTi daavadebebis dros da
zegavlenas axdens mikrofloris struqturaze.
qveda sasunTqis gzebis infeqciebi:
Haemophilus influenzae, Moraxella (branhamella) catarrhalis da Streptococcus pneumoniae –iT
gamowveuli filtvebis qronikuli obstruqciuli daavadebebi; Streptococcus pneumoniae da
Haemophilus influenzae – iT gamowveuli pnevmoniebi.
SeniSvna: aziTromicinis daniSvna ar aris rekomendebuli saSualo da mZime formis
pnevmoniebis dros, aseve Semdegi risk-faqtorebis arsebobis SemTxvevaSi: nozokomialuri
infeqcia, baqteriemia da misi arsebobis SesaZlebloba, daqveiTebuli imuniteti.
zeda sasunTqi gzis infeqciebi: Streptococcus pyogenes-iT gamowveuli mwvave
faringiti an tonziliti, mwvave Sua yuris otiti, qronikuli bronqitis gamwvaveba,
sinusitebi.
kanisa da rbili qsovilebis infeqciebi: Staphylococcus aureus, Streptococcus pyogenes
da Streptococcus agalacticae-iT gamowveuli kanisa da rbili qsovilebis gaurTulebeli
daavadebebi. (wiTela, impetigo, infeqciuri dermatozebi), migrirebadi eriTemis (laimis
daavadeba) qronikuli stadia.
sqesobrivi gziT gadamdebi infeqciebi: Chlamydia trachomatis, Mycoplasma hominis,
Neisseria gonorrhoeae – iT gamowveuli ureTriti da cerviciti.
ukuCvenebebi:
maRali mgrZnobiaroba makrolidebis mimarT
zog SemTxvevebSi, aziTromiciniT mkurnalobis dros SesaZlebelia gamovlindes mZime
alergiuli reaqciebi, agreTve, angionevrozuli SeSupeba da anafilaqsiuri Soki. aseT
SemTxvevaSi, saWiroa mkurnalobis dauyovnebliv Sewyveta. zog SemTxvevaSi, preparatis
miRebis Sewyvetis Semdeg hipermgrZnobelobis reaqciebi grZeldeba, rac moiTxovs eqimis
xangrZliv dakvirvebas da simptomur mkurnalobas. aRniSnuli gamowveulia aziTromicinis
organizmSi xangrZlivi drois ganmavlobaSi arsebobobiT.
iseve, rogorc sxva antibaqteriuli saSualebebi, aziTromicinic Clostridium difficile-iT
gamowveuli fsevdomembranuli kolitis mizezi SeiZleba gaxdes. am dros preparatis
miReba unda Sewydes da aucilebelia, dainiSnos Clostridium difficle-s mimarT aqtiuri
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antibiotiki, eleqtrolitebi da gamoxdili wyali. aziTromicinma SeiZleba gamoiwvios
QT- intervalis gaxangrZliveba, rac SeiZleba gaxdes ariTmiis_Torsades de pointes-is
mizezi. aqedan gamomdinare, QT-is intervalis gaxangrZliveba an masze eWvi mniSvnelovania.
qalebSi Torsades de pointes- is ganviTarebis riski ufro maRalia, vidre kacebSi.
sifrTxile:
1. aziTromicini gamoiyofa naRveliT, amitom azoqsini sifrTxiliT unda daeniSnos im
pacientebs, romelTac aReniSnebaT RviZlis funqciis moSla.
2. Tirkmlis darRveuli funqciis mqone pacientebSi. am kategoriis avadmyofebSi
aziTromicinis miRebis Sesaxeb informacia arasakmarisia.
3. zogierTi makrolidi SeiZleba gaxdes QT intervalis gaxangrZlivebis,
ventrikuluri taqikardiis da Torsades de pointes-is mizezi.
4. azoqsinis miReba SeiZleba Wamis dros an kvebis SualedebSi; aqve sayuradReboa rom
sakvebTan miRebis dros aziTromicini ufro kargi amtanobiT xasiaTdeba.
5. azoqsinis miReba ar unda xdebodes magniumis an aluminis Semcvel antacidebTan.
6. alergiuli reaqciebis pirvelive niSnis gamovlenisTanave, saWiroa preparatis miRebis
Sewyveta da eqimTan mimarTva.
orsulobis da laqtaciis dros miReba.
miekuTvneba B-kategorias. eqsperimentuli cdebis dros, teratogenuri an embriotoqsiuri
efeqti gamovlenili ar iqna. amasTan, orsul qalebSi detaluri gamokvleva Catarebuli
ar aris, ris gamoc orsulebSi azoqsinis gamoyeneba mizaSewonilia mxolod
gansakuTrebuli saWiroebis SemTxvevaSi.
laqtaciis periodSi gamoyeneba: AaziTromicinis dedis rZeSi gadasvlis Sesaxeb
informacia ar moipoveba. laqtaciis periodSi preparatis miRebis SemTxvevaSi ZuZuTi kveba
unda Sewydes.
xandazmuli pacientebi
xabdazmulebSi dozis koreqtireba saWiro ar aris.
gverdiTi movlenebi:
klinikur kvlevebSi gamovlenili iqna mxolod 0.7%-Si.
1%-ze met SemTxvevaSi gamovlenili iqna diarea, gulisreva, tkivili muclis areSi.
1%-ze nakleb sixSiriT gamovlenil iqna qvemoT mocemuli movlenebi:
gul-sisxlZarRvTa sistema: guliscemis gaxSireba, tkivili gulis areSi.
saWmlis momnelebeli sistema: dispefsia, meteorizmi, Rebineba, qolestazuri
siyviTle, melena
Sard-sasqeso sistema: kandidozi, vaginiti, nefriti.
nervuli sistema: Tavbrusxveva, Tavis tkivili, Zilianoba
sxva: daRliloba
alergiuli reaqciebi: kanis qavili, fotomgrZnobeloba, angionevrozuli SeSupeba.
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laboratoriuli maCveneblebis cvlilebebi.
klinikur kvlevebSi dafiqsirebulia 1-2%-is sixSiriT plazmis kreatininis,
fosfokinazebis, kaliumis, ALT, ACT donis momateba, magram am cvlilebebis
aziTromicinTan kavSiri dadgenili ar aris.
1%-ze naklebi sixSiriT_ leikopenia, neitropenia, Trombocitopenia; fosfotazebis,
bilirubinis, kreatininis, glukozis da fosfatebis donis momateba.
moulodneli gverdiTi efeqtebis gamovlenisas mimarTeT eqims.
sxva preparatebTan urTierTqmedeba
1. magniumisa da aluminis Semcvel antacidebTan aziTromicinis maqsimaluri
koncentracia mcirdeba, magram “koncentracia-dro” maCveneblis qveda zRvari ar icvleba.
2. Teofilinisa da varfarinis plazmur koncentraciaze aziTromicinis efeqtis Sesaxeb
informacia ar moipoveba, Tumca imis gaTvaliswinebiT, rom makrolidebis zemoTaRniSnul
preparatebTan erTad miRebisas, SesaZlebelia plazmuri koncentraciis donis momateba,
aucilebelia Teofilinis plazmuri koncentraciis kontroli.
3. makrolidebi xels uwyoben digoqsinis, triazolamis, ergotaminis, fenitoinis,
karbamazepinis, ciklosporinis da heqsobarbitalis plazmuri koncentraciis donis
momatebas.
4. aziTromicinis rekomendebuli dozebis miRebisas, pacientisTvis erTjeradad
micemuli varfarini proTrombinis droze gavlenas ar axdens, magram makrolidebTan erTad
miRebisas, varfarinis antikoagulianturi moqmedeba izrdeba, azoqsinis da varfarinis
erTad miRebis SemTxvevaSi, saWiroa sifrTxile.
5. aziTromicinis zidovudinTan da didanozinTan erTad miRebisas, klinikurad
mniSvnelovani urTierTqmedeba gamovlenili ar aris.
6. aziTromicinis da rifambutinis erTdrouli miReba maT plazmur koncentraciebze
gavlenas ar axdens.
7. cimetidinis 2 saaTiT adre miReba, aziTromicinis Sewovaze gavlenas ar axdens.
miRebis wesi:
azoqsini miiReba kvebamde erTi saaTiT adre, an ori saaTis Semdeg.
mozrdilTaTvis:
filtvebis qronikuli obstruqciuli daavadebebebis mwvave baqteriuli infeqciebis,
pnevmoniis, faringitis da tonzilitis, kanisa da rbili qsovilebis infeqciebis dros
iniSneba pirvel dRes erTi tableti, 500mg, SemdgomSi 2-5 dReebSi 250mg (1/2 tab) dReSi
erTxel.
Haemophilus ducreyi-iT gamowveuli genitaluri infeqciebis da Chlamydia trachomatis-iT
gamowveuli aragonokokuri ureTritis an cervicitis dros iniSneba erTjeradad 1000
mg.(2 tab) doziT.
gonokokuri ureTritis an cervicitis SemTxvevaSi iniSneba erTjeradad 2g-is (2000mg
anu 4 tab) doziT.
bavSvebSi:
Sua yuris mwvave otiti: doza ganisazRvreba erTjeradad 30mg/kg-ze an 3 dRe 10mg/kg-ze
an 5 dRe; aqedan, pirvel dRes iniSneba 10mg/kg, 2-5 dReebSi 5mg/kg.
streptokokuri faringiti: 5 dRe 12mg/kg-ze.
sxva Cvenebebebisas 3 dRe 10mg/kg-ze an 5 dRe, aqedan pirveli dRe 10mg/kg-ze 2-5 dReebSi
5mg/kg-ze.
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sxeulis wona
(kg.)
samdRiani mkuranloba
(dReSi erTxel)
xuTdRiani mkurnaloba (dReSi
erTxel)
I dRe II – III dRe I dRe II – V dRe
< 15 kg. 2.5 ml. (100 mg.) 2.5 ml. (100 mg.) 2.5 ml. (100 mg.) 1.25 ml. (50 mg.)
15 – 25 kg. 5 ml. (200 mg.) 5 ml. (200 mg.) 5 ml. (200 mg.) 2.5 ml. (100 mg.)
26 – 35 kg. 7.5 ml. (300 mg.) 7.5 ml. (300 mg.) 7.5 ml. (300 mg.) 3.75 ml. (150 mg.)
36 – 45 kg. 10 ml. (400 mg.) 10 ml. (400 mg.) 10 ml. (400 mg.) 5 ml. (200 mg.)
> 45 kg. iseve rogorc mozrdilebSi
suspenziis damzadeba:
1. flakonSi arsebuli fxvnili gaxsnamde 2-3 jer SeanjRrieT.
2. gamWvirvale plastmasis flakonSi arsebuli siTxe SeurieT flakonSi arsebul
fxvnils.
3. flakoni jer kargad SeanjRrieT.
4. yoveli moxmarebis win flakoni kargad SeanjRrieT.
dozirebis pipetis gamoyenebis wesi:
dozirebis pipeti iyofa 0,25ml-ian danayofebad.
suspenziis raodenoba gamoiTvleba qvemoT mocemuli formuliT:
suspenziis raodenoba (ml): sxeulis wona (kg)XsaWiro doza (mg/kg)X5
200
1. suspenziis damzadebis Semdeg moxseniT pipets Tavsaxuri da CadeT suspenziis
flakonSi.
2. pipetSi amotumbeT masSi suspenziis is raodenoba, romelic gamoTvlilia formuliT
an dadgenilia eqimis mier.
3. suspenziis miReba SesaZlebelia, aseve kovziT.
4. gamoyenebis Semdeg pipets daaxureT Tavsaxuri.
Warbi dozireba
dozis gadaWarbebisas tardeba simptomuri mkurnaloba. specialuri antidoti ar
arsebobs.
Senaxvis pirobebi:
SeinaxeT bavSvebisTvis miuwvdomel adgilas. suspenziis damzadebis Semdeg misi Senaxva
mizanSewonilia 30C-ze dabal oTaxis temperaturaze mxolod 5 dRe.
vargisianobis vada: mSrali fxvnili peroraluri suspenziis damzadebisaTvis -2 weli.
SefuTvaze miTiTebuli TariRis Semdeg misi gamoyeneba dauSvebelia.
gamoSvebis forma:
azoqsini pediatriuli: 15ml mza suspenziis 5ml Seicavs 200mg aziTromocinis
eqvivalentur aziTromicinis dihidrats. peroraluri suspenziis dasamzadebeli mSrali
fxvnili plastmasis flakonSi_ 7,5ml gamoxdili wyali, dozirebuli pipeti da kovzi
erT SefuTvaSi.
azoqsini tabletebi 500mg #3 blisterSi.
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afTiaqidan gacemis wesi
gaicema receptiT
mwarmoebeli da licenziis mflobeli
Биофарма Илач Сан. ве Тидж. А.Ш samandira/stamboli. TurqeTi
Akpinar Mah. Fatih Cad No: 17
Phone 0216 398 10 63
gamWvirvale plastmasis flakonSi gamoxdili wylis gamoSvebis adgili:
s.s. “sanovel ilaj sanai ve TijareT”, silivri/stamboli.
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