Umarnin don yin amfani da kwayoyi, analogues, bita

Allunan-fim mai hade, 40 MG

Tabletaya daga cikin kwamfutar hannu ya ƙunshi

abu mai aiki - sinadarin atorvastatin allurar 41.44 mg (daidai da atorvastatin 40,00 mg)

amagabata: povidone, sodium lauryl sulfate, carbon dioxide, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, crospovidone, magnesium stearate,

harsashi: Opadry White Y-1-7000 (ya ƙunshi hypromellose, titanium dioxide (E 171) da macrogol 400)

Zagayen allunan zagaye tare da farin fim shafi, dan kadan convex

Kayan magunguna

Atorvastatin yana shan saurin hanzari bayan gudanar da maganin baka, maida hankali a cikin jini na jini ya kai matsakaici bayan sa'o'i 1-2. Matsayi na sha da maida hankali ne akan atorvastatin a cikin jini yana ƙaruwa bisa gwargwado. Cikakken bioavailability na atorvastatin kusan 14%, kuma tsarin bioavailability na aikin inhibitory ya yi daidai da 3-hydroxy-3-methylglutaryl coenzyme reduarar sauyawa (HMG-CoA reductase) kusan 30%. Systemarancin tsarin bioavailability yana faruwa ne ta dalilin tsarin ƙwaƙwalwar ƙwayar cuta a cikin mucous membrane na jijiyoyin ciki da / ko yayin "hanyar farko" ta hanta.

Abinci kaɗan rage ƙima da digiri na shan ƙwayoyi (ta 25% da 9%, bi da bi, kamar yadda aka tabbatar da sakamakon ƙudurin Cmax da AUC), amma raguwar ƙwayar lipoprotein low-density yawa (LDL-C) daidai yake da lokacin shan atorvastatin akan komai a ciki. Bayan shan atorvastatin da maraice, yawan ƙwayar plasma yana da ƙananan (Cmax da AUC da kusan 30%) fiye da bayan shan shi da safe. An bayyana alaƙar layin tsakanin matakin ɗaukar kwayar cutar.

Matsakaicin girman rarraba atorvastatin shine kimanin lita 381. Sadarwa tare da ƙwayoyin plasma na akalla 98%. Matsakaicin abubuwan da ke cikin erythrocyte / plasma atorvastatin shine kusan 0.25, i.e. atorvastatin baya shiga cikin sel jini ja da kyau.

Atorvastatin ne mafi yawan metabolized don samar da ortho- da para-hydroxylated Kalam da samfurori hada hada hada-hada da hada hada guba na beta. Ortho- da para-hydroxylated metabolites suna da sakamako mai hanawa akan HMG-CoA reductase. Kimanin 70% raguwa a cikin aikin HMG-CoA reductase yana faruwa ne saboda aiwatar da aiki mai gudana metabolites. A cikin metabolism na atorvastatin, hanta cytochrome P450 3A4 yana taka muhimmiyar rawa: taro na atorvastatin a cikin jini na jini na mutum yana ƙaruwa yayin shan erythromycin, wanda shine mai hana wannan isoenzyme. Atorvastatin, bi da bi, mai rauni ne mai hana cytochrome P450 3A4. Atorvastatin bashi da tasirin gaske a cikin ƙwayar plasma na terfenadine, wanda yake metabolized galibi ta hanyar cytochrome P450 3A4, sabili da haka, ba lallai bane cewa atorvastatin yana da tasiri a cikin magungunan magunguna na sauran abubuwan cytochrome P450 3A4.

Atorvastatin da metabolites din an kebe su musamman tare da bile a sakamakon hepatic da / ko extrahepatic metabolism (atorvastatin baya fama da matsanancin matsanancin yanayin ciwon ciki). Rabin rayuwar atorvastatin kusan awanni 14. Ayyukan hanawa na hanawa HMG-CoA ragewa yai tsawan awanni 20-30, saboda kasancewar metabolites mai aiki. Bayan gudanarwar baka, kasa da 2% na atorvastatin ana samun su a cikin fitsari.

Groupsungiyoyin haƙuri na musamman

Dattijo: plasma taro na atorvastatin a cikin mutane shekaru 65 da haihuwa sun fi girma (Cmax da kusan 40%, AUC da kusan 30%) fiye da marasa lafiyar matasa, bambance-bambance a cikin aminci, inganci ko cimma nasarar burin lipid-low a cikin tsofaffi idan aka kwatanta da Ba a samu adadi mai yawa ba

Yara: nazarin karatun magungunan ƙwayoyi a cikin yara ba a gudanar da su ba.

Jinsi: maida hankali na atorvastatin a cikin jini na jini a cikin mata ya bambanta (Cmax da kusan 20% mafi girma, da kuma AUC ta 10% ƙananan) daga wannan a cikin maza, duk da haka, babu wasu bambance-bambance na asibiti a cikin tasirin magani a cikin ƙwayar lipid a cikin maza da mata.

Rashin wahala: cutar koda ba ta shafi yawan atorvastatin a cikin jini na plasma ko tasirinsa akan metabolism na lipid, sabili da haka, ba a buƙatar canje-canje na kashi a cikin marasa lafiya da keɓaɓɓen aikin na koda.

Kwarewar Zuciya: rashin lafiyar hemodialysis ba zai yiwu ba ya haifar da gagarumar karuwa a cikin aikin atorvastatin, tunda maganin yana da alaƙa da kariyar plasma.

Rashin hanta: Atorvastatin maida hankali yana ƙaruwa sosai (Cmax kusan sau 16, AUC kusan sau 11) a cikin marasa lafiya da ke fama da guguwar giya (Childe-Pugh B).

Pharmacodynamics

Atoris® magani ne mai haɓaka mai saurin rage ƙwayar cuta, zaɓin mai haɓaka mai hana HMG-CoA reductase, wani enzyme mai mahimmanci wanda ke canza 3-hydroxy-3-methylglutaryl-CoA zuwa mevalonic acid, mai hana steroids, gami da cholesterol. A cikin marasa lafiya tare da homozygous da heterozygous familial hypercholesterolemia, siffofin rashin dangi na hypercholesterolemia da cakuda dyslipidemia, Atoris® lowers jimlar cholesterol (Cs), low-low lipoprotein cholesterol da apolipoprotein B da low-density chopoe triglycerides, yana haifar da haɓaka mara ƙarfi a cikin ƙwayar lipoprotein cholesterol (HDL-C).

A cikin hanta, triglycerides da cholesterol an haɗo su a cikin abubuwan da ke tattare da ƙananan ƙwayoyin lipoproteins mai ƙarancin jini (VLDL), shigar da jini jini kuma an canza shi zuwa kyallen na gefe. Poarancin lipoproteins mai ƙarancin ƙarfi (LDL) an samo shi ne daga VLDL, wanda ke rikicewa ta hanyar hulɗa tare da masu karɓar LDL mai ƙarfi.

Atoris® yana rage yawan tasirin cholesterol da lipoproteins a cikin jini na jini, yana hana HMG-CoA reductase da haɗin cholesterol a cikin hanta da haɓaka adadin "hanta" LDL masu karɓa a farfajiyar tantanin halitta, wanda ke haifar da karuwar haɓakawa da catabolism na LDL cholesterol.

Alamu don amfani

- a haɗe tare da tsarin abinci don lura da marasa lafiya tare da ƙara yawan ƙwayar plasma na jimlar cholesterol, HDL-C, apolipoprotein B da triglycerides, da kuma karuwa a HDL-C a cikin marasa lafiya tare da hypercholesterolemia na farko (heterozygous familial da rashin familial hypercholesterolemia), haɗe (hade) hyperliplestia IIa da IIb a cewar Frederickson), tare da haɓaka abun ciki na triglycerides a cikin jini plasma (nau'in IV a cewar Frederickson) da kuma marasa lafiya da dysbetalipoproteinemia (nau'in III a cewar Frederickson), in babu cikakken isasshen sakamako tare da di oterapii

- don rage matakan plasma na jini na jimlar cholesterol da LDL-C a cikin marasa lafiya tare da hyzycholesterolemia na homozygous tare da isasshen ingancin maganin rashin abinci da sauran hanyoyin magani na rashin magani

- don rage haɗarin mutuwar cutar cututtukan zuciya da kuma haɗarin ci gaba na infyoction na myocardial infarction, angina pectoris, bugun jini da rage buƙatu na hanyoyin farfadowa a cikin marasa lafiya da cututtukan zuciya da / ko dyslipidemia, kamar yadda kuma idan ba a gano waɗannan cututtukan ba, amma akwai a kalla uku dalilai masu haɗari don haɓakar cututtukan zuciya na zuciya, kamar shekaru fiye da shekaru 55, shan taba, hauhawar jini, ƙananan ƙwayar cutar plasma na HDL-C, da kuma lokuta na farkon haɓaka cututtukan zuciya na jijiya a cikin dangi.

- a haɗe tare da rage cin abinci don lura da yara masu shekaru 10-17 shekaru tare da karuwar abun cikin plasma na jimlar cholesterol, LDL-C da apolipoprotein B tare da heterozygous familial hypercholesterolemia, idan bayan isasshen maganin warkewar cutar matakin LDL-C ya rage> 190 mg / dl ko kuma matakin LDL ya rage> 160 mg / dl, amma akwai lokuta na haɓakar cutar sankarar zuciya a cikin dangi ko biyu ko sama da abubuwan haɗari don haɓaka cututtukan zuciya a cikin yaro

Sashi da gudanarwa

Kafin fara magani tare da Atoris®, ya kamata kuyi ƙoƙarin cimma iko na hypercholesterolemia ta hanyar rage cin abinci, motsa jiki da kuma asarar nauyi a cikin marasa lafiya tare da kiba, har ma da kula da cutar rashin lafiyar. Lokacin da yake rubuta magani, mai haƙuri yakamata ya bayar da shawarar daidaitaccen tsarin abinci, wanda dole ne ya bi yayin jiyya.

Ana shan maganin a kowane lokaci na rana, ba tare da la'akari da yawan abinci ba. Yawan maganin yana bambanta daga 10 zuwa 80 MG sau ɗaya a rana, zaɓi yana yin la’akari da abubuwan farko na LDL-C, manufar farfaɗiya da tasirin mutum. A farkon jiyya da / ko yayin haɓaka yawan ƙwayar Atoris®, ya wajaba a kula da abin da ke cikin ƙwayar jini a cikin jini na kowane mako na 2-4 kuma daidaita sashi gwargwado.

Primary hypercholesterolemia da hade (hade) hyperlipidemia: ga yawancin marasa lafiya - 10 MG sau ɗaya a rana, ana nuna tasirin warkewa a cikin makonni 2 kuma yawanci ya kai matsakaici a cikin makonni 4, tare da tsawan magani, sakamakon yana ci gaba.

Homozygous dangi na hypercholesterolemia: 80 MG sau ɗaya a rana (a mafi yawan lokuta, maganin ya haifar da raguwa cikin abubuwan LDL-C ta ​​18-45%).

Mai tsananin cutar dyslipidemia a cikin cututtukan yara: Shafin farawa shine 10 Mita sau ɗaya a rana. Za'a iya ƙara kashi zuwa 80 MG kowace rana daidai da amsawar asibiti da haƙuri. Ya kamata a zaba allurai dabam-dabam don yin la'akari da dalilin shawarar da aka bayar da magani.

Yi amfani da marasa lafiya da cututtukan hanta: duba "Contraindications."

Sashi a cikin marasa lafiya da renal gazawar: cutar koda ba ta da hankali da haɗuwar Atoris® a cikin jini na jini ko kuma digiri na raguwa a cikin abubuwan LDL-C, saboda haka ba a buƙatar daidaita sashi na maganin.

Yi amfani da tsofaffi: babu bambance-bambance a cikin aminci, inganci, ko cimma burin kwaskwarimar rage yawan lipid a cikin tsofaffi idan aka kwatanta da na yawan jama'a.

Side effects

zafi a makogwaro da maƙogwaron, hanci

dyspepsia, tashin zuciya, flatulence, ciki na rashin jin daɗi, belching, zawo

arthralgia, jinƙai a cikin gabobin, murƙwalwar tsoka, myalgia, myositis, myopathy

alamu na yau da kullum na hanta aiki, ƙara serum creatine phosphokinase (CPK)

rauni na tsoka, ciwon wuya

malaise, zazzabi

fitowar farin sel cikin fitsari

An gano tasirin sakamako masu zuwa a cikin karatun dabarun tallatawa:

rashin lafiyan halayen (ciki har da anaphylaxis)

nauyi

hypesthesia, amnesia, dizziness, daɗin ɓarna

Stevens-Johnson syndrome, mai guba necrolysis mai guba, erythema multiforme, tashin hankali mai ƙarfi

rhabdomyolysis, ciwon baya

ciwon kirji, farji na ciki, gajiya

Contraindications

rashin jituwa ga kowane ɓangaren magungunan

cutar hanta mai aiki ko karuwar ƙwayar ƙwayar transumase (fiye da sau 3 idan aka kwatanta da babba na al'ada) na asalin da ba a sani ba

mata masu juna biyu da masu shayarwa, da kuma mata masu haihuwa wadanda ba sa amfani da hanyoyin isasshen hanyoyin yin riga-kafi

marasa lafiya da rashin haƙuri a cikin lactose, LAPP-lactase enzyme rashi, glucose-galactose malabsorption

Mu'amala da Lafiya

Hadarin cutar myopathy yana ƙaruwa yayin jiyya tare da Hhib-CoA reductase inhibitors da kuma amfani da lokaci ɗaya cyclosporin, abubuwan da ake amfani da su na fibric acid, nicotinic acid da cytochrome P450 3A4 inhibitors (erythromycin, wakilan antifungal da ke da alaƙa da jijiyoyin).

P450 3A4 Masu hana masu shiga ciki: atorvastatin yana metabolized ta cytochrome P450 3A4. Yin amfani da atorvastatin da kuma cytochrome P450 3A4 na lokaci guda zai iya haifar da karuwar yawan ƙwayoyin plasma na atorvastatin. Matsakaicin ma'amala da ƙarfin tasirin yana dogara da bambancin aikin akan cytochrome P450 3A4.

Masu hanawa: atorvastatin da metabolites din sa suna canza fasinjojin OATP1B1. OATP1B1 inhibitors (misali, cyclosporine) na iya haɓaka bioavailability na atorvastatin. Amfani guda 10 na Atoris® da cyclosporine (5.2 mg / kg / rana) yana haifar da karuwa a cikin atorvastatin sau 7.7.

Sankarinka / clarithromycin: tare da yin amfani da atorvastatin da erythromycin (500 mg sau hudu a rana) ko clarithromycin (500 mg sau biyu a rana), wanda ke hana cytochrome P450 3A4, an lura da karuwar taro na atorvastatin a cikin jini na jini.

Kare masu hana: amfani da atorvastatin tare da inhibvastatin mai kariya wanda aka sani da cytochrome P450 3A4 inhibitors yana haɗuwa tare da haɓaka yawan ƙwayar plasma na atorvastatin.

Diltiazem hydrochloride: amfani da Atoris® (40 MG) da diltiazem (240 mg) a lokaci guda yana haifar da karuwar yawan atorvastatin a cikin jini.

Cimetidine: nazarin hulɗa da atorvastatin da cimetidine basu bayyana ma'amala mai mahimmanci a asibiti ba.

Itraconazole: amfani da Atoris® lokaci guda (20 mg-40 mg) da itraconazole (200 mg) yana haifar da karuwa a cikin AUC na atorvastatin.

Ruwan Inabi: ya ƙunshi abubuwa guda ɗaya ko biyu waɗanda ke hana CYP 3A4 kuma suna iya haɓaka yawan atorvastatin a cikin jini, musamman tare da wuce kima na ruwan innabi (fiye da lita 1.2 a rana).

Indoctors na cytochrome P450 3A4: amfani da Atoris® lokaci guda tare da cytochrome P450 3A4 inducers (efavirenz, rifampin) na iya haifar da raguwa a cikin ƙwayoyin plasma na atorvastatin. Ganin yadda abubuwa biyu ke gudana na rifampin (shigo da cytochrome P450 3A4 da hana enzyme hanta OATP1B1), ana ba da shawarar yin at Atisisi sau ɗaya tare da rifampin, tunda shan Atoris® bayan shan rifampin yana haifar da raguwa mai yawa a matakin atorvastatin a cikin jini.

Antacids: lokaci guda na dakatarwa wanda ya ƙunshi magnesium da hydro hydroxides ya rage yawan atorvastatin a cikin jini na kimanin kashi 35%, duk da haka, matakin rage girman abubuwan LDL-C bai canza ba.

Kwayar cutar ƙwaƙwalwa: Atoris® baya tasiri kan magunguna na antipyrine, sabili da haka, hulɗa tare da sauran kwayoyi metabolized by cytochrome isoenzymes iri ɗaya ba a sa ran su.

Colestipol: tare da yin amfani da colestipol na lokaci daya, yawan atorvastatin a cikin jini yana raguwa da kusan 25%, duk da haka, tasirin rage ƙwayar lipid na haɗarin atorvastatin da colestipol sun wuce na kowane ƙwayoyi daban-daban.

Digoxin: Tare da maimaita gudanarwar digoxin da atorvastatin a kashi 10 na MG, daidaitawar digoxin a cikin jini bai canza ba. Kodayake, lokacin da aka yi amfani da digoxin a hade tare da atorvastatin a kashi 80 na MG / rana, yawan narkewar ya karu da kusan 20%. Marasa lafiya da ke karɓar digoxin a hade tare da Atoris® suna buƙatar saka idanu da suka dace.

Azithromycin: tare da amfani da atorvastatin lokaci guda (10 mg sau ɗaya a rana) da azithromycin (500 MG sau ɗaya a rana), yawan atorvastatin a cikin plasma bai canza ba.

Na'urar hana haihuwa: tare da yin amfani da atorvastatin na lokaci daya da maganin hana haihuwa wanda ke dauke da northindrone da ethinyl estradiol, an sami karuwa sosai a cikin AUC na northindrone da ethinyl estradiol da kusan 30% da 20%, bi da bi. Yakamata a yi la’akari da wannan sakamako lokacin zabar maganin hana yaduwa ga mace mai shan Atoris®.

Warfarin: Babu wata ma'amala mai ma'ana ta atorvastatin tare da warfarin da aka gano.

Amlodipine: tare da yin amfani da atorvastatin da amlodipine 10 MG na lokaci daya, magungunan likitancin atorvastatin a cikin daidaitattun ma'aurata basu canza ba.

Fusidic acid: karatu ba game da hulɗa da atorvastatin da fusidic acid ba a gudanar da su, duk da haka, lokuta na rhabdomyolysis tare da yin amfani da su a lokaci guda a cikin binciken sayar da bayan. Sabili da haka, ya kamata a kula da marasa lafiya kuma, idan ya cancanta, ana iya dakatar da maganin Atoris® na ɗan lokaci.

Sauran hanyoyin kwantar da hankali: lokacin amfani da atorvastatin a hade tare da wakilai na rigakafin jini da estrogens, ba a lura da manyan mu'amala mara amfani ta hanyar asibiti ba.

Umarni na musamman

Aiwatar da hanta

Bayan jiyya tare da atorvastatin, an lura da mahimmancin (fiye da sau 3 idan aka kwatanta da babba na al'ada) an lura da karuwa a cikin ƙwayar ƙwayar jijiyoyin “hanta”.

Anara yawan ayyukan hematic transaminases yawanci ba ya tare da jaundice ko wasu bayyananniyar asibiti. Tare da raguwa a cikin adadin atorvastatin, na ɗan lokaci ko cikakkiyar dakatar da miyagun ƙwayoyi, ayyukan hepatic transaminases ya koma matakin asali. Yawancin marasa lafiya sun ci gaba da shan atorvastatin a cikin ragewa ba tare da wani sakamako ba.

Wajibi ne a lura da alamun aikin hanta yayin duk aikin jiyya, musamman idan alamun alamun cutar lalacewar hanta suka bayyana. Game da karuwa a cikin abubuwan da ke tattare da cututtukan hepatic, ya kamata a sanya ido a kan ayyukanta har sai an cimma iyakar ka'idojin. Idan an sami ƙaruwa a cikin ayyukan AST ko ALT ta fiye da sau 3 idan aka kwatanta da babba na ƙa'idar aiki, ana ba da shawarar rage kashi ko sokewa.

Tsarin tsoka mai narkewa

Lokacin da yake tsara Atoris® a cikin maganin ƙwayar cuta a haɗe tare da abubuwan da ake amfani da su na fibroic acid, erythromycin, immunosuppressants, magungunan azole antifungal ko nicotinic acid, likita yakamata yayi la'akari da fa'idodin da ake tsammanin da kuma haɗarin magani da saka idanu akai-akai ga marasa lafiya don gano ciwo ko rauni a cikin tsokoki, musamman yayin farkon watanni na jiyya da kuma lokacin lokacin ƙara allurai na kowane magani. A cikin irin waɗannan yanayi, za a iya ba da shawarar ƙayyadadden lokaci na aikin CPK, kodayake irin wannan sa ido ba ya hana ci gaba da cutar myopathy. Atorvastatin na iya haifar da karuwa a cikin aikin aikin phosphokinase.

Lokacin amfani da atorvastatin, ba a bayyana maganganun lokuta marasa sauƙi na rhabdomyolysis tare da gazawar ƙoshin yara saboda myoglobinuria. Dole ne a dakatar da maganin Atoris® na ɗan lokaci ko kuma a daina shi gaba ɗaya idan akwai alamun yiwuwar rashin lafiyar myopathy ko haɗarin haɗari don haɓaka rashin nasara na renal sakamakon rhabdomyolysis (misali, matsanancin ciwo mai rauni, ƙwanƙwasa jijiyoyin jiki, mummunan tiyata, rauni, tashin hankali, metabolism, endocrine da tashin hankali da rashin tashin hankali).

Bayani ga mara lafiya: ya kamata a faɗakar da marasa lafiya cewa ya kamata su gargadi likita nan da nan idan zafin da ba a bayyana ba ko rauni a cikin tsokoki ya bayyana, musamman idan suna tare da zazzabi ko zazzabi.

Yi amfani da hankali a cikin marasa lafiya waɗanda ke shan barasa da / ko fama da cutar hanta (tarihin).

Marasa lafiya ba tare da cututtukan zuciya na zuciya ba (CHD) tare da bugun jini na kwanan nan ko tashin hankali ischemic attack (TIA) ya nuna wani mummunan tashin hankali na bugun jini wanda ya fara karbar atorvastatin a kashi 80 MG idan aka kwatanta da marasa lafiya da ke karbar placebo. Marasa lafiya da ke fama da basur sun nuna haɗarin cutar bugun jini ko da yaushe. Koyaya, marassa lafiya da ke shan atorvastatin 80 MG suna da karancin bugun jini na kowane nau'in kuma karancin cututtukan zuciya.

Haihuwa da lactation

Ya kamata matan da suka isa haihuwa suyi amfani da isassun hanyoyin rigakafi yayin aikin jiyya. Ana iya ba da allurar Atoris to ga mata masu haihuwa kawai idan yuwuwar samun juna biyu ya ragu, kuma aka sanar da mara lafiyar game da yiwuwar haɗarin tayin a yayin jiyya.

Musammangargadi filler

Atoris® ya ƙunshi lactose. Marasa lafiya da ke tattare da cututtukan da ke gado na ƙarancin galactose, ƙarancin Lappase, ko malalaror na glucose galactose malabsorption bai kamata su sha wannan maganin ba. Siffofin tasiri na miyagun ƙwayoyi akan karfin tuƙin abin hawa da ƙwararrun hanyoyin haɗari

Gwargwadon sakamako masu illa na miyagun ƙwayoyi, yakamata a yi taka tsantsan lokacin tuki motocin da sauran hanyoyin haɗari.

Tare da kulawa

Alcoholism, tarihin cututtukan hanta.
A cikin marasa lafiya da dalilai masu haɗari don rhabdomyolysis (tabarbarewa na renal, hypothyroidism, rikicewar ƙwayar tsoka a cikin tarihin mai haƙuri ko tarihin dangi, sakamakon mai guba na HMG-CoA reductase inhibitors na statins ko fibrates a kan ƙwayar tsoka, tarihin cutar hanta da / / ko marasa lafiya waɗanda ke cinye yawan ƙwayoyi, tsofaffi marasa lafiya waɗanda suka girmi shekaru 70, yanayin da ake tsammanin karuwar yawan ƙwayar cuta ta atorvastatin, alal misali, hulɗa da wasu kwayoyi).

Yi amfani da lokacin daukar ciki da lokacin shayarwa

Atoris® yana contraindicated a cikin ciki da lokacin shayarwa. Nazarin dabbobi sun nuna cewa hadarin ga tayin na iya wuce duk wata fa'ida ga mahaifiyar.
A cikin mata masu haihuwa, waɗanda ba sa amfani da hanyoyin ingantaccen maganin hana haihuwa, ba da shawarar amfani da Atoris®. Lokacin da kake shirin yin juna biyu, dole ne ka daina amfani da Atoris® aƙalla wata 1 kafin yin cikin da kake shirin ciki.
Babu wani tabbaci game da rarraba atorvastatin tare da madara. Koyaya, a cikin wasu nau'in dabbobi yayin shayarwa, yawan atorvastatin a cikin jijiyoyin jini kuma a cikin madara daidai yake. Idan ya zama dole a yi amfani da maganin Atoris® a lokacin shayarwa, don guje wa hadarin da ke faruwa a cikin jarirai, ya kamata a daina shayar da jarirai.

Sashi da gudanarwa

Kafin fara amfani da miyagun ƙwayoyi Atoris®, ya kamata a tura mai haƙuri zuwa abincin da ke tabbatar da raguwa a cikin yawan ƙwayar lipids a cikin jini, wanda dole ne a lura yayin duk jiyya tare da miyagun ƙwayoyi. Kafin farawa da jiyya, ya kamata kuyi ƙoƙarin cimma iko na hypercholesterolemia ta hanyar motsa jiki da asarar nauyi a cikin marasa lafiya tare da kiba, kazalika da magani don cututtukan da ke tattare da cutar.
Ana ɗaukar miyagun ƙwayoyi a baka, ba tare da la'akari da lokacin cin abinci ba. Yawan maganin yana bambanta daga 10 MG zuwa 80 MG sau ɗaya a rana kuma an zaɓi yin la'akari da farkon maida hankali na LDL-C a cikin jini, manufar farji da tasirin magani na mutum.
Ana iya daukar Atoris® sau ɗaya a kowane lokaci na rana, amma a lokaci guda kowace rana. Ana lura da tasirin warkewa bayan makonni 2 na magani, kuma mafi girman tasirin yana tasowa bayan makonni 4.
A farkon farfajiya da / ko yayin karuwa a cikin kashi, yana da mahimmanci don saka idanu kan yawan ƙwayar lipids a cikin jini na jini a kowane mako na 2-4 kuma daidaita sashi gwargwado.
Primary hypercholesterolemia da hade (hade) hyperlipidemia
Ga yawancin marasa lafiya, maganin da aka bayar da shawarar Atoris® shine 10 MG sau ɗaya a rana, tasirin warkewa yana bayyana kanta a cikin makonni 2 kuma yawanci ya kai matsakaici bayan makonni 4. Tare da jiyya na tsawan lokaci, sakamakon ya ci gaba.
Homozygous familial hypercholesterolemia
A cikin mafi yawan lokuta, ana tsara 80 MG sau ɗaya a rana (raguwa a cikin taro na LDL-C a cikin plasma da 18-45%).
Heterozygous familial hypercholesterolemia
Maganin farko shine 10 MG kowace rana. Ya kamata a zaɓi kashi ɗin daban-daban kuma ku kimanta mahimmancin kashi kowane mako 4 tare da yuwuwar karuwa zuwa 40 MG kowace rana. Sannan, ko dai ana iya ƙara yawan zuwa adadin zuwa 80 MG kowace rana, ko kuma yana yiwuwa a haɗu da jerin abubuwan bile acid tare da amfani da atorvastatin a kashi 40 MG kowace rana.
Rashin Cutar zuciya
A cikin nazarin rigakafin farko, kashi na atorvastatin ya kasance 10 MG kowace rana. Increaseara yawan kashi na iya zama dole don samun mahimmancin LDL-C daidai da jagororin yanzu.
Amfani a cikin yara daga 10 zuwa 18 tare da heterozygous familial hypercholesterolemia
Maganin farawa shine 10 MG sau ɗaya a rana. Za'a iya ƙara yawan zuwa 20 MG kowace rana, gwargwadon sakamakon asibiti. Warewa tare da kashi fiye da 20 MG (wanda ya yi daidai da kashi na 0.5 mg / kg) yana iyakantacce.
Dole ne a zaba adadin maganin kamar yadda ya dogara da dalilin maganin rage kiba. Ya kamata a aiwatar da gyaran fuska gwargwado na 1 lokaci cikin makonni huɗu ko fiye.
Rashin hanta
Idan aikin hanta bai isa ba, ya kamata a rage yawan ƙwayar Atoris®, tare da saka idanu akai-akai na ayyukan “hanta” transaminases: aspartate aminotransferase (AST) da alanine aminotransferase (ALT) a cikin jini na jini.
Rashin wahala
Renarancin ƙwayar cuta mara nauyi ba ya shafar maida hankali na atorvastatin ko matakin raguwa a cikin taro na LDL-C a cikin plasma, saboda haka, ba a buƙatar daidaita sashi na maganin ba (duba sashe "Pharmacokinetics").
Tsofaffi marasa lafiya
Babu bambance-bambance a cikin ingancin warkewa da amincin atorvastatin a cikin tsofaffi marasa lafiya idan aka kwatanta da yawan jama'a, ba a buƙatar daidaita sashi (duba sashin Pharmacokinetics).
Yi amfani dashi a hade tare da wasu kwayoyi
Idan ya cancanta, yin amfani da lokaci daya tare da cyclosporine, telaprevir ko haɗuwa da tipranavir / ritonavir, kashi na miyagun ƙwayoyi Atoris® bai kamata ya wuce 10 mg / rana ba (duba sashe "Umarni na Musamman").
Yakamata a yi taka tsantsan kuma mafi ƙarancin ingancin atorvastatin yakamata a yi amfani dashi yayin da ake amfani da shi tare da masu hana HIV kariya, kwayar cutar hepatitis C mai hana garkuwar jiki (boceprevir), clarithromycin da itraconazole.
Shawarwarin Societyungiyar ofwararrun Zuciya ta Rasha, Societyungiyoyin forasa don Nazarin Atherosclerosis (NLA) da Russianungiyar Russianwararrun ofwararrun Lafiya na Cardiosomatic da rigakafin Sakandare (RosOKR)
(V sake bita 2012)
Mafi kyawun abubuwan tattarawa na LDL-C da LDL na marasa lafiya masu haɗari sune: ≤ 2.5 mmol / L (ko ≤ 100 mg / dL) da ≤ 4.5 mmol / L (ko ≤ 175 mg / dL), bi da bi kuma ga marasa lafiya da haɗarin gaske: ≤ 1.8 mmol / l (ko ≤ 70 mg / dl) da / ko, idan ba za a iya cimma hakan ba, ana ba da shawarar rage yawan LDL-C ta ​​50% daga darajar farko da ≤ 4 mmol / l (ko mg 150 mg / dl), bi da bi.

Side sakamako

Cututtuka da cututtukan fata:
sau da yawa: nasopharyngitis.
Rashin hankali daga jini da tsarin lymphatic:
da wuya: thrombocytopenia.
Rashin rigakafin tsarin cuta:
sau da yawa: halayen rashin lafiyan,
da wuya sosai: anaphylaxis.
Take hakkin metabolism da abinci mai gina jiki:
a lokuta da dama: riba mai nauyi, anorexia,
da wuya sosai: hyperglycemia, hypoglycemia.
Rashin hankalin mutum:
sau da yawa: hargitsi na bacci, gami da rashin bacci da mafarkin "mafarki mai ban tsoro",
ba a san mita ba: ɓacin rai.
Rashin damuwa daga tsarin juyayi:
sau da yawa: ciwon kai, tsananin farin ciki, paresthesia, cututtukan asthenic,
infrequently: na gefe neuropathy, hypesthesia, ƙarancin dandano, asara ko asarar ƙwaƙwalwa.
Rashin jin kunne da kuma rikicewar lamuran:
infrequently: tinnitus.
Rashin hankali daga tsarin na numfashi, kirji da gabobin jiki:
sau da yawa: ciwon makogwaro, ciwon hanci,
ba a san tazararwa ba: keɓaɓɓun lokuta na cututtukan huhu na kewayon cuta (yawanci tare da amfani da tsawan lokaci).
Rashin narkewa:
sau da yawa: maƙarƙashiya, dyspepsia, tashin zuciya, zawo, zazzabin cizon kumburi (mama), zafin ciki,
infrequently: vomiting, pancreatitis.
Take hakkin hanta da kuma hanjin biliary:
da wuya: hepatitis, cholestatic jaundice.
Rashin lafiya daga fata da ƙananan kasusuwa:
sau da yawa: fatar fata, itching,
yawanci: urticaria,
da wuya sosai: angioedema, alopecia, bullying fyaɗe, erythema multiforme, Stevens-Johnson syndrome, mai guba da ƙwayar cutar ƙwaƙwalwa.
Take hakkin tsoka da kasusuwa mai hadewa:
sau da yawa: myalgia, arthralgia, ciwon baya, kumburi daga gidajen abinci,
na yawan lokaci: myopathy, cramps muscle,
da wuya: myositis, rhabdomyolysis, tendopathy (a wasu lokuta tare da fashewar jijiya),
mita ba a sani ba: lokuta na rigakafin-matsakanci necrotizing myopathy.
Take hakkin yara da hanjin urinary:
infrequently: na biyu renal gazawar.
Take hakkin gabobi da mammary gland shine yake:
infrequently: jima'i dysfunction,
da wuya sosai: gynecomastia.
Gabaɗaya cuta da rikicewa a wurin yin allura:
sau da yawa: na waje edema,
infrequently: zafi kirji, malaise, gajiya, zazzabi.
Bayanai da kayan aikin:
na yawan lokaci: karuwar ayyukan aminotransferases (AST, ALT), karuwar ayyukan kwayar halitta phosphokinase (CPK) a cikin jini,
da wuya sosai: karuwar taro na gemocosylated haemoglobin (HbA1).
Ba a kafa dangantakar musamman na wasu tasirin da ba a ke so ba tare da amfani da miyagun ƙwayoyi Atoris®, waɗanda ake ɗauka a matsayin "mafi wuya", ba a kafa su ba. Lokacin fitowar mummunan tasirin amfani da miyagun ƙwayoyi Atoris® ya kamata a dakatar da shi.

Yin hulɗa tare da wasu kwayoyi

Amfani da atorvastatin tare da cyclosporine, maganin rigakafi (erythromycin, clarithromycin, chinupristine / dalphopristine), masu hana HIV kariya (indinavir, ritonavir), jami'in antifungal (fluconazole, itraconazole, ketoconazole) ko hawan jini yana kara hadarin kamuwa da cutar sankarar mahaifa tare da rhabdomyolysis da gazawar koda. Don haka, tare da yin amfani da eCthromycin TCmax na lokaci guda, atorvastatin yana tsawan 40%. Duk waɗannan magungunan suna hana CenP3A4 isoenzyme, wanda ke cikin metabolism na atorvastatin a cikin hanta. Ana iya yin ma'amala mai kama da wannan tare da yin amfani da atorvastatin lokaci guda tare da fibrates da acid nicotinic a cikin matakan rage ƙwayar lipid (fiye da 1 g kowace rana).
Amfani da ezetimibe yana da alaƙa da haɓakar halayen masu illa, gami da rhabdomyolysis, daga tsarin musculoskeletal. Hadarin irin wannan halayen yana ƙaruwa tare da yin amfani da lokaci guda na ezetimibe da atorvastatin. Ana ba da shawarar kulawa da rufewa don waɗannan marasa lafiya.
Yin amfani da atorvastatin lokaci guda a kashi 40 MG tare da diltiazem a kashi 240 MG yana haifar da karuwa a cikin atorvastatin a cikin jini na jini.
CYP3A4 Isoenzyme Inductors
Haɗakar amfani da atorvastatin tare da ininzyme CYP3A4 na isoenzyme (alal misali, efavirenz, rifampicin ko Hypericum perforatum) na iya haifar da raguwa a cikin atorvastatin a cikin jini na jini. Sakamakon tsarin biyu na ma'amala tare da rifampicin (inginer na CYP3A4 isoenzyme da hepatocyte sufurin furotin mai hana OATP1B1), ana bada jinkiri ga atorvastatin, tunda yin amfani da atorvastatin da rifampicin yana haifar da raguwa sosai a cikin yawan atorvastatin a cikin jini na jini. Bayanai kan tasirin rifampicin akan maida hankali akan atorvastatin a hepatocytes ba shi, saboda haka, idan baza'a iya yin amfani da amfani da lokaci daya ba, ya kamata a sa ido sosai game da irin wannan hadewar yayin aikin tiyata.
Tunda atorvastatin yana metabolized ta hanyar isoenzyme CYP3A4, yin amfani da atorvastatin lokaci daya tare da hana masu shiga cikin CYP3A4 isoenzyme na iya haifar da karuwar yawan atorvastatin a cikin jini.
OATP1B1 jigilar furotin masu hana furotin (misali, cyclosporine) na iya haɓaka ƙwayar atorvastatin.
Tare da amfani da lokaci guda tare da antacids (dakatar da magnesium hydroxide da aluminum hydroxide), maida hankali ga atorvastatin a cikin jini yana raguwa.
Tare da yin amfani da atorvastatin tare da colestipol lokaci guda, yawan atorvastatin a cikin jini yana rage 25%, amma warkewar cutarwa yana haɗuwa da tasirin atorvastatin kadai.
Amfani da atorvastatin na lokaci guda tare da kwayoyi waɗanda ke rage maida hankali na kwayoyin steroid na endogenous (wanda ya hada da cimetidine, ketoconazole, spironolactone) yana ƙara haɗarin rage ƙananan kwayoyin steroid na endogenous (yakamata a yi taka tsantsan).
A cikin marasa lafiya a lokaci guda suna karɓar 80 na atorvastatin da digoxin, yawan ƙwaƙwalwar digoxin a cikin jini yana ƙaruwa da kusan 20%, sabili da haka, ya kamata a kula da irin waɗannan marasa lafiya.
Tare da yin amfani da atorvastatin na lokaci daya tare da hana haihuwa don gudanar da maganin baka (norethisterone da ethinyl estradiol), yana yiwuwa a ƙara ɗaukar abubuwan hana haifuwa da kuma ƙara maida hankali a cikin jini. Ya kamata a kula da zaɓin rigakafin mata masu shan atorvastatin.
Yin amfani da atorvastatin lokaci guda tare da warfarin a farkon kwanakin na iya ƙara tasirin warfarin akan coagulation na jini (rage lokacin prothrombin). Wannan tasirin ya ɓace bayan kwanaki 15 na amfani da waɗannan magunguna a lokaci guda.
Duk da gaskiyar cewa binciken da aka yi amfani da su na colchicine da atorvastatin ba a gudanar da su ba, akwai rahotannin ci gaba da cutar ta rashin haɓaka tare da wannan haɗin. Ta yin amfani da atorvastatin da colchicine lokaci guda, yakamata ayi taka tsantsan.
Tare da yin amfani da atorvastatin da terfenadine a lokaci guda, ba a gano canje-canje masu mahimmanci a cikin magungunan likita na terfenadine ba.
Atorvastatin baya tasiri kan magunguna na phenazone.
Amfani da haɗin kai tare da masu hana kariya yana haifar da karuwa a cikin yawan ƙwayoyin plasma na atorvastatin.
Tare da yin amfani da atorvastatin lokaci daya a kashi 80 MG da amlodipine a kashi 10 MG, magungunan magunguna na atorvastatin a cikin daidaitattun yanayin bai canza ba.
An sami maganganu na rhabdomyolysis a cikin marasa lafiya ta amfani da atorvastatin da fusidic acid.
Gudanar da aikin likita
Lokacin amfani da atorvastatin tare da wakilai na antihypertensive da estrogens a matsayin wani ɓangare na magani mai sauyawa, babu alamun hulɗar asibiti a cikin mahimmancin hulɗa mara kyau.
Yin amfani da ruwan 'ya'yan innabi a lokacin amfani da Atoris® na iya haifar da karuwar yawan ƙwayar ƙwayar plasma na atorvastatin. A wannan batun, marasa lafiya da ke shan magani Atoris® ya kamata su guji shan ruwan innabi fiye da lita 1.2 a rana.

Yawan abin sama da ya kamata

Kwayar cutar: kara tasirin sakamako.

Jiyya: babu takamaiman maganin rigakafin cutar Atoris® yawan ƙwayar cuta. Game da yawan abin sama da ya kamata, ya kamata a gudanar da aikin tiyata kamar yadda ya cancanta (kamar yadda likitan ya umarce shi). Tunda maganin yana da alaƙa da kariyar plasma, ba a ƙara samun ƙaruwa game da zubar Atoris® yayin hemodialysis ba.

Rijistar Rijistar Rijista

Krka, dd, Novo Mesto, Slovenia

Adireshin kungiyar wanda ya yarda da da'awar daga masu sayayya kan ingancin kayayyaki (kayayyaki) a Jamhuriyar Kazakhstan

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

gini 1 b, bene na biyu, ofis 207

tel.: +7 (727) 311 08 09

fax: +7 (727) 311 08 12

11.04.05

Hotunan 3D

Bayanin sigar sashi

Allunan, 10 da 20 MG: zagaye, dan kadan biconvex, an rufe shi da membrane fim na farin launi. Kink view: farin m taro tare da fim membrane na farin ko kusan farin launi.

Allunan, 30 MG: zagaye, dan kadan biconvex, an rufe shi da membrane fim na farin ko kusan farin launi, tare da bevel.

Allunan, 40 MG: zagaye, dan kadan biconvex, an rufe shi da membrane fim na farin ko kusan fari. Kink view: farin m taro tare da fim membrane na farin ko kusan farin launi.

Pharmacodynamics

Atorvastatin wakili ne na jini daga rukunin mutum-mutumi. Babban aikin aiwatar da atorvastatin shine hana ayyukan HMG-CoA reductase, enzyme wanda ke haifar da juyawar HMG-CoA zuwa mevalonic acid. Wannan canjin yana ɗayan matakan farko a sarkar ƙirar Chs a cikin jiki. Atorvastatin hanawa da kira na XC yana haifar da ƙara ƙarfin aiki na masu karɓa na LDL a cikin hanta, da kuma a cikin ƙwayoyin cuta na extrahepatic. Waɗannan masu karɓa suna ɗaukar barbashi na LDL kuma suna cire su daga plasma jini, wanda ke haifar da raguwa a cikin taro na LDL-C a cikin jini.

Sakamakon antiatherosclerotic na atorvastatin sakamako ne sakamakon tasirinsa akan bangon jijiyoyin jini da abubuwan haɗin jini. Atorvastatin yana hana ayyukan haɗin gwiwar isoprenoids, waɗanda sune abubuwan haɓaka abubuwan haɓaka ƙwayoyin sel na ciki na jijiyoyin jini. A ƙarƙashin tasirin atorvastatin, haɓaka aikin endothelium wanda ke dogara da tasoshin jini yana inganta, maida hankali ne kan LDL-C, LDL (Apo-B), triglycerides (TG) ya ragu, kuma maida hankali kan HDL-HDL da Apolipoprotein A (Apo-A) yana ƙaruwa.

Atorvastatin yana rage dankowar jinin jini da aikin wasu abubuwan hadewar jini da hadewar platelet. Saboda wannan, yana haɓaka hemodynamics kuma yana daidaita yanayin tsarin coagulation. HMG-CoA reductase inhibitors suma suna shafar metabolism na macrophages, toshe tasirinsu da hana katsewa daga cikin matsanancin yanayin atherosclerotic.

A matsayinka na mai mulkin, ana lura da warkewar cutar atorvastatin bayan makonni 2 na magani, kuma mafi girman tasirin yana tasowa bayan makonni 4.

Atorvastatin a kashi 80 MG yana rage haɗarin rikice rikice rikicewar cutar ischemic (ciki har da mutuwa daga myocardial infarction) ta hanyar 16%, haɗarin sake komawa asibiti don angina pectoris, tare da alamun ischemia na myocardial, ta 26%.

Pharmacokinetics

Atorvastatin sha yana da girma, kusan kashi 80% yana ɗaukar daga narkewa. Matsakaicin narkewa da maida hankali a cikin jini na jini yana ƙaruwa daidai gwargwado. T_max a kan matsakaita na awa 1-2. Mata T_max mafi girma da kashi 20%, sannan kuma kungiyar ta AUC ta ragu da kashi 10%. Bambanci a cikin magunguna a cikin marasa lafiya ta hanyar shekaru da jinsi ba su da mahimmanci kuma baya buƙatar daidaita sashi.

A cikin marasa lafiya da giya cirrhosis na hanta T_max 16 sau sama da na al'ada. Cin dan kadan yana rage gudu da tsawon lokacin shan ƙwayoyi (ta hanyar 25 da 9%, bi da bi), amma raguwa a cikin taro na LDL-C yana kama da wannan tare da yin amfani da atorvastatin ba tare da abinci ba.

Atorvastatin bioavailability yana da ƙasa (12%), bioavailability na tsari na aikin inhibitory na hanawa HMG-CoA rage 30%. Rashin tsarin bioavailability na tsari saboda metabolism na metabolism a cikin mucosa na ciki da kuma hanyar farko ta hanta.

Matsakaici V_d atorvastatin - 381 l. Fiye da 98% na atorvastatin sun ɗaure zuwa sunadaran plasma. Atorvastatin ba ya ƙetare BBB. Metabolized galibi a cikin hanta a ƙarƙashin aikin na isoenzyme CYP3A 4 na cytochrome P450 tare da ƙirƙirar metabolites na aiki metabolites (ortho- da para-hydroxylated metabolites, samfurori na hadawan abu da iskar shaka), wanda ke haifar da kusan 70% na aikin inhibitory a kan ragewar HMG-CoA, na 20-30 hours .

T_1/2 atorvastatin 14 h. An keɓe shi musamman da bile (ba a sa shi cikin maimaitawa ba, ba a ƙoshin shi lokacin jiyya). Kimanin kashi 46% na atorvastatin an kewaya shi a cikin hanjin ciki kuma kasa da 2% daga kodan.

Groupsungiyoyin haƙuri na musamman

Yara. Akwai iyakataccen bayanai game da nazarin bude mako na 8 na likitancin yara a cikin yara (shekaru 6 zuwa 17) tare da heterozygous familial hypercholesterolemia da kuma farkon taro na LDL cholesterol mm4 mmol / l, tare da kula da atorvastatin a cikin nau'in ƙwayoyin chewable na 5 ko 10 mg ko Allunan, mai rufin fim, a kashi 10 ko 20 MG sau 1 a rana, bi da bi. Theaya kawai ma'anar covariate a cikin tsarin magunguna na yawan jama'a yana karɓar atorvastatin shine nauyin jikin. Bayyananniyar kyautar atorvastatin a cikin yara bai bambanta da wannan ba a cikin manya marasa lafiya tare da ma'aunin allometric ta nauyin jiki. A cikin kewayon aikin atorvastatin da o-hydroxyatorvastatin, an lura da raguwa mai daidaituwa a cikin LDL-C da LDL.

Tsofaffi marasa lafiya. C_max a cikin jini na jini da AUC na miyagun ƙwayoyi a cikin tsofaffi marasa lafiya (fiye da shekaru 65) da 40 da 30%, bi da bi, mafi girma daga waɗanda ke cikin matasa marasa lafiya manya. Babu wani bambance-bambance a cikin inganci da amincin miyagun ƙwayoyi ko cinma burin da aka samu na rage ƙarfin jinya a cikin tsofaffi marasa lafiya idan aka kwatanta da yawan jama'a.

Paarancin aiki na haya. Imarancin aikin na yara mai lalacewa baya shafar maida hankali na atorvastatin a cikin jini na jini ko kuma tasirinsa akan metabolism na lipid; saboda haka, ba a buƙatar canza sashi a cikin marasa lafiya tare da aikin na koda

Rashin aikin hanta. Cutar da ƙwayar cuta ta tashi sosai (C_max - kusan sau 16, AUC - kusan sau 11) a cikin marasa lafiya da ke fama da cutar guguwar giya (aji B bisa ga rarrabuwa da Yara-Pugh).

Alamun magunguna Atoris ®

- azaman kari don rage cin abinci don rage tasirin cholesterol, cholesterol-LDL, apo-B da TG a cikin jini na jini a cikin tsofaffi marasa lafiya, matasa da yara masu shekaru 10 ko mazan da ke da hypercholesterolemia na farko, gami da familial hypercholesterolemia (heterozygous) ko haɗe ( gauraye) hyperlipidemia (nau'in IIa da IIb, bi da bi, gwargwadon rarrabuwa da Fredrickson), lokacin da amsawar abinci da sauran hanyoyin magunguna marasa amfani,

- don rage yawan jimillar Chs, Chs-LDL a cikin plasma a cikin tsofaffi marasa lafiya tare da hyzycholesterolemia na homozygous familial a matsayin ƙari ga sauran hanyoyin maganin rage ƙwayar lipid (alal misali, LDL apheresis), ko kuma idan ba a sami irin waɗannan hanyoyin maganin ba.

rigakafin cututtukan zuciya:

- rigakafin abubuwan da suka faru na zuciya da jijiyoyin jini a cikin manya masu hadarin gaske na haɓaka abubuwan da suka faru na farko na zuciya, ban da gyaran sauran abubuwan haɗari,

- rigakafin sakandare na rikicewar cututtukan zuciya a cikin marasa lafiya da ke fama da cututtukan zuciya na zuciya (CHD) don rage yawan mace-mace, myocardial infarction, shanyewar jiki, sake komawa asibiti don angina pectoris da buƙatar farfadowa.

Haihuwa da lactation

Magungunan Atoris ® an ta'allaka ne yayin daukar ciki da kuma yayin shayarwa. Nazarin dabbobi sun nuna cewa hadarin ga tayin na iya wuce duk wata fa'ida ga mahaifiyar.

A cikin mata masu haihuwa, waɗanda ba sa amfani da hanyoyin ingantaccen maganin hana haihuwa, ba da shawarar amfani da Atoris ®. Lokacin da kake shirin yin juna biyu, dole ne ka daina amfani da Atoris ® aƙalla wata 1 kafin haihuwar da ka shirya.

Babu wani tabbaci game da rarraba atorvastatin tare da madara. Koyaya, maida hankali ga atorvastatin a cikin jini da madara na dabbobi masu shayarwa sunyi kama da wasu nau'in dabbobi. Idan ya zama dole ayi amfani da magungunan Atoris ® yayin shayarwa, don guje wa hadarin da ke faruwa a cikin jarirai, ya kamata a daina shayar da jarirai.

Fom ɗin saki

Allunan da aka sanya fim, 10 MG da 20 MG. Allunan 10 A cikin murfin kumburi (marfin kuɗaɗɗen fenti) da aka yi da kayan haɗin polyamide / tsare-tsare na alumini / tsarewar PVC-aluminum (Cold samar da OPA / Al / PVC-Al). 3 ko 9 bl. (blisters) ana sanya su a cikin kwali.

Allunan da aka saka fim, 30 MG. Allunan 10 A cikin farin ciki na hade kayan aikin polyamide / aluminum / PVC-aluminum tsare. 3 bl. (blisters) ana sanya su a cikin kwali.

Allunan-fim mai hade, 40 MG. Allunan 10 A cikin gilashi da aka ɗauka (blister strip pack) waɗanda aka yi da kayan haɗin polyamide / aluminium tsare-tsare / kayan kwanciyar hankali na PVC-aluminum. 3 bl. (blisters) ana sanya su a cikin kwali.

Mai masana'anta

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

2. LLC KRKA-RUS, 143500, Russia, Yankin Moscow, Istra, ul. Moskovskaya, 50, tare da haɗin gwiwar JSC “KRKA, dd, Novo mesto”, cmarješka cesta 6, 8501 Novo mesto, Slovenia.

Tẹli: (495) 994-70-70, fax: (495) 994-70-78.

Lokacin shirya da / ko marufi a cikin kamfanin kasuwanci na Rasha, za a nuna shi: "KRKA-RUS" LLC. 143500, Rasha, Yankin Moscow, Istra, ul. Moscow, 50.

Tẹli: (495) 994-70-70, fax: (495) 994-70-78.

CJSC Vector-Medica, 630559, Russia, Novosibirsk yankin, Novosibirsk gundumar, r.p. Koltsovo, gini 13, gini 15.

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

Ofishin wakilci na Krka, dd, Novo mesto JSC a cikin Federationungiyar Rasha / ƙungiyar da ke karɓar korafin mabukaci: 125212, Moscow, Golovinskoye sh., 5, bldg. 1, bene 22.

Waya: (495) 981-10-88, fax (495) 981-10-90.

Sharhi

Atoris ® shine kawai asalin atorvastatin da ke da irin wannan ƙarfin tushe mai ƙarfi dangane da inganci da aminci.

A cikin binciken da yawa, an samo bayanan da ke ƙasa.

Binciken INTER-ARS. Nazarin kamfani na duniya na Atoris ® (Krka) da asalin atorvastatin. Binciken ya dauki tsawon makonni 16 kuma anyi shi a cikin kasashe 3 (Slovenia, Poland da Czech Republic). Binciken ya haɗa da marasa lafiya 117 waɗanda bazuwar cikin rukuni biyu - rukuni ɗaya sun karɓi maganin Atoris ® (n = 57), ɗayan sun karɓi ainihin atorvastatin (n = 60). A lokacin da aka kammala binciken, matsakaicin sigar Atoris mg shine 16 mg. Binciken ya tabbatar da daidaituwar warkewar Atoris ® zuwa atorvastatin na asali wajen daidaita rawar lipid. Atoris ® kuma ya nuna sakamako mai kama da na asali na atorvastatin wajen rage furotin na C-mai amsawa. Bayanin haƙuri na Atoris ® ya yi daidai da bayanan bayanan haƙuri na asali na atorvastatin.

Bincike ATLANTICA. Valuididdigar inganci da amincin Atoris ® a cikin kulawa na lokaci mai tsawo na marasa lafiya masu fama da cututtukan dyslipidemia da kuma haɗarin cikakkiyar haɗarin kamuwa da cututtukan zuciya. Binciken ya hada da marasa lafiya 655. An raba marasa lafiya zuwa rukunoni uku.

Marasa lafiya a cikin rukuni na A (n = 216) sun karɓi Atoris ® a cikin adadin 10 mg, marasa lafiya a Rukunin B (n = 207) sun karɓi Atoris a cikin kashi 10 mg zuwa 80 mg (matsakaici sati a ƙarshen binciken shine 28.6 mg ), marasa lafiya a rukunin C (n = 209) sun karɓi daidaitaccen farjin (sauye-sauyen salon rayuwa, maganin ƙwaƙwalwar magani ya haɗa da maganin rage yawan lipid).

Babban canji mai mahimmanci a cikin LDL-C (raguwa 42%), OXc (30% raguwa), TG (24% raguwa) bayan makonni 24 an lura da marasa lafiya da ke karɓar ƙarin kulawa mai zurfi tare da atorvastatin (rukunin B) idan aka kwatanta da marasa lafiya da ke karɓar Atoris ® a cikin sashi na 10 mg, kuma ta hanyar marasa lafiya suna karɓar magani na al'ada.Binciken ya nuna inganci da amincin Atoris ® don kula da marasa lafiya da ke cikin dyslipidemia na dogon lokaci da ƙara haɗarin cututtukan zuciya.

Nazarin ATOP. Kimantawa game da inganci da amincin Atoris ® a cikin yawan haƙuri (marasa lafiya da cututtukan jijiyoyin zuciya, cututtukan cututtukan hanji, cututtukan sukari, cututtukan cututtukan cututtukan da ke fama da jijiyoyin zuciya). Tsawon lokacin binciken shine makonni 12. Marasa lafiya (n = 334) sun karɓi Atoris ® a allurai daga 10 zuwa 40 mg. Matsakaicin maganin yau da kullun na Atoris ® a ƙarshen binciken shine 21.3 MG. Atoris ® farjin likita ya haifar da raguwar ƙididdiga a LDL-C ta ​​hanyar 36% da OXc ta 26%. Binciken ya tabbatar da ingancin warkewa da kyakkyawan amincin Atoris ® a cikin yawan rukuni na marasa lafiya.

FARVATER Bincike. Kimantawa game da tasirin tasirin magungunan Atoris ® 10 da 20 mg akan matakan lipids, furotin na C-reactive da fibrinogen a cikin marasa lafiya da cututtukan jijiyoyin zuciya da dyslipidemia. Nazarin ya haɗa da marasa lafiya 50 waɗanda, bayan bazuwar, suka karɓi Atoris ® a allurai na 10 ko 20 mg / rana. Yin amfani da magungunan Atoris ®, duka 10 da 20 mg / rana don makonni 6, yana tare da babban raguwa a matakin OXs, TG da Chs-LDL. A cikin rukuni na marasa lafiya da ke karɓar 10 mg / ranar Atoris ®, wannan raguwa ya kasance 24.5% (OXc), 18.4% (TG), 34.9% (Chs-LDL), kuma a cikin waɗanda suke karɓar Atoris ® 20 mg / rana - 29,1% (OXc), 28.2% (TG), 40.9% (LDL-C) bi da bi. Bayan makonni 12 na jiyya, ESA (endothelium-vasodilation-endothelium-dogara) yana ƙaruwa da 40.2% (10 mg / rana) da 51.3% (20 mg / rana). Stiarfin bango na jijiyoyin jiki ya ragu da 23.4% (p = 0.008) da 25.7% (p = 0.002) a cikin rukuni na 10 da 20 mg / rana, bi da bi. Binciken ya nuna ingantacciyar raguwa a cikin matakan rage kiba da tasirin sha'awa a cikin marasa lafiya da cututtukan jijiyoyin zuciya da hyperlipidemia.

Nazarin OSCAR. Kimantawa da inganci da amincin Atoris ® a zahiri na asibiti. Binciken ya haɗa da marasa lafiya 7098 waɗanda suka karɓi atka na kamfanin Krka - Atoris ® (10 mg / day). Bayan makonni 8 na magani tare da Atoris ®, matakin OXs ya ragu da 22.7%, Chs-LDL - da 26.7% da TG - da 24%. Jimlar kasadar zuciya ya ragu da kashi 33%. Binciken ya nuna tasiri da amincin Atoris ® a cikin ainihin aikin asibiti.

1. Inter Ars. Bayanai kan fayil, KRKA d.d., Novo mesto.

2. ATLANTICA (Inganci da amincin Atoris (atorvastatin, KRKA) da tasirin sa game da haɗarin abubuwan da suka shafi jijiyoyin jini a cikin marasa lafiya tare da hyperlipidemia) - Belenkov Yu.N., Oganov R.G. Ma'aikatar Nazarin Ilimin Kimiyya ta Cibiyar Kimiyyar Zinare mai suna A.L. Myasnikova.- FGU RKNPK Rosmedtekhnologii. // Cardiology.- №11.- 2008.

3. ATOP. Bayanai kan fayil, KRKA d.d., Novo mesto.

4. FARVATER (Tasirin Atorvastatin akan bango na jijiyoyin jiki da CRP) - A. Susekov, V. Kukharchuk.- FGU RKNPK Ma'aikatar Lafiya ta Tarayyar Rasha da SR Moscow.- 2006.- Cardiology.- A'a. 9. 06.- P.4-9 .

5. Shalnova SA, Deev AD Darasi daga nazarin OSCAR - Epidemiology da fasalin jiyya na marasa lafiyar masu haɗarin gaske a cikin aikin asibiti na ainihi 2005-2006 // Magungunan zuciya da rigakafin. - 2007 - 6 (1).

Homozygous maganin gadoji

Matsakaicin adadin iri ɗaya ne da na sauran nau'in hyperlipidemia.

An zaɓi kashi na farko akayi daban-daban dangane da tsananin cutar. A cikin mafi yawan marasa lafiya tare da hyzycholesterolemia na homozygous, ana lura da ingantaccen sakamako tare da amfani da miyagun ƙwayoyi a cikin adadin yau da kullun na 80 MG (sau ɗaya). Ana amfani da Atoris® a matsayin maganin haɗin kai zuwa wasu hanyoyin magani (plasmapheresis) ko azaman babban magani idan magani tare da sauran hanyoyin ba zai yiwu ba.

Yi amfani da tsofaffi

A cikin tsofaffi marasa lafiya da marasa lafiya da cutar koda, kashi na Atoris bai kamata a canza ba. Renarancin aiki na ƙarancin ƙwayar cuta ba ya tasiri da maida hankali na atorvastatin a cikin jini na jini ko kuma digiri na raguwa a cikin taro na LDL-C tare da yin amfani da atorvastatin, sabili da haka, ba a buƙatar canza adadin maganin ba.

Rashin aikin hanta

A cikin marasa lafiya da ke fama da aikin hanta, taka tsantsan wajibi ne (saboda jinkirin kawar da miyagun ƙwayoyi daga jiki). A cikin irin wannan yanayin, yakamata a kula da sigogin asibiti da dakin gwaje-gwaje (sanya ido akai-akai game da ayyukan aspartate aminotransferase (ACT) da alanine aminotransferase (ALT). Tare da haɓaka mai mahimmanci a cikin ayyukan hepatic transaminases, ya kamata a rage kashi na Atoris ko ya kamata a dakatar da jiyya.

Yi amfani da lokacin daukar ciki da lactation

Atoris yana contraindicated a cikin ciki da lokacin shayarwa. Nazarin dabbobi sun nuna cewa hadarin ga tayin na iya wuce duk wata fa'ida ga mahaifiyar.

A cikin mata masu haihuwa da basa amfani da hanyoyin ingantaccen maganin hana haihuwa, ba a bada shawarar yin amfani da Atoris ba. Lokacin da kake shirin yin juna biyu, dole ne ka daina amfani da Atoris aƙalla wata 1 kafin yin cikin da kake shirin ciki.

Babu wani tabbaci game da rarraba atorvastatin tare da madara. Koyaya, a wasu nau'in dabbobi, tarawar atorvastatin a cikin jini kuma a cikin madara na dabbobi masu shayarwa iri ɗaya ne. Idan ya zama dole a yi amfani da maganin Atoris yayin shayarwa, don guje wa hadarin da ke tattare da hadari a cikin jarirai, ya kamata a daina shayarwa.

Hulɗa da ƙwayoyi

Tare da yin amfani da Atoris a lokaci guda tare da diltiazem, ana iya ƙaruwa cikin haɗuwa da Atoris a cikin jini na jini.

Hadarin rikice-rikice yana ƙaruwa lokacin da aka yi amfani da Atoris a cikin haɗin gwiwa tare da fibrates, acid nicotinic, maganin rigakafi, jami'in antifungal.

Tasirin Atoris yana raguwa tare da amfani da lokaci ɗaya na Rifampicin da Phenytoin.

Tare da yin amfani da lokaci guda tare da shirye-shiryen antacid, wanda ya haɗa da aluminium da magnesium, ana lura da raguwa a cikin haɗakar Atoris a cikin jini na jini.

Shan Atoris tare da ruwan 'ya'yan itace na innabi zai iya kara maida hankali kan miyagun ƙwayoyi a cikin jini na jini. Marasa lafiya waɗanda suka ɗauki Atoris ya kamata su tuna cewa shan ruwan 'ya'yan innabi a cikin girma fiye da 1 lita kowace rana ba a yarda da su ba.