atorisi, 10 mg, apkiT Semogarsuli tabletebi atorisi, 20 mg ... - GPC

atorisi, 10 mg, apkiT Semogarsuli tabletebi
atorisi, 20 mg, apkiT Semogarsuli tabletebi
atorisi, 40 mg, apkiT Semogarsuli tabletebi
atorvastatini
preparatis miRebamde yuradRebiT, srulad gaecaniT instruqcias.
- SeinaxeT instruqcia, vinaidan misi wakiTxva SeiZleba kidev dagWirdeT.
- damatebiTi kiTxvebis SemTxvevaSi, mimarTeT eqims an farmacevts.
- aRniSnuli preparati Tqven dageniSnaT. nu gadascemT mas sxvebs. preparats SeuZlia avnos, Tundac maTi
simptomebi Tqvensas emTxveodes.
- Tu romelime gverdiTi efeqti damZimda an SeniSneT am instruqciaSi aRniSnulTagan gansxvavebuli gverdiTi
efeqti, mimarTeT eqims an farmacevts.
instruqciis Sinaarsi:
1. ras warmoadgens da risTvis gamoiyeneba atorisi
2. atorisis miRebamde
3. atorisis miRebis wesi
4. SesaZlo gverdiTi efeqtebi
5. atorisis Senaxvis pirobebi
6. damatebiTi informacia
1. ras warmoadgens da risTvis gamoiyeneba atorisi
atorisi miekuTvneba preparatTa jgufs, romlebsac statinebi ewodeba da lipidebis (cximebis) maregulirebel
preparatebs warmoadgenen.
atorisi gamoiyeneba sisxlSi lipidebis – qolesterinis da trigliceridebis - donis dasawevad, roca mxolod
dabalcximiani dieta da cxovrebis stilis Secvla uSedegoa. Tu gulis daavadebis gazrdili riskis qveS xarT,
atorisis gamoyeneba am riskis Sesamcirebladac SeiZleba, Tundac qolesterinis done normaluri iyos. mkurnalobis
periodSi unda daicvaT standartuli qolesterinis damwevi dieta.
qolesterini warmoadgens nivTierebas, romelic organizmSi bunebrivadaa warmodgenili da aucilebelia normaluri
ganviTarebisTvis. Tumca, Tu sisxlSi qolesterini momatebulia, igi SeiZleba daileqos sisxlZarRvebis kedlebze da
sabolood, maTi blokireba gamoiwvios. es gulis daavadebebis erT-erTi yvelaze xSiri mizezia. cnobili faqtia, rom
qolesterinis maRali done gulis daavadebebis momatebul risks gansazRvravs. sxva faqtorebs, romlebic gulis
daavadebis risks zrdian, miekuTvneba arteriuli hipertenzia, Saqriani diabeti, Warbi wona, fizikuri aqtiobis
nakleboba, moweva an gulis daavadebebis ojaxuri istoria.
2. atorisis miRebamde
ar miiRoT atorisi
- Tu alergiuli (hipersensitiuri) xarT atorvastatinis an atorisis sxva komponentebis mimarT;
- Tu RviZlis darRvevebi gaqvT;
- Tu RviZlis funqciebze sisxlis analizebis darRveuli maCveneblebi gqondaT, ucnobi mizeziT;
- Tu reproduqciuli asakis qali xarT da ar iyenebT saimedo kontracefcias;
- Tu orsulad xarT, daorsulebas cdilobT an meZuZuri deda xarT.
- Tu kunTebis daavadeba gaqvT, romelic miopaTiis saxeliTaa cnobili (kunTebis ganmeorebadi an auxsneli
tkivili)
atorisi gansakuTrebuli sifrTxiliT gamoiyeneT
- Tu Tirkmlis problemebi gaqvT
- Tu daqveiTebuli gaqvT farisebri jirkvlis funqcia (hipoTiroidizmi)
- Tu gaqvT an odesme gqoniaT kunTebis ganmeorebadi da auxsneli tkivili, aseve, kunTebTan dakavSirebuli
problemebis piradi an ojaxuri istoria
- Tu warsulSi, lipidebis damaqveiTebeli sxva preparatebiT mkurnalobisas (mag., sxva “-statinebi” an “fibratebi”),
gqoniaT kunTebTan dakavSirebuli problemebi
- Tu regularulad RebulobT didi raodenobiT alkohols
- Tu RviZlis daavadebis istoria gaqvT
- Tu 70 wels gadacilebuli xarT
Tu CamoTvlilTagan romelime gexebaT, eqimma unda CagitaroT sisxlis analizi atorisiT mkurnalobamde da,
SesaZlebelia, mis ganmavlobaSic, raTa Tavidan aicilos kunTebTan dakavSirebuli gverdiTi efeqtebi. cnobilia, rom
kunTebTan dakavSirebuli gverdiTi efeqtebis, mag., rabdomiolizis riski matulobs, roca erTdroulad miiReba
garkveuli praparatebi (ixileT punqti 2, “sxva preparatebis miReba”).
atorisis miRebamde, gaarkvieT eqimTan an farmacevtTan
- xom ar gaqvT sunTqvis mZime ukmarisoba
sxva preparatebis miReba
garkveul preparatebs SeuZliaT Secvalon atorisis efeqti an maTi efeqti Secvalos atorisma. amgvarma
urTierTqmedebam, SesaZlebelia, erTi an orive preparati nakleb efeqturi gaxados. agreTve, SeiZleba gazardos
gverdiTi efeqtebis riski an simZime, maT Soris, rabdomiolizis saxeliT cnobili, mZime, kunTebis gamomfitavi
mdgomareoba, romelic me-4 punqtSia aRwerili. eqimi amas mxedvelobaSi miiRebs atorisis dozis dadgenisas.
garkveuli preparatebi urTierTqmedeben atorisTan:
- preparatebi, romlebic gamoiyeneba imunuri sistemis moqmedebis Sesacvlelad, mag., ciklosporini

- zogierTi antibiotiki an sokos sawinaaRmdego preparati, mag., eriTromicini, klariTromicini, ketokonazoli,
itrakonazoli, rifampini;
- lipidebis donis maregulirebeli sxva preparatebi, mag., gemfibrozili, sxva fibratebi, nikotinis mJavis
warmoebulebi, qolestipoli;
- kalciumis arxebis zogierTi blokatori, romelic stenokardiis an sisxlis maRali wnevis dros gamoiyeneba,
mag., dilTiazemi;
- gulis riTmis maregulirebeli preparatebi, mag., digoqsini, amiodaroni;
- zogierTi benzodiazepini, romelic SfoTvis an sxva darRvevebis dros gamoiyeneba, mag., nefazodoni;
- proteazas inhibitorebi, romlebic aiv infeqciis samkurnalod gamoiyeneba;
- sxva preparatebi, romlebic atorisTan urTierTqmedeben Semdegia: varfarini (amcirebs sisxlis Sededebas),
oraluri kontraceptivebi, fenitoini (antikonvulsanti, gamoiyeneba epilefsiis dros) da antacidebi
(aluminis an magniumis Semcveli saWmlis monelebis darRvevis samkurnalo produqtebi)
SeatyobineT eqims an farmacevts Tqvens mier amJamad an axlo warsulSi miRebuli nebismieri sxva preparatis Sesaxeb,
ureceptod gacemulis CaTvliT.
atorisis miReba sakvebTan da sasmelebTan erTad
atorisis miRebis instruqciebi ixileT punqtSi 3. yuradReba miqacieT Semdegs:
greipfrutis wveni
greipfrutis wveni ar miiRoT dReSi erT an or patara Wiqaze meti, vinaidan didi roadenobiT miRebam SeiZleba
atorisis efeqtebi Secvalos.
alkoholi
preparatiT mkurnalobis periodSi, moerideT alkoholis Warbad miRebas. ixileT punqti 2 “atorisi gansakuTrebuli
sifrTxiliT gamoiyeneT”.
orsuloba da laqtacia
ar miiRoT atorisi Tu orsulad xarT, fiqrobT, rom SeiZleba orsulad iyoT an daorsulebas cdilobT.
reproduqciuli potencialis mqone qalebma Sesabamisi zomebi unda miiRon.
nebismieri preparatis miRebamde, rCevisTvis eqims an farmacevts mimarTeT.
avtomanqanis da meqanizmebis marTva
ar marToT avtomanqana, Tu preparati aRniSnul unarze moqmedebs. ar gamoiyenoT xelsawyoebi da meqanizmebi, Tu
preparati gavlenas axdens maTi gamoyenebis unarze.
mniSvnelovani informacia atorisis zogierTi ingredientis Sesaxeb
atorisi Seicavs laqtozas. Tu eqimma giTxraT, rom zogierTi Saqris autanloba gaqvT, preparatis miRebamde
daukavSirdiT mas.
3. atorisis miRebis wesi
atorisi yovelTvis zustad eqimis daniSnulebisamebr miiReT. Tu rameSi darwmunebuli ar xarT, gaesaubreT eqims an
farmacevts.
atorisis Cveuli sawyisi dozaa - 10 mg dReSi erTxel. saWiroebis SemTxvevaSi, eqimma SeiZleba gazardos igi, sanam
TqvenTvis aucilebel dozas ar miaRwevs. eqimi dozis koreqcias 4 kviriani an ufro didi intervalebiT moaxdens.
atorisis maqsimaluri dozaa – 80 mg dReSi erTxel.
atorisis tabletebi mTlianad unda dagaylapoT, wylis miyolebiT, SegiZliaT dRis nebismier dros miiRoT,
sakvebTan erTad an mis gareSe. Tumca, ecadeT, Tqveni tabletebi yoveldRe erTsa da imave dros miiRoT.
mkurnalobis dawyebamde, eqimi qolesterinis dabali Semcvelobis dietas daginiSnavT, romelic atorisiT
mkurnalobis manZilzec unda daicvaT.
Tu atorisi saWiroze didi raodenobiT miiReT
Tu SemTxveviT, atorisis tabletebis Warbi raodenoba miiReT (Cveul dRiur dozaze meti), rCevisTvis mimarTeT eqims
an uaxloes saavadmyofos.
Tu dagaviwydaT atorisis miReba
Tu dozis miReba dagaviwydaT, ganagrZeT Tqveni Cveulebrivi doziT, ganrigis mixedviT. ar miiRoT ormagi doza
gamotovebulis anazRaurebis mizniT.
Tu SewyviteT atorisis miReba
Tu atorisis miRebas xangrZlivad SewyvetT, sisxlSi qolesterinma SeiZleba isev moimatos, rac, agreTve, gazrdis
gulis an sisxlZarRvebis daavadebebis risks.
Tu preparatis gamoyenebis Taobaze damatebiTi kiTxvebi gagiCndaT an mkurnalobis Sewyveta gsurT, mimarTeT eqims an
farmacevts.
4. SesaZlo gverdiTi efeqtebi
yvela sxva preparatis msgavsad, atorismac SeiZleba gverdiTi efeqtebi gamoiwvios, Tumca ara yvela pacientSi.
Semdegi gverdiTi efeqtebi mniSvnelovania da, ganviTarebis SemTxvevaSi, dauyovnebel Carevas moiTxovs:
Zalian iSviaTi gverdiTi efeqtebi: uviTardeba 10000 pacientidan 1-ze naklebs
atorisis gamoyeneba unda SewyvitoT da dauyovnebliv mimarToT eqims, Tu Semdegi simptomebi ganviTarda:
angionevrozuli SeSupeba (saxis, enis da xorxis SeSupeba, ramac SeiZleba sunTqvis gaZneleba gamoiwvios),
anafilaqsia (uecari alergiuli reaqcia, romelsac Tan axlavs qoSini, gamonayari, xmauriani sunTqva da sisxlis
wnevis daqveiTeba), toqsikuri epidermuli nekrolizi (mZime da eqstensiuri gamonayari, kanis siwiTliT da
aqercvliT), stivens-jonsonis sindromi (kanis, piris Rrus, Tvalebis da sasqeso organoebis mZime vezikuluri
daavadeba), multiformuli eriTema (kanze gamonayari wiTeli laqebis saxiT).
Tu uCveulo sisxldena an sisxlnaJRenTebi aRgeniSnebaT, es SesaZlebelia RviZlis daavadebis maCvenebeli iyos.
iSviaTi gverdiTi efeqtebi: uviTardeba 10000 pacientidan 10-ze naklebs

kunTebis dazianeba an anTeba da momatebuli mgrZnobeloba, romelic SeiZleba gadaizardos mZime, sicocxlisaTvis
potenciurad saSiS daavadebaSi (e.w. rabdomiolizi). es SeiZleba aSkara mizezis gareSe moxdes (magaliTad, fizikuri
aqtiobis gareSe). Tu kunTebis sisuste, mgrZnobiaroba an tkivili gaqvT da, gansakuTrebiT, Tu imavdroulad Tavs
SeuZlod grZnobT an maRali temperatura gaqvT, SewyviteT atorisis gamoyeneba da maSinve acnobeT eqims.
atorisis sxva SesaZlo gverdiTi efeqtebi
xSiri gverdiTi efeqtebi: uviTardeba 10000 pacientidan, sul mcire, 100-s
gulisreva, muclis tkivili, yabzoba, Seberiloba, saWmlis mounelebloba, diarea, Tavis tkivili, kunTebis tkivili,
sisuste, Zilis darRvevebi, maT Soris, uZiloba da koSmaruli sizmrebi, Tavbrusxveva, tkivili gulmkerdis areSi,
alergiuli reaqciebi, xelis da fexis TiTebis dabuJeba da Cxvletis SegrZnebebi, tkivilis an Sexebis SegrZnebis
daqveiTeba, saxsrebis an zurgis tkivili, koWebis SeSupeba, gamonayari, qavili.
naklebad xSiri gverdiTi efeqtebi: uviTardeba 10000 pacientidan 100-ze naklebs
yvela aRniSnuli gverdiTi efeqti aucileblad preparatis gamoyenebasTan ar aris dakavSirebuli.
anoreqsia (umadoba), kunTebis krunCxvebi, uCveulo sisxldena an sisxlnaJRenTebi, rac sisxldenis SemaCerebeli
ujredebis SemcirebiT aris gamowveuli, xmauri yurebSi da/an TavSi, wonis momateba, mexsierebis daqveiTeba, WinWris
cieba, gulisrevis SegrZneba, impotencia, Tmis cvena, pankreatiti (pankreasis anTeba, rac mucilis tkivils iwvevs),
sisxlSi Saqris donis momateba an dakleba (Tu diabeti gaqvT, mudmivad unda akontroloT sisxlSi Saqris done).
iSviaTi gverdiTi efeqtebi: uviTardeba 10000 pacientidan 10-ze naklebs
hepatiti (RviZlis anTeba), siyviTle (kanis da Tvalebis gayviTleba).
Zalian iSviaTi gverdiTi efeqtebi: uviTardeba 10000 pacientidan 1-ze naklebs
gemos SegrZnebis cvlileba, mxedvelobis darRvevebi, RviZlis ukmarisoba, siyrue, ginekomastia (mamakacebSi da
qalebSi sarZeve jirkvlebis gazrda) da myesebis dazianeba.
ucnobi sixSiris gverdiTi efeqtebi, romelTa Sefaseba SeuZlebelia arsebul monacemebze dayrdnobiT
depresia, sunTqvis darRvevebi, maT Soris, mudmivi xvela da/an qoSini an maRali temperatura.
gverdiTi efeqtebis ganviTarebis SemTxvevaSi, acnobeT eqims. is gadawyvets, rogor unda moiqceT.
Tu romelime gverdiTi efeqti damZimda an SeniSneT am instruqciaSi CamoTvlilTagan gansxvavebuli gverdiTi efeqti,
acnobeT eqims an farmacevts.
5. atorisis Senaxvis pirobebi
SeinaxeT bavSvebisTvis miuwvdomel adgilze.
SeinaxeT originalur SefuTvaSi, sinaTlisgan da tenisgan dasacavad.
ar gamoiyenoT atorisi SefuTvaze miTiTebuli vargisianobis vadis amowurvis Semdeg. vargisianobis vada gulisxmobs
miTiTebuli Tvis bolo dRes.
medikamentebi ar gadayaroT kanalizaciis wyalSi an sayofacxovrebo nagavSi. arasaWiro medikamentebis moSorebis
gzebis Sesaxeb hkiTxeT farmacevts. es zomebi garemos dacvas Seuwyobs xels.
6. damatebiTi informacia
atorisis Semadgenloba
aqtiuri nivTierebaa atorvastatini. atorisis apkiT Semogarsuli yoveli 10 mg, 20 mg, 40 mg tableti, Seicavs,
Sesabamisad, 10, 20, 40 mg atorvastatins, kalciumis atorvastatinis saxiT.
sxva ingredientebia: birTvi – natriumis hidroqsidi, natriumis lauril sulfati,
hidroqsipropilceluloza, laqtozis monohidrati, mikrokristaluri celuloza, natriumis kroskarmeloza,
krospovidoni, magniumis stearati; garsi – polivinilis spirti, titanis dioqsidi (E171), makrogoli 3000 da
talki.
rogor gamoiyureba atorisi da ra Sedis SefuTvaSi
atorisi 10 mg, 20 mg, da 40 mg: mrgvali, apkiT Semogarsuli, ormxrivamozneqili, TeTri feris tabletebi, damreci
kideebiT.
muyaos kolofi Seicavs blisterebs 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 apkiT Semogasuli tabletiT.
SefuTvis yvela zoma ar xvdeba gayidvaSi.
gaicema mxolod receptiT:
savaWro licenziis mflobeli da mwarmoebeli
krka, d.d., novo mesto, smarJeska cesta 6, 8501 novo mesto, slovenia