danarti N 1 - HYZAAR FORTE_100_25 instrukcia

danarti N 1 - HYZAAR FORTE_100_25 instrukcia

samkurnalo saSualebis samedicino gamoyenebis
instruqcia
hizaar forte / HYZAAR FORTE
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saerTaSoriso
arapatentirebuli
saxelwodeba:
lozartani
da
hidroqlorTiazidi
aRwera:
100mg/12,5 mg tabletebi: ovaluri formis, apkiani garsiT dafaruli, TeTri
feris. tabletis erT mxareze aris markireba “745”, meore mxares gluvi.
100mg/25 mg tabletebi: ovaluri formis apkiani garsiT dafaruli, Ria yviTeli
feris. tabletis erT mxareze aris markireba “747”, gluvi meore mxridan.
Semadgenloba:
1 apkiani garsiT dafaruli tableti Seicavs:
aqtiuri nivTierebebi: 100 mg lozartanis kaliumi da 12,5 da 25 mg
hidroqlorTiazidi
damxmare nivTierebebi: mikrokristaluri celuloza, laqtozis monohidrati,
simindis Jelatinizirebuli kraxmali, magniumis stearati.
tabletis
garsi:
hidroqsilpropilmeTilceluloza,
hidroqsipropilceluloza, titaniumis dioqsidi (E171), qinolinis aluminis
laqi yviTeli (E104), karnaubis cvili.
gamoSvebis forma: apkiani garsiT dafaruli tabletebi
farmakoTerapiuli jgufi:
hipoTenziuri kombinirebuli saSualeba (angiotenzin II -is
receptorTa
antagonisti + diuretiki)
ATX kodi: C09DA01
farmakologiuri Tvisebebi
moqmedebis meqanizmi:
lozartan-hidroqlorTiazidi.
hizaar
fortes
preparatis
komponentebi
aCveneben aditiur gavlenas arteriuli wnevis daqveiTebaze, ufro metad sweven
ra dabla arteriul wnevas vidre TiToeuli komponenti calcalke. iTvleba
rom es efqti aris orive komponentis urTierTSevsebadi moqmedebis Sedegi.
Semdeg, diuretiuli moqmedebis Sedegad, hidroqlorTiazidi zrdis reninis
aqtiobas sisxlis plazmaSi, zrdis aldosteronis sekrecias, amcirebs
kaliumis dones sisxlis SratSi da zrdis angiotenzin II-is dones.
lozartanis gamoyeneba blokavs angiotenzin II-is yvela fiziologiurad
mniSvnelovan moqmedebas da aldosteronis inhibirebis saSualebiT amcirebs
diuretikis gamoyenebasTan dakavSirebul kaliumis danakargebs.
lozartani
avlens
msubuq
da
xanmokle
urikozul
moqmedebas.
hidroqlortiazids mivyavarT Sardis mJavis donis zomier matebasTan.
lozartanisa da hidroqlorTiazidis kombinacia xels uwyobs diuretikiT
inducirebuli hiperurikimiis Sesustebas.
preparat hizaar fortes antihipertenziuli efeqti narCundeba 24 saaTis
ganmavlobaSi. klinikur kvlevebSi romlebic grZeldeboda ara nakleb erTi
wlis manZilze, Terapiis gagrZelebisas narCundeboda antihipertenziuli
efeqti. arteriuli wnevis mniSvnelovani Semcirebis miuxedavad preparat
hizaar fortes miReba ar iwvevs gulis SekumSvaTa sixSireze mniSvnelovan
klinikur gavlenas. klinikur kvlevebSi 12-kviriani Terapiis Semdeg 50mg
lozartaniT da 12,5 mg hidroqlorTiazidiT
minimaluri diastoluri
arteriuli wneva (mjdomare mdgomarobaSi gazomili) mcirdeboda saSualod
13,2 mm vrcxl.sv.-iT.
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hizaar forte efeqturad amcirebs arteriul wnevas qalebsa da kacebSi,
negroiduli rasis pacientebSi, aseve sxva rasebSi, ufo axalgazrda (<65) Tu
ufro mozrdil (>65) pacientebSi da arteriuli hipertenziis nebismieri
xarisxis dros.
lozartani. lozartani aris angiotenzin II-is receptorebis sinTetiuri
antagonisti ( T1-is tipis) peroraluri gamoyenebis. angiotenzin II, mZlavri
vazokonstriktori, warmoadgens renin-angiotenzinis sistemis mTavar aqtiur
hormons da arteriuli hipertenziis paTofiziologiaSi mTavar ganmsazRvrel
faqtors.
angiotenzin
II
ukavSirdeba
mraval
qsovilSi
(rogoricaa
sisxlZarRvebis gluvi kunTebi, Tirkmelzeda jirkvlebi, RviZli da guli)
arsebul T1 receptorebs da avlens ramdenime metad mniSvelovan biologiur
moqmedebas vazokonstriqciis da aldosteronis gamoTavisuflebis CaTvliT.
angiotenzin II aseve astimulirebs gluvkunTovani ujredebis proliferacias.
lozartani seleqciurad blokavs T1 receptorebs in vitro da in vivo
gamokvlevebSi lozartani da misi farmakologiurad aqtiuri metabolitikarboqsilis mJava— 3174 blokaven angiotenzin II-is yvela fiziologiurad
mniSvnelovan efeqts damoukideblad wyarosi an misi sinTezis gzisa.
lozartani ar avlens agonistur moqmedebas da ar blokavs hormonebis sxva
receptorebs
da
ionur
arxebs
romlebic
monawileobas
iReben
gulsisxlZarRvTa sistemis regulaciaSi. ufro metic, lozartani ar
Trgunavs АПФ (kininaza II)-s – ferments, romelic xels uwyobs bradikininis
daSlas. amis Sedegad ar SeimCneva bradikiniT ganpirobebuli gverdiTi
movlenebis warmoSobis potencia. lozartanis gamoyenebisas angiotenzin II-is
reninis sekreciaze negatiuri uku reaqciis moxsnas mivyavarT reninis
aqtivobis gazrdisken sisxlis plazmaSi (arp). aseTi zrdis miuxedavad
narCundeba aldosteronis antihipertenziuli aqtivoba da sisxlis plazmaSi
koncentraciis Semcireba rac mowmobs angiotenzin II-is receptorebis efeqtur
blokadaze. lozartanis gamoyenebis Sewyvetis mere reninis aqtivoba sisxlis
plazmaSi da angiotenzin II-is doneebi 3 dRis manZilze ubrundeba sawyis
maCvenebels.
lozartansac iseve, rogorc mis ZiriTad metabolits gaaCniaT meti naTesaoba
T1
receptorebis mimarT vidre T2-sa. aqtiuri metaboliti 10-40 -jer ufro
aqtiuria vidre lozartani (masaze gadaangariSebiT).
lozartanis mimReb pacientebSi xvelebis warmoSobis sixSiris Sesafaseblad
specialurad SemuSavebul kvlevebSi angiotenzinis gardamqmneli fermentis
(agf) inhibitorebis mimRebebisgan SedarebiT xvelebis sixSire lozartanisa
da hidroqlorTiazidis mimReb pacientebSi iyo msgavsi da kidev ufro dabali
vidre im pacientebSi romlebic mkurnalobas iRebdnen agf inhibitorebiT.
garda amisa 16 ormag-brma 4,131 pacientis monawileobiT Caatarebul klinikur
gamokvlevebis saerTo analizSi spontanuri Setyobinebebis sixSire xvelaze
lozartanis mimReb pacientebSi iyo msgavsi (3,1%) sixSirisa im pacientebSi
romlebic iRebdnen placebos (2,6%) an hidroqlortiazids (4,1 %) xolo
xvelebis sixSire agf inhibitorebis miRebisas Seadgenda 8,8 %-s.
pacientebSi arteriuli hipertenziiT da proteinuriiT romlebic ar arian
daavadebuli Saqriani diabetiT kaliumis lozartani namdvilad aqveiTebda
proteinuriis gamoxatulebas, albuminis fraqcionalur eqskrecias da Ig –
is. lozartani unarCunebda gorglisebri filtraciis siCqares da amcirebda
filtraciis fraqcias. mTlianobaSi, lozartanis gamoyenebas Tan axlda
Sardis mJavas donis Semcireba sisxlis Sratis (Cveulebriv < 0,4 mg/dcl) rac
narCundeboda xangrZlivi Terapiis manZilze.
lozartani ar axdens gavlenas avtonomiur refleqsebze da ar gaaCnia
xangrZlivi efeqti sisxlis plazmaSi norepinefrinis donesTan mimarTebaSi.
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pacientebSi marcxena parkuWis ukmarisobiT lozartani 25 da 50 mg dozebiT
dadebiT hemodinamikur da neirohormonalur efeqts axdenda rac moicavda
gulis indeqsis gazrdas da filtvis kapilarebSi gaWedvis wnevis Semcirebas,
sistemuri sisxlZarRvovani winaaRmdegobis, saSualo sistemuri arteriuli
wnevis
da
gulis
SekumSvaTa
sixSiris
Semcirebas
da
Sesabamisad
aldosteronisa da noradrenalinis doneebis daqveiTebas cirkulirebad
sisxlSi. arteriuli hipotenziis warmoSobis sixSire pacientebSi gulis
ukmarisobiT iyo dozadamokidebuli.
hidroqlorTiazidi
–
es
aris
tiaziduri
diuretiki.
tiazidebis
antihipertenziuli efeqtis zusti meqanizmi ucnobia. tiazidebi moqmedeben
eleqtrolitebis reabsorbciis Tirkmelovani arxebis meqanizmebze, zrdian ra
uSualod natriumis da qloris gamoyofas daaxloebiT Tanabari raodenobiT.
hidroqlorTiazidis diuretiul moqmedebas mivyavarT sisxlis plazmis
moculobis SemcirebasTan, reninis aqtiurobis zrdasTan sisxlis plazmaSi da
aldosteronis sekreciis gazrdisken kaliumis da bikarbonatis SardTan
gamoyofis Semdgomi zrdiT da kaliumis donis daqveiTebiT sisxlis SratSi.
renin-aldosteronis kavSiri ganpirobebulia
angiotenzin II-iT
da amitom
angiotenzin II-is antagonistebis erTdrouli gamoyeneba asustebs tiaziduri
diuretikis gamoyenebasTan dakavSirebuli kaliumis kargvas.
peroraluri miRebisas diuretiuli moqmedeba dgeba 2 saaTis ganmavlobaSi,
piks aRwevs daaxloebiT 4 saaTis mere da grZeldeba daaxloebiT 6-12 saaTi.;
antihipertenziuli efeqti narCundeba 24 saaTi
farmakokinetika
Sewova
lozartani. perioraluri gamoyenebis mere lozartani kargad absorbirdeba
da
eqvemdebareba
presistemur
metabolizms
karbonis
mJavis
aqtiuri
metebolitis da danarCeni araaqtiuri metabolitebis warmoSobiT.lozartanis
sistemuri bioxelmisawvdomoba tabletebis saxiT Seadgens daaxloebiT
33%.lozartanis
da misi aqtiuri metabolitis saSualo maqsimaluri
koncentracia
miiRweva
1
saaTis
da
3-4
saaTis
mere
Sesabamisad.
standartizirebul sakvebTan erTad lozartanis miRebisas ar SeiniSneboda
klinikurad mniSvnelovani gavlena preparatis koncentraciis profilze
sisxlis plazmaSi.
ganawileba
lozartani. lozartani ise rogorc misi aqtiuri metaboliti, >99%iT
ukavSirdebian
sisxlis
plazmis
cilebs
ZiriTadad
ki
albuminebs.
lozartanis gadanawilebis moculoba Seadgens 34 litrs. virTxebze
gamokvlevebma aCvenes rom lozartani cudad aRwevs an saerTod ar aRwevs
hematoencefaliur barierSi.
hidroqlorTiazidi.hidroqlorTiazidi aRwevvs placentarul barierSi magram
ver aRwevs hematoencefalur barierSi da ar gamoiyofa dedis rZeSi.
metabolizmi
daaxloebiT 14% lozartanis dozisa Sidavenuri an peroraluri gamoyenebisas
gadaiqceva mis aqtiur metabolitad. 14 C - moniSnuli kaliumis lozartanis
Sidavenuri Tu peroraluri gamoyenebisas cirkulirebadi sisxlis plazmis
radoiaqtiuroba warmodgenilia ZiriTadad lozartaniT da misi aqtiuri
metabolitiT.minimaluri gadaqceva lozartanis mis aqtiur metabolitSi
SeiniSneboda kvlevebis monawileTa daaxloebiT 1%-Si.
aqtiuri metabolitis garda warmoiSoba araaqtiur metabolitebi 2 ZiriTadi
metabolitis CaTvliT romlebic
formirdebian butilis gverdiTi jaWvis
hidroqsilirebis
gziT
da
araZiriTadi
metaboliti- -2
tetrazol
glukuronidi.
gamoyofa
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lozatrani. lozatranis da misi aqtiuri metabolitis plazmuri klirensi
Seadgens daaxloebiT 600 da 50 ml/wT Sesabamisad. Tirkmluri klirensi
lozatranis da misi aqtiuri metabolitis Seadges daaxloebiT 74 da 26 ml/wT
–s Sesabamisad. peroraluri gamoyenebisas lozatranis dozis daaxloebiT 4%
gamoiyofa Seucvleli saxiT SardSi da daaxloebiT 6% dozisa gamoiyofa
aqtiuri metabolitis saxiT.lozatranis da misi aqtiuri metabolitis
farmakokimetika aris xazobrivi kaliumis lozartanis 200 mg –mde dozebSi
peroraluri miRebisas.peroraluri gamoyenebis Semdeg lozartanis da misi
aqtiuri
metabolitis
koncentracia
sisxlis
plazmaSi
mcirdeba
polieqsponencialurad, naxevradgamoyofis Sesabamisad 2 saaTi da 6-9 saaTi
saboloo periodebiT.100mg dozis erTxel dReRameSi miRebisas lozartani da
misi aqtiuri metaboliti ar grovdeba mniSvnelovani xarisxiT sisxlis
plazmaSi.
lozatrani da misi aqturi metaboliti gamoiyofa naRvliT da SardiT.
moniSnuli lozatranis peroraluri gamoyenebis Semdeg pirebSi 35%
daaxloebiT gamoiyofa SardiT da 58%-ganavaliT.
hidroqlorTiazidi. hidroqlorTiazidi ar ganicdis metabolizms magram
swrafad gamoiyofa TirkmlebiT.donis
24 saaTiani gansazRvrisas sisxlis
plazmaSi naxevradgamoyofis periodi sisxlis plazmidan varirebda 5,6 da 14,8
saaTs Soris.peroralurad miRebuli dozis rogorc minimum 61% Seucvleli
saxiT gamoiyofa 24 saaTis ganmavlobaSi.
pacientTa calkeul jgufebSi farmakokinetika
lozatran-hidrdoqlorTiazidi
lozatranis da misi aqtiuri metabolitis koncentracia sisxlis plazmaSi
aseve
hidroqlorTiazidis
absorbcia
xandazmuli
asakis
pacientebSi
arteriuli hipertenziiT mniSvnelovnad ar gansxvavdeba axalgazrda asakis
pacientebisgan hipertenziiT.
lozatrani
peroraluri miRebis Semdeg RviZlis alkoholuri cirozis msubuqi da
saSualo xarisxis simZimis
pacientebSi lozartanis da misi aqtiuri
metabolitis koncentracia sisxlis plazmaSi iyo Sesabamisaad 5 jer da
1,7jer meti vidre axalgazrda moxalise kacebSi.
lozartani da misi aqtiuri metabolitia ar gamoiyofa hemodializis
Catarebisas
usafrTxoebaze klinikuramdeli monacemebi
klinikuramdeli monacemebi miuTiTeben admianisTvis specifiuri riskis
ararsebobaze zogadi farmakologiis,genotoqsikurobisa da
kancerogenuli
potencialis
saerTo
miRebuli
kvlevebidan
gamomdinare.lozartanhidroqlorTiazidis
kombinaciis
toqsikuri
potenciali
fasdeboda
mravaljeradi peroraluri dozebis toqsikurobis 6Tvian gamokvlevebSi
virTxebsa da ZaRlebSi;kombinaciis gamoyenebisas SeniSnuli cvlilebebi
gamowveuli
iyo
ZiriTadad
lozartaniT.lozartan/hidroqlorTiazidis
gamoyeneba
inducirebda:
eriTrocitebis,hemoglobinis,hematokritis
donis
Semcirebas;Sardovanas azotis gazrdas sisxlis.
SratSi,gulis masis
daqveiTebas(histologiuri Sepirispirebis garSe,kuW-nawlavis traqtis( kWt)
mxridan
cvlilebebs(lorwovani
garsis
dazianeba,wylulebi,eroziebi,sisxldinebebi)
ar iyo teratogenurobis niSnebi lozartan/ hidroqlorTiazidis kombinaciis
Seyvanisas virTxebsa da bocvrebSi.virTxebis mamrebSi preparatis Seyvanisas
hestaciis periodamde
an mis ganmavlobaSi SeiniSneboda fataluri
toqsikuroba rac gamoixateboda 1 TaobaSi damatebiTi neknebis ganviTarebis
sixSiris odnav zrdaSi.
mxolod lozartanis gamoyenebis kvlevebSi
SeiniSneboda fetaluri da neonataluri reaqciebi nayofis Tirkmluri
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toqsikurobisa
da
sikvdilis
CaTvliT
orsul
virTxebSi
lozartan/hidroqlorTiazidis kombinaciis Seyvanisas orsulobis periodis
damTavrebis ganmavlobaSi
gamoyenebis Cveneba:
arteriuli hipertenzia.hizaar forte naCvenebia esencialuri hipertenziis
samkurnalod
pacientebSi
romelTa
arteriuli
wneva
arasakmarisad
kontrolirdeba mxolod lozartanisa an hidroqlorTiazidis miRebisas.
gulsisxlZarRvTa
daavedebebis
da
sikvdilianobis
riskis
Semcireba
pacientebSi arteriuli hipertenziiT da marcxena parkuWis hipertrofiiT.
hizaar forte aris lozartanis (kozaar) da hidroqlorTiazidis kombinacia.
marcxena parkuWis hipertrofiis da hipertenziis mqone pacientebSi lozartani
xSirad hidrqlortiazidTan kombinaciaSi aqveiTebs gulsisxlZarRvovani
daavadebebis
risks
da
sikvdilianobas,rac
gansazRvrulia
gulsisxlZarRvovani sikvdilebis, insultebisa da moikardis infarqtebis
saerTo sixSiriT marcxena parkuWis hipertrofiis da hipertenziis mqone
pacientebSi (ix. ganyofileba “rasa”)
gamoyenebis meTodi da dozireba
preparati hizaar forte Seizleba gamoyenebuli iqnas sxva antihipertenziul
preparatebTan erTad.
preparati hozaar forte unda gamoyenebuli iqnes peroralurad wylis Wiqis
miyolebiT.
preparati
SeiZleba
miRebuli
iyos
sakvebis
miRebisgan
damoukideblad
arteriuli hipertenzia
lozartansa da hidroqlortiazids ar gamoiyeneben sawyisi Terapiis saxiT
aramed gamoiyeneben mxolod im pacientebSi romelTa arteriuli wneva
arasakmarisad kontrolirdeba mxolod lozartanis an hidroqlorTiazidis
miRebisas.
rekomendirebulia TiToeuli komponentis (lozartani da hidroqlorTiazidis
)dozis SerCeva.
klinikuri aucileblobisas Tuki ver xerxdeba arteriuli wnevis adeqvaturi
kontrolis miRweva SeiZleba gadasvla uSualod monoTerapiidan fiqsirebul
kombinaciamde.
preparatis Cveulebrivi sawyisi da SenarCunebis doza Seadgens preparat
hizaaris 50/12,5 1 tablets (lozartani 50 mg, hidroqlorTiazidi 125 mg|)
erTxel dReSi im pacientebisTvis romelTaTvisac ar SeiniSneba sakmarisi
pasuxi doza SeiZleba gaizardos preparat hizaar fortes 100/25 1 tabletamde
dReRameSi (lozartani 100 mg, hidroqlorTiazidi 25 mg) maqsimaluri doza –
preparat hizaar fortes 100/25 1 tableti erTxel dReRameSi. rogorc wesi,
antihipertenziuli efeqti miiRweva 3-4 kviris manZilze mkurnalobis
dawyebidan.
preparat
hizaar
fortes
100/12,5
(100
mg
lozartani,hidroqlorTiazidi 12,5 mg) rekomendirebulia im pacientebisTvis
romelTa wnevis kontrolisTvis preparat kozaaris dozam miaRwia 100 mg-s.
miReba Tirkmlebis funqcia darRveul pacientebSi da imaTSi visac utareben
hemodializs.
zomieri
simZimiT
Tirkmlebis
funqcia
darRveul
pacientebSi(klirens
kreatinini 30-50 ml/wT)ar aris preparatos sawyisi dozis koreqciis
aucilebloba.ar aris rekomendirebuli lozaratis da hidroqlorTiazidis
tabletebis daniSvna
pacientebisTvis romelTac utareben hemodilizs.ar
Rirs lozartan/hidroqlorTiazidis kombinaciis daniSvna pacientebisTvis
Tirkmlis funqciis mZime darRvevebiT. (klirens kreatinini <30 ml/wT)
gamoyeneba pacientebSi SidasisxlZarRvovani hipovolemiiT
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lozartan hidroqlorTiazidiT mkurnalobis dawyebis win aucilebelia iseTi
mdgomareobebis koreqcia moxdes rogoricaa SidasisxlZarRvovani hipobolemia
natriumis doneebis Semcireba
RviZlis darRveuli funqciis mqone pacientebSi gamoyeneba
ar
aris
rekomendirebuli
lozartan/hidroqlorTiazidis
kombinaciis
gamoyeneba RviZlis mZime daRRvevebis mqone pacientebSi
xandazmuli asakis pacientebSi gamoyeneba
rogorc wesi ar arsebobs preparat hizaar 50/12,5 is dozis koreqciis
aucilebloba xandazmuli asais pacientebSi. xandazmuli asakis pacientebSi
ar aris rekomendirebuli mkurnalobis dawyeba preparat hizaar forte 100/25
is gamoyenebiT.
gamoyeneba bavSvebsa da mozardebSi (18 wlamde asakis|)
vinaidan ar arsebobs preparatis bavSvebsa da mozardebSi gamoyenebis
gamocdileba,ar Rirs preparatis miReba pcientTa am jgufisTvis.
gulsisxlZarRvTa
daavadebebis
riskis
da
sikvdilianobis
Semcireba
arteriuli
hipertenziis
da
marcxena
parkuWis
hipertrofiis
mqone
pacientebSi.Cveulebrivi sawyisi doza Seadgens lozartanis 50 mg-s erTxel
dReRameSi. pacientebisTvis visTvisac ar xerxedeba wnevis samizne doneebis
miRweva lozartanis 50 mg dozis miRebis fonze moiTxoveba Terapiis SerCeva
lozartanis hidrokorTiazidis dabal dozasTan(12,5|) kombinaciis gamoyenebiT
da
Tuki
es
aucilebelia,gaizardos
doza
lozartanis
100mg-mde
hidroqlorTiazidis 12,5 mg dozasTan SerwymiT erTxel dReSi.Tuki es
aucilebelia doza unda gaizardos 100mg-mde lozartanis da 25 mg
hidroqlorTiazidis erTxel dRe-RameSi.preparatebi hizaar 50/12,5, hizaar
forte 100/12,5 da hizaar forte 100/25 warmoadgenen Sesaferis alternatiul
preparatebs im
pacientebisTvis misaRebad romlebic erTdroulad iReben
lozartans da hidroqlortiazids Sesabamis dozebSi.
gverdiTi movlenebi
qvemoT CamoTvlili arasasurveli reaqciebi klasificirebulia organoTa
sistemebis klasebis da warmoSobis sixSiris mixedviT Zalian xSirad(.2/100,,1/10)
xSiradara(.1/1000,,1/100|), iSviaTad (.1/10000,,1/1000,<1/1000) Zalian iSviaTad (,1/100000
ucnobia(SeuZlebelia dadgena mocemuli monacemebiT)
klinikur
gamokvlevebSi
kaliumis
marilis
lozartanis
da
hidroqlorTiazidis gamoyenebiT ar SeiniSneboda arasasurveli movlenebi
specifiuri mocemuli kombinaciisTvis. gverdiTi reaqciebi Semoifargleboda
kaliumis marilis lozartanisa da hidroqlorTiazidis gamoyenebisas adre
SeniSnuliT.
erTaderTi
gverdiTi
efeqti
dakavSirebuli
preparatis
miRebasTan
romelzedac moixsenieboda esencilur hipertenziis kontrolirebad klinikur
gamokvlevebSi iyo Tavbrusxveva romelic warmoiqmneboda sixSiriT romelic
maRali
iyo
placebos
gamoyenebis
SemTxvevaze
lozartanisa
da
hidroqlorTiazidis mkurnalobis mimReb pacientTa 1%-Si.
kontrolirebul klinikur gamokvlevebSi hipertenziisa da marcxena parkuWis
hipertrofiis mqone pacientebSi lozartani xSirad hidroqlortiazidTan
kombinaciaSi gadaitaneboda kargad.yvelaze xSirad warmoqmnili gverdiTi
movlenebi iyo Tavbusxveva,asthenia/daRliloba da vertigo.
Semdeg gverdiT movlenebze ukve ityobinebodnen preparatis bazarze
gamosvlis mere.RviZlis da naRvlisgamomyofi gzebis darRvevebi:iSviaTadhepatiti.
laboratoriuli
kvlevebi:iSviaTad-hiperglikemia,
alt
donis
momateba.
damatebiTi gverdiTi movlenebi SeiniSneboda calke TiToeuli komponentis
gamoyenebisas
da
SeiZleba
iyos
potenciuri
gverdiTi
reaqciebi
lozartan/hidroqlorTiazidis kombinaciis gamoyenebisas.
C
om
pa
ny
C
on
fid
en
tia
l
lozartani
darRvevebi sisxlis da limfuri sistemis mxridan: arcTuise xSirad-anemia,
henox-Senleinis purpura, ekqimozi,hemolizi;ucnobia – Trombocitopenia.
imunuri sistemis mxridan darRvevebi; iSviaTad-hipermgZnobelobis reaqciebianafilaqtiuri reaqciebi, WinWris gamonayari, angionevrotiuli SeSupeba,
xorxisa da xmovani napralis SeSupebebis CaTvliT romelsac mivyavarT
sasunTqi gzebis obstuqciamde an saxis, tuCebis, xaxis an enis SeSupeba)
zogierT am pacientSi anamnezSi iyo angionevrotonuli SeSupeba rac
dakavSirebulia
sxva
preparatebis
gamoyenebasTan
maT
Soris.
(agf
inhibitorebis).
metabolizmisa da kvebis darRveva: arcTu ise xSirad - anoreqsia, podagra.
fsiqikuri mxridan darRvevebi: xSirad-uZiloba, arcTuise xSirad- mousvenroba,
mousvenroba, gangaSis grZnoba, panikuri darRvevebi, cnobierebis areva,
depresia, uCveulo sizmrebi, Zilis darRveva, Zilianoba, mexsierebis gauareseba
nerviuli sistemis mxridan darRvevebi; xSirad – Tavis tkivili, Tavbrusxveva,
iSviaTad- momatebuli aRgznebadoba, paresteziebi, periferiuli nevropaTia,
tremori, migreni, sinkope, disgezia.
mxedvelobis organos mxridan darRvevebi; iSviaTad- mxedvelobis arasizuste,
wvis SegrZneba, Cxvleta TvalebSi koniunqtiviti, mxedvelobis siZlieris
daqveiTeba.
smenis organoebis da vestibulaciis aparatis mxridan darRvevebi. iSviaTadvertigo,xmauri yurebSi.
gulis mxridan darRvevebi:iSviaTad-hipotenzia, orTostatikuri hipotenzia,
sternalgia,
stenokardia,
atriovertikularuli
blokada
II
xarisxis,
insulti, miokardis infarqti, palpitacia, ariTmia (winagulis fibrilacia,
sinusuri
bradikardia,
taxikardia,
parkuWis
taxikardia,
parkuWebis
fibrilacia)
sisxlZarRvovani sistemis mxridan darRvevebi: iSviaTad- vaskuliti, dozaze
damokidebuli orTostatikuli efeqti.
respiratoruli traqtis,gulmkerdis organoTa da Suakedlis mxridan
darRvevebi
xSirad-xveleba, zemo sasunTqi gzebis infeqcia, cxviris
gaWediloba, sinusitis, sinusebis mxridan darRvevebi, iSviaTad—diskomforti
xaxaSi, faringiti, laringiti, dispnoe, bronqiti, sisxldena cxvirSi, riniti,
sasunTq gzebSi SegubebiTi movlenebi.
darRvevebi knt-s mxridan: xSirad-tkivili mucelSi, gulisreva, diaurea,
dispepsia: iSviTad-Sekruloba, tkivili kbilebSi, simSrale pirSi, meteorizmi,
gastritis, Rebineba, myari Sekruoba, spazmebi; ucnobia-pankreatiti.
RviZlis da naRvlisgamomyofi gzebis mxridan darRvevebi: ucnobia—RviZlis
funqciebis darRveva.
kanis da kanqveSa ujredisis mxridan darRvevebi: iSviaTad: alopecia,
dermatiti, kanis simSrale, eritema, sisxlis mowola, fotomgZnobeloba,
qavili, gamonayari, WinWris gamonayari, oflianoba, erotrodermia.
kunTovan-Conxis sistemis da SemaerTebeli qsovilis mxridan darRvevebi:
xSirad-kunTovani krunCxvebi, kunTovani spazmebi, tkivili zurgSi, tkivili
fexebSi, mialgia, iSviaTad-tkivili xelebSi, saxsrebis
SeSupeba, tkivili
muxlebSi, ConCx-kunTovani tkivili, tkivili mxarSi, SeboWiloba, arTralgia,
arTriti, koksalgia, fibromialgia, sisuste kunTebSi;
ucnobia- rabdomiolizi
Tirkmlis da Sardgamomyofi gzebis mxridan darRvevbi; xSirad---Tirkmlis
funqciaTa darRveva, Tirkmlis ukmarisoba, iSviaTad—nikturia, xSirad
Sarddena, Sardgamomyofi traqtis infeqcia.
reproduqciuli sistemis da rZis jirkvlebis mxridan darRvevebi: iSviaTadlibidos daqveiTeba, eriktiluri disfunqcia/impotencia.
C
om
pa
ny
C
on
fid
en
tia
l
zogadi mdgomareobis
da preparatis miRebis xerxTan dakavSirebuli
darRvevebi: xSirad-astenia, daRliloba, tkivili gulmkerdis areSi, iSviaTadsaxis SeSupeba, sisuste, cieb-cxeleba, SeSupeba, SeuZlod yofna ucnobia gripismagvari simptomebi.
laboratoriulli gamokvlevebi: xSirad—hiperkaliemia, umniSvnelo daqveiTeba
hematokritis da hemoglobinis, hipoglikemia; iSviaTad-sisxlis SratSi
Sardovanasa da kreatininis doneebis umniSvnelo zrda; Zalze iSviaTadTirkmlis
fermentebisa
da
bilirubinis
donis
momateba;
ucnobia—
hiponatriemia
hidroqlortiziadi
sisxlis da limfuri sistemis mxridan darRvevebi:iSviaTad—agranulocitozi,
aplastikuri anemia, hemolituri anemia, leikopenia, purpura, Trombocitopenia
imunuri sistemis mxridan darRvevebi: iSviaTad - anafilaqtiuri reaqcia.
metabolizmisa da kvebis darRveva|: anoreqsia, hiperglikemia, hiperurikemia,
eleqtrolituri disbalansi hipokaliemiis CaTvliT.
fsiqikis mxridan darRvevebi: iSviaTad – uZiloba
nerviuli sistemis mxridan darRvevebi: xSirad — cefalgia
mxedvelobis organoebis mxridan darRvevbi: xSirad – garadamavali
mxedvelobis uzustoba, qsantopsia.
darRvevebi
sisxlZrRvovani
sistemidan:
iSviaTad---nekrotikuli
angiiti
(vaskuliti, kanis vaskuliti)
darRvevebi respiratoruli traqtis, gulmkerdis organoebis da Suakedlis
mxridan: iSviaTad - respiratoruli distresi pnevmonitis da filtvebis
SeSupebis CaTvliT. nt-is mxridan darRvevebi: iSviaTad-sialadeniti, spazmebi,
kuWis lorwovanis gaRizianeba, gulisreva, Rebineba, diarea, Sekruloba.
RviZlis da naRvlisgamomyofi gzebis mxridan darRvevbi; iSviaTad---siyviTle
(RviZlis Sida qolestazi), pankreatiti
kanisa da kanqveSa mxridan darRvevebi: iSviaTad - fotomgZnobeloba, WinWris
cieba, toqsikuri epidermialuri nekrolizi, kanis wiTeli mWamela
kunTovani-ConCxis sistemis da SemaerTebeli qsovilis mxridan darRvevebi:
iSviaTad—kunTovani
darRvevebi Tirkmlebis da Sardgamomyofi gzebis mxridan: iSviaTadglukozuria, inersticialuri nefriti, Tirkmlebis funqciis darRveva,
Tirkmlebis ukmarisoba.
saerTo mdgomareobis da preparatis miRebis meTodTan dakavSirebuli
darRvevebi:iSviaTad ciebcxeleba Tavbrusxveva.
ukuCveneba
• gazrdili
mgZnobeloba
lozartanis
mimarT,
sulfonamidis
warmoebulebis (magaliTad hidroqlorTiazidi) an sxva nebismieri
preparatis SemadgenlobaSi Semavali komponentis mimarT
• Terapiisadmi rezistentuli hipokaliemia da hiperkalciemia
• RviZlis funqciis mZime darRveva qolestazi da naRvelgamomyofi gzebis
gamtareblobis darRveva
• refleqtoruli hiponatriemia
• simptomaturi hiperurikemia/podagra
• orsulobis meore an mesame trimestri(ix.ganyofileba usafrTxobis
zomebi da miReba orsulobisas da ZuZuTi kvebisas|)
• RviZlis funqciaTa mZime darRveva(kreatiininis klirensi, 30ml/wT)
• anuria
dozis gadaWarbeba
fid
en
tia
l
specifiuri informacia ar arsebobs preparat hizaar fortes dozis
gadaWarbebasTan
dakavSirebiT.
mkurnaloba
aris
simptomaturi
da
SenarCunebadi.mkurnaloba preparat hizaar forteTi unda Sewydes xolo
pacienti srulad gamokvleuli. rekomendirebulia Rebinebis provokacia Tu
preparati axali miRebulia da aseve dehidrataciis,eleqtrolituri balansis,
Tirkmlis komis da hipotenziis koreqcias miRebuli procedurebis Seasbamisad
lozatrani.
preparatis
Warbi
dozis
miRebis
monacemebi
adamianebSi
SezRudulia. yvelaze ufro mosalodnelia rom Warbi dozis miRebis
gamovlineba
iqneba
hipotenzia
da
taqikardia;
bradikardia
SeiZleba
warmoiSvas parasimpaTiuri vagusuri stimulaciis Sedegad. simptomaturi
arteriuli
hipotenziis
ganviTarebis
SemTxvevaSi
mizanSewonilia
SenarCunebadi Terapiis gatareba.lozartani da misi aqtiuri metaboliti ar
gamoiyofa hemodializis meSveobiT.
hidroqlorTiazidi.Warbi dozis yvelaze ufro SeamCnevi niSnebi da simptomebi
aris eleqtrolitebis deficitis simptomebi (hipokaliemia, hipoqloremia,
hiponatriemia) da dehidratacia Zlieri diurezis Sedegad. digitalisis.
preparatebis erTdrouli miRebisas hipoglikemiam SeiZleba gaamwvavos gulis
ariTmia.
ar aris dadgenili hidroqlorTiazidi rogori xarisxiT SeiZleba iyos
organizmidan gamoyofili hemodializis saSualebiT
C
om
pa
ny
C
on
usafrTxoebis zomebi
lozartan-hodroqlorTiazidi
hipermgZnobeloba. angionevrotikuli SeSupeba. ix. ganyofileba “gverdiTi
movlenebi”
RviZlisa da Tirkmlebis funqciis darRveva: hizaar forte ar aris
rekomendirebuli pacientebSi RviZlis funqciis daRveviT da Tirkmlebis
funqciis
darRvevis
mZime
formiT.
klirens
kreatinini
<30
ml/wT)(ix.ganyofilebebi “dozireba da gamoyenebis meTodebi”)
lozartani
angionevrotiuli SeSupeba. moiTxoveba saguldagulo dakvirveba pacientTa
mdgomareobaze angionevrotiuli SeSupebiT anamnezSi (saxis, tuCebis, xaxis da
enis SeSupeba)
hipotenzia da SidasisxlZarRvovani hipovolemia. SesaZlebelia simptomaturi
hipotenziis warmoSoba gansakuTrebiT ki pirveli dozis miRebis Semdeg
diuretikebis intensiuri miRebis, marilis dieturi SezRudvis, diareis da
Rebinebis Sedegad ganviTarebuli hipovoleemiis da an hiponatriemiis mqone
pacientebSi. aucilebelia moxdes aseTi mdgomareobebis koreqtireba preparat
hizaar forteTi mkurnalobis dasrulebamde.
eleqtrolituri balansi.
unda gvaxsovdes rom Tirkmlebis funqcia
darRveul pacientebSi (Saqriani diabetiT an mis gareSe) xSirad SeiniSneba
eleqtrolituri
disbalansi.
amitom
aucilebelia
xSirad
kaliumis
koncentraciis da klirens kreatininis maCveneblebis kontroli sisxlis
plazmaSi; gansakuTrebiT xSirad aseTi kontroli unda Sesruldes gulis
ukmarisobis da kreatinins klirensis 30-50 ml.wT is mqone pacientebSi.
ar aris rekomendirebuli lozartan/hidroqlortiazidTan erTad kaliumis
damzogavi diuretikebis kaliumis danamtebis da kaliumis Semcvleli marilis
Semcvlelebis gamoyeneba.
RviZlis funqciaTa darRveva. farmakokinetikuri monacemebis safuZvelze,
romlebic mowmoben lozartanis did koncentraciebze sisxlis plazmaSi
RviZlis cirozis mqone pacientebSi rekomendirebulia hizaar fortes
frTxili miReba im pacientebSi romelTac anamnezSi aqvT RviZlis funqciis
msubuqi da saSualo xarisxis darRveva.ar arsebobs lozartanis miRebis
C
om
pa
ny
C
on
fid
en
tia
l
Terapiuli gamocdileba pacientebSi RviZlis funqciis mZime darRvevebiT
amitom preparat hizaar forte ukunaCvenebia aseT pacientebSi misaRebad.
Tirkmlebis funqciaTa darRveva. ityobinebodnen Tirkmlebis funqciaTa
cvlilebebze
maT
Soris
renin-angiotenzin
sistemis
daqveiTebasTan
dakavSirebuli
Tirkmlis
ukmarisoba
(gansakuTrebiT
ki
pacientebSi
romlebSic
Tirkmlebis
funqcia
damokedebulia
renin-angiotenzinaldosteronis sistemaze anu pacientebi gulis funqciaTa mZime darRvevebiT
an Tirkmlebis furqciebis ukve arsebuli darRvevebiT) Tirkmlebis funqciebis
amgvari cvlilebebs SeuZliaT hqondeT Seqcevadi xasiaTi Terapiis Sewyvetis
Semdeg.
rogorc renin-angiotenzin-aldosteronis sistemaze moqmedi sxva preparatebis
gamoyenebisas moixsenieboda
sisxlSi Sardovanas da sisxlis Sratis
kreatininis gazrdil doneze pacientebSi Tirkmlis arteriebis ormxrivi
stenoziT an erTaderTi Tirkmlis arteriis stenoziT. Tirkmlebis funqciaTa
es cvlilebebi SeiZleba iyos Seqcevadi Terapiis Sewyvetis Semdeg. lozartani
frTxilad unda iqnes miRebuli pacientebSi Tirkmlis arteriebis ormxrivi
stenoziT an kidev erTaderTi Tirkmlis arteriis stenoziT.
Tirkmlis transplantacia.a ar arsebobs raime gamocdileba preparatis
miRebisa
im
pacientebSi
romelTac
exlaxans
Cauteres
Tirkmlis
transplantacia.
pirveladi
hiperaldosteronizmi.pirveladi
hiperaldosteronizmis
mqone
pacientebSi antihipertenziuli preparatebi romlebic moqmedeben reninangiotenzinis sistemis inhibitorebad rogorc wesi aris araefeqturi. amitom
preparat hozaar fortes moReba ar aris rekomendirebuli.
koronaluri arteriebis daavadebebi da cerebrovaskularuli daavadebebi.
rogorc es sxva antihipertenziuli preparatebis gamoyenebisasaa arteriuli
wnevis Zlierma daqveiTebam gulsisxlZarRvTa iSemiuri daavadebebis da
cerebrovaskularuli daavadebebis mqone pacientebSi SeiZleba migviyvanos
moikardis infarqtisa da insultis ganviTarebasTan.
gulis ukmarisoba. rogorc sxva danarCebi preparatebis gamoyenebisas
romlebic moqmedeben renin-angiotenziur sistemaze gulis ukmarisobisa da
Tirkmlis funqciis darRvevis mqone paientebSi an mis gareSe arsebobs mZime
arteriuli hipotenziis da (Zalian xSirad) Tirkmlebis funqciebis darRvevis
ganviTarebis riski.
aortuli da mitraluri sarqvelebis stenozi,obstuqtiuli hipertrofuli
kardiomiopaTia. rogorc sxva vazodilatorebis miRebisas gansakuTrebuli
sifrTxiliT niSnaven preparats pacientebs aortuli da mintraluri
sarqvelebis stenoziT an obstruqtiuli hipertrofuli kardiomiopaTiiT.
rasa. rogorc es dadgenilia agf inhibitorebisTvis, lozartani da danarCeni
antagonistebi angiotenzinisa naklebad efeqturia Savi rasis pacientebSi,
vidre danarCen pacientebSi, SesaZlebelia reninis dabali aqtiobis Sexvedris
maRali sixSiris mizeziT hipertenziis mqone pacientebSi romlebic arian Savi
rasis warmomadgenlebi.
orsuloba. angiotenzin II-is receptorebis antagonistebi (ara II) ar unda
dainiSnos orsulobis periodis ganmavlobaSi. Tuki ara II-iT mkurnalobis
gagrZeleba ar iTvleba Seucvlelaad pacientebSi romlebic gegmaven
fexmZimobas unda dainiSnos alternatiuli antihipertenziuli saSualeba
usafrTxoebis dadgenili profiliT orsulobis periodSi gamoyenebisas. Tuki
dasturdeba feZmZimoba ara II-iT mkurnaloba unda iqnes dauyovnebliv
Sewyvetili da Tuki es saWiroa dawyebuli alternatiuli mkurnaloba.
hidroqlorTiazidi
hipotencia
da
eleqtrilituri/wylis
disbalansi.
rogorc
nebismieri
antihipertenziuli Terapiisas zogierT pacientebSi SeiZleba warmoiqmnas
C
om
pa
ny
C
on
fid
en
tia
l
simptomaturi
arteriuli
hipotenzia.
pacientTa
mdgomareobas
unda
davukvirdeT wylis da eleqtrolituri balansis darRvevis klinikur
niSnebTan mimarTebaSi magaliTad hipovolemia, hiponatriemia, hipoqloremiuli
alkaloza, hipomagniemia an hipokaliemia, romlebic SeiZleba ganviTardnen
interkurentuli
diareis
da
Rebinebis
fonze.aseT
pacientebSi
periodulad,drois Sesabamisi monakveTebiT, unda gaisinjos eleqtrolitebis
done sisxlis SratSi.pacientebSi periferiiuli SeSupepebiT cxel amindSi
mosalodnelia ganzavebis hiponatriemiis ganviTareba
metabolituri da endokrinuli efeqtebi.tiazidebiT Terapiam SeiZleba
gaauaresos
glukozisadmi
tolerantuloba.
SeiZleba
saWiro
gaxdes
hipoglikemiuri saSualebebis dozis koreqcia maT
Soris insulinis
(ix.ganyofileba
“sxva
samkurnalo
saSualebebTan
urTierTqmedeba”).
tiazidebiT mkurnalobisas SesaZlebelia latenturi Saqrovani diabetis
manifestacia.
tiazidebma SeiZleba Seasuston kalciumis SardTan erTad gamoyofa da
gamoiwvion kalciumis donis xanmokle da umniSvnelo zrda sisxlis SratSi.
gamoxatuli hiperkalciemia SeiZeba mowmobdes farul hiperparatireozze.
tiaziduri diuretiki unda amoRebuli iqnas farisebri jirkvlis funqciis
gamokvlevis Catarebamde. qolesterinis da trigliceridebis donis mateba
SeiZeba aseve dakavSirebuli iyos tiaziduri diuretikebiT TerapiasTan.
zogierT pacientSi tiaziduri diuretikebis miRebam Seizleba migviyvanos
hiperurikemiamde an podagris ganviTarebamde. vinaidan lozartani aqveiTebs
Sardis
mJavis
dones,
misi
hidroqlortizidTan
kombinacia
amcirebs
diuretikis miRebiT inducirebul hiperurikemiis gamoxatulebas.
RviZlis funqciis darRveva. RviZlis darRvevis an progresirebadi daavadebis
mqone pacientebSi tiazidebi unda dainiSnon sifrTxiliT vinaidan aseTi
preparatebi Seizleba gaxdnen TirkmelSida qolestazis mizezi. xolo
umniSvnelo cvlilebebma wyali-eleqtroituri balansisa SeiZleba gamoiwvios
Tirkmlis koma.
preparati hizaar forte ukunaCvenebia RviZlis mZime darRvevis mqone
pacientebSi.
sxva efeqtebi. tiaziduri diuretikebis mimReb pacientebSi hipermgznobelobis
reaqciebi Seizleba warmoiSvebodnen anamnezSi alergiis an bronqialuri
asTmis arsebobisgan damoukideblad. ityobinebodnen wiTeli mWamelas
sistemur gamwvavebaze an progresze tiaziduri diuretikebis miRebis fonze.
damxmare nivTierebebi.preparatis SemadgenlobaSi Sedis laqtoza.iseTi iSviaTi
memkvidruli
daavadebis
mqone
pacientebma
rogoricaa
galaqtozis
gadautanloba, lapa laqtazis deficiti da gluko-galaqtozuri mcire
absorbcia ar unda miiRon aRniSnuli preparati.
miReba orsulobis da ZuZuTi kvebis periodSi
orsuloba
fexmZimobis meore da mesame trimestris ganmavlobaSi preparatebis miReba
romlebic uSualo gavlenas axdenen renin-angiotenziur sistemaze SeiZleba
ziani miayenos ganviTarebd nayofs da misi daRupvac ki gamoiwvios.
orsulobis dadgenidan maSinve unda Sewydes hizar fortes miReba.
apaII-is miReba ar aris rekomendirebuli orsulobis pirveli trimestris
ganmavlobaSi da ukunaCvenebia orsulobis meore da mesame trimestrebis
periodSi.
epidemiologiuri monacemebi teratogenuobis riskze apf inhibitorebis
miRebis
Semdeg
orsulobis
pirveli
trimestris
manZilze
araa
damajerebadi;Tumca ar aris gamoricxuli riskis odnavi mateba.vinaidan ar
arsebobs kontrolirebuli epidemiologiuri monacemebi riskis mimarTebaSi
apaII-is miRebisas amdagvari riskebi SeiZleba arsebobdes preparatebis am
C
om
pa
ny
C
on
fid
en
tia
l
klasisTvisac. garda im SemTxvevebisa rodesac apaII Terapiis gagrZeleba
iTvleba aucileblad, pacientebSi romlebic gegmaven fexmZimobas unda
daeniSnoT alternatiuli hipertenziuli Terapia usafrTxoebis dadgenili
profiliT
fexmZimobis
periodTan
mimarTebiT.Tuki
diagnozirebulia
orsuloba apaII-iT mkurnaloba maSinve unda Sewydes da Tuki SesaZlebelia
unda daiwyos alternatiuli mkurnaloba.
cnobilia rom apaII-is miReba orsulobis meore da mesame trimestris manZilze
inducirebs
fetotoqsikurobas
(Tirkmlebis
funqciis
Sesustebas,
ologohidrmnions, qalis Zvlebis osifikaciis Seferxeba)
Tuki orsulobis meore trimestris manZilze miiReboda apaII, rekomedirebulia
ultrabgeriTi gamokvlevis Catareba Tirkmlebis funqciaTa da qalis Zvlebis
mdgomareobis Sesaswavlad
axaldabadebulTa mdgomareoba romelTa dedebi iRebdnen apaII-s xSirad unda
Semowmdes arteriuli hipertenziis warmoSobaze.
orsulobis
periodSi
hidroqlorTiazidis
gamoyenebis
gamocdileba
gansakuTrebiT ki pirvel trimestrSi SezRudulia. kvlevebis monacemebi
cxovelebze araa sakmarisi.
hidrokorTiazidi gadis placentarul barierSi da ganisazRvreba Wiplaris
sisxlSi.diuretikebis rutinuli gamoyeneba orsulTa sisxlSi romelTac ar
aqvT sxva daavadebebi araa rekomedirebuli. radgan qmnis arasasurveli
movlenebis
ganviTarebis
met
risks.
hidroqlorTiazidis
moqmedebis
farmakologiuri meqnizmis Sedegad misma gamoyenebam meore da mesame
trimestrebSi SeiZleba gaauaresos fetoplacenturi perfuzia da gamoiwvios
iseTi gverdiTi movlenebi nayofSida axaldabadebulSi rogoricaa siyviTle,
wylovan-eleqtrolituri
balansis
darRveva
da
Trombocitopenia.aseve
arsebobs
mozardebSi SemCneuli arasasurveli
reaqciebis warmoSobis
albaToba.
hidrokorTiazidi
ar
unda
gamoiyenebodees
orsulebSi
SeSupebebis.hipertenziisa da preeklampsiis mosarCenad vinaidan arsebobs
cirkulirebadi sisxlis moculobis daqveiTebis
da placentaruli
hipoperfuziis riski da daavadebis mimdinareobaze keTilsasurveli gavlenas
ar aqvs adgili.diuretikebi ar uSlian xels toqsikozis ganviTrebas
orsulebSi amasTan ar arsebobs raime damajerebeli damamtkicebeli sabuTi
imisa rom mas gaaCnia dadebiTi efeqti toqsikozis mkurnalobaSi.
hidroqlorTiazidi ar unda iqnes gamoyenebuli esencialuri hipertenziis
samkurnalod orsul qalebSi iSviaTi SemTxvevebis garda rodesac sxva
arteriuli mkurnaloba SeuZlebelia.
ZuZuTi kveba
ar arsebobs informacia preparat hizaar fortress ZuZuTi kvebis periodSi
miRebasTan
dakavSirebiT.ucnobia
gadidis
Tu
ara
lozartani
dedis
rZeSi.hidroqlorTiazidi gadadis dedis rZeSi. amitom araa rekomendirebuli
hizaar fortes miReba ZuZuTi kvebis periodSi. umjobesia preparatebiT
alternatiuli mkurnaloba rZiT mkurnalobis periodSi miRebis usafrTxoebis
ukeT Seswavlili profiliT
avtotransportiT da sxva meqanizmebiT marTvis unarze gavlena
ar Catarebula kvlevebi preparatis gavlenaze avtotransportiT da sxva
meqanizmebiT sargeblobaze.magram avtotransportiT da sxva meqanizmebiT
marTvisas
unda
gvaxsovdes
iseTi
gverdiTi
reaqciebis
ganviTarebis
SesaZleblobaze
rogoricaa
Tavbusxveva
da
Zilianoba,gansakuTrebiT
mkurnalobis dasawyisSi da preparatis dozis momatebisas.
gamoyeneba bavSvebSi
preparat hizaar fortes efeqtiuroba da usafrTxoeba bavSvebSi 18 wlamde
miRebisas araa dadgenili
C
om
pa
ny
C
on
fid
en
tia
l
xandazmuli asakis pacientebSi miReba
arteriuli
hipertenziis
kontrolirebul
klinikur
gamokvlelvebSi
monawileobas iRebdnen 206 (19%) pacientebisa 65 da meti wlis asakSi. ar
SeiniSneboda gansxvaveba preparat hizaar fortes miRebis efeqturobis da
usafrTxoebis profilebSi xandazmuli asakis pacientebSi ( 65weli) da ufro
axalgazrda pacientebSi (<65welze) magram ar unda gamovricxoT xandazmuli
asakis calkeul pacientebSi didi mgZnobiaroba.
rasa
LIFE-is gamokvlevebis Sedegebidan gamomdinare (hipertenziisas lozartanis
saboloo wertilebis maCvenebelze gavlenis kvleva) lozartanis miRebis
dadebiTi gavlena gulsisxlZarRvovan daavadebebis
da sikvdilianobis
maCveneblebze atenololTan SedarebiT araa damaxasiaTebeli negroiduli
rasis pacientebisTvis hipertenziiT da marcxena parkuWis hipertrofiiT.
Tumca ki mkurnalobis orive reJimi iyo efeqturi arteriuli wnevis
daqveiTebis mxriv negroiduli rasis pacientebSi. LIFE-s mTlian populaciaSi
(n=9193) gamokvlevaSi lozartaniT mkurnalobam migviyvana riskis 13,0%-iT
(p=0.021) Semcirebisken atenolTan im pacientebTan
SedarebiT romlebic
aRweven kardiovaskularuli sikvdilis, insultisa da miokardis infarqtis
ganviTarebis kombinirebuli sixSiris pirvelad saboloo wertils.
am gamokvlevaSi lozartani amcirebda gulsisxlZarRvoovani daavadebis da
sikvdilianobis risks atenololTan SedarebiT pacientebSi hipertenziiT da
marcxena parkuWis hipertrofiiT romlebic ar miekuTvnebian negroidul rasas
(n=8660) rac dadgenilia gulsisxlZarRvovani kombinirebuli sixSiris
pirvelad saboloo wertiliT(p=0.003). Tumca am gamokvlevaSi atenololis
mimReb negroiduli rasis pacientebSi iyo pirveladi Semadgeneli saboloo
wertilis warmoqmnis ufro dabali riski negroiduli rasis im pacientebTan
SedarebiT romlebic lozartaniT iRebdnen mkurnalobas(p=0.03). negroiduli
rasis qvejgufSi (n=533;6% pacientebisa I - gamokvlevebis) iyo 29 pirveladi
saboloo werili 263 atenolis mimReb pacients Soris (11% 25.9 1000 sapaciento
welze) da 46 pirveladi saboloo wertili lozartanis mimReb 270 pacients
Soris (17%,41,8 1000 sapaciento welze)
sxva samkurnalo saSualebebTan urTierTqmedeba
lozartani
klinikur gamokvlevebSi farmakokinetikaze araa identificirbuli klinikurad
mniSvnelovani
urTierTqmedebani
iseT
preparatebTan
rogoricaa
hidroqlorTiazidi,
digoksini,varfarini,
cimetidini,fenobarbitali
(ix.
qvemoT hidroqlorTiazidi, alkoholi, barbituratebi an narkotikuli
saSualebebi)ketokonazoli da eriTromicini.
ityobinebodnen rom rifampicini da flukonazoli aqveiTeben aqtiuri
metabolizmis dones.klinikuri Sedegebi am urTierTqmedebisa ucnobia.
rogorc sxva danarCeni preparatebis gamoyenebisas romlebic blokireben
angiotenzin II an mis efeqtebs erTdrouli gamoyeneba kaliumis-SemnarCunebeli
diuretikebis
(magaliTad
spironolaktonis,
triamterenis,
amiloridis)
kaliumis an kaliumis Semcvleli marilTa Semcvlelebis damateba SeiZleba
migviyvanos kaliumis domis matebamde sisxlis SratSi.
mitom maTi
ertdrouli miReba araa rekomendirebuli.
rogorc sxva preparatebis miRebisas romlebic moqmedeben matriumis
gamoyofaze SeiZleba sustdebodes liTiumis gamoyofa. amitom liTiumis done
sisxlis SratSi saguldagulod unda vakontroloT Tuki apaII -Tan erTad
miiReba liTiumis marilis preparatebi.
angiotenzin II-is antagonistebisa da arasteroiduli anTebiTsawinaaRmdego
preparatebis(aasp) erTdrouli miRebisas (magaliTad, cikllooqsigenaza-2is
(co2)
seleqciuri
inhibitorebi,
acetilsalicilis
mJava
C
om
pa
ny
C
on
fid
en
tia
l
anTebissawinaaRmdego, oqmedebis dozebSi) an araseleqciur aasp-s SeiZleba
Seusustdes antihipertenziuli efeqti. angiotenzin II-ia antagonistebis da
aasp diuretikebis erTdroulma gamoyenebam SeiZleba migviyvanos tirkmlebis
funqciis gauaresebis riskis momatebasTan Tirkmlis mwvave ukmarisobis
SesaZlo ganviTarebis
CaTvliT aseve kaliumis donis momateba sisxlis
SratSi gansakuTrebiT ki Tirkmlis funqciaTa darRvevis mqone pacientebSi.
aseTi kombinacia unda davniSnoT sifrTxiliT gansakuTrebiT ki xandazmuli
asakis pacientebSi.pacientebs unda CautardeT saTanado dehidratacia aseve
unda ganvixiloT Tirkmlis funqciis monitoringis sakiTxi Tanmdevi Terapiis
dawyebis Semdeg xolo SemdegSi – periodulad.
zogierT pacientSi Tirkmlis Sesustebuli funqciiT romlebic iReben aap
mkurnalobas
seleqtiuri
inhibitorebis
CaTvliT
angiotenzin
II-is
receptoris antagonistebis erTdroulma miRebam SeiZleba migviyvanos
Tirkmlis funqciis Semdgom gauaresebasTan. Rogorc weesi es efeqtebi aris
Seqcevadi.amitom am kombinacias sifrTxiliT gamoiyeneben pacientTa am
jgufSi.
zogierTi
nivTierebebi
rogoricaa
tricikluri
antidepresantebi,
antipsiqotiuri saSualebebi, balkofeni, amifostini, SeiZleba moaxdinon
arteriuli hipertenziis ganviTarebis inducireba. erTdrouli miReba
preparatebTan romelTa mTavar an gverdiT efeqts warmoadgens arteriuli
wnevis Semcireba Seizleba gaaZlieros arteriuli hipotenziis warmoSobis
riski.
renin-angiutenzin-aldosteronuli sistemis ormagi blokada. literaturaSi
moixseneboda
rom
pacientebSi
diagnostirebuli
aTerosklerozuli
daavadebiT gulis ukmarisobiT da samizne organoebis dazianebis diabetiT
rennin-angiotenzin-aldosteronis sistemis ormagi blokada asocirdeba
arteriuli hipertenziis, gulis wasvla, hiperglikemiis da Tirkmlis funqciis
darRvevis warmoSobis momatebuli sixSiriT (mwvave Tirkmlis ukmarisobis
CaTvliT) penin-angiotenzin-aldosteronuli sistemaze moqmedi erTi preparati.
apf inhibitoris apaII-Tan daniSvna) SemTxvevebSi Tirkmlis funqciis
hidroqlorTiazidi
Tanadrouli miRebisas Semdegi preparatebi SeiZleba urTierTqmedebdnen
tiazidur diuretikebTan.
alkoholi,barbiturebi da narkotikuli saSualebebi.SeiZleba adgili hqondes
ortostatiuri hipotenziis potencirebas.
antidiabeturi
preparatebi
(peroraluri
saSualebebi
da
insulini).
tiazidebiT
mkurnalobam
SeiZleba
gavlena
moaxdinos
glukozisadmi
tolerantulobaze. SeiZleba saWiro gaxdes antidiabeturi preparatis dozis
koreqcia.
sifrTxiliT
unda
miviRoT
metformini,
vinaidan
arsebobs
laktacidozis ganviTarebis riski romelic inducirebulia Tirkmlebis
funqciis darRveviT hidroqlorTiazidis miRebis fonze.
sxva antihipertenziuli preparatebi.urTierTSemavsebadi efeqti.
kolestiramini
da
fisi.
anionebisgacvliTi
fisis
arsebobisas
hidroqloridis absorbcia uaresdeba. erTjeradi dozebi kolestiraminis
iseve rogorc kolestipolis uerTdebian hidroqlortiazids da aqveiTeben mis
absorbcias kuWnawlavis traqtidan 85 da 43% -iT Sesabamisad.
kortikosteroidebi, adrenokortikitropuli hormoni (akth) an glicirizini
(Zirtkbila).
Zlierdeba
eleqtrolitebis
donis
daqveiTeba
kerZod
hipokaliemia.
presoruli aminebi (magaliTad adrenalini). SesaZlebelia presorul aminebze
pasuxis daqveiTeba magram araa sakmarisi maTi gamoyenebis gamosaricxad.
ConCxis kunTebis (mag tubokurarinis) aramadepolarizebeli relaqsantebi.
SeasZlebelia kunTovani relaqsantebis miRebaze reaqtiulobis gazrda.
C
om
pa
ny
C
on
fid
en
tia
l
liTiumi. diuretikebi amcireben liTiumis Tirkmlovan klirenss da zrdian
liTiumis toqsikurobis risks;erTdrouli miReba araa rekomednirebuli. aseTi
preparatebis miRebamde gaecaniT instuqcuias liTiumis preparatze.
npbp
maT Soris seleqciuri
inhibitorebi
cog-2. arasteroiduli
anTebiTsawinaaRmdego
saSualebebi
maT
Soris
cog-2
is
seleqciur
inhibitorebs
SeuZliaT
diuretikebis
diuretiuli,natriumuretiuli
da
antihipertenziuli efeqtebis daqveiTeba.
zogierT pacientSi Tirkmlis funqciis darRveviT (magaliTad, xandazmuli
asakis pacientebi an pacientebi hipovolemiiT maT Soris diuretikebis
mimRebni), romlebic iReben npbp mkurnalobas cog-2 seleqciuri inhibitorebis
CTvliT angiotenzin II-is antagonistebis da apf inhibitorebis erTdroulma
gamoyenebam SeiZleba migviyvanos Tirkmlebis funqciis Semdgom gauaresebasTan
mwvave Tirkmlovani ukmarisobis warmoSobis riskis CaTvliT.rogorc wesi, es
efeqtebi aris Seqcevadi. amitom aseTi kombinaciebi unda davniSnoT
sifrTxiliT darRveuli Tirkmlis funqciis mqone pacientebSi.
podagris
(probenecidi,sulfinpirazoni
da
alopurinoli)
samkurnalo
preparatebi. SeasaZlebelia saWiro gaxdes urikozuriuli preparatebis dozis
koreqcia radgan hidroqlortiazidma SeiZleba gazardos Sardis mJavas done
sisxlis SratSi. SesaZlebelia aucilebeli gaxdes probenecidis da
sulfinpirazonis dozis gazrda. Tiazidis erTdrouli miRebam SeiZleba
gazardos alopurinolze hipermgZnobelobis reaqciis warmoSobis sixSire.
antiqolinergiuli
saSualebebi
(magaliTad,
atropine,
biperideni).
bioxelmisawvdomoba tiaziduri diuretikebis matulobs knt-is motorikis da
kuWis daclis daqveiTebisas.
citotoqsikuri preparatebi (magaliTad, ciklofosfamidi, metotreqsati)
tiazidebs SeuZliaT Seasuston citotoqsikuri samkurnao preparatebis
gamoyofa SardTan da gaaZlieron maTi mielosupresoruli efeqti.
salicilatebi. salicilatebis maRali dozebis miRebisas hidroqlortiazidma
SeiZleba gaaZlieros salicilatebis toqsikuri moqmedeba centralur
nerviul sistemaze.
meTildopa.
miRebulia
calkeuli
Setyobinebebi
hemolitikuri
anemiis
ganviTarebaze hidroqloTiazidis da meTildopis erTdrouli gamoyenebisas.
ciklosporini. ciklosporinTan erTdrouli miReba Seizleba gazardos
hiperurikemiis da podagris msgavsi garTulebebis warmoSobis riski.
glikozidebi. TiazidebiT gamowveulma hipoglikemiam an hipomagniemiam
SeiZleba gaaRrmavos glikozidebis preparatebis gamoyenebiT inducirebuli
gulis ariTmiis mimdinareoba.
samkurnalo preparatebi romlebzec moqmedebs kaliumis donis cvlileba
sisxlis SratSi.
rekomendirebulia kaliumis doneebis perioduli kontroli sisxlis SratSi
da ekg-s regitrireba Tuki lozartan/hidroqlorTiazidi miiReba im
preparatebTa erTdroulad romlebzec moqmedebs kaliumis donis cvlileba
(magaliTad glikozidebi da antiariTmiuli sasualebebi) da preparatebi
(zogierTi antiariTmiuli preparatebis CaTvliT romlebic inducireben
“piruetis” tipis kuWis taxikardias xolo am ukanasknelTa warmoqmnisTvis
midrekil faqtorad warmogvidgeba hipoglikemia.
• Ia klasis antiaritmiuli preparatebi(magaliTad qimidini, hidroqinidini,
dizopiramidi|)
• III
klasis
antiariTmiuli
preparatebi
(magaliTad
amiodaroni,
sotaloli, dofetilidi, ibutilidi)
• zogierTi
antipsiqotiuri
preparati
(magaliTad,
tiopidazini,
qlorpromazini,
levomepromazini,
triftorperazini,
ciamemazini,
C
on
fid
en
tia
l
sulpiridi,
sultopriidi,
amisupridi,
tiapridi,
pimozidi,
galoperidoli, droperidoli)
• danarCeni preparatebi (magaliTad bepridili, cizapridi, difemanili,
eriTromicini v/v, galofantrini, mizolastini, peptamidini, terfenadini,
vinkamini v/v )
kalciumis marilebi. tiazidur diuretikebs SeuZliaT kalciumis donis
momateba sisxlis SratSi eqskreciis Semcirebis Sedegad. alciumis
danamatebis miRebis aucileblobis SemTxvevaSi unda vakontroloT
kalciumis done sisxlis SratSi da Sesabamisad koreqtireba vawarmooT
kalciumis dozis.
laboratoriuli analizebis rezultatebze gavlena. tiazidebis kalciumis
metabolozmze gavlenis gamo maTma miRebam SieZleba daamaxinjos farisebri
jirkvlis funqciis gamokvlevis Sedegebi.
karbamezapenini.simptomaturi hiponatriemiis riski.moiTxoveba klinikuri da
biologiuri maCveneblebis kontroli.
iodis
Semcvleli
kontrastuli
preparatebi.diuretikebis
miRebiT
gamowveuli dehidrataciisas matulobs mwvave Tirkmlis ukmarisobis
ganviTarebis riski gansakuTrebiT ki ioduri preparatebis maRal dozebSi.
aseTi preparatebis miRebamde pacientebSi unda CavataroT dehidratacia.
amfotericini b (parenteraluri forma) kortikosteroidebi, aktg anu
mastimulirebeli safaRaraTo saSualebebi. hidroqlorTiazidi SeiZleba
aZlierebdes wylis-eleqtrolituri disbalansis gamoxatulebas kerZod
hipokaliemiis.
ny
gamoSvebis forma
14
tableti
blisterSi
polivinilqloridi/
polieTileni/
polivinilidinqloridi/ aklari 2 blisteri erTad gamoyenebis instruqciiT
kartonis yuTSi.
Senaxvis pirobebi
30 ze nakleb temperaturaze. SeinaxeT safuTavi sawyis sinaTlisa da
sinestisgan dasacavad. SeinaxeT bavSvebisTvis miuwvdomel adgilas.
Senaxvis vada
3 weli. ar gamoiyenoT safuTavi vadis Semodeg
afTiaqidan gacemis pirobebi
pa
ფარმაცევტული პროდუქტის ჯგუფი II - გამოიყენება ექიმის დანიშნულებით
C
om
mwarmoebeli firma
merk Sarp da doum b.v. vaarderveg 39, 2031 bn haarlem, niderlandebi
(Merk Sharp & Dohme B.V., Waarderweg 39,2031 BN Haarlem, The Netherlands).