danarti N 1 - Atacandi (geo)

preparatis samedicino gamoyenebis
instruqcia
atakandi
Atacand®
saerTaSoro arapatentirebuli dasaxeleba: kandesartani
wamlis forma: tabletebi
fid
en
tia
l
Semadgenloba
aqtiuri nivTiereba
erTi tableti Seicavs kandesartani cileqsetilis aqtiur nivTierebas 8 mg da
16 mg.
damxmare nivTierebebi
kalciumis karmeloza (karmelozis kalciumis marili) 5,6 mg, hiproloza
(hidroqsipropil celuloza) 4,0 mg, rkinis oqsidis wiTeli saRebavi Е 172 0,065
mg ( 8 mg dozirebisaTvis), 0,26 mg (16 mg dozirebisaTvis ); laqtozis monohidrati
89,4 mg ( 8 mg dozirebisaTvis), 81,4 mg (16 mg dozirebisaTvis), magniumis stearati
0,4 mg, simindis saxamebeli 20,0 mg, makragoli 2,6 mg.
C
on
aRwera
atakandi® 8 mg: Ria-vardisferi mrgvali ormxrivad amozneqili tabletebi,
naWdeviT da gravirebiT A erTi mxridan da 008 meore mxridan.
atakandi® 16 mg: vardisferi mrgvali ormxrivad amozneqili tabletebi, naWdeviT
da gravirebiT A erTi mxridan da 016 meore mxridan.
farmakoTerapevtuli jgufi: angioTenzini II receptorebis antagonisti
kodi АТХ: С09СА06
pa
ny
farmakologiuri Tvisebebi
farmakodinamika
angioTenzini II – renin-angiotenzin-aldosteronuli sistemis ZiriTadi hormoni,
romelic mniSvnelovan rols TamaSobs arteriuli hipertenziis, gulis
ukmarisobis da gul-sisxlZarRvTa sxva daavadebebis paTogenezSi. angioTenzini
II ZiriTadi
fiziologiuri
efeqtebia
vazokonstriqcia,
aldosteronis
produqciis stimulacia, wyal-eleqtrolituri homeostazis regulacia da
ujredovani zrdis stimulacia. yvela es efeqti miiReba angioTenzini II da 1
tipis angioTenzinis receptorebis urTierTqmedebiT (aT1 receptorebi).
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om
kandesartani - angioTenzini II 1 tipis receptorebis seleqtiuri antagonisti
kandesartani ar inhibirebs angioTenzingardamqmnel ferments, romelic axdens
angioTenzin I gardaqmnas angioTenzin II da Slis bradikinins; ar moqmedebs
angioTenzingardamqmnel fermentze da ar iwvevs bradikininis dagrovebas an Р
substancias. kandesartanis Sedarebisas angioTenzingardamqmnel fermentebis
inhibitorebTan xvelis ganviTareba ufro iSviaTi iyo pacientebSi, romlebic
iRebdnen kandesartani cileqsetils.
kandesartani ar ukavSirdeba sxva
hormonebis receptorebs da ar ukeTebs blokirebas ionur arxebs, romlebic
monawileoben gul-sisxlZarRvTa sistemis funqciis regulaciaSi. angioTenzin II
angioTenzin1 receptorebiT blokirebis Sedegad xdeba reninis, angioTenzin I,
angioTenzin II donis dozaze damokidebuli momateba da sisxlis plazmaSi
aldosteronis koncentraciis daqveiTeba.
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arteriuli hipertenzia
arteriuli hipertenziisas kandesartani iwvevs arteriuli wnevis dozaze
damokidebul xangrZliv daqveiTebas. preparatis antihipertenziuli efeqti
ganpirobebulia sisxlZarRvebis zogadi periferiuli winaRobis daqveiTebiT,
gulis SekumSvis sixSiris Seucvlelad. ar aRniSnula gamoxatuli arteriuli
hipotenzia, SemTxvevebi preparatis pirveli dozis miRebis Semdeg, agreTve
moxsnis sindromi ( “rikoSetis” sindromi) Terapiis Sewyvetis Semdeg.
hipotenziuri moqmedebis dasawyisi kandesartani cileqsetilis pirveli dozis
miRebis Semdeg viTardeba 2 saaTis ganmavlobaSi. preparatis fiqsirebuli doziT
Terapiis gagrZelebis fonze arteriuli wnevis maqsimaluri daqveiTeba miiRweva
4 kviris manZilze da SenarCundeba mkurnalobis periodSi. kandesartani
cileqsetilis miReba erTxel dRe-RameSi uzrunvelyofs arteriuli wnevis
efeqtur da TandaTanobiT daqveiTebas 24 saaTis ganmavlobaSi arteriuli wnevis
umniSvnelo meryeobiT preparatis morigi dozis miRebaTa Soris intervalebSi.
kandesartani cileqsetilis da hidroqlortiazidis erTdrouli miReba iwvevs
hipotenziuri
efeqtis
gaZlierebas.
kandesartani
cileqsetilis
da
hidroqlortiazidis
(an
amlodipinis)
erTdrouli
miReba
mimdinareobs
dadebiTad.
preparatis efeqturoba ar aris damokidebuli pacientebis asaksa da sqesze.
kandesartani cileqsetili zrdis Tirkmlis sisxlCaqcevas
da ar cvlis an
zrdis
gorgliseburi
filtraciis
siCqares,
maSin,
rodesac
Tirkmlis
sisxlZarRvovani winaRoba da filtraciuli fraqcia qveiTdebian. kandesartani
cileqsetilis miReba 8-16 mg doziT 12 kviris ganmavlobaSi ar axdens negatiur
zegavlenas glukozis doneze da lipidur profilze arteriuli hipertenziis
da 2 tipis Saqriani diabetis mqone pacientebSi.
kandesartani cileqsetilis klinikuri moqmedeba daavadebis da sikvdilianobis
doneze 8-16 mg doziT erTxel dRe-RameSi (saSuali doza 12 mg) gamokvleuli
iqna randomizirebul klinikur kvlevaSi 4937 xandazmuli pacientis (70-dan 89
wlamde asaki, pacientebis 21% 80 wlis da zemoT asakSi) monawileobiT
arteriuli hipertenziis simZimis msubuqi da zomieri xarisxiT, romlebis
iRebdnen kandesartani cileqsetilis Terapias saSualod 3,7 wlis ganmavlobaSi
( COPE-s kvleva – kognitiuri funqciebis da prognozis kvleva xandazmul
pacientebSi). pacientebi iRebdnen kandesartans an placebos, saWiroebisas sxva
antihipertenziul saSualebebTan erTad. pacientebis jgufSi, romlebic iRebdnen
kandesartans, aRiniSna arteriuli wnevis daqveiTeba 166/90-dan 145/80 mm.v.s-mde da
sakontrolo
jgufSi
167/90-dan
149/82
mm.v.s.-mde.
gul-sisxlZarRvTa
garTulebebis
(letaluroba
gul-sisxlZarRvTa
daavadebebis
Sedegad,
miokardiumis infarqtis da insultis sixSire, romelTac ar gamouwveviaT
sikvdili) sixSiris statistikurad mniSvnelovani gansxvavebebi pacientTa or
jgufs Soris ar aRniSnula.
pacientebis
jgufSi,
romlebic
iRebdnen
kandesartans,
aRiniSna
gulsisxlZarRvTa garTulebebis warmoSobis 26,7 SemTxveva 1000 pacient-welze 30,0
SemTxvevasTan SedarebiT
1000 pacient-welze sakontrolo jgufSi (riskebis
Sesabamisoba = 0,89, 95% ndobis intervali 0,75 - 1,06, р=0,19).
qronikuli gulis ukmarisoba
CHARM-is kvlevis Sedegebis Tanaxmad (kandesartani qronikuli gulis
ukmarisobisas – sikvdilianobis da daavadebis donis daqveiTebis Sefaseba)
kandesartani cileqsetilis gamoyeneba iwvevda letaluri Sedegebis sixSiris
daqveiTebas, hospitalizaciis aucileblobas qronikuli gulis ukmarisobis
gamo da marcxena parkuWis sistoluri funqciis gaumjobesebas.
qronikuli gulis ukmarisobis mqone pacientebi ZiriTad TerapiasTan erTad
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damatebiT iRebdnen kandesartani cileqsetilis 4-8 mg dozas dRe-RameSi dozis
momatebiT 32 mg-mde dRe-RameSi an maqsimalur gadasatan Terapiul dozas
(kandesartanis saSualo doza Seadgenda 24 mg). dakvirvebis xangrZlivobis
mediana Seadgenda 37,7 Tves. 6 Tvis Terapiis Semdeg pacientTa 63%, romlebic
agrZelebdnen kandesartanis cileqsetilis miRebas (89%), iRebdnen 32 mg
Terapiul dozas.
CHARM-s sxva gamokvlevaSi -Alternative-gamokvlevaSi (n=2,028) monawileobdnen
pacientebi marcxena parkuWis amovardnis daqveiTebuli fraqciiT < 40%,
romlebic
ar
iRebdnen
angiotenzingardamqmneli
fermentis
inhibitors
autanlobis gamo
(72% - ZiriTadad xvelebis gamo);
gul-sisxlZarRvTa
daavadebebiT gamowveuli letaluri Sedegis da qronikuli gulis ukmarisobis
gamo pirveli hospitalizaciis sixSiris maCveneblebi iyo gacilebiT dabali
pacientTa jgufSi, romlebic iRebdnen kandesartans, vidre placebos jgufSi
(riskebis Sesabamisoba = 0,77, 95% ndobis intervali 0,67 - 0,89, р < 0,001).
SedarebiTi riskis daqveiTeba Seadgenda 23%. statistikurad am kvlevaSi gulsisxlZarRvTa garTulebis Sedegad letaluri Sedegis erTi SemTxvevis Tavidan
asacileblad an
qronikuli gulis ukmarisobiT hospitalizaciisaTvis
aucilebeli iyo 14 pacientis mkurnaloba gamokvlevis mTel periodSi.
kombinirebuli kriteriumi, romelic moicavda letaluri Sedegis sixSires
maTi mizezebisgan damoukideblad da qronikuli gulis ukmarisobiT pirveli
hospitalizaciis maCvenebeli iyo agreTve mniSvnelovnad dabali pacientTa
jgufSi, romlebic iRebdnen kandesartans (riskebis Sesabamisoba = 0,80, 95%
ndobis intervali 0,70 - 0,92, р = 0,001). amasTan aRiniSna kandesartanis dadebiTi
moqmedeba am kombinirebuli kriteriumis TiToeul Semadgenelze – letaluri
Sedegebis
sixSireze
da
daavadebaze (qronikuli
gulis
ukmarisobiT
hospitalizaciis sixSiris maCvenebeli). kandesartani cileqsetilis gamoyeneba
iwvevda qronikuli gulis ukmarisobis funqcionaluri klasis gaumjobesebas
NYHA-is klasifikaciiT (р = 0,008).
CHARM-Added-gamokvlevaSi (n = 2548) marcxena parkuWis amovardnis fraqciis
daqveiTebis
mqone
pacientebSi
<
40%,
romlebic
iRebdnen
angiotenzingardamqmneli fermentebis inhibitorebs, kombinirebuli kriteriumi,
romelic moicavda gul-sisxlZaRvTa daavadebiT gamowveuli letalurobis da
qronikuli gulis ukmarisobiT pirveli hospitalizaciis maCvenebels, iyo
mniSvnelovnad dabali pacientebis jgufSi, romlebic iRebdnen kandesartans,
placebos jgufTan SedarebiT
(riskebis Sesabamisoba = 0,85, 95% ndobis
intervali 0,75 - 0,96, р = 0,011), rac Seesabameboda SedarebiTi riskis daqveiTebas
15%-iT.
am
gamokvlevaSi
qronikuli
gul-sisxlZarRvTa
garTulebiT
gamowveuli letaluri Sedegis erTi SemTxvevis Tavidan asacileblad an
qronikuli gulis ukmarisobiT hospitalizaciisaTvis aucilebeli iyo 23
pacientisaTvis mkurnalobis Catareba gamokvlevis mTel periodSi. efeqturobis
kombinirebuli
kriteriumis
mniSvneloba,
romelic
moicavda
letaluri
Sedegebis sixSiris Sefasebas maTi mizezebisgan an
qronikuli gulis
ukmarisobiT pirveli hospitalizaciis sixSirisgan damoukideblad,
iyo
gacilebiT dabali pacientebis jgufSi, romlebic iRebdnen
kandesartans
(riskebis Sesabamisoba = 0,87, 95% ndobis intervali 0,78 - 0,98, р = 0,021), romelic
agreTve miuTiTebda kandesartanis miRebis dadebiT efeqtze. kandesartani
cileqsetilis gamoyeneba iwvevda qronikuli gulis ukmarisobis funqcionaluri
klasis gaumjobesebas
NYHA-is klasifikaciiT (р = 0,020).
CHARM-Preserve kvlevaSi (n=3023) SenarCunebuli sistoluri funqciis (marcxena
parkuWis amovardnis fraqcia > 40%) mqone pacientebSi ar yofila gamovlenili
efeqturobis kombinirebuli kriteriumis mniSvnelobis statistikurad sarwmuno
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sxvaoba, romelic moicavs letaluri Sedegebis sixSires da pirveli
hospitalizaciis sixSires qronikuli gulis ukmarisobis gamo kandesartanis da
placebos jgufebSi (riskebis Sesabamisoba = 0,89, 95% ndobis intervali 0,77 1,03, р = 0,118). am kriteriumis umniSvnelo ricxobrivi daqveiTeba ganpirobebuli
iyo hospitalizaciis sixSiris daqveiTebiT qronikuli gulis ukmarisobis gamo.
mocemul kvlevaSi ar iqna naCvenebi kandersartanis zemoqmedeba letaluri
Sedegebis sixSireze.
CHARM programis 3 kvlevis Sedegebis calk-calke analizisas ar iqna miRebuli
letaluri Sedegebis sixSiris sarwmuno gansxvavebebi kandesartanis da
placebos jgufebSi. Tumca letaluri Sedegebis sixSire Sefasebuli iqna
CHARM kvlevebis gaerTianebul populaciaSi - Alternative da CHARM - Added da
samive gamokvlevaSi (riskebis Sefardeba = 0,91, 95% ndobis intervali 0,83 - 1,00, р
= 0,055). letaluri Sedegebis sixSiris da hospitalizaciis sixSiris daqveiTeba
qronikuli gulis ukmarisobis gamo kandesartaniT Terapiis fonze ar iyo
damokidebuli asakze, sqesze da Tanmxleb Terapiaze. kandesartani efeqturi iyo
agreTve
pacientebSi,
romlebic
iRebdnen
beta-adrenoblokatorebs
angiotenzingardamqmneli
fermentebis
inhibitorebTan
erTad,
amasTan
kandesartanis efeqturoba ar aris damokidebuli imaze, iRebs Tu ara pacienti
angiotenzingardamqmneli fermentebis inhibitorebis optimalur dozas.
qronikuli gulis ukmarisobis da marcxena parkuWis daqveiTebuli sistoluri
funqciis (marcxena parkuWis amovardnis fraqcia < 40%) mqone pacientebis mier
kandesartanis miReba xels uwyobda zogadi periferiuli sisxlZarRvovani
winaaRmdegobis
da
filtvebSi
kapilaruli
wnevis
daqveiTebas, reninis
aqtiurobis momatebas da sisxlis plazmaSi angiotenzini II koncentracias,
agreTve aldosteronis donis daqveiTebas.
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ny
farmakokinetika
Sewova da ganawileba
kandesartani cileqsetili warmoadgens preparats Sinaganad misaRebad. Cqara
gardaiqmneba aqtiur nivTierebad – kandesartani eTerhidrolizis saSualebiT
saWmlis momnelebeli traqtidan Sewovisas, mWidrod ukavSirdeba angiotenzin 1
receptorebs da nela disocirebs, ar gaaCnia agonistis Tvisebebi. kandesartanis
absoluturi biomisawvdomoba kandesartani cileqsetilis xsnaris Sinaganad
miRebisas Seadgens daaxloebiT 40%. tabletirebuli preparatis SedarebiTi
biomisawvdomoba Sinaganad misaReb xsnarTan SedarebiT Seadgens daaxloebiT
34%.
amrigad,
preparatis
tabletirebuli
formis
absoluturi
biomisawvdomobis
gaTvla
Seadgens 14%. sisxlis
SratSi
maqsimalur
koncentracias (Сmax) aRwevs preparatis tabletirebuli formis miRebidan 3-4
saaTSi. rekomendebul farglebSi preparatis dozis momatebisas kandesartanis
koncentracia imatebs xazurad. kandesartanis farmakokinetikuri parametrebi ar
aris damokidebuli pacientis sqesze. sakvebis miReba ar axdens mniSvnelovan
zegavlenas
farTobze
mrudiT
”koncentracia-dro” (AUC), anu
sakvebis
erTdrouli miReba arsebiTad ar moqmedebs preparatis biomisawvdomobaze.
kandesartani
aqtiurad
ukavSirdeba
sisxlis
plazmis
cilebs (>99%).
kandesartanis ganawilebis moculoba Seadgens 0,1 l/kg.
metabolizmi da organizmidan gamoyvana
kandesartani ZiriTadad gamoiyofa organizmidan TirkmelebiT da
Seucvleli
saxiT
da
mxolod
umniSvnelod
metabolizdeba
kandesartanis naxevradgamoyvanis periodi Seadgens daaxloebiT
kumulacia organizmSi ar SeimCneva.
naRveliT
RviZlSi.
9 saaTs.
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kandesartanis saerTo klirensi Sedgens daaxloebiT 0,37 ml/wT/kg, amasTan,
Tirkmlis klirensi – daaxloebiT 0,19 ml/wT/kg. kandesartanis Tirkmlis
eqskrecia xorcieldeba gorgliseburi filtraciiT da aqtiuri arxovani
sekreciiT. radioaqtiurad-niSnuli kandesartani
cileqsetilis Sinaganad
miRebisas Seyvanili raodenobidan daaxloebiT 26% gamoiyofa TirkmelebiT
kandesartanis saxiT da 7% araaqtiuri metabolitis saxiT, maSin, rodesac
ganavalSi aRmoCenilia Seyvanili raodenobidan kandesartanis saxiT 56% da 10%
araaqtiuri metabolitis saxiT.
xandazmul avadmyofebSi ( 65 welze zemoT) kandesartanis Cmax da AUC izrdeba
Sesabamisad 50% da 80% axalgazrda pacientebTan SedarebiT. Tumca hipotenziuri
efeqti da gverdiTi efeqtebis warmoSobis sixSire atakandis miRebisas ar aris
damokidebuli pacientebis asakze.
Tirkmlis funqciis msubuqi da zomieri darRvevis mqone pacientebSi
kandesartanis Cmax da AUC izrdeboda Sesabamisad 50% da 70%, maSin, rodesac
preparatis naxevradgamoyvanis periodi ar icvleba Tirkmlis normaluri
funqciis mqone avadmyofebTan SedarebiT. Tirkmlis funqciis mZime darRvevis
mqone pacientebSi kandesartanis Cmax da AUC izrdeboda Sesabamisad 50% da
110%,
xolo
preparatis naxevradgamoyvanis periodi
izrdeboda
2-jer.
hemodializze myof pacientebSi gamovlenili iqna kandesartanis iseTive
farmakokinetikuri parametrebi, rogoric Tirkmlis funqciis mZime darRvevis
mqone pacientebSi.
RviZlis funqciis msubuqi da zomieri darRvevis mqone pacientebSi aRiniSneboda
kandesartanis AUC momateba 23%-iT.
ny
gamoyenebis Cveneba
arteriuli hipertenzia
qronikuli gulis ukmarisoba da marcxena parkuWis sistoluri funqciis
darRveva (marcxena parkuWis amovardnis fraqciis daqveiTeba ≤ 40%) angiotenzingardamqmneli
fermentis
inhibitorebis
damatebiTi
Terapiis
saxiT
an
angiotenzin-gardamqmneli fermentis inhibitorebis autanlobisas (ix. Tavi
“farmakodinamika”).
pa
ukuCvenebebi
kandesartani cileqsetilis an preparatis SemadgenlobaSi Semavali sxva
komponentebis mimarT momatebuli mgrZnobeloba.
orsuloba da laqtaciis periodi (ix. Tavi “orsuloba da laqtaciis periodi”).
RviZlis funqciis gamoxatuli darRvevebi da/an qolestazi.
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om
sifrTxiliT:
gamoxatuli Tirkmlis ukmarisobis mqone avadmyofebi (kreatininis klirensi 30
ml/wT qvemoT), Tirkmlis arteriebis ormxrivi stenozi an erTaderTi Tirkmlis
arteriis stenozi aortaluri da mitraluri sarqvelis hemodinamiurad
mniSvnelovani
stenozi
anamnezSi
Tirkmlis
gadanergvis
Semdeg,
cerebrovaskularuli da gulis iSemiuri daavadebis mqone pacientebi,
hiperkaliemia, macirkulirebeli sisxlis daqveiTebuli moculobis avadmyofebi,
pirveladi hiperaldosteronizmis mqone avadmyofebi (klinikuri kvlevebis
mixedviT
ar
aris
monacemebis
sakmarisi
raodenoba), hipertrofiuli
kardiomiopaTia, 18 wlamde asaki (efeqturoba da usafrTxoeba dadgenili ar
aris).
orsuloba da laqtaciis periodi
orsuloba
fid
en
tia
l
adamianis embrionis Tirkmlis sisxliT momaragebis sistema, romelic
damokidebulia renin-angiotenzin-aldosteronuli sistemis ganviTarebaze,
iwyebs formirebas orsulobis meore trimestrSi. amgvarad, atakandis
daniSvnisas orsulobis meore da mesame trimestrebSi izrdeba riski
nayofisaTvis. preparatebma, romlebic pirdapir zemoqmedeben renin-angiotenzinaldosteronul sistemaze, SesaZloa gamoiwvion nayofis ganviTarebis
darRvevebi an negatiurad imoqmedon axalSobilze, letaluri Sedegis CaTvliT
orsulobis meore da mesame trimestrebSi preparatis gamoyenebisas.
cxovelebze
kvlevebis
Catarebisas
gamovlinda
Tirkmelebis
dazianeba
embrionul da neonatalur periodebSi kandesartani cileqsetilis miRebisas.
varaudoben,
rom
dazianebis
meqanizmi
ganpirobebulia
preparatis
farmakologiuri zemoqmedebiT renin-angiotenzin-aldosteronul sistemaze.
miRebul informaciaze dayrdnobiT, dauSvebelia atakandis miReba orsulobisas.
Tu orsuloba gamovlinda atakandiT mkurnalobis periodSi, aucilebelia
Terapiis Sewyveta (ix. Tavi “ukuCvenebebi”).
laqtaciis periodi
amJamad ucnobia, aRwevs Tu ara kandesartani dedis rZeSi.
Cvil bavSvebze SesaZlo arasasurveli moqmedebis gamo atakandis miReba ZuZuTi
kvebis periodSi rekomendebuli ar aris.
gamoyenebis wesi da dozireba
ny
C
on
atakandi gamoiyeneba erTxel dRe-RameSi sakvebis miRebisgan damoukideblad
arteriuli hipertenzia
atakandis rekomendebuli sawyisi da damxmare dozaa 8 mg erTxel dRe-RameSi.
pacientebisaTvis, romelTac esaWiroebaT arteriuli wnevis Semdgomi dakleba,
rekomendebulia
dozis
momateba
16
mg-mde
dRe-RameSi.
maqsimaluri
antihipertenziuli efeqti miiReba mkurnalobis dawyebidan
4 kviris
ganmavlobaSi.
Tu atakandiT Terapia ar iZleva sasurvel Sedegs arteriuli wnevis daklebiT
optimalur donemde, rekomendebulia Terapias daematos Tiaziduri diuretiki.
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pa
xandazmuli asakis pacientebi
xandazmuli asakis pacientebSi preparatis sawyisi dozis koreqcia aucilebeli
ar aris.
Tirkmlis funqciis darRvevis mqone pacientebi
Tirkmlis funqciis msubuqi an zomieri darRvevis mqone pacientebisaTvis
(kreatininis klirensi > 30 ml/wT/1,73 m2 sxeulis zedapiris farTobisaTvis )
preparatis sawyisi dozis Secvla saWiro ar aris.
preparatis gamoyenebis klinikuri gamocdileba Tirkmlis funqciis mZime
darRvevebis mqone pacientebisaTvis (kreatininis klirensi < 30 ml/wT/1,73 m2
sxeulis zedapiris farTobisaTvis) SezRudulia; am SemTxvevaSi saWiroa
ganxiluli iqnes mkurnalobis dawyebis SesaZlebloba 4 mg sadReRamiso
dozidan.
RviZlis funqciis darRvevis mqone pacientebi
RviZlis
funqciis
msubuqi
da
saSualo
simZimis
darRvevis
mqone
pacientebisaTvis rekomendebulia mkurnalobis dawyeba 2 mg sadReRamiso
dozidan erTxel dRe-RameSi. saWiroebis SemTxvevaSi dasaSvebia dozis gazrda.
RviZlis mZime dazianebis mqone avadmyofebSi gamoyenebis klinikuri gamocdileba
SezRudulia.
Tanmxlebi Terapia
C
om
pa
ny
C
on
fid
en
tia
l
atakandis miRebam Tiaziduri tipis diuretikebTan erTad
(magaliTad,
hidroqloroTiazidi) SesaZloa gaaZlieron atakandis hipotenziuri efeqti.
qronikuli gulis ukmarisoba
atakandis rekomendebuli sawyisi doza Seadgens 4 mg erTxel dRe-RameSi. dozis
momateba 32 mg-mde erTxel dRe-RameSi an maqsimalurad gadasatan dozamde
xdeba misi gaormagebis gziT aranakleb ori kviris intervalebiT (ix. Tavi
“gansakuTrebuli miTiTebebi”)
pacientTa gansakuTrebuli jgufebi
xandazmuli asakis da Tirkmelebis an RviZlis funqciis darRvevis mqone
pacientebisaTvis saWiro ar aris preparatis sawyisi dozis Secvla.
gamoyeneba bavSvebSi da mozardebSi
bavSvebSi da mozardebSi (18 wlamde asaki) atakandis gamoyenebis efeqturoba da
usafrTxoeba dadgenili ar aris.
Tanmxlebi Terapia
atakandis daniSvna SesaZlebelia qronikuli gulis ukmarisobis Terapiisas
gamosayenebel sxva saSualebebTan erTad, magaliTad, apf-inhibitorebTan, betaadrenoblokatorebTan, diuretikebTan da sagule glikozidebTan erTad (ix.
Tavebi “gansakuTrebuli miTiTebebi”, “farmakodinamika”).
gverdiTi movlenebi
arteriuli hipertenzia
gverdiTi efeqtebi klinikuri kvlevebis Catarebisas atarebdnen zomier xasiaTs
da sixSiriT iyo SedarebiTi placebos jgufTan.
atakandis miRebis fonze
gverdiTi efeqtebis warmoqmnis saerTo sixSire ar iyo damokidebuli preparatis
dozaze da pacientis asakze. Terapiis Sewyvetis SemTxvevebis sixSire gverdiTi
efeqtebis gamo msgavsi iyo kandesartani cileqsetilis (2,4%) da placebos (2,6%)
gamoyenebisas.
Catarebuli kvlevebis monacemebis analizisas aRiniSneboda gverdiTi efeqtebi,
romlebic xSiri iyi (>1/100) kandesartani cileqsetilis miRebis fonze. aRwerili
gverdiTi efeqtebi aRiniSneboda Tundac 1% meti sixSiriT, vidre placebos
jgufSi.
centraluri nervuli sistemis mxriv: Tavbrusxveva/sisuste, Tavis tkivili;
Zval-kunTovani sistemis, SemaerTebeli qsovilis mxriv: tkivili welis areSi;
infeqciebi: respiratoruli infeqciebi;
laboratoriuli
maCveneblebi:
mTlianobaSi
atakandis
gamoyenebisas
ar
aRniSnula
standartuli
laboratoriuli
maCveneblebis
klinikurad
mniSvnelovani cvlilebebi. iseve rogorc renin-angiotenzin-aldosteronuli
sistemis sxva inhibitorebis gamoyenebisas, SesaZlebelia aRiniSnos hemoglobinis
koncentraciis umniSvnelo daqveiTeba. aRiniSna kreatininis, Sardovanas an
kaliumis Semcvelobis momateba da natriumis Semcvelobis daqveiTeba.
alaninaminotransferazas (alt) donis momateba ufro xSirad aRiniSna atakandis
miRebisas placebosTan SedarebiT (1,3% nacvlad 0,5%). zogadad, atakandis
miRebisas saWiro ar aris laboratoriuli maCveneblebis regularuli
kontroli. Tumca Tirkmelebis funqciis darRvevis mqone pacientebisaTvis
rekomendebulia sisxlis SratSi kaliumis da kreatininis donis perioduli
kontroli.
qronikuli gulis ukmarisoba
atakandis gamoyenebis fonze gamovlenili gverdiTi efeqtebi qronikuli gulis
ukmarisobis mqone pacientebSi Seesabamebodnen preparatis farmakologiur
Tvisebebs da damokidebuli iyo pacientis mdgomareobaze.
CHARM-is klinikuri gamokvlevebisas Catarda 32 mg-mde (n=3803) doziT atakandis
Sedareba (n=3803) placebosTan (n=3796), pacientTa 21% jgufidan, romlebic
iRebdnen kandesartani cileqsetils da pacientTa 16,1% jgufidan, romlebic
iRebdnen placebos, Sewyvites mkurnaloba gverdiTi reaqciebis gamo.
pa
ny
C
on
fid
en
tia
l
yvelaze xSirad aRniSnuli gverdiTi efeqtebi (>1/100, <1/10):
gul-sisxlZarRvTa sistemis mxriv: arteriuli wnevis gamoxatuli daqveiTeba;
Sardgamomyofi sistemis mxriv: Tirkmelebis funqciis darRveva;
laboratoriuli cvlilebebi: kreatininis, Sardovanas da kaliumis donis
momateba;
rekomendebulia sisxlis SratSi kreatininis da kaliumis donis kontroli.
preparatis postmarketinguli gamoyenebis msvlelobisas Semdgomi gverdiTi
efeqtebis Sesaxeb cnobebi iyo Zalian iSviaTad (<1/10000):
sisxlis
da
limfaturi
sistemis
mxriv:
leikopenia,
neitropenia
da
agranulocitozi;
metabolizmis darRveva da metabolizmis darRveviT gamowveuli daavadebebi:
hiperkaliemia, hiponatriemia;
nervuli sistemis mxriv: Tavbrusxveva, sisuste, Tavis tkivili;
kuW-nawlavis traqtis mxriv: gulisreva;
RviZlisa da sanaRvle gzebis mxriv: “RviZlis”fermentebis aqtivobis momateba,
RviZlis funqciis darRveva an hepatiti;
alergiuli reaqciebi: angionevrotuli SeSupeba, gamonayari kanze, WinWris cieba,
kanis qavili;
Zval-kunTovani sistemis, SemaerTebeli qsovilebis mxriv: tkivili welis areSi,
arTralgia, mialgia;
Sardgamomyofi sistemis mxriv: Tirkmelebis funqciis darRveva, Tirkmlis
ukmarisobis CaTvliT midrekilebis mqone pacientebSi
Warbi dozireba
simptomebi
preparatis farmakologiuri Tvisebebis analizi saSualebas iZleva vivaraudoT,
rom dozis gadametebis ZiriTadi gamovlinebaa klinikurad gamoxatuli
arteriuli wnevis daqveiTeba da Tavbrusxveva. aRiniSna preparatis dozis
gadametebis calkeuli SemTxvevebi (672 mg-mde kandesartani cileqsetili),
romlebic dasrulda pacientebis gamojanmrTelebiT mZime Sedegebis gareSe.
mkurnaloba
klinikurad gamoxatuli arteriuli hipotenziis ganviTarebisas aucilebelia
simptomaturi mkurnalobis Catareba da pacientis mdgomareobis kontroli.
rekomendebulia pacientis dawvena, sawolis Tavis wamoweva. saWiroebis
SemTxvevaSi SeiZleba macirkulirebeli plazmis moculobis gazrda, magaliTad
natriumis
qloridis
izotonuri
xsnaris
intravenurad Seyvanis
gziT.
aucileblobidan gamomdinare, SeiZleba dainiSnos simpatomimeturi preparatebi.
kandesartanis gamoyvana hemodializis daxmarebiT naklebad savaraudoa.
C
om
urTierTqmedeba
sxva
samkurnalo
saSualebebTan
da
samkurnalo
urTierTqmedebis sxva formebi
farmakokinetikur
gamokvlevebSi
Seswavlili
iqna
atakandis
erToblivi
gamoyeneba
hidroqlorotiazidTan,
varfarinTan,
digoqsinTan,
peroralur
kontraceptivebTan
(eTinilestradioli/levonorgestreli),
glibenklamidTan,
nifedipinTan da enalaprilTan.
wamlis klinikurad mniSvnelovani urTierTqmedeba ar gamovlenila.
kandesartani
metabolizdeba
RviZlSi
umniSvnelo
doniT
(CYP2C9).
urTierTqmedebaze Catarebulma gamokvlevebma ar gamoavlines preparatis
zemoqmedeba CYP2C9
da CYP3A4-ze.
Р450 citoqromis
sistemis
sxva
izofermentebze moqmedeba Seswavlili ar yofila.
atakandis da sxva antihipertenziuli saSualebebis erTdrouli miReba
potenciurs xdis hipotenziur efeqts.
tia
l
renin-angiotenzin-aldosteronul
sistemaze
moqmedi
sxva
samkurnalo
saSualebebis gamoyenebis gamocdilebam aCvena, rom Tanmxlebma Terapiam
kaliumdamzogavi diuretikebiT, kaliumis preparatebiT, kaliumis Semcveli
marilis SemcvlelebiT da sxva saSualebebiT, romelTac SeuZliaT sisxlis
SratSi kaliumis donis momateba (magaliTad, heparini ), SesaZloa gamoiwvios
hiperkaliemia.
liTiumis preparatebis da angiotenzingardamqmneli fermentebis inhibitorebis
erTdrouli daniSvnisas aRiniSna sisxlis SratSi liTiumis koncentraciis
Seqcevadi momateba da toqsikuri reaqciebis ganviTareba. msgavsi reaqciebi
SeiZleba aRiniSnos angiotenzin II receptorebis antagonistebis gamoyenebisas,
ris gamoc rekomendebulia sisxlis SratSi liTiumis donis kontroli am
preparatebis kombinirebuli gamoyenebisas. kandesartanis biomisawvdomoba ar
aris damokidebuli sakvebis miRebaze.
ny
C
on
fid
en
gansakuTrebuli miTiTebebi
Tirkmelebis funqciis darRveva
atakandiT Terapiis fonze, iseve rogorc renin-angiotenzin-aldosteronuli
sistemis damTrgunveli sxva saSualebebis gamoyenebisas, zogierT pacientebs
SesaZloa aReniSnoT Tirkmelebis funqciis darRveva.
atakandis gamoyenebisas arteriuli hipertenziis da gamoxatuli Tirkmlis
ukmarisobis mqone pacientebSi rekomendebulia sisxlis SratSi kaliumis da
kreatininis donis perioduli kontroli.
Tirkmelebis funqciis mZime darRvevis an Tirkmlis ukmarisobis terminaluri
stadiis mqone pacientebSi preparatis gamoyenebis klinikuri gamocdileba
SezRudulia (kreatininis klirensi 15 ml/wT-ze qvemoT).
qronikuli gulis ukmarisobis mqone pacientebSi aucilebelia Tirkmelebis
funqciis perioduli kontroli, gansakuTrebiT 75 wlis da zeviT asakis
pacientebSi, agreTve Tirkmelebis funqciis darRvevis mqone pacientebSi.
atakandis dozis momatebisas agreTve rekomendebulia kaliumis da kreatininis
donis kontroli.
atakandis klinikur gamokvlevaSi qronikuli gulis ukmarisobisas ar
monawileobdnen pacientebi kreatininis doniT > 265 mkmol/l (> 3 mg/dl).
C
om
pa
angiotenzingardamqmneli fermentebis inhibitorebTan erTdrouli gamoyeneba
qronikuli gulis ukmarisobisas
kandesartanis
da
angiotenzingardamqmneli
fermentebis
inhibitorebTan
erTdrouli
gamoyenebisas
SesaZloa
gaizardos
gverdiTi
movlenebis
ganviTarebis riski, gansakuTrebiT Tirkmelebis funqciis darRvevebis
da
hiperkaliemiis riski (ix. Tavi “gverdiTi movlenebi”).
am SemTxvevebSi
aucilebelia meTvalyureoba da laboratoriuli maCveneblebis kontroli.
Tirkmlis arteriis stenozi
Tirkmlis arteriis ormxrivi stenozis an erTaderTi Tirkmelis arteriis
stenozis mqone pacientebSi preparatebma, romlebic gavlenas axdenen reninangiotenzin-aldosteronul
sistemaze,
kerZod
angiotenzingardamqmneli
fermentebis inhibitorebma SesaZloa gamoiwvion Sardovanas da kreatininis
donis momateba sisxlis SratSi. msgavsi efeqtebi mosalodnelia angiotenzini II
receptorebis antagonistebis daniSvnisas.
Tirkmlis gadanergva
axlaxans Tirkmelgadanergil mqone pacientebSi atakandis gamoyenebis monacemebi
ar arsebobs.
arteriuli hipotenzia
C
om
pa
ny
C
on
fid
en
tia
l
qronikuli gulis ukmarisobis mqone pacientebs atakandiT Terapiis fonze
SesaZloa ganuviTardeT arteriuli hipotenzia. iseve rogorc renin-angiotenzinaldosteronul sistemaze moqmedi sxva preparatebis gamoyenebisas, arteriuli
hipotenziis ganviTarebis mizezi arteriuli hipertenziis mqone pacientebSi
SeiZleba iyos macirkulirebeli sisxlis moculobis Semcireba, rogoric
SeiniSneba pacientebSi, romlebic iReben diuretikebis did dozebs. amitom
Terapiis dawyebisas saWiroa sifrTxile da aucileblobisas Catardes
hipovolemiis koreqcia.
zogadi anesTezia da qirurgia
pacientebs, romlebic iReben angiotenzini II antagonistebs, zogadi anesTeziis
Catarebisas da qirurgiuli Carevisas, SesaZloa ganuviTardeT arteriuli
hipotenzia renin-angiotenzinis sistemis blokadis Sedegad. Zalian iSviaTad
SesaZloa aRiniSnos mZime arteriuli hipotenziis SemTxvevebi, romlebic
saWiroeben siTxis da/an vazopresorebis intravenur Seyvanas.
aortis an mitraluri sarqvelis stenozi (obstruqciuli hipertrofuli
kardiomiopaTia)
iseve
rogorc
sxva
vazodilatatorebis,
aseve
atakandis
daniSvnisas
obstruqciuli hipertrofuli kardiomiopaTiis, aortuli an mitraluri
sarqvelis hemodinamiurad mniSvnelovani stenozis mqone pacientebisaTvis
saWiroa sifrTxilis dacva.
pirveladi hiperaldosteronizmi
pirveladi hiperaldosteronizmis mqone pacientebi zogadad rezistentuli
arian renin-angiotenzin-aldosteronul sistemaze moqmedi antihipertenziuli
preparatebiT
Terapiis
mimarT.
amis
gamo
atakandis
daniSvna
aseTi
pacientebisaTvis rekomendebuli ar aris.
hiperkaliemia
renin-angiotenzin-aldosteronul
sistemaze
moqmedi
sxva
preparatebis
gamoyenebis klinikuri gamocdileba aCvenebs, rom atakandis da kaliumSemnaxveli
diuretikebis, kaliumis preparatebis, kaliumSemcveli Semcvleli marilebis an
sxva preparatebis, romelTac SeuZliaT sisxlSi kaliumis Semcvelobis momateba
(magaliTad, heparini) daniSvnam SesaZloa gamoiwvios hiperkaliemiis ganviTareba
arteriuli hipertenziis mqone pacientebSi.
qronikuli gulis ukmarisobis mqone pacientebs atakandiT Terapiis fonze
SesZloa ganuviTardeT hiperkaliemia. atakandis daniSvnisas qronikuli gulis
ukmarisobis mqone pacientebisaTvis rekomendebulia sisxlSi kaliumis donis
regularuli kontroli, gansakuTrebiT angiotenzingardamqmneli fermentebis
inhibitorebTan da kaliumSemnaxvel diuretikebTan erTdrouli daniSvnisas.
zogadi
pacientebi, romelTa sisxlZarRvTa tonusi da Tirkmelebis funqcia upiratesad
damokidebulia
renin-angiotenzin-aldosteronuli
sistemis
aqtiurobaze
(magaliTad, mZime qronikuli gulis ukmarisobis an Tirkmelebis daavadebis
mqone avadmyofebi, maT Soris Tirkmlis arteriis stenozi), gansakuTrebiT
mgrZnobiareni
arian
preparatebis
mimarT,
romlebic
moqmedeben
reninangiotenzin-aldosteronul sistemaze. am avadmyofebSi msgavsi preparatebis
daniSvna iwvevs mkveTr arteriul hipotenzias, azoTemias, oligurias da
iSviaTad – mwvave Tirkmlis ukmarisobas. CamoTvlili efeqtebis ganviTarebis
SesaZlebloba ar aris gamoricxuli angiotenzin II receptorebis antagonistebis
gamoyenebisasac. arteriuli wnevis mkveTrma dacemam iSemiuri kardiopaTiis an
iSemiuri
genezis
cerebrovaskularuli
daavadebebis
mqone
pacientebSi
nebismieri antihipertenziuli saSualebis gamoyenebisas SesaZloa gamoiwvios
miokardiumis infarqtis an insultis ganviTareba.
zemoqmedeba avtomobilis marTvis an teqnikasTan muSaobis unarze
tia
l
zemoqmedeba avtomobilis marTvis an teqnikasTan muSaobis unarze ar
Seswavlila, magram preparatis farmakodinamikuri Tvisebebi miuTiTebs, rom
amgvari zemoqmedeba ar arsebobs.
avtotransportis marTvisas da potenciurad saSiSi saxeebiT moqmedebisas,
romlebic moiTxoven yuradRebis momatebul koncentracias da fsiqomotoruli
reaqciis
siswrafes,
saWiroa
gaTvaliswinebuli
iqnes,
rom
preparatis
gamoyenebisas SesaZloa aRiniSnos Tavbrusxveva da momatebuli daRliloba.
gamoSvebis forma
tabletebi 8 da 16 mg
14 tableti aluminis blisterSi, 2-2 blisteri muyaos kolofSi gamoyenebis
instruqciasTan erTad.
en
Senaxvis pirobebi
inaxeba 30°С temperaturaze qvemoT, bavSvebisgan miuwvdomel adgilas.
CamonaTvali Б.
vargisianobis vada
3 weli. ar gamoiyeneba vargisianobis vadis gasvlis Semdgom.
afTiaqidan gacemis pirobebi
fid
ფარმაცევტული პროდუქტის ჯგუფი II - გამოიყენება ექიმის დანიშნულებით
C
on
saregistracio mowmobis mflobeli
astrazeneka АБ, SЕ-151 85 sodertalie, SvedeTi
AstraZeneca AB, Sweden, SЕ-151 85 Sodertalje, Sweden
mwarmoebeli
astrazeneka АБ, SE-151 85 sodertalie, SvedeTi
AstraZeneca AB, Sweden, SE-151 85 Sodertalje, Sweden
C
om
pa
ny
xarisxis kontrolis gamomSvebi
1. astrazeneka АБ, SE-151 85 sodertalie, SvedeTi
AstraZeneca AB, Sweden, SE-151 85 Sodertalje, Sweden
2. korden farma ГмбХ, oto-xan-Strase, D-68723plankStadti, germania
Corden Pharma GmbH, Otto-Hahn-Strasse, D-68723 Plankstadt, Germany
3. astrazeneka ГмбХ, tinsdaleri Вег 183, 22880, vedeli, germania
AstraZeneca GmbH, Tinsdaler Weg 183, 22880 Wedel, Germany
damatebiTi informaciis warmodgena xdeba moTxovniT:
astrazeneka limitedis warmomadgenloba, didi britaneTi, q. moskovSi da Sps
astrazeneka farmasiutikalzi
125284 moskovi, begovaias q. 3, mS. 1
tel. +7495 7995699
faqsi +7495 7995698
kandesartana cileqsetilis warmoeba xdeba licenziiT “Takeda Pharmaceutical
Company Limited”
atakandi –savaWro niSani, astrazenekas kompaniebis jgufis kuTvnileba.
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