Malangizo ogwiritsira ntchito mankhwala osokoneza bongo, analogi, ndemanga

Mapiritsi okhala ndi mafilimu, 40 mg

Piritsi limodzi lili

ntchito yogwira - calcium wa atorvastatin 41.44 mg (wofanana ndi atorvastatin 40,00 mg)

muzokopa: povidone, sodium lauryl sulfate, calcium carbonate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, crospovidone, magnesium stearate,

chipolopolo: Opadry White Y-1-7000 (imakhala ndi hypromellose, titanium dioxide (E 171) ndi macrogol 400)

Mapiritsi ozungulira okhala ndi zokutira zoyera za film, pang'ono zotumphukira

Mankhwala

Atorvastatin imadziwitsidwa mwachangu pambuyo pakukonzekera kwamlomo, kuchuluka kwake m'madzi am'magazi kumafika pazofunikira pambuyo pa maola 1-2. Mlingo wa mayamwidwe ndi kuchuluka kwa atorvastatin mu madzi a m'magazi kumaonjezera kuchuluka kwa mlingo. Mtheradi wa bioavailability wa atorvastatin ndi pafupifupi 14%, ndipo dongosolo la bioavailability la inhibitory zochita motsutsana 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMG-CoA reductase) ndi pafupifupi 30%. Systemic bioavailability yochepa imayamba chifukwa cha kagayidwe kachakudya ka mucous membrane wa m'mimba ndipo / kapena pa "gawo loyambirira" kudzera m'chiwindi.

Chakudya chimachepetsa pang'onopang'ono kuchuluka kwake ndi kuchuluka kwa mankhwalawa (mwa 25% ndi 9%, motsatana, monga momwe zikuwonekera ndi zotsatira za kutsimikiza kwa Cmax ndi AUC), koma kuchepa kwa kachulukidwe kotsika kwa lipoprotein cholesterol (LDL-C) kuli kofanana ndi pamene mukumwa atorvastatin pamimba yopanda kanthu. Pambuyo potenga atorvastatin madzulo, ndende yake ya plasma ndiyotsika (Cmax ndi AUC ndi 30%) kuposa atatha kudya m'mawa. Ubale wapakati pakati pa kuchuluka kwa mayamwidwe ndi mlingo wa mankhwalawo unawululidwa.

Kuchulukitsa kwapakati pakugawa kwa atorvastatin ndi pafupifupi 381 malita. Kuyankhulana ndi mapuloteni a plasma osachepera 98%. Chiyero cha erythrocyte / plasma atorvastatin pafupifupi 0.25, i.e. atorvastatin simalowa m'magazi ofiira magazi.

Atorvastatin imapangidwa kwakukulu kuti ipange ma ortho- ndi para-hydroxylated exivatives ndi zinthu zosiyanasiyana za beta oxidation. Ortho- ndi para-hydroxylated metabolites imalepheretsa kusintha kwa HMG-CoA. Kutsika kwapafupifupi 70% kwa ntchito ya HMG-CoA reductase kumachitika chifukwa cha zochita za metabolites zomwe zimagwira. Mu kagayidwe ka atorvastatin, chiwindi cytochrome P450 3A4 chimagwira ntchito yofunika kwambiri: kuchuluka kwa atorvastatin m'madzi am'magazi a anthu kumawonjezeka pamene akutenga erythromycin, yomwe imalepheretsa izi isoenzyme. Atorvastatin, ndiye choletsa chofooka cha cytochrome P450 3A4. Atorvastatin ilibe gawo lalikulu pama protein a terfenadine, omwe amapangidwa makamaka ndi cytochrome P450 3A4, chifukwa chake, sizokayikitsa kuti atorvastatin imathandizanso kwambiri pa pharmacokinetics yamagawo ena a cytochrome P450 3A4.

Atorvastatin ndi ma metabolites ake amachotseredwa ndi bile chifukwa cha hepatic ndi / kapena extrahepatic metabolism (atorvastatin sichikumana kwambiri ndi kulowereratu kwa poserohepatic). Hafu ya moyo wa atorvastatin ndi pafupifupi maola 14. Ntchito yoletsa kuyesa kutsutsana ndi HMG-CoA reductase imangokhalira pafupifupi maola 20-30, chifukwa cha kukhalapo kwa metabolites yogwira. Pambuyo pakukonzekera pakamwa, ochepera 2% ya atorvastatin amapezeka mu mkodzo.

Magulu apadera a odwala

Okalamba: kuchuluka kwa plasma ya atorvastatin mwa anthu azaka 65 ndi akulu omwe ndi apamwamba (Cmax ndi 40%, AUC ndi 30%) kuposa odwala achinyamata, kusiyana pakubeteka, kuchita bwino, kapena kukwaniritsa zolinga zamankhwala ochepetsa lipid mu okalamba poyerekeza ndi anthu sanapezeke.

Ana: maphunziro a pharmacokinetics a mankhwalawa mu ana sanachitike.

Okwatirana: kuchuluka kwa atorvastatin m'madzi am'madzi mwa amayi amasiyana (Cmax ndi 20% apamwamba, ndi AUC ndi 10% kutsika) kuchokera kwa amuna, komabe, palibe kusiyana kwakukulu pakukhudzidwa kwa mankhwalawa pamipid metabolism mwa amuna ndi akazi.

Kulephera kwinaMatenda a impso sasokoneza kukhudzana kwa atorvastatin m'madzi am'magazi kapena kukhudzika kwa metabolidi ya metabolid, motero, kusintha kwa odwala omwe ali ndi vuto laimpso sikofunikira.

Hemodialysis: hemodialysis ndiyokayikitsa kuti ingayambitse chiwonetsero chachikulu cha atorvastatin, popeza mankhwalawa amagwirizana kwambiri ndi mapuloteni a plasma.

Kulephera kwa chiwindi: Kuzunza kwa Atorvastatin kumawonjezeka kwambiri (Cmax pafupifupi nthawi 16, AUC pafupifupi nthawi 11) mwa odwala omwe ali ndi vuto la chiwindi cha chidakwa (Childe-Pugh B).

Mankhwala

Atoris ® ndi mankhwala opangira lipid-kuchepetsa, chopatsa mphamvu chopikisana cha HMG-CoA reductase, kiyi ya enzyme yofunika kwambiri yomwe imatembenuza 3-hydroxy-3-methylglutaryl-CoA kukhala mevalonic acid, yomwe imayambitsa ma steroid, kuphatikiza cholesterol. Odwala omwe ali ndi homozygous ndi heterozygous mabanja a hypercholesterolemia, osakhala a mabanja a hypercholesterolemia ndi dyslipidemia, Atoris® lowers whole cholesterol (Cs), otsika Mlingo wa lipoprotein cholesterol ndi apolipoprotein B komanso otsika-kachulukidwe choleoprotein. triglycerides, imayambitsa kuwonjezeka kosasunthika kwa high-density lipoprotein cholesterol (HDL-C).

Mu chiwindi, triglycerides ndi cholesterol zimaphatikizidwa pakupanga milingo yotsika kwambiri ya lipoproteins (VLDL), kulowa m'magazi am'magazi ndipo zimasunthidwa ku zotumphukira. Ma lipoproteins otsika kwambiri (LDL) amapangidwa kuchokera ku VLDL, omwe amathandizidwa ndi kuyanjana ndi ma receptors apamwamba a LDL.

Atoris® imachepetsa kuchuluka kwa cholesterol ndi lipoproteins m'madzi am'magazi, kuletsa HMG-CoA reductase ndi kapangidwe ka cholesterol mu chiwindi ndikuwonjezera kuchuluka kwa "chiwindi" LDL receptors pamaselo a cell, zomwe zimapangitsa kuti pakhale kuchuluka komanso kukopa kwa cholesterol ya LDL.

Zizindikiro zogwiritsidwa ntchito

- kuphatikiza ndi zakudya zochizira odwala omwe ali ndi cholesterol yokwanira, HDL-C, apolipoprotein B ndi triglycerides, komanso kuchuluka kwa HDL-C kwa odwala omwe ali ndi hypercholesterolemia (heterozygous Famal komanso hypercholesterolemia), yophatikizika (yosakanikirana) hyperlipidia IIa ndi IIb malinga ndi Frederickson), okhala ndi triglycerides m'magazi am'magazi (mtundu IV malinga ndi Frederickson) ndi odwala dysbetalipoproteinemia (mtundu wa III malinga ndi Frederickson), pakalibe zotsatira zokwanira ndi di oterapii

- Kuchepetsa kuchuluka kwamadzi am'magazi a cholesterol yathunthu ndi LDL-C odwala omwe ali ndi homozygous Famer hypercholesterolemia osakwanira pakulimbitsa mankhwala

- Kuchepetsa chiopsezo cha kufa ndi matenda amtima komanso kuopsa kwa matenda opatsirana, matenda a angina pectoris, stroko komanso kuchepetsa kufunikira kwa njira zophunzitsila kwa odwala omwe ali ndi matenda amtima komanso / kapena dyslipidemia, komanso ngati matendawa sanapezeka, koma alipo atatu zinthu zomwe zingayambitse matenda oyamba ndi mtima, monga zaka zopitilira 55, kusuta, matenda oopsa, kuchepa kwa plasma kwa HDL-C, komanso milandu yakukula kwa matenda amtima wapachibale

- kuphatikiza ndi zakudya zochizira ana a zaka zapakati pa 10 mpaka 17 ndi kuchuluka kwa mafuta am'madzi ambiri, LDL-C ndi apolipoprotein B ndi heterozygous Famel hypercholesterolemia, ngati pambuyo poti adye chakudya chokwanira, mulingo wa LDL-C watsala> 190 mg / dl kapena kuchuluka kwa LDL imatsalira> 160 mg / dl, koma pali milandu ya matenda oyambitsidwa ndi mtima mwa abale kapena ziwiri kapena zingapo zomwe zingayambitse matenda a mtima mwa mwana

Mlingo ndi makonzedwe

Musanayambe chithandizo ndi Atoris ®, muyenera kuyesa kuthana ndi hypercholesterolemia kudzera mu chakudya, masewera olimbitsa thupi komanso kuchepa thupi kwa odwala omwe ali ndi kunenepa kwambiri, komanso chithandizo cha matenda oyambitsidwa. Popereka mankhwala, wodwalayo ayenera kulimbikitsa mtundu wa zakudya zomwe ayenera kutsatira pakumwa.

Mankhwalawa amatengedwa nthawi iliyonse masana, mosasamala za kudya. Mlingo wa mankhwalawa umasiyana 10 mpaka 80 mg kamodzi patsiku, ndikusankha poganizira zomwe zili LDL-C, cholinga cha mankhwala ndi zomwe munthu akuchita. Kumayambiriro kwa mankhwalawa komanso / kapena pakuwonjezeka kwa mlingo wa Atoris®, ndikofunikira kuyang'anitsitsa zomwe zili m'magazi a plasma masabata onse a 2-4 ndikusintha mlingo moyenerera.

Hypercholesterolemia yoyamba komanso yophatikiza (yophatikizika) hyperlipidemia: Kwa odwala ambiri - 10 mg kamodzi patsiku, achire amawonetseredwa mkati mwa masabata awiri ndipo nthawi zambiri amafika pazaka 4, mutalandira chithandizo kwa nthawi yayitali, zotsatira zake zimatsalira.

Homozygous m'mabanja hypercholesterolemia: 80 mg kamodzi patsiku (nthawi zambiri, chithandizo chamankhwala chidayambitsa kutsika kwa LDL-C ndi 18-45%).

Kwambiri dyslipidemia odwala anaMankhwala oyambira ndi 10 mg kamodzi patsiku. Mlingo umatha kuwonjezeka mpaka 80 mg tsiku lililonse malinga ndi kuyankha kwa chipatala ndi kulolera. Mlingo uyenera kusankhidwa payekha poganizira cholinga cha mankhwala.

Gwiritsani ntchito odwala omwe ali ndi matenda a chiwindi: onani "Contraindication."

Mlingo wa odwala ndi aimpso kulephera: matenda a impso sasokoneza kukhudzana kwa Atoris ® mu plasma wamagazi kapena kuchepa kwa zomwe zili LDL-C, chifukwa chake kusintha kwa mankhwalawa sikofunikira.

Gwiritsani ntchito mwa okalamba: panalibe kusiyana pakukhazikika, kuchita bwino, kapena kukwaniritsa zolinga zamankhwala ochepetsa lipid mu okalamba poyerekeza ndi anthu ambiri.

Zotsatira zoyipa

kupweteka pakhosi ndi m'mimba, mphuno

dyspepsia, nseru, kusefukira kwam'mimba, kusapeza pamimba, kuyimitsa, kutsegula m'mimba

arthralgia, kupweteka kwa miyendo, kukokana minofu, myalgia, myositis, myopathy

Zizindikiro zamtundu wa chiwindi, kuchuluka kwa seramu creatine phosphokinase (CPK)

kufooka kwa minofu, kupweteka kwa khosi

malaise, malungo

mawonekedwe a maselo oyera amkodzo

Zotsatira zotsatirazi zadziwika mu maphunziro atatsatsa malonda:

thupi lawo siligwirizana (kuphatikizapo anaphylaxis)

kunenepa

Hypesthesia, amnesia, chizungulire, kukoma kosokoneza

Stevens-Johnson syndrome, poermal necrolysis yoopsa, erythema multiforme, zidzolo

rhabdomyolysis, kupweteka kumbuyo

kupweteka pachifuwa, zotupa za kufinya, kutopa

Contraindication

Hypersensitivity ku zilizonse za mankhwala

matenda a chiwindi kapena kuchuluka kwa ntchito ya seramu transaminase (zochulukirapo katatu poyerekeza ndi malire apamwamba) abwinobwino

azimayi oyembekezera komanso oyembekezera, komanso azimayi azaka zosabereka omwe sagwiritsa ntchito njira zoyenera zakulera

odwala ndi cholowa lactose tsankho, LAPP-lactase enzyme akusowa, shuga-galactose malabsorption

Zochita zamankhwala osokoneza bongo

Chiwopsezo chokhala ndi myopathy chimawonjezeka panthawi ya chithandizo ndi HMG-CoA reductase inhibitors komanso kugwiritsa ntchito munthawi yomweyo cyclosporin, zotumphukira za fibric acid, nicotinic acid ndi cytochrome P450 3A4 inhibitors (erythromycin, antifungal agents zokhudzana ndi azoles).

P450 3A4 Inhibitors: atorvastatin imapangidwa ndi cytochrome P450 3A4. Kugwiritsa ntchito pamodzi kwa atorvastatin ndi cytochrome P450 3A4 inhibitors kungayambitse kuchuluka kwa plasma mozungulira atorvastatin. Mlingo wogwirizana komanso kuthekera kwa zotengera kumatengera kusinthasintha kwa zochitika pa cytochrome P450 3A4.

Conhibor Inhibitors: atorvastatin ndi ma metabolites ake ndi magawo a transporter ya OATP1B1. OATP1B1 inhibitors (mwachitsanzo, cyclosporine) angakulitse bioavailability wa atorvastatin. Kugwiritsa ntchito nthawi imodzi kwa 10 mg ya Atoris ® ndi cyclosporine (5.2 mg / kg / tsiku) kumabweretsa chiwonetsero chachikulu cha atorvastatin ndi nthawi 7.7.

Erythromycin / clarithromycin: ndi munthawi yomweyo kugwiritsa ntchito atorvastatin ndi erythromycin (500 mg kanayi patsiku) kapena clarithromycin (500 mg kawiri pa tsiku), zomwe zimalepheretsa cytochrome P450 3A4, kuwonjezeka kwa kuchuluka kwa atorvastatin m'magazi a magazi kumawonedwa.

Mapuloteni oletsa: Kugwiritsa ntchito kwa atorvastatin ndi ma proteinase inhibitors otchedwa cytochrome P450 3A4 inhibitors limodzi ndi kuwonjezeka kwa plasma mozama kwa atorvastatin.

Diltiazem hydrochloride: Kugwiritsa ntchito pamodzi kwa Atoris® (40 mg) ndi diltiazem (240 mg) kumawonjezera kuchuluka kwa atorvastatin m'madzi a m'magazi.

Cimetidine: Kafukufuku wokhudzana ndi kuyenderana kwa atorvastatin ndi cimetidine sikunawonetse mgwirizano wamphamvu.

Itraconazole: kugwiritsa ntchito nthawi yomweyo kwa Atoris® (20 mg-40 mg) ndi itraconazole (200 mg) kumabweretsa kuwonjezeka kwa AUC ya atorvastatin.

Madzi a Mphesa: ili ndi chimodzi kapena ziwiri zomwe zimalepheretsa CYP 3A4 ndipo zitha kuwonjezera kuchuluka kwa atorvastatin m'madzi am'magazi, makamaka kumwa kwambiri madzi a mphesa (oposa malita 1.2 patsiku).

Zowonetsa za cytochrome P450 3A4: kugwiritsa ntchito munthawi yomweyo Atoris® ndi ma cytochrome P450 3A4 inducers (efavirenz, rifampin) kungayambitse kuchepa kwa plasma woipa wa atorvastatin. Popeza magawo awiri a zochita za rifampin (kulowetsedwa kwa cytochrome P450 3A4 ndi kuletsa kwa chiwindi enzyme OATP1B1).

Maantacid okhala: munthawi yomweyo kuyimitsidwa kwa kuyimitsidwa komwe kuli ndi magnesium ndi ma aluminium hydroxides kunachepetsa kuchuluka kwa atorvastatin m'madzi amwazi ndi pafupifupi 35%, komabe, kuchepa kwa zomwe LDL-C sinasinthe.

Antipyrine: Atoris ® sichikhudza ma pharmacokinetics a antipyrine, chifukwa chake, kuyanjana ndi mankhwala ena omwe amapangidwa ndi cytochrome isoenzymes yomweyo sikuyembekezeredwa.

Colestipol: ndi munthawi yomweyo kugwiritsa ntchito colestipol, kuchuluka kwa atorvastatin m'madzi am'magazi kunachepa pafupifupi 25%, komabe, lipid-kutsitsa mphamvu ya kuphatikiza kwa atorvastatin ndi colestipol imaposa ya aliyense mankhwala payekhapayekha.

Digoxin: Mobwerezabwereza makonzedwe a digoxin ndi atorvastatin pa 10 mg, kuchuluka kwa ndende ya digoxin m'madzi a m'magazi sikunasinthe. Komabe, pamene digoxin imagwiritsidwa ntchito limodzi ndi atorvastatin pa mlingo wa 80 mg / tsiku, kuchuluka kwa digoxin kumawonjezeka pafupifupi 20%. Odwala omwe amalandira digoxin osakanikirana ndi Atoris® amafunikira kuwunika koyenera.

Azithromycin: ndi munthawi yomweyo kugwiritsa ntchito atorvastatin (10 mg kamodzi patsiku) ndi azithromycin (500 mg kamodzi patsiku), kuchuluka kwa atorvastatin mu plasma sikunasinthe.

Kulera kwamlomo: ndi munthawi yomweyo kugwiritsa ntchito atorvastatin komanso kuletsa kwa pakamwa komwe kumakhala ndi norethindrone ndi ethinyl estradiol, panali kuwonjezeka kwakukulu mu AUC ya norethindrone ndi ethinyl estradiol pafupifupi 30% ndi 20%, motero. Izi ziyenera kuganiziridwa posankha njira yakulera yolerera yomwe mayi atenga Atoris®.

Warfarin: Palibe kuyanjana kwakukulu kwa atorvastatin ndi warfarin komwe kwapezeka.

Amlodipine: ndi munthawi yomweyo kugwiritsa ntchito atorvastatin ndi amlodipine 10 mg, ma pharmacokinetics a atorvastatin m'chigawo chofanana sanasinthe.

Fusidic acid: Kafukufuku wokhudzana ndi mgwirizano wa atorvastatin ndi fusidic acid sanachitike, komabe milandu ya rhabdomyolysis ndi kugwiritsidwa ntchito kwawo munthawi yomweyo yanenedwapo m'maphunziro otsatsa malonda. Chifukwa chake, odwala ayenera kuyang'aniridwa ndipo ngati kuli koyenera, chithandizo cha Atoris® chitha kuyimitsidwa kwakanthawi.

Mankhwala ena ophatikizika: Pogwiritsa ntchito atorvastatin osakanikirana ndi ma antihypertensive othandizira komanso ma estrogens, zovuta zina zoyipa sizinaoneke.

Malangizo apadera

Zochita pa chiwindi

Pambuyo pa mankhwala a atorvastatin, kuwonjezeka kwakukulu (kopitilira katatu poyerekeza ndi malire apamwamba) a serum ntchito ya "chiwindi" transaminases adadziwika.

Kuwonjezeka kwa ntchito ya hepatic transaminases nthawi zambiri sikumayendetsedwa ndi jaundice kapena mawonekedwe ena achipatala. Ndi kuchepa kwa mlingo wa atorvastatin, kusiya kwakanthawi kapena kwathunthu kwa mankhwalawa, zochitika za hepatic transaminases zimabweza msanga. Odwala ambiri anapitiliza kumwa atorvastatin muyezo wochepetsedwa popanda zotsatira.

Ndikofunikira kuwunika zizindikiro za chiwindi nthawi yonse ya chithandizo, makamaka ngati zizindikiro za kuwonongeka kwa chiwindi zikuwoneka. Pakuwonjezereka kwa zomwe zili mu hepatic transaminases, ntchito zawo ziyenera kuyang'aniridwa mpaka malire azomwe amapezeka. Ngati kuchuluka kwa ntchito ya AST kapena ALT mwa kuchulukitsa katatu poyerekeza ndi malire apamwamba anakhalabe, tikulimbikitsidwa kuti mankhwalawo athetsedwe kapena kufooketsedwa.

Mafupa a minofu

Mukamapereka mankhwala a Atoris® mu hypolipidemic Mlingo wosakanikirana ndi zotumphukira za fibroic acid, erythromycin, immunosuppressants, azole antifungal mankhwala kapena nicotinic acid, dokotala ayenera kuyang'anitsitsa mosamala zopindulitsa ndi zoopsa zamankhwala ndikuwonetsetsa odwala kuti azindikire kupweteka kapena kufooka kwa minofu, makamaka panthawi yoyamba miyezi chithandizo ndi nthawi kuchuluka Mlingo wa mankhwala. Muzochitika zotere, kutsimikiza kwakanthawi kantchito ya CPK kungalimbikitsidwe, ngakhale kuwunika koteroko sikumalepheretsa kukula kwa myopathy. Atorvastatin ikhoza kuyambitsa kuwonjezeka kwa ntchito ya creatine phosphokinase.

Pogwiritsa ntchito atorvastatin, zochitika zapadera za rhabdomyolysis ndi kulephera kwa impso chifukwa cha myoglobinuria zafotokozedwa. Therapy ya Atoris ® iyenera kusiyidwa kwakanthawi kapena kulekeka kwathunthu ngati pali chizindikiro cha myopathy chotheka kapena choopsa chothandizira kukulitsa kulephera kwa impso chifukwa cha rhabdomyolysis (mwachitsanzo, matenda opweteka kwambiri, kusokonekera kwa hypotension, opaleshoni yayikulu, zoopsa, metabolic, endocrine ndi electrolyte zosokoneza ndikulanda kosagwirizana).

Zambiri za wodwala: odwala akuyenera kuchenjezedwa kuti ayenera kupita kwa dokotala nthawi yomweyo ngati ululu wosakhudzika kapena kufooka m'misempha kumawonekera, makamaka ngati akuphatikizidwa ndi malaise kapena malungo.

Gwiritsani ntchito mosamala odwala omwe amamwa mowa kwambiri komanso / kapena omwe ali ndi matenda a chiwindi (mbiri).

Odwala opanda coronary mtima matenda (CHD) omwe ali ndi vuto la kugwedezeka kwaposachedwa kapena kufupika kwa ischemic (TIA) adawonetsa kuchuluka kwamatenda a hemorrhagic omwe adayamba kulandira atorvastatin pa mlingo wa 80 mg poyerekeza ndi odwala omwe akulandira placebo. Odwala omwe ali ndi hemorrhagic stroke adawonetsa chiopsezo chobwereza sitiroko. Komabe, odwala omwe amamwa atorvastatin 80 mg anali ndi mikwingwirima yochepa yamtundu uliwonse komanso matenda ochepa a mtima.

Mimba komanso kuyamwa

Amayi a msinkhu wobereka ayenera kugwiritsa ntchito njira zokwanira zolerera panthawi ya chithandizo. Atoris® imatha kupatsidwa kwa azimayi azaka zakubadwa pokhapokha ngati mwayi wokhala ndi pakati ndi wochepa kwambiri, ndipo wodwalayo akudziwitsidwa za chiopsezo chotheka kwa mwana wosabadwayo panthawi ya chithandizo.

Zapaderakuchenjeza

Atoris® ili ndi lactose. Odwala omwe ali ndi matenda osowa kwambiri obwera chifukwa cha galactose tsankho, kuperewera kwa lappase, kapena shuga galactose malabsorption sayenera kumwa mankhwalawa Zomwe zimachitika chifukwa cha mankhwalawa amatha kuyendetsa galimoto komanso njira zoopsa

Poganizira zovuta za mankhwalawa, kusamala kuyenera kugwiritsidwa ntchito poyendetsa magalimoto ndi njira zina zowopsa.

Ndi chisamaliro

Mowa, mbiri ya matenda a chiwindi.
Odwala omwe ali pachiwopsezo cha rhabdomyolysis (kuperewera kwa impso, hypothyroidism, kusokonezeka kwa minofu m'mbiri ya wodwalayo kapena mbiri ya banja, zotsatira zoyipa za HMG-CoA reductase inhibitors a statins kapena ma fiber pamisempha minofu, mbiri yamatenda a chiwindi ndi / / kapena odwala omwe amamwa mowa wambiri, okalamba omwe ali ndi zaka zopitilira 70, mikhalidwe yomwe kuchuluka kwa plasma kwa atorvastatin kuyembekezeredwa, mwachitsanzo, kuchita ndi mankhwala ena).

Gwiritsani ntchito pa nthawi yoyembekezera komanso nthawi yoyamwitsa

Atoris ® imaphatikizidwa pakati pa nthawi yakhanda komanso yoyamwitsa. Kafukufuku wazinyama akuwonetsa kuti chiwopsezo kwa mwana wosabadwa chingadutse phindu lililonse kwa mayi.
Mwa amayi omwe ali ndi zaka zakubala omwe sagwiritsa ntchito njira zodalirika zakulera, kugwiritsa ntchito Atoris® sikulimbikitsidwa. Pokonzekera kutenga pakati, muyenera kusiya kugwiritsa ntchito Atoris® osachepera mwezi umodzi musanakonzekere kutenga pakati.
Palibe umboni pakugawika kwa atorvastatin mkaka wa m'mawere. Komabe, mitundu ina ya nyama pa mkaka wa m'mawere, kuchuluka kwa atorvastatin m'madzi a seramu ndi mkaka ndi ofanana. Ngati ndi kotheka kugwiritsa ntchito mankhwala Atoris® nthawi yoyamwitsa, kuti mupewe chiwopsezo cha zochitika zoyipa makanda, kuyamwitsa kuyenera kuyimitsidwa.

Mlingo ndi makonzedwe

Asanayambe kugwiritsa ntchito mankhwala Atoris ®, wodwalayo ayenera kusinthidwa ku chakudya chomwe chimatsimikizira kuchepa kwa kuchuluka kwa lipids mu madzi am'magazi, omwe amayenera kuwonedwa panthawi yonse ya mankhwalawa. Musanayambe chithandizo, muyenera kuyesa kuthandizira kuwongolera kwa hypercholesterolemia kudzera mu masewera olimbitsa thupi komanso kuchepa thupi kwa odwala omwe ali ndi kunenepa kwambiri, komanso chithandizo cha matenda oyambitsidwa.
Mankhwala amatengedwa pakamwa, ngakhale nthawi yakudya. Mlingo wa mankhwalawa umasiyana 10 mg mpaka 80 mg kamodzi patsiku ndipo umasankhidwa poganizira kuchuluka kwa LDL-C m'magazi am'magazi, cholinga chamankhwala ndi chithandizo cha munthu.
Atoris® imatha kutengedwa kamodzi nthawi iliyonse patsiku, koma nthawi yomweyo tsiku lililonse. The achire zotsatira zimawonedwa pambuyo 2 milungu mankhwala, ndipo pazotheka zambiri pambuyo 4 milungu.
Kumayambiriro kwa mankhwalawa komanso / kapena pakukula kwa kuchuluka kwa mankhwalawa, ndikofunikira kuyang'anira kuchuluka kwa zamadzimadzi m'madzi a m'magazi onse a 2-4 ndikusintha mlingo moyenerera.
Hypercholesterolemia yoyamba komanso yophatikiza (yophatikizika) hyperlipidemia
Kwa odwala ambiri, mlingo woyenera wa Atoris® ndi 10 mg kamodzi patsiku, achire amadziwonetsa yekha mkati mwa masabata awiri ndipo nthawi zambiri amafika pakatha masabata anayi. Ndi chithandizo chakanthawi, zotsatira zake zimapitilira.
Homozygous achibale hypercholesterolemia
Nthawi zambiri, 80 mg amadziwika kamodzi patsiku (kuchepa kwa ndende ya LDL-C mu plasma ndi 18-45%).
Heterozygous achibale hypercholesterolemia
Mlingo woyambirira ndi 10 mg patsiku. Mlingo uyenera kusankhidwa payekhapayekha ndikuwunika kuyeneranso kumwa kwa masabata anayi alionse ndikuwonjezereka kwa 40 mg patsiku. Kenako, mwina mlingo utha kuwonjezereka mpaka 80 mg tsiku lililonse, kapena n`zotheka kuphatikiza olowa ndi michere ya bile pogwiritsa ntchito atorvastatin pa mlingo wa 40 mg patsiku.
Mtima Kupewa matenda
Mu maphunziro a kupewera koyambirira, mlingo wa atorvastatin anali 10 mg patsiku. Kuchulukitsa kwa mankhwalawa kungakhale kofunikira kuti mukwaniritse zofunika za LDL-C zogwirizana ndi malangizo apano.
Gwiritsani ntchito ana kuyambira zaka 10 mpaka 18 ndi heterozygous Famer hypercholesterolemia
Mlingo woyambira wabwino ndi 10 mg kamodzi patsiku. Mlingo utha kuwonjezeka mpaka 20 mg patsiku, kutengera zovuta zamatenda. Zochitika ndi mlingo wopitilira 20 mg (wofanana ndi 0,5 mg / kg) ndizochepa.
Mlingo wa mankhwalawa umayenera kusankhidwa malinga ndi cholinga cha kutsitsa kwa lipid. Kusintha kwa Mlingo kuyenera kuchitika mosiyanasiyana nthawi 1 m'milungu inayi kapena kupitilira.
Kulephera kwa chiwindi
Ngati chiwindi sichikwanira, mlingo wa Atoris® uyenera kuchepetsedwa, kuwunikira zochitika za "chiwindi" transaminases: aspartate aminotransferase (AST) ndi alanine aminotransferase (ALT) m'magazi a m'magazi.
Kulephera kwina
Kuwonongeka kwa impso sikukhudza kuchuluka kwa atorvastatin kapena kuchepa kwa kuchuluka kwa LDL-C mu plasma, motero, kusintha kwa mankhwalawa sikofunikira (onani gawo "Pharmacokinetics").
Odwala okalamba
Panalibe kusiyanasiyana pakuchita bwino kwa achire ndi chitetezo cha atorvastatin mwa odwala okalamba poyerekeza ndi anthu ambiri, kusintha kwa mankhwalawa sikofunikira (onani gawo la Pharmacokinetics).
Gwiritsani ntchito limodzi ndi mankhwala ena
Ngati ndi kotheka, kugwiritsa ntchito nthawi yomweyo ndi cyclosporine, telaprevir kapena kuphatikiza kwa tipranavir / ritonavir, mlingo wa mankhwala Atoris® sayenera kupitirira 10 mg / tsiku (onani gawo "Malangizo apadera").
Muyenera kusamala ndikuwonetsetsa kuti mankhwala ochepetsa mphamvu ya atorvastatin azigwiritsidwa ntchito pamene akugwiritsidwa ntchito ndi kachilombo ka HIV proteinase inhibitors, ma virus a hepatitis C proteinase inhibitors (boceprevir), clearithromycin ndi itraconazole.
Malangizo a Russian Society of Cardiology, National Society for the Study of Atherosulinosis (NLA) ndi Russian Society of Cardiosomatic Regencyitation and Secondary Prevention (RosOKR)
(V. Kukonzanso 2012)
Kuzungulira kwakukulu kwa LDL-C ndi LDL kwa odwala omwe ali pachiwopsezo chachikulu ndi: ≤ 2.5 mmol / L (kapena ≤ 100 mg / dL) ndi ≤ 4.5 mmol / L (kapena ≤ 175 mg / dL), motsatana komanso kwa odwala omwe ali ndi chiopsezo chachikulu: ≤ 1.8 mmol / l (kapena ≤ 70 mg / dl) ndi / kapena, ngati sizingatheke, tikulimbikitsidwa kuti muchepetse kuchuluka kwa LDL-C ndi 50% kuchokera pamtengo woyambira ndi ≤ 4 mmol / l (kapena ≤ 150 mg / dl), motero.

Zotsatira zoyipa

Matenda opatsirana komanso parasitic:
Nthawi zambiri: nasopharyngitis.
Kusokonezeka kwa magazi ndi dongosolo la lymphatic:
kawirikawiri: thrombocytopenia.
Matenda owononga chitetezo chamthupi:
Nthawi zambiri:
chosowa kwambiri: anaphylaxis.
Kuphwanya kagayidwe ndi zakudya:
pafupipafupi: kulemera, kudwala,
osowa kwambiri: hyperglycemia, hypoglycemia.
Mavuto amisala:
Nthawi zambiri: Kusokonezeka kwa tulo, kuphatikizira kugona tulo ndi "maloto" oyipa ",
pafupipafupi osadziwika: kukhumudwa.
Kuphwanya kwamanjenje:
Nthawi zambiri: mutu, chizungulire, paresthesia, asthenic syndrome,
pafupipafupi: zotumphukira neuropathy, Hypesthesia, kukoma mkhutu, kuwonongeka kapena kuiwalika.
Kumva mavuto ndi vuto la labyrinth:
pafupipafupi: tinnitus.
Zovuta za kupuma,
Nthawi zambiri: zilonda zapakhosi, mphuno,
pafupipafupi osadziwika: milandu yokhala patali ya matenda am'mapapo (nthawi zambiri amakhala akugwiritsidwa ntchito kwa nthawi yayitali).
Matumbo:
Nthawi zambiri: kudzimbidwa, dyspepsia, nseru, kutsegula m'mimba, kusanza (kutulutsa mabala), kupweteka kwam'mimba,
pafupipafupi: kusanza, kapamba.
Kuphwanya chiwindi ndi chindapusa:
kawirikawiri: hepatitis, cholestatic jaundice.
Zovuta za pakhungu ndi minofu yolowera:
Nthawi zambiri: zotupa pakhungu, kuyabwa,
kawirikawiri: urticaria,
osowa kwambiri: angioedema, alopecia, zidzolo zokupha, erythema multiforme, Stevens-Johnson syndrome, poermal necrolysis yoopsa.
Kuphwanya minofu:
Nthawi zambiri: myalgia, arthralgia, kupweteka kwa msana, kutupa kwa mafupa,
kawirikawiri: myopathy, minofu kukokana,
kawirikawiri: myositis, rhabdomyolysis, tendopathy (nthawi zina amakhala ndi chotupa cha tendon),
pafupipafupi osadziwika: milandu ya noncrotizing myopathy.
Kuphwanya impso ndi kwamikodzo thirakiti:
pafupipafupi: kulephera kwachiwiri kwaimpso.
Kuphwanya maliseche ndi chithokomole:
chosawerengeka: kusowa pogonana,
osowa kwambiri: gynecomastia.
Zovuta ndi zovuta zina pamalo opangira jakisoni:
Nthawi zambiri: zotumphukira edema,
pafupipafupi: kupweteka pachifuwa, malaise, kutopa, kutentha thupi.
Zambiri zasayansi:
pafupipafupi: kuchuluka kwa aminotransferases (AST, ALT), kuchuluka kwa serum creatine phosphokinase (CPK) m'madzi am'magazi,
kawirikawiri kwambiri: kuchuluka kwa glycosylated hemoglobin (HbA1).
Chiyanjano cha zotsatira zina zosasangalatsa ndikugwiritsa ntchito mankhwala Atoris®, omwe amadziwika kuti "osowa kwambiri", sanakhazikitsidwe. Ngati zovuta zazikulu zosafunikira zikuwoneka, kugwiritsa ntchito Atoris® kuyenera kusiyidwa.

Kuchita ndi mankhwala ena

Kugwiritsidwa ntchito kwa atorvastatin ndi cyclosporine, maantibayotiki (erythromycin, clarithromycin, chinupristine / dalphopristine), HIV proteinase inhibitors (indinavir, ritonavir), ma antifungal agents (fluconazole, itraconazole, ketoconazole) kapena nerazazone kumawonjezera chiopsezo chokhala ndi myopathy ndi rhabdomyolysis ndi kulephera kwa aimpso. Chifukwa chake, pogwiritsa ntchito munthawi yomweyo erythromycin TCmax, atorvastatin imachulukitsa ndi 40%. Mankhwalawa amaletsa CYP3A4 isoenzyme, yomwe imakhudzidwa ndi metabolism ya atorvastatin m'chiwindi. Kuyanjana kofananako ndikotheka ndikugwiritsa ntchito nthawi yomweyo atorvastatin wokhala ndi michere ndi nicotinic acid mu milid yotsitsa lipid (1 g patsiku).
Kugwiritsa ntchito kwa ezetimibe kumalumikizidwa ndi kukula kwa zoyipa, kuphatikiza rhabdomyolysis, kuchokera ku dongosolo la musculoskeletal. Chiwopsezo chotere chimawonjezeka ndikugwiritsa ntchito nthawi yomweyo za ezetimibe ndi atorvastatin. Kuyang'anira bwino ndikofunika kwa odwalawa.
Kugwiritsa ntchito munthawi yomweyo mankhwala a atorvastatin 40 mg ndi diltiazem pa mlingo wa 240 mg kumabweretsa kuwonjezeka kwa ndende ya atorvastatin m'madzi a m'magazi.
CYP3A4 Isoenzyme Inductors
Kugwiritsira ntchito pamodzi kwa atorvastatin ndi ma inducers a isoenzyme CYP3A4 (mwachitsanzo, efavirenz, rifampicin kapena Hypericum perforatum) kungayambitse kuchepa kwa kuchuluka kwa atorvastatin m'madzi a m'magazi. Chifukwa cha kuphatikiza kwapawiri kwa mgwirizano ndi rifampicin (inducer wa CYP3A4 isoenzyme ndi hepatocyte transport protein inhibitor OATP1B1), kuchedwa kwa atorvastatin ndikulimbikitsidwa, popeza kugwiritsa ntchito munthawi yomweyo atorvastatin ndi rifampicin kumabweretsa kuchepa kwakukulu kwa kuchuluka kwa atorvastatin m'magazi. Zambiri pazokhudzana ndi rifampicin pazakudya za atorvastatin mu hepatocytes sizikupezeka, chifukwa chake, ngati ntchito imodzi singathe kupewedwa, kuyeserera kwa kuphatikiza koteroko panthawi ya mankhwalawa kuyenera kuyang'aniridwa mosamala.
Popeza atorvastatin imapangidwa ndi isoenzyme CYP3A4, kugwiritsa ntchito pamodzi kwa atorvastatin ndi zoletsa za isoenzyme CYP3A4 kungayambitse kuchuluka kwa atorvastatin m'madzi a m'magazi.
OATP1B1 mayendedwe apuloteni oyendetsa mapuloteni (mwachitsanzo, cyclosporine) angakulitse bioavailability wa atorvastatin.
Ndi munthawi yomweyo kugwiritsa ntchito ma antacid (kuyimitsidwa kwa magnesium hydroxide ndi aluminium hydroxide), ndende ya atorvastatin m'madzi a m'magazi amachepa.
Ndi munthawi yomweyo kugwiritsa ntchito atorvastatin ndi colestipol, ndende ya atorvastatin m'madzi am'madzi amachepetsa 25%, koma achire zotsatira zakuphatikiza ndizapamwamba kuposa mphamvu ya atorvastatin yokha.
Kugwiritsa ntchito munthawi yomweyo mankhwala a atorvastatin okhala ndi mankhwala omwe amachepetsa kuchuluka kwa mahomoni amkati (kuphatikizapo cimetidine, ketoconazole, spironolactone) kumawonjezera chiopsezo chochepetsera mahomoni amkati a steroid (kusamala kuyenera kuchitidwa).
Odwala omwe amalandila 80 mg ya atorvastatin ndi digoxin, kuchuluka kwa digoxin m'madzi a m'magazi kumawonjezeka pafupifupi 20%, chifukwa chake, odwala oterowo amayenera kuyang'aniridwa.
Pogwiritsa ntchito munthawi yomweyo mankhwala a atorvastatin omwe ali ndi vuto lothandizira pakamwa (norethisterone ndi ethinyl estradiol), ndizotheka kuwonjezera mayamwidwe oletsa kubereka ndikuwonjezera kukhudzidwa kwawo m'madzi a m'magazi. Kusankhidwa kwa njira zakulera mwa amayi omwe akutenga atorvastatin kuyenera kuyang'aniridwa.
Kugwiritsa ntchito munthawi yomweyo atorvastatin ndi warfarin m'masiku oyambilira kumatha kuwonjezera mphamvu ya warfarin pa coagulation ya magazi (kuchepetsa kwa prothrombin nthawi). Izi zimatha pambuyo masiku 15 ogwiritsa ntchito limodzi mankhwalawa.
Ngakhale kuti maphunziro ogwiritsira ntchito munthawi yomweyo a colchicine ndi atorvastatin sanachitike, pali malipoti akusintha kwa myopathy ndi kuphatikiza uku. Pogwiritsa ntchito munthawi yomweyo atorvastatin ndi colchicine, muyenera kusamala.
Ndi munthawi yomweyo kugwiritsa ntchito atorvastatin ndi terfenadine, kusintha kwakukulu mu pharmacokinetics ya terfenadine sikunapezeka.
Atorvastatin sichikhudza pharmacokinetics ya phenazone.
Kugwiritsa ntchito limodzi ndi proteinase inhibitors kumabweretsa kuwonjezeka kwa plasma wozungulira atorvastatin.
Ndi munthawi yomweyo kugwiritsa ntchito atorvastatin pa mlingo wa 80 mg ndi amlodipine pa 10 mg, ma pharmacokinetics a atorvastatin m'chigawo chofanana sanasinthe.
Pakhala pali milandu ya rhabdomyolysis mwa odwala omwe amagwiritsa ntchito atorvastatin ndi fusidic acid.
Chithandizo chothandizirana
Pogwiritsa ntchito atorvastatin ndi antihypertensive othandizira ndi ma estrogens ngati gawo lamankhwala olowa m'malo, panalibe zizindikilo zokhudzana ndi kukhudzidwa kosafunikira kwenikweni.
Kugwiritsa ntchito msuzi wa mphesa panthawi yogwiritsira ntchito Atoris® kungapangitse kuwonjezeka kwa plasma mozama kwa atorvastatin. Mwakutero, odwala omwe amamwa mankhwalawa Atoris® ayenera kupewa kumwa madzi a mphesa oposa malita 1.2 patsiku.

Bongo

Zizindikiro: Zotsatira zoyipa.

Chithandizo: Palibe mankhwala enieni a mankhwalawa atoris® osokoneza bongo. Pankhani ya bongo, chithandizo chamankhwala chiyenera kuchitidwa monga zofunika (monga momwe dokotala wanenera). Popeza mankhwalawa amamangika kumapuloteni a plasma, kuwonjezeka kwakukulu kwa chilolezo cha Atoris® pa hemodialysis ndikosatheka.

Wogwirizira Sitifiketi Yoyang'anira

Krka, dd, Novo Mesto, Slovenia

Adilesi ya bungweli yomwe imavomereza zodula kuchokera kwa ogula pamsika wazogulitsa (katundu) ku Republic of Kazakhstan

Krka Kazakhstan LLP, Kazakhstan, 050059, Almaty, Al-Farabi Ave. 19,

kumanga 1 b, 2nd floor, 207 office

tel.: +7 (727) 311 08 09

fakisi: +7 (727) 311 08 12

11.04.05

Zithunzi za 3D

Kufotokozera za mtundu wa kipimo

Mapiritsi, 10 ndi 20 mg: mozungulira, biconvex pang'ono, wokutidwa ndi kanema wamtundu wakuda. Mawonedwe a kink: misa yoyera ndi filimu yotulutsa yoyera kapena yoyera.

Mapiritsi, 30 mg: mozungulira, biconvex pang'ono, wokutidwa ndi kanema wamitundu yoyera kapena pafupifupi yoyera, yokhala ndi bevel.

Mapiritsi, 40 mg: mozungulira, biconvex pang'ono, wokutidwa ndi kanema wamitundu yoyera kapena yoyera. Mawonedwe a kink: misa yoyera ndi filimu yotulutsa yoyera kapena yoyera.

Mankhwala

Atorvastatin ndi wothandizira wa hypolipidemic kuchokera pagulu la ma statins. Njira yayikulu yogwirira ntchito ya atorvastatin ndikulepheretsa ntchito ya HMG-CoA reductase, enzyme yomwe imathandizira kutembenuka kwa HMG-CoA kukhala mevalonic acid. Kusinthaku ndi gawo limodzi mwatsatanetsatane kwambiri mwatsatanetsatane wa kapangidwe ka Ch m'thupi. Atorvastatin kuponderezana ndi kaphatikizidwe ka XC kumabweretsa kuwonjezereka kwa zolandila za LDL mu chiwindi, komanso mu minofu yowonjezera. Ma receptor amenewa amamanga tinthu tating'ono ta LDL ndikuwachotsa m'madzi a m'magazi, zomwe zimapangitsa kuchepa kwa kuchuluka kwa LDL-C m'magazi.

Mphamvu ya antiatherosulinotic ya atorvastatin ndi chifukwa cha momwe imakhudzira makoma amitsempha yamagazi ndi zigawo zamagazi. Atorvastatin linalake ndipo tikulephera kapangidwe ka isoprenoids, omwe ndi zinthu zomwe zimapanga kukula kwamitsempha yamagazi. Mothandizidwa ndi atorvastatin, kuchuluka kwa magazi a endothelium kumayenda bwino, kuchuluka kwa LDL-C, LDL (Apo-B), triglycerides (TG) kumachepa, ndipo kuchuluka kwa HDL-HDL ndi Apolipoprotein A (Apo-A) kumawonjezeka.

Atorvastatin amachepetsa mamasukidwe akayendedwe amwazi ndi ntchito zina zophatikizika ndi kuphatikizira kwa maselo. Chifukwa cha izi, imakonza hemodynamics ndipo imasintha mkhalidwe wamathandizo. HMG-CoA reductase inhibitors imakhudzanso kagayidwe ka macrophages, kutseka kutsegulira kwawo ndikutchingira kupasuka kwa zolembera za atherosulinotic.

Monga lamulo, achire zotsatira za atorvastatin zimawonedwa pambuyo 2 milungu mankhwala, ndipo pazotheka zotsatira zimachitika pambuyo 4 milungu.

Atorvastatin pa mlingo wa 80 mg kwambiri amachepetsa chiopsezo chokhala ndi zovuta za ischemic (kuphatikizapo kufa kuchokera ku infarction ya myocardial) ndi 16%, chiwopsezo chogonekedwanso kuchipatala cha angina pectoris, chotsatira ndi zizindikiro za myocardial ischemia, ndi 26%.

Pharmacokinetics

Kuthiridwa kwa Atorvastatin ndiwokwera, pafupifupi 80% kumatenga kuchokera m'mimba. Mlingo wa mayamwidwe ndi ndende mu madzi am`magazi ukuwonjezeka mogwirizana ndi mlingo. T_max pafupifupi maola 1-2. Mu akazi, T_max okwera ndi 20%, ndi AUC kutsika ndi 10%. Kusiyana kwa pharmacokinetics mwa odwala ndi zaka komanso jenda ndizochepa ndipo sikufuna kusintha kwa mlingo.

Odwala zakumwa zoledzeretsa za chiwindi T_max Nthawi 16 kapamwamba kuposa zabwinobwino. Kudya pang'ono kumachepetsa kuthamanga ndi kutalika kwa mankhwalawa (mwa 25 ndi 9%, motsatana), koma kuchepa kwa ndende ya LDL-C ndikofanana ndi kugwiritsidwa ntchito kwa atorvastatin popanda chakudya.

Atorvastatin bioavailability wotsika (12%), systemic bioavailability of inhibitory zochita motsutsana ndi HMG-CoA reductase ndi 30%. Low systemic bioavailability chifukwa cha pang'onopang'ono kagayidwe kam'mimba mucosa ndi gawo loyambira kudzera pachiwindi.

Pakati V_d atorvastatin - 381 l. Zoposa 98% za atorvastatin zimamanga mapuloteni a plasma. Atorvastatin sikuwoloka BBB. Zimapangidwa makamaka mu chiwindi mothandizidwa ndi isoenzyme CYP3A 4 ya cytochrome P450 ndikupanga ma cellacologically yogwira metabolites (ortho- ndi para-hydroxylated metabolites, zinthu za beta oxidation), zomwe zimapangitsa pafupifupi 70% ya zochita zoletsa motsutsana ndi HMG-CoA reductase, kwa maola 20-30 .

T_1/2 atorvastatin 14 h. Amapukusidwa ndi bile (samayikidwanso mobwerezabwereza, samatulutsidwa panthawi ya hemodialysis). Pafupifupi 46% ya atorvastatin imachotsedwa m'matumbo ndikuchepera 2% ndi impso.

Magulu apadera a odwala

Ana. Pali zowerengeka pazosankha zowerengeka zamasabata a 8 za ana a pharmacokinetics mwa ana (azaka 6 mpaka 17) ndi heterozygous Famel hypercholesterolemia ndi kuphatikizika koyambirira kwa LDL cholesterol ≥4 mmol / l, omwe amathandizidwa ndi atorvastatin monga mapiritsi osavuta a 5 kapena 10 mg kapena mapiritsi, filimu yokutira, pa mlingo wa 10 kapena 20 mg 1 nthawi patsiku, motero. Covariate yekha wofunikira mu pharmacokinetic chitsanzo cha anthu omwe amalandila atorvastatin anali kulemera kwa thupi. Kuwonekera kwa atorvastatin mwa ana sikunali kosiyana ndi kwa achikulire odwala omwe ali ndi muyeso wa allometric mwa kuchuluka kwa thupi. Mu machitidwe a atorvastatin ndi o-hydroxyatorvastatin, kuchepa kosasintha kwa LDL-C ndi LDL kunawonedwa.

Odwala okalamba. C_max mu plasma wamagazi ndi AUC ya mankhwalawa okalamba odwala (opitilira zaka 65) ndi 40 ndi 30%, motero, apamwamba kuposa omwe ali ndi odwala achinyamata achikulire. Panalibe kusiyana pakukhudzika ndi chitetezo cha mankhwalawo kapena kukwaniritsa zolinga za kutsitsa kwa lipid mwa odwala okalamba poyerekeza ndi anthu ambiri.

Matenda aimpso. Aimpso kuwonongeka ntchito sizikhudza kuchuluka kwa atorvastatin mu madzi am`magazi kapena kukhudzana ndi lipid kagayidwe, kotero, kusintha kwa odwala omwe ali ndi vuto laimpso sikofunikira.

Kuwonongeka kwa chiwindi. Kuzunza kwa mankhwalawa kumakwera kwambiri (C_max - pafupifupi nthawi 16, AUC - pafupifupi nthawi 11) mwa odwala omwe ali ndi vuto la chiwindi cha chidakwa (kalasi B malinga ndi gulu la Mwana-Pugh).

Zisonyezero za mankhwala Atoris ®

- monga zowonjezera pakudya kuti muchepetse cholesterol yokwanira, cholesterol-LDL, apo-B ndi TG m'magazi am'magazi akuluakulu odwala, achinyamata ndi ana azaka 10 kapena kuposerapo ndi hypercholesterolemia, kuphatikiza mabanja a hypercholesterolemia (heterozygous) kapena kuphatikiza ( chosakanikirana) hyperlipidemia (mtundu IIa ndi IIb, motero, malinga ndi gulu la Fredrickson), mayankho pazakudya ndi njira zina zosagwiritsa ntchito mankhwala sizili zokwanira,

- Kuchepetsa ma Ch okwera, Chs-LDL mu plasma mwa anthu akuluakulu omwe ali ndi homozygous Famel hypercholesterolemia monga njira yothandizira njira zina zolembetsera lipid zotsitsa lipid (mwachitsanzo, apheresis LDL), kapena ngati njira zotere sizipezeka.

matenda a mtima kupewa:

- kupewa zochitika zamtima mu mtima mwa odwala omwe ali pachiwopsezo chachikulu chokhala ndi zochitika zamkati pamtima, kuwonjezera pa kukonza ziwopsezo zina.

- kupewa kwachiwiri kwamatenda amtima mwa odwala omwe ali ndi matenda a mtima (CHD) kuti muchepetse kufa, matenda amitsempha, mikondo, kuyambiranso kuchipatala kwa angina pectoris ndi kufunika kosinthanso.

Mimba komanso kuyamwa

Mankhwala Atoris ® amatsutsana panthawi ya pakati komanso poyamwitsa. Kafukufuku wazinyama akuwonetsa kuti chiwopsezo kwa mwana wosabadwa chingadutse phindu lililonse kwa mayi.

Mwa amayi omwe ali ndi zaka zakubala omwe sagwiritsa ntchito njira zodalirika zakulera, kugwiritsa ntchito Atoris ® sikulimbikitsidwa. Pokonzekera kukhala ndi pakati, muyenera kusiya kugwiritsa ntchito Atoris ® osachepera mwezi umodzi musanakonzekere kutenga pakati.

Palibe umboni pakugawika kwa atorvastatin mkaka wa m'mawere. Komabe, kuchuluka kwa atorvastatin mu seramu yamagazi ndi mkaka wa mkaka wa mkaka wa nyama ndizofanana mu mitundu ina ya nyama. Ngati mukufunika kugwiritsa ntchito mankhwala Atoris ® poyamwitsa, kuti mupewe chiwopsezo cha zochitika zoyipa makanda, kuyamwitsa kuyenera kuyimitsidwa.

Kutulutsa Fomu

Mapiritsi okhala ndi mafilimu, 10 mg ndi 20 mg. Mapiritsi 10 mu chithuza (cholumikizira chida cholumikizira) chopangidwa ndi polyamide / aluminium foil / PVC-aluminium yopanga (Cold kupanga OPA / Al / PVC-Al). 3 kapena 9 bl. (matuza) aikidwa pabokosi lamakhadi.

Mapiritsi okhala ndi mafilimu, 30 mg. Mapiritsi 10 mu chithuza chophatikizika cha polyamide / aluminium / PVC-aluminium chophatikizika. 3 bl. (matuza) aikidwa pabokosi lamakhadi.

Mapiritsi okhala ndi mafilimu, 40 mg. Mapiritsi 10 mu chithuza (chithuza chamtundu) chopangidwa ndi polyamide / aluminium foil / PVC-aluminium. 3 bl. (matuza) aikidwa pabokosi lamakhadi.

Wopanga

1. JSC "Krka, dd, Novo mesto". Šmarješka cesta 6, 8501 Novo mesto, Slovenia.

2. LLC KRKA-RUS, 143500, Russia, Moscow Region, Istra, ul. Moskovskaya, 50, mogwirizana ndi JSC "KRKA, dd, Novo mesto", Šmarješka cesta 6, 8501 Novo mesto, Slovenia.

Tele. ((495) 994-70-70, fakisi: (495) 994-70-78.

Mukamayala ndi / kapena kumanga ku bizinesi yaku Russia, idzawonetsedwa: "KRKA-RUS" LLC. 143500, Russia, Moscow Region, Istra, ul. Moscow, 50.

Tele. ((495) 994-70-70, fakisi: (495) 994-70-78.

CJSC Vector-Medica, 630559, Russia, dera la Novosibirsk, chigawo cha Novosibirsk, r.p. Koltsovo, nyumba 13, bldg. 15.

Tel./fax: (383) 363-32-96.

Oimira ofesi ya Krka, dd, Novo mesto JSC ku Russian Federation / bungwe lolandila madandaulo a ogula: 125212, Moscow, Golovinskoye sh., 5, bldg. 1, pansi 22..

Tele. ((495) 981-10-88, fakisi (495) 981-10-90.

Ndemanga

Atoris ® ndi genor atorvastatin yokhayo yomwe ili ndi umboni wolimba motere pakuchita bwino ndi chitetezo.

Mu maphunziro angapo, zotsatirazi zidapezeka.

Kafukufuku INTER-ARS. Kafukufuku woyerekeza wapadziko lonse wa Atoris ® (Krka) ndi atorvastatin woyambirira. Kafukufukuyu adatenga masabata 16 ndipo adachitika m'maiko atatu (Slovenia, Poland ndi Czech Republic). Phunziroli lidaphatikizapo odwala 117 omwe adasinthidwa mosagawika m'magulu awiri - gulu limodzi limalandira mankhwalawo Atoris ® (n = 57), linalo lidalandira atorvastatin (n = 60) yoyambirira. Panthawi yomaliza phunziroli, pafupifupi avareji ya Atoris ® inali 16 mg. Kafukufukuyu adatsimikizira kufanana kwa Atoris ® ndi atorvastatin choyambirira polimbitsa mawonekedwe a lipid. Atoris ® adawonetsanso zotsatira zofananira ndi atorvastatin yoyambirira pochepetsa mapuloteni a C-reactive. Mbiri yolekerera ya Atoris ® imafanana kwathunthu ndi mawonekedwe ololera a atorvastatin apachiyambi.

Kafukufuku ATLANTICA. Kuwunikira kwa magwiridwe antchito ndi chitetezo cha Atoris ® pakukonzekera kwachangu kwa odwala omwe ali ndi dyslipidemia ndi chiwopsezo chokwanira chotenga matenda a mtima. Phunziroli lidaphatikizapo odwala 655. Odwala adasankhidwa mosiyanasiyana m'magulu atatu.

Odwala omwe ali mgulu la A (n = 216) adalandira Atoris ® pa mlingo wa 10 mg, odwala omwe ali mu Gulu B (n = 207) adalandira Atoris pa mlingo wa 10 mg mpaka 80 mg (Mlingo wamba kumapeto kwa kafukufuku anali 28.6 mg ), odwala omwe ali mgululi C (n = 209) adalandira chithandizo chokwanira (kusintha kwa moyo, mankhwala othandizira omwe amaphatikizidwa ndi lipid-kuchepetsa mankhwala).

Kusintha kwakukulu mu LDL-C (42% kuchepa), OXc (30% kuchepa), TG (24% kuchepa) pambuyo pa masabata 24 kumawonedwa mwa odwala omwe amalandila chithandizo chambiri ndi atorvastatin (gulu B) poyerekeza ndi odwala omwe amalandila Atoris ® Mlingo wa 10 mg, ndi odwala omwe amalandila chithandizo chamankhwala.Kafukufukuyu adawonetsa kugwira ntchito ndi chitetezo cha Atoris ® kwa nthawi yayitali odwala omwe ali ndi dyslipidemia ndikuwonjezera chiopsezo chamtima.

Phunziro la ATOP. Kuunikira kwa magwiridwe antchito ndi chitetezo cha Atoris ® pagulu lalikulu la odwala (odwala omwe ali ndi matenda amitsempha yamagazi, matenda a metabolic, matenda a shuga, kuthana ndi matenda am'mitsempha yama coronary. Kutalika kwa kafukufukuyu kunali masabata 12. Odwala (n = 334) adalandira Atoris ® mu mlingo kuchokera 10 mpaka 40 mg. Mlingo wamba wa Atoris ® tsiku lililonse kumapeto kwa kafukufuku anali 21.3 mg. Mankhwala a Atoris ® adatsogolera kutsika kwakukulu mu LDL-C ndi 36% ndi OXc ndi 26%. Kafukufukuyu adatsimikizira kuthandizira kochiritsira ndikuwonetsetsa bwino chitetezo cha Atoris ® pagulu lonse la odwala.

FARVATER Wofufuza. Kuunika kwa mphamvu ya zotsatira za mankhwala Atoris ® 10 ndi 20 mg pa milomo ya lipids, C-yogwira mapuloteni ndi fibrinogen mwa odwala omwe ali ndi matenda amitsempha yamagazi ndi dyslipidemia. Phunziroli lidaphatikizapo odwala 50 omwe, atasankha mwachisawawa, adalandira Atoris ® mu Mlingo wa 10 kapena 20 mg / tsiku. Kugwiritsa ntchito kwa mankhwala a Atoris ®, onse 10 ndi 20 mg / tsiku masabata 6, kunayendetsedwa ndi kuchepa kwakukulu pamlingo wa OXs, TG ndi Chs-LDL. Mu gulu la odwala omwe alandira 10 mg / tsiku la Atoris ®, kuchepa kumeneku kunali 24,5% (OXc), 18.4% (TG), 34.9% (Chs-LDL), komanso mwa omwe amalandira Atoris ® 20 mg / tsiku - 29.1% (OXc), 28.2% (TG), 40.9% (LDL-C), motsatana. Pambuyo pa chithandizo cha milungu 12, ESA (endothelium-amadodilation vasodilation) inakula kwambiri ndi 40.2% (10 mg / tsiku) ndi 51.3% (20 mg / tsiku). Kuuma kwa khoma la mtima kumachepa ndi 23.4% (p = 0.008) ndi 25,7% (p = 0.002) m'magulu a 10 ndi 20 mg / tsiku, motsatana. Phunziroli lidawonetsa kuchepa kwamphamvu kwa milingo ya lipid ndi zotsatira za pleiotropic kwa odwala omwe ali ndi matenda amitsempha yamagazi ndi matenda oopsa.

Phunziro la OSCAR. Kuwunika kwa kuthekera ndi chitetezo cha Atoris ® machitidwe enieni azachipatala. Phunziroli lidaphatikizapo odwala 7098 omwe adalandira atka kampani ya Krka - Atoris ® (10 mg / tsiku). Pambuyo pa milungu 8 ya chithandizo ndi Atoris ®, kuchuluka kwa OX kunatsika ndi 22.7%, Chs-LDL - ndi 26.7% ndi TG - mwa 24%. Chiwopsezo chonse chamtima chatsika ndi 33%. Kafukufukuyu adawonetsa kugwira ntchito ndi chitetezo cha Atoris ® machitidwe enieni azachipatala.

1. Inter Ars. Zambiri pa fayilo, KRKA d.d., Novo mesto.

2. ATLANTICA (Mwachangu ndi chitetezo cha Atoris (atorvastatin, KRKA) ndi momwe zimawonera pangozi ya zochitika zamtima mwa odwala omwe ali ndi hyperlipidemia) - Belenkov Yu.N., Oganov R.G. Science Science Dispensary department of Institute of Cardiology yotchedwa A.L. Myasnikova.— FGU RKNPK Rosmedtekhnologii.67 Cardiology.— №11.- 2008.

3. ATOP. Zambiri pa fayilo, KRKA d.d., Novo mesto.

4. FARVATER (Kugwira bwino ntchito kwa Atorvastatin pakhoma lamankhwala ndi CRP) - A. Susekov, V. Kukharchuk.- FGU RKNPK Ministry of Health of the Russian Federation and SR Moscow.- 2006.- Cardiology.— No. 9.- 06. P.4-9 .

5. Shalnova SA, Deev AD. Maphunziro kuchokera ku kafukufuku wa OSCAR - Epidemiology ndi mawonekedwe a chithandizo cha odwala omwe ali pachiwopsezo chachikulu muzochita zenizeni zamankhwala 2005-22006 // Mtima ndi kupewa. - 2007.— 6 (1).

Homozygous cholowa hypercholesterolemia

Mulingo wofanana ndi mitundu ina ya hyperlipidemia.

Mlingo woyambirira amasankhidwa payekha kutengera kuopsa kwa matendawa. Odwala ambiri omwe ali ndi homozygous cholowa hypercholesterolemia, amatha kugwiritsa ntchito mankhwalawa tsiku lililonse 80 mg (kamodzi). Atoris ® imagwiritsidwa ntchito ngati adjunctive Therapy njira zina zamankhwala (plasmapheresis) kapena chithandizo chachikulu ngati chithandizo chamankhwala ndi njira zina sichingatheke.

Gwiritsani ntchito mwa okalamba

Mwa odwala okalamba ndi odwala omwe ali ndi matenda a impso, mlingo wa Atoris suyenera kusinthidwa. Kuwonongeka kwa impso sikukhudza kuchuluka kwa atorvastatin m'madzi am'magazi kapena kuchepa kwa kuchuluka kwa LDL-C kugwiritsa ntchito atorvastatin, motero, kusintha kwa mankhwalawa sikufunika.

Kuwonongeka kwa chiwindi

Odwala omwe ali ndi vuto la chiwindi ntchito, kusamala ndikofunikira (chifukwa cha kutsika pang'ono pa mankhwalawa kuchokera mthupi). Muzochitika zotere, magawo azachipatala ndi a labotale amayenera kuyang'aniridwa mosamala (kuwunika pafupipafupi zochitika za aspartate aminotransferase (ACT) ndi alanine aminotransferase (ALT). Ndi kuwonjezeka kwakukulu kwa ntchito ya hepatic transaminases, mlingo wa Atoris uyenera kuchepetsedwa kapena chithandizo chitha.

Gwiritsani ntchito pa nthawi yoyembekezera

Atoris amatsutsana ndi pakati komanso poyamwitsa. Kafukufuku wazinyama akuwonetsa kuti chiwopsezo kwa mwana wosabadwa chingadutse phindu lililonse kwa mayi.

Mwa amayi omwe ali ndi zaka zakubala omwe sagwiritsa ntchito njira zodalirika zakulera, kugwiritsa ntchito Atoris sikofunikira. Pokonzekera kukhala ndi pakati, muyenera kusiya kugwiritsa ntchito Atoris osachepera mwezi umodzi musanakonzekere kutenga pakati.

Palibe umboni pakugawika kwa atorvastatin mkaka wa m'mawere. Komabe, mitundu ina ya nyama, kuchuluka kwa atorvastatin mu seramu yamagazi ndi mkaka wa nyama yotsekera ndi zofanana. Ngati n`kofunika kugwiritsa ntchito mankhwala Atoris pa mkaka wa m`mawere, pofuna kupewa chiopsezo cha zovuta mavuto ana, kuyamwitsa kuyimitsidwa.

Kuyanjana kwa mankhwala osokoneza bongo

Ndi munthawi yomweyo kugwiritsa ntchito Atoris ndi diltiazem, kuwonjezeka kwa ndende ya Atoris m'madzi a m'magazi kungaoneke.

Chiwopsezo cha zovuta zimawonjezeka pamene Atoris imagwiritsidwa ntchito molumikizana ndi fibrate, nicotinic acid, maantibayotiki, othandizira antifungal.

Kuchita bwino kwa Atoris kumachepa ndi kugwiritsa ntchito pamodzi kwa Rifampicin ndi Phenytoin.

Pogwiritsa ntchito imodzi ndi antacid kukonzekera, omwe akuphatikizapo aluminiyamu ndi magnesium, kuchepa kwa ndende ya Atoris m'madzi a m'magazi kumawonedwa.

Kutenga Atoris limodzi ndi madzi a mphesa kumatha kuwonjezera kuchuluka kwa mankhwalawa m'madzi a m'magazi. Odwala omwe amatenga Atoris ayenera kukumbukira kuti kumwa madzi a mphesa m'milingo yoposa 1 lita imodzi sikuvomerezeka.