Atoris - litaelo tsa semmuso bakeng sa tšebeliso

matlapa a koahetsoeng ka filimi

Letlapa le 1 le koahetsoeng filimi 10 mg / 20 mg le na:
Ntho ea bohlokoa
Lintho tse sebetsang:
Atorvastatin calcium 10,36 mg / 20,72 mg (e lekanang le atorvastatin 10.00 mg / 20.00 mg)
Baeti:
povidone - K25, sodium lauryl sulfate, calcium carbonate, cellcose ea microcrystalline, lactose monohydrate, croscarmellose sodium, magnesium stearate
Filimi sheath
Opadry II HP 85F28751 White *
* Opadry II HP 85F28751 tšoeu e na le: joala ba polyvinyl, titanium dioxide (E171), macrogol-3000, talc

Tlhaloso

Ho pota, matlapa a biconvex hanyane, filimi e koahetsoeng e tšoeu kapa e tšoeu hoo e ka bang.
Pono ea "Kink"

Mofumahali

Atorvastatin ke moemeli oa hypolipidemic ea tsoang sehlopheng sa li-statins. Mochine o ka sehloohong oa ts'ebetso ea atorvastatin ke ho thibela ts'ebetso ea 3-hydroxy-3-methylglutaryl-coenzyme A - (HMG-CoA) reductase, enzyme e thusang ho fetoloa ha HMG-CoA ho mevalonic acid. Phetoho ena ke e meng ea mehato ea pele ho ketane ea kholeseterole ea 'mele.

Khatello ea Atorvastatin ea motsoako oa cholesterol e lebisa ho ho eketseha hape ha litekanyetso tsa methapo ea methapo ea methapo ea methapo ea methapo ea methapo (LDL) le sebete. Li-receptor tsena li tlama likaroloana tsa LDL le ho li tlosa plasma ea mali, e lebisang ho fokotseheng hoa khatello ea LDL cholesterol (Ch) LDL (Ch-LDL) maling. Matla a antisulinotic a atorvastatin ke litholoana tsa phello ea eona marakong a methapo ea mali le likarolo tsa mali. Atorvastatin e thibela motsoako oa li-isoprenoids, e leng lintlha tsa kholo tsa lisele tse kahare tsa methapo ea mali. Tlas'a tšusumetso ea atorvastatin, ho eketsoa ha methapo ea methapo ea mali hoa ntlafala, khatello ea methapo ea LDL-C, LDL, apolipoprotein B, triglycerides (TG) ea fokotseha, 'me khatello ea lipalo tsa lipoprotein tse phahameng (HDL-C) le apolipoprotein Keketseho.

Atorvastatin e fokotsa ponahalo ea plasma ea mali le ts'ebetso ea lintlha tse ling tsa ho tsikinyeha le ho kopana ha liplatelete. Ka lebaka lena, e ntlafatsa hemodynamics mme o etsa maemo a sistimi ea makhopho. HMG-CoA reductase inhibitors e boetse e ama metabolism ea li-macrophages, e thibela ts'ebetso ea eona mme e thibele ho phatloha ha li-plaque atherosranceotic.

E le molao, phello ea kalafo ea atorvastatin e hlaha kamora libeke tse peli tsa ho sebelisa atorvastatin, mme phello e phahameng e fumanoa kamora libeke tse 'ne.

Atorvastatin ka tekanyo ea 80 mg e fokotsa haholo menyetla ea ho ba le mathata a ischemic (ho kenyelletsa le lefu le tsoang myocardial infarction) ka 16%, kotsi ea ho kenngoa sepetlele hape bakeng sa angina pectoris, e tsamaeang le matšoao a ischemia ea myocardial - ka 26%.

Mofumahali

Ho amoheloa ha Atorvastatin ho phahame, hoo e ka bang 80% e nkuoa ho tsoa mokokotlong oa mpa. Tekanyo ea ho amoheloa le ho kenngoa ha plasma ea mali e eketseha ka tekanyo ea lethal dose. Nako ea ho fihlela mahloriso a phahameng (TCmax) ke, ka karolelano, lihora tse 1-2. Bakeng sa basali, TCmax e phahame ka 20%, mme sebaka se tlasa khatello ea nako ea mahloriso (AUC) se tlase ka 10%. Phapang ea li-pharmacokinetics ho bakuli ka lilemo le bong ha e na thuso ebile ha e hloke phetoho ea tekanyetso.

Ho bakuli ba nang le cirrhosis ea joala bo tahang, TCmax e makhetlo a 16 ho feta e tloaelehileng. Ho ja hanyane ho fokotsa lebelo le nako ea ho amoheloa ha moriana (ka 25% le 9%, ka ho latellana), empa ho fokotseha hoa khatello ea LDL-C ho tšoana le ha atorvastatin e se na lijo.

Atorvastatin bioavailability e tlase (12%), systemic bioavailability ea mesebetsi ea inhibitory khahlano le HMG-CoA reductase ke 30%. Bioavailability e tlase e bakoa ke tšebeliso ea "metabolism" mucous membrane ea mucous ea "gastrointestinal" le "ntlha" ea mantlha ka har'a sebete.

Boholo bo boholo ba kabo ea atorvastatin ke lilithara tse 381. Ho feta 98% ea atorvastatin e tlama ho protheine ea plasma.

Atorvastatin ha e tšele mekoallo ea mali le bokong.

E tšelisoa haholo-holo ka har'a sebete ka tlasa ts'ebetso ea ZA4 isoenzyme ea cytochrome P450 ka sebopeho sa li-metabolites tse sebetsang tsa k'hemik'hale (ortho- le parahydroxylated metabolites, lihlahisoa tsa beta-oxidation), tse ikarabellang ho 70% ea ts'ebetso ea thibelo khahlano le HMG-CoA nako e fetang ea lihora tse 20-30.

Nako ea halofo ea bophelo (T1 / 2) ea atorvastatin ke lihora tse 14. E hloekisoa haholo ka bile (ha e phatlalatsoe ka ho pheta-pheta ha e felle nakong ea haemodialysis). Hoo e ka bang 46% ea atorvastatin e epolloa ka mala le ka tlase ho 2% ke liphio.

Matšoao a ho sebelisoa

Matšoao a sebelisang lithethefatsi Atoris 20 mg ke:

Hypercholesterolemia ea mantlha (heterozygous hypercholesterolemia ea mantlha le lelapa) (mofuta II ho latela Fredrickson),
Mefuta e kopaneng (e tsoakaneng) hyperlipidemia (IIa le IIb ho latela Fredrickson),
Dysbetalipoproteinemia (mofuta oa III ho ea ka Fredrickson) (e le tlatsetso ea lijo),
Famertal endo native hypertriglyceridemia (mofuta oa IV oa Fredrickson), e hanelang ho ja,
Homozygous Familyal hypercholesterolemia e nang le katleho e lekaneng ea kalafo ea ho ja le mekhoa e meng ea kalafo eo e seng ea pharmacological,

Thibelo ea Maloetse a amanang le pelo le pelo:

Thibelo ea mantlha ea mathata a pelo le methapo ho bakuli ba se nang matšoao a lefu la pelo, empa ka mabaka a 'maloa a tlisoang ke kholo ea bona: lilemo tse kaholimo ho lilemo tse 55, tšibollo ea khatello ea kelello, khatello ea maikutlo, lefu la tsoekere, maemo a tlase a HDL-C ho plasma ea mali, ho ba le liphatsa tsa lefutso. Khahlano le semelo sa dyslipidemia,
Thibelo ea bobeli ea mathata a pelo le bakuli ba nang le lefu la pelo (CHD) e le ho fokotsa palo ea batho ba shoang, lefu la myocardial, stroke, ho kenella sepetlele bakeng sa angina pectoris le tlhokeho ea ho nchafatsoa.

Contraindication

Contraindication mabapi le ts'ebeliso ea matlapa a Atoris:

hypersensitivity ho efe kapa efe ea likarolo tsa moriana,
lefu la sebete sethaleng se sebetsang (ho kenyeletsa le hepatitis e sa foleng e sa foleng, lefu le sa foleng la joala le sa foleng),
cirrhosis ea sebete sa etiology efe kapa efe,
ts'ebetso e eketsehileng ea "sebete" transaminase ea tlhaho e sa tsejoeng ka makhetlo a fetang a 3 ha e bapisoa le moeli o kaholimo oa se tloaelehileng,
lefu la masapo a mokopa
ho ima le ho nyekeloa,
lilemo ho isa ho lilemo tse 18 (ho se sebetse hantle le polokeho ea tšebeliso),
khaello ea lactase, ho se mamellane ha lactose, tsoekere ea malabsorption ea glucose-galactose.

Sebelisa nakong ea bokhachane le nakong ea matsoele

Atoris e kopantsoe le ho ima le nakong ea ho anyesa. Boithuto ba liphoofolo bo supa hore kotsi ho lesea le ka fetisoang e ka fetisa molemo ofe kapa ofe o ka bang teng ho mme.

Ho basali ba lilemo tsa ho ba le bana ba sa sebeliseng mekhoa e tšepahalang ea ho thibela pelehi, ha ho khothalletsoe tšebeliso ea Atoris. Ha u rera ho ima, u tlameha ho khaotsa ho sebelisa Atoris bonyane khoeli e le 'ngoe pele u ima ka mokhoa o reriloeng.

Ha ho na bopaki ba kabo ea atorvastatin ka lebese la matsoele. Leha ho le joalo, mefuteng e meng ea liphoofolo, ho kenella ha atorvastatin ka serum ea mali le lebese la liphoofolo tse anyesang ho joalo. Haeba ho hlokahala ho sebelisa Atoris ea lithethefatsi nakong ea ho nyekeloa, e le ho qoba kotsi ea ho ba le liketsahalo tse bohloko ho masea, ho anyesa ho lokela ho emisoa.

Tekanyetso le tsamaiso

Pele a qala ts'ebeliso ea Atoris, mokuli o lokela ho fetisetsoa lijong. ho fana ka phokotseho ea khoholeho ea lipids maling, e lokelang ho bonoa nakong ea kalafo kaofela le moriana. Pele o qala kalafo, o lokela ho leka ho fihlela taolo ea hypercholesterolemia ka ho ikoetlisa le ho theola boima ba 'mele ho bakuli ba nang le botenya, hammoho le kalafo ea lefu lena le tlase.

Setlhare se nooa ka molomo, ho sa tsotelehe lijo. Tekanyetso ea lithethefatsi e fapana ho tloha ho 10 mg ho isa ho 80 mg hang ka letsatsi 'me e khethoa ho nahanela khatello ea mantlha ea LDL-C, sepheo sa kalafo le phello ea kalafo e le' ngoe.

Atoris e ka nooa hanngoe ka nako efe kapa efe ea letsatsi, empa ka nako e tšoanang letsatsi le leng le le leng.

Phello ea kalafo e bonoa kamora libeke tse peli tsa kalafo, mme phello e kholo ea hlaha kamora libeke tse 'ne. Ka hona, litekanyetso ha lia lokela ho fetoloa pele ho libeke tse 'ne ka mor'a ho qala ha moriana ho lethal dose le fetileng.

Qalong ea kalafo le / kapa nakong ea keketseho ea lethal dose, ho hlokahala hore ho be leihlo le ho potoloha ha lipid ka plasma ea mali ka mor'a libeke tse ling le tse ling le tse ling tse 2 'me u lokise lethal dose ho latela.

Homozygous hereditary hypercholesterolemia

Lenane la litekanyo le tšoana le mefuta e meng ea hyperlipidemia.

Tekanyetso ea pele e khethoa ka bonngoe ho latela botebo ba lefu lena. Ho bakuli ba bangata ba nang le homozygous hereditary hypercholesterolemia, phello e nepahetseng e bonoa ka ts'ebeliso ea lithethefatsi ka tekanyetso ea letsatsi le letsatsi ea 80 mg (hang). Atoris® e sebelisoa e le pheko e kopanyang ho mekhoa e meng ea kalafo (plasmapheresis) kapa joalo ka kalafo ea mantlha haeba kalafo e nang le mekhoa e meng e sa khonehe.

Sebelisa ho batho ba baholo

Ho bakuli ba tsofetseng le bakuli ba nang le lefu la liphio, lethal dose la Atoris ha lea lokela ho fetoloa. Ts'ebetso ea renal e senyehileng ha e ame ho kenella ha atorvastatin ka plasma ea mali kapa tekanyo ea ho fokotseha ha mahloriso ea LDL-C ka tšebeliso ea atorvastatin, ka hona, ho fetola tekanyetso ea lithethefatsi ha ho hlokahale.

Ts'ebetso ea sebete e sa sebetseng

Bakeng sa bakuli ba nang le ts'ebetso ea sebete e sa sebetseng, ho hlokahala tlhokomeliso (ka lebaka la ho fokotsa lithethefatsi kapele). Boemong bo joalo, litekanyetso tsa bongaka le tsa laboratori li lokela ho behoa leihlo ka hloko (ho lekola kamehla ts'ebetso ea aspartate aminotransferase (ACT) le alanine aminotransferase (ALT). Ka keketseho e kholo mosebetsing oa hepatic transaminases, tekanyo ea Atoris e lokela ho fokotsoa kapa kalafo e lokela ho emisoa.

Litlamorao

Nakong ea ts'ebeliso ea matlapa a Atoris 20 mg, litla-morao li ka hlaha:

Ho tsoa tsamaisong ea methapo: khafetsa: hlooho ea hlooho, ho hloka boroko, ho tsekela, paresthesia, asthenic syndrome, hangata: peripheral neuropathy. amnesia, hypesthesia,
Ho tsoa lithong tsa maikutlo: khafetsa: tinnitus, ka seoelo: nasopharyngitis, nosebleeds,
Ho tsoa lithong tsa hemopoietic: khafetsa: thrombocytopenia,
Ho tsoa ts'ebetsong ea phefumoloho: khafetsa: bohloko ba sefuba,
Ho tsoa ts'ebetsong ea tšilo ea lijo: hangata: ho sokela, dyspepsia, ho nyekeloa le pelo, lets'ollo. flatulence (bloating), bohloko ba ka mpeng, bohloko bo sa tloaelehang: ho ipolaisa tlala, tatso e sa foleng, ho hlatsa, pancreatitis, ka seoelo: hepatitis, cholestatic jaundice,
Ho tsoa ts'ebetsong ea musculoskeletal: khafetsa: myalgia, arthralgia, bohloko ba morao. ho ruruha ho kopaneng, hangata: myopathy, mesifa crump, ka seoelo: myositis, rhabdomyolysis, tendopathy (maemong a mang e na le ropo ea tendon),
Ho tsoa ts'ebetsong ea genitourinary: khafetsa: ho fokotseha ha potency, ho se sebetse hantle ha rems,
Ka lehlakoreng la letlalo: lekhopho la letlalo, ho hlohlona, khafetsa: urticaria, hangata haholo: angioedema, alopecia, lefu la mothapo o mongata, erythema multiforme, Stevens-Johnson syndrome, lefu le bolaeang lera le nang le chefo.
Boitšoaro bo kulisang: khafetsa: lintho tse hohelang, ka seoelo: anaphylaxis,
Matšoao a laboratori: hangata: ts'ebetso e eketsehileng ea aminotransferases (ACT, ALT), ts'ebetso e eketsehileng ea serum creatine phosphokinase (CPK), ka seoelo: hyperglycemia, hypoglycemia,
Tse ling: khafetsa: edema ea peripheral, hangata: malaise, mokhathala, feberu, boima ba 'mele.
Kamano ea ho qhekella ea litlamorao tse ling tse sa rateheng ka tšebeliso ea lithethefatsi Atoris, tse nkoang e le "tse fumanehang haholo", ha e so thehiloe. Haeba ho na le litlamorao tse matla tse sa batleheng, ts'ebeliso ea Atoris e lokela ho emisoa.

Bongata

Litaba tsa ho fetoloa ha bongoana ha li hlalosoe.

Haeba ho na le overdose, ho hlokahala mehato e latelang ka kakaretso: ho lekola le ho boloka mesebetsi ea bohlokoa ea 'mele, le ho thibela ho ts'oaroa ha lithethefatsi ka mokhoa o mong (gastric lavage, ho nka mashala a ts'ebetso kapa a laxatives).

Ka nts'etsopele ea myopathy, e lateloang ke rhabdomyolysis le ho hloleha ha renal (sesosa se sengata empa se matla), moriana o tlameha ho hlakoloa hang-hang mme ts'oaetso ea diuretic le sodium bicarbonate e qale. Haeba ho hlokahala, hemodialysis e lokela ho etsoa. Rhabdomyolysis e ka lebisa ho hyperkalemia, e hlokang tsamaiso e kenang ea tharollo ea calcium chloride kapa tharollo ea calcium gluconate, infusion ea tharollo ea 5% ea dextrose (glucose) ka insulin, ts'ebeliso ea li-resin tsa potasiamo, kapa, maemong a tebileng, hemodialysis. Hemodialysis ha e na thuso.

Ha ho na litlhare tse tobileng.

Ho sebelisana le lithethefatsi

Ts'ebeliso e ts'oanang ea atorvastatin e nang le cyclosporine, lithibela-mafu (erythromycin ,cacithromycin, quinupristine / dalphopristine), li-virus tse thibelang kokoana-hloko ea HIV (indinavir, ritonavir), li-antifungal (fluconazole, itraconazole, ketoconazole) kapa ka mahlaseli a mokokotlo oa mokokotlo oa mokokotlo oa mokokotlo ka mokokotlo oa mokokotlo oa mokokotlo ka mokokotlo oa mokokotlo. kotsi ea ho ba le myopathy ka rhabdomyolysis le ho hloleha ha renal. Kahoo, ka ts'ebeliso e tšoanang ea erythromycin TCmax atorvastatin e eketseha ka 40%. Lithethefatsi tsena kaofela li thibela cytochrome CYP4503A4 isoenzyme, e amehang ho metabolism ea atorvastatin e leng sebete.

Tšebelisano e tšoanang e ka etsahala ka tšebeliso e le 'ngoe ea atorvastatin e nang le fiber le nicotinic acid ho litekanyetso tse theolang lipid (tse fetang 1 g ka letsatsi). Ts'ebeliso e ts'oanang ea atorvastatin ka tekanyo ea 40 mg e nang le diltiazem ka tekanyo ea 240 mg e lebisa hoketseho ea khatello ea atorvastatin ho plasma ea mali. Ts'ebeliso e tšoanang ea atorvastatin e nang le phenytoin, rifampicin, e leng li-inducers tsa cytochrome CYP4503A4 isoenzyme, e ka lebisa ho fokotseha ha katleho ea atorvastatin. Kaha atorvastatin e thehiloe ke eyetoyme ea CYP4503A4 cytochrome, tšebeliso ea nako e tšoanang ea atorvastatin e nang le li-inhibitors tsa cytochrome CYP4503A4 isoenzyme e ka lebisa ho eketseho ea plasma mahloriso a atorvastatin.

Li-inhibitors tsa liprotheine tsa OAT31B1 (mohlala, cyclosporine) li ka eketsa bioavailability ea atorvastatin.

Ka tšebeliso e le 'ngoe le li-antacids (ho emisoa ha magnesium hydroxide le aluminium hydroxide), mahloriso a atorvastatin ka plasma ea mali a fokotseha.

Ka tšebeliso e tšoanang ea atorvastatin e nang le colestipol, mahloriso a atorvastatin ho plasma ea mali a fokotsoe ka 25%, empa phello ea kalafo ea ho kopanya e phahame ho feta phello ea atorvastatin feela.

Ts'ebeliso e tšoanang ea atorvastatin e nang le lithethefatsi tse fokotsang khoholeho ea lihormone tsa endidie tsa steroid (ho kenyeletsa cimetidine, ketoconazole, spironolactone) e eketsa kotsi ea ho theola lihormone tsa endidia tsa steroid (tlhokomeliso e lokela ho sebelisoa).

Ka tšebeliso e tšoanang ea atorvastatin e nang le lithibela-pelehi tsa molomo (norethisterone le ethinyl estradiol), hoa khoneha ho eketsa ho amoheloa ha lithibela-pelehi le ho eketsa khatello ea bona plasma ea mali. Khetho ea lithibela-pelehi ho basali ba sebelisang atorvastatin e lokela ho beoa leihlo.

Ts'ebeliso e tšoanang ea atorvastatin e nang le warfarin matsatsing a pele e ka eketsa phello ea warfarin ho mali coagulation (ho fokotsa nako ea prothrombin).Tšusumetso ena e nyamela kamora matsatsi a 15 a ts'ebeliso ea lithethefatsi tsena ka nako e tšoanang.

Ka tšebeliso e le 'ngoe ea atorvastatin le terfenadine, liphetoho tse bohlokoa litabeng tsa pharmacokinetics tsa terfenadine ha lia ka tsa fumanoa.

Ha o sebelisa atorvastatin e nang le li-antihypertgency agents le li-estrogens e le karolo ea kalafo e nkang sebaka, ho ne ho se na matšoao a ts'ebelisano e sa hlokahaleng ea kliniki.

Ts'ebeliso ea lero la grapefruit nakong ea ts'ebeliso ea Atoris® e ka lebisa keketseho ea likhakanyo tsa plasma tsa atorvastatin. Ntlheng ena, bakuli ba noang moriana Atoris® ba lokela ho qoba ho noa lero la morara ho feta lilitara tse 1,2 ka letsatsi.

Litaelo tse khethehileng

Ha u ntse u nka Atoris, menyetla ea ho ba le myalgia ea eketseha. Bakuli ba lokela ho lula ba behiloe leihlo ke ngaka kamehla. Maemong moo ho nang le litletlebo tsa bofokoli le nts'etsopele ea bohloko ba mesifa, ts'ebeliso ea Atoris e emisoa hang-hang.

Sebopeho sa moriana o kenyelletsa lactose, sena se lokela ho tsotelloa ho bakuli ba nang le lactose ts'oarello le khaello ea lactase.

Moriana oa Atoris o lokela ho sebelisoa ka hloko e kholo ho bakuli ba nang le joala le haeba ho na le nalane ea ts'ebetso e tloaelehileng ea sebete.

Ketsahalong eo lipontšo tsa myopathy li bonoang, ts'ebeliso ea Atoris e tlameha ho emisoa.

Atoris e ka kenya letsoho kholisong ea ho tsekela, ka hona, nako ea kalafo e lokela ho hana ho khanna likoloi le liketso tse hlokang tlhokomelo e matla.

Lipehelo tsa Maemo a Phomolo ea meriana

Atoris analogues ke lithethefatsi tse latelang: Liprimar, Atorvastatin-Teva, Torvakard, Liptonorm. Haeba ho hlokahala hore u khethoe sebaka se seng, ho khothalletsoa hore u buisane le ngaka ea hau pele.

Litšenyehelo tsa matlapa a Atoris 20 mg libakeng tsa litlama meriana ho la Moscow ke:

Matlapa a 20 mg, li-pcs tse 30. - 500-550 rub.
Matlapa a 20 mg, 90 likhomphutha. - 1100-1170 rub.

Melemo ea pharmacological

Mofumahali
Atorvastatin ke moemeli oa hypolipidemic ea tsoang sehlopheng sa li-statins. Mochine o ka sehloohong oa ts'ebetso ea atorvastatin ke ho thibela ts'ebetso ea 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, enzyme e thusang ho fetoloa ha HMG-CoA ho mevalonic acid. Phetoho ena ke e meng ea mehato ea pele ho ketane ea kholeseterole ea 'mele. Ho hatelloa ha atorvastatin cholesterol synthesis ho lebisa ho ho eketseha hape ha density lipoprotein receptors (LDL) ka har'a sebete, hammoho le liseleng tse eketsehileng. Li-receptor tsena li tlama ho likaroloana tsa LDL le ho li tlosa plasma ea mali, e lebisang ho fokotseheng ha plasma cholesterol (Ch) LDL (Ch-LDL) plasma ea mali.
Matla a antisulinotic a atorvastatin ke litholoana tsa phello ea eona marakong a methapo ea mali le likarolo tsa mali. Atorvastatin e thibela motsoako oa li-isoprepoids, e leng lintlha tsa kholo bakeng sa lisele tsa methapo e ka hare ea methapo ea mali. Tlas'a tšusumetso ea atorvastatin, ho atoloha ho itšetlehileng ka methapo ea mali hoa ntlafala, khatello ea LDL-C, apolipyrotein B (apo-B) ea fokotseha. triglycerides (TG). ho na le keketseho ea khoholeho ea cholesterol ea density lipoprotein e phahameng (HDL-C) le apolipoprotein A (apo-A).
Atorvastatin e fokotsa ponahalo ea plasma ea mali le ts'ebetso ea lintlha tse ling tsa ho tsikinyeha le ho kopana ha liplatelete. Ka lebaka lena, e ntlafatsa hemodynamics mme o etsa maemo a sistimi ea makhopho. HMG-CoA reductase inhibitors e boetse e ama metabolism ea li-macrophages, e thibela ts'ebetso ea eona mme e thibele ho phatloha ha li-plaque atherosranceotic.
E le molao, phello ea kalafo ea atorvastatin e bonoa kamora libeke tse peli tsa kalafo, mme phello e kholo e ba teng kamora libeke tse 4.
Atorvastatin ka tekanyo ea 80 mg e fokotsa haholo menyetla ea ho ba le mathata a ischemic (ho kenyeletsa le lefu le tsoang myocardial infarction) ka 16%, kotsi ea ho kenngoa sepetlele hape bakeng sa angina pectoris e tsamaeang le matšoao a ischemia ea myocardial ke 26%.
Mofumahali
Ho amoheloa ha Atorvastatin ho phahame, hoo e ka bang 80% e nkuoa ho tsoa mokokotlong oa mpa. Tekanyo ea ho amoheloa le ho teba ha plasma ea mali e eketseha ka tekanyo ea sefate sa morara. Nako ea ho fihlela khatello e phahameng (TCmax), ka karolelano, lihora tse 1-2. Ho basali, TCmax e phahame ho feta 20%, mme sebaka se katlasehong ea nako ea mahloriso (AUC) se tlase ka 10%. Phapang e teng ho li-pharmacokyetics ho bakuli ka lilemo le bong ha e na thuso ebile ha e hloke ho lokisoa ha sefate sa morara.
Ho bakuli ba nang le cirrhosis ea joala bo tahang, TCmax e makhetlo a 16 ho feta e tloaelehileng. Ho ja hanyane ho fokotsa lebelo le nako ea ho amoheloa ha moriana (ka 25% le 9%, ka ho latellana), empa ho fokotseha hoa khatello ea LDL-C ho tšoana le ha atorvastatin e se na lijo. Atorvastatin bioavailability e tlase (12%), systemic bioavailability ea mesebetsi ea inhibitory khahlano le HMG-CoA reductase ke 30%. Bioavailability e tlase e bakoa ke kemiso ea "mesy" ea "mucous membrane" ea "mucous" ea "gastrointestinal" le "ntlha" ea mantlha ka har'a sebete. Boholo bo boholo ba kabo ea atorvastatin ke lilithara tse 381. Ho feta 98% ea atorvastatin e tlama ho protheine ea plasma. Atorvastatin ha e tšele mekoallo ea mali le bokong. E tšelisoa haholo-holo ka har'a sebete ka tlasa ts'ebetso ea CYP3A4 isoenzyme ka ho thehoa ha methapo ea methapo ea methapo (ortho- le parahydroxylated metabolites, lihlahisoa tsa beta-oxidation), tse ikarabellang ho 70% ea ts'ebetso ea inhibitory khahlano le HMG-CoA-reductase bakeng sa lihora tse 20-30.
Half-life (T1 / 2) ea atorvastatin ke lihora tse 14. E tšeloa ka bongata haholo ka bile (ha e phatlalatsoe ka ho pheta-pheta, ha e qhaloe nakong ea haemodialysis). Hoo e ka bang 46% ea atorvastatin e epolloa ka mala le ka tlase ho 2% ke liphio.
Lihlopheng tse khethehileng tsa bakuli
Bana
Ho na le data e lekanyelitsoeng thutong e bulehileng ea libeke tse 8 ho bana (ba lilemo li 6 ho isa ho tse 6) le heterozygous Famal hypercholesterolemia le khatello ea mantlha ea LDL cholesterol ≥4 mmol / l, e tšoaroang ka atorvastatin ka mokhoa oa matlapa a hlahang a 5 mg kapa 10 mg kapa matlapa filimi e koahetsoeng ka tekanyetso ea 10 mg kapa 20 mg 1 nako ka letsatsi, ka ho latellana. Covariate ea bohlokoa feela mohlaleng oa pharmacokinetic oa baahi ba amohelang atorvastatin e ne e le boima ba 'mele. Tlhahiso e hlakileng ea atorvastatin ho bana e ne e sa fapana le ho bakuli ba baholo ba nang le tekanyo ea allometric ka boima ba 'mele. Boemong ba liketso tsa atorvastatin le o-hydroxyatorvastatin, ho ile ha bonoa ho fokotseha ho sa feleng ha LDL-C le LDL.
Bakuli ba baholo
Phekolo e phahameng ka ho fetisisa (Cmax) ho plasma le AUC ea lithethefatsi ho bakuli ba tsofetseng (ba fetang 65) ke 40% le 30%, ka ho fapana, e phahame ho feta ho bakuli ba baholo ba lilemo tse tlase. Ho ne ho se na phapang ea matla a ts'ebetso le polokeho ea moriana, kapa ho fihlella lipheo tsa kalafo e fokotsang lipid ho bakuli ba tsofetseng ha ho bapisoa le bongata ka kakaretso.
Ts'ebetso ea mokokotlo e sa sebetseng
Ts'ebetso e sa sebetseng ea renal ha e ame ho kenella ha atorvastatin plasma ea mali kapa phello ea eona metabolism ea lipid, ka hona, phetoho ea tekanyetso ho bakuli ba nang le ts'ebetso ea renal e sa sebetseng ha e hlokahale.
Ts'ebetso ea sebete e sa sebetseng
Keketseho ea lithethefatsi e eketseha haholo (Cmax - makhetlo a ka bang 16, AUC - makhetlo a ka bang 11) ho bakuli ba nang le cirrhosis ea joala (sehlopha sa B ho latela sehlopha sa bana-Pugh).

Sebelisa nakong ea bokhachane le nakong ea ho anyesa

Lithethefatsi Atoris ® e tšoaetsanoa nakong ea kemolo le nakong ea ho anyesa.
Boithuto ba liphoofolo bo supa hore kotsi ho lesea le ka fetisoang e ka fetisa molemo ofe kapa ofe o ka bang teng ho mme.
Ho basali ba lilemo tsa ho ba le bana ba sa sebeliseng mekhoa e tšepahalang ea ho thibela pelehi, ha ho khothalletsoe tšebeliso ea Atoris ®. Ha u rera ho ima, u tlameha ho khaotsa ho sebelisa Atoris ®, bonyane, khoeli e le 'ngoe pele ho kemaro le reriloeng.
Ha ho na tlhahisoleseling mabapi le kabo ea atorvastatia ka lebese la matsoele. Leha ho le joalo, mefuteng e meng ea liphoofolo nakong ea lebese, khatello ea li-atorvastatia ka serum ea mali le lebese le eona e joalo. Haeba o hloka ho sebelisa lithethefatsi Atoris ® nakong ea ho anyesa, e le ho qoba kotsi ea liketsahalo tse bohloko ho masea, ho anyesa ho lokela ho emisoa.

Tekanyetso le tsamaiso

Pele a qala ts'ebeliso ea lithethefatsi Atoris ®, mokuli o lokela ho fetisetsoa lijong tse netefatsang ho fokotseha ha bongata ba lipids ka plasma ea mali, e lokelang ho shejoa nakong eohle ea kalafo le moriana. Pele o qala kalafo, o lokela ho leka ho fihlela taolo ea hypercholesterolemia ka ho ikoetlisa le ho theola boima ba 'mele ho bakuli ba nang le botenya, hammoho le kalafo ea lefu lena le tlase.
Setlhare se nooa ka molomo, ho sa tsotelehe nako ea lijo. Tekanyo ea lithethefatsi e fapana ho tloha ho 10 mg ho isa ho 80 mg ke le 'ngoe ka letsatsi' me e khethoa ho nahanela khatello ea mantlha ea LDL-C ho plasma, sepheo sa kalafo le phello ea motho ka mong.
Atoris ® e ka nkuoa hanngoe ka nako efe kapa efe ea letsatsi, empa ka nako e tšoanang letsatsi le leng le le leng. Phello ea kalafo e bonoa kamora libeke tse peli tsa kalafo, mme phello e kholo ea hlaha kamora libeke tse 4.
Qalong ea kalafo le / kapa nakong ea keketseho ea lethal dose, ho hlokahala hore ho be leihlo le ho potoloha ha lipid ka plasma ea mali ka mor'a libeke tse ling le tse ling le tse ling tse 2 'me u lokise lethal dose ho latela.
Hypercholesterolemia ea mantlha le hyperlipidemia e kopaneng
Bakeng sa bakuli ba bangata, tekanyetso e khothalletsoang ea Atoris ® ke 10 mg hang ka letsatsi, phello ea kalafo e iponahatsa ka nako ea libeke tse 2 mme hangata e fihla holimo kamora 4 pedals. Ka kalafo ea nako e telele, phello e phehella.
Homozygous Familia hypercholesterolemia
Maemong a mangata, empa 80 mg e beoa hang ka letsatsi (ho fokotseha hoa khatello ea LDL-C ho plasma ka 18-45%).
Heterozygous Familia hypercholesterolemia
Motsoako oa pele ke 10 mg ka letsatsi. Tekanyetso e lokela ho khethoa ka bonngoe le ho lekola bohlokoa ba lethal dose ka mor'a libeke tse 'ne le keketseho e ka bang 40 mg ka letsatsi. Joale, ekaba lethalinyana le ka eketsoa ho fihla ho 80 mg ka letsatsi, kapa ho ka khoneha ho kopanya li-acids tsa morao-rao ka tšebeliso ea atorvastatin ka tekanyo ea 40 mg ka letsatsi.
Thibelo ea Maloetse a amanang le pelo le pelo
Thutong ea thibelo ea mantlha, lethal dose ea atorvastatin e ne e le 10 mg ka letsatsi.
Keketseho ea tekanyetso e ka hlokahala bakeng sa ho fihlela boleng ba LDL-C bo lumellanang le tataiso ea hona joale.
Sebelisa ho bana ho tloha ho lilemo tse 10 ho isa ho 18 le heterozygous Familia hypercholesterolemia
Morara oa pele o khothalelitsoeng ke 10 mg hang ka letsatsi. Tekanyetso e ka eketsoa ho 20 mg ka letsatsi, ho latela phello ea kliniki. Phihlelo ea lethal dose e fetang 20 mg (e lekanang le tekanyetso ea 0.5 mg / kg) e lekanyelitsoe.
Tekanyetso ea moriana e lokela ho khethoa ho latela sepheo sa kalafo e fokotsang lipid. Phetoho ea litekanyetso li lokela ho etsoa nako le nako ka nako ea 1 ka libeke tse 4 kapa ho feta.
Ho hloleha ha sebete
Haeba ts'ebetso ea sebete e sa lekana, tekanyo ea Atoris ® e lokela ho fokotsoa, ka ho lekola khafetsa ts'ebetso ea li-transaminase tsa "sebete": aspartate aminotransferase (ACT) le alanine aminotransferase (ALT) plasma ea mali.
Ho hloleha hape
Ts'ebetso ea renal e sa sebetseng ha e ame ho kenella ha atorvastatin kapa tekanyo ea ho fokotseha ha mahloriso a LDL-C ka plasma, ka hona, tokiso ea litheko ea lithethefatsi ha e hlokehe (bona karolo "Pharmacokinetics").
Bakuli ba baholo
Ho ne ho se na phapang ho phekolo e sebetsang le polokeho ea atorvastatin ho bakuli ba tsofetseng ha ho bapisoa le bongata ka kakaretso, ho fetoloa ha litekanyetso ha ho hlokahale (bona karolo ea Pharmacokinetics).
Sebelisa hammoho le meriana e meng
Haeba ho hlokahala ho e sebelisa ka nako e le ngoe le cyclosporine, telaprevir, kapa motsoako oa tipranavir / ritonavir, lethal dose la Atoris ® ha lea lokela ho feta 10 mg / ka letsatsi (bona karolo "Litaelo tse Khethehileng").
Ho lokela hore ho sebelisoe tlhokomeliso 'me ho sebelisoe lethalose le sebetsang ka ho fetisisa la atorvastatin ha le ntse le sebelisoa le li-inhibitors tsa HIV, viral hepatitis C proteinase inhibitors (boceprevir), clarithromycin le itraconazole.
Litlhahiso tsa Mokhatlo oa Russian Cardiological Society, Mokhatlo oa Sechaba bakeng sa Thupelo ea Atherosclerosis (NLA) le Mokhatlo oa Russia oa Cardiosomatic Regencyation and Secondary Prevention (RosOKR) (V rev 2012)
Litekanyetso tse nepahetseng tsa LDL-C le cholesterol e felletseng bakeng sa bakuli ba kotsing e kholo ke: ≤2.5 mmol / L (kapa ≤100 mg / dL) le ≤4.5 mmol / L (kapa ≤ 175 mg / dL), ka ho latellana. le bakeng sa bakuli ba nang le kotsi e kholo haholo: 81.8 mmol / l (kapa ≤70 mg / dl) le / kapa, haeba e sa khonehe, ho khothalletsoa ho fokotsa khatello ea LDL-C ka 50% ho tloha boleng ba pele le ≤4 mmol / l (kapa ≤150 mg / dl), ka ho latellana.

Litla-morao

Ho hlophisoa ha liketsahalo tsa litlamorao tsa Mokhatlo oa Lefatše oa Bophelo (WHO):

khafetsa

≥1/10

khafetsa

≥1 / 100 ho isa 1/1000 ho Mafu a tšoaetsanoang le likokoana-hloko:
khafetsa: nasopharyngitis.
Lits'oaetso tse tsoang methapong ea mali le ea li-lymphatic:
ka seoelo: thrombocytopenia.
Mathata a tsamaiso ea 'mele ea ho itšireletsa mafung:
hangata:
ka seoelo: anaphylaxis.
Mathata a amanang le metabolism le phepo e nepahetseng:
khafetsa: boima ba 'mele, ho ipolaisa tlala,
ka seoelo: hyperglycemia, hypoglycemia
Mathata a kelello:
khafetsa: likhathatso tsa boroko, ho kenyelletsa ho hloka boroko le litoro tsa "bosiu"
khafetsa ha e tsejoe: khatello ea maikutlo.
Mathata a tsoang tsamaisong ea methapo:
khafetsa: hlooho ea hlooho, ho tsekela, paresthesia, asthenic syndrome,
khafetsa: peripheral neuropathy, hypesthesia, tatso e sa khaotseng, tahlehelo kapa ho lahleheloa ke mohopolo.
Mathata a utloang le mathata a labyrinth:
khafetsa: tinnitus.
Mathata a tsoang tsamaisong ea matšoafo: sefuba le litho tsa kahare:
khafetsa: 'metso o bohloko, nosebleeds,
khafetsa ha e tsejoe: linyeoe tse ka thoko tsa lefu la masapo la setho sa boteng (hangata li sebelisoa ka nako e telele).
Mathata a amanang le ho ja:
khafetsa: ho sokela, ho hlohlona, ho nyekeloa, lets'ollo, ho phatloha (bloating), bohloko ba ka mpeng,
khafetsa: ho hlatsa, pancreatitis.
Tlokotsi ea sebete le pampitšana ea ho phelisa:
ka seoelo: hepatitis, cholestatic jaundice.
Mathata a tsoang letlalong le linthong tse ka tlasana:
khafetsa: lekhopho la letlalo, ho hlohlona,
khafetsa: urticaria
ka seoelo: angioedema, alopecia, rashful, erythema multiforme, Stevens-Johnson syndrome, chefo e matla ea li-epidermal necrolysis.
Tlolo ea thipa ea musculoskeletal le connective:
khafetsa: myalgia, arthralgia, bohloko ba morao, ho ruruha ha manonyeletso,
hangata: myopathy, mesifa cramps,
ka seoelo: myositis, rhabdomyolysis, genopathy (maemong a mang ka ho phatloha ha tendon),
maqhubu a sa tsejoeng: linyeoe tsa necrotizing myopathy.
Ho tlosoa ha liphio le pampitšana ea ho ntša metsi:
khafetsa: ho se sebetse hantle ha likotsi.
Tlokotsi ea litho tsa botona le botšehali
khafetsa: ho hloka thobalano,
ka seoelo: gynecomastia.
Mathata le mathata a teng ka kakaretso setsing sa ente:
khafetsa: edema ea haufi,
khafetsa: bohloko ba sefuba, malaise, mokhathala, feberu.
Lintlha le tsebiso ea laboratori:
khafetsa: ts'ebetso e eketsehileng ea aminotransferase (ACT, ALT), ts'ebetso e eketsehileng ea serum creatine phosphokinase (CPK) ka plasma ea mali,
ka seoelo: ho eketseha ha khatello ea "glycosylated hemoglobin" (HbAl).
Kamano ea causal ea litlamorao tse ling tse sa rateheng ka tšebeliso ea lithethefatsi Atoris ®, tse nkoang e le "tse fumanehang haholo", ha e e-so theoe. Haeba ho na le litlamorao tse matla tse sa batleheng, ts'ebeliso ea Atoris ® e lokela ho khaotsa.

Fomu ea tokollo

Matlapa a koahetsoeng ka filimi, 10 mg le 20 mg.
Ho na le matlapa a 10 ka blister (blister strip package) ho tsoa ho kopaneng ea lisebelisoa tsa polyamide / aluminium foil / PVC - foil ea aluminium (Coldforming OPA / A1 / PVC-AI).
1, 3, 6 kapa 9 malepa (maleiri) hammoho le litaelo tsa tšebeliso li tla beoa ka lebokoseng la karete.

Ho sebelisana le lithethefatsi

Kotsi ea ho ba le myopathy e eketseha nakong ea kalafo ka li-inhibitors tsa HMG-CoA reductase le tšebeliso e ts'oanang ea cyclosporin, li-derivatives tsa fibroic acid, boceprevir, nicotinic acid le cytochrome P450 3A4 inhibitors (erythromycin, li-antifungal agents tse amanang le azoles). Ho bakuli ka nako e tšoanang ba nka atorvastatin le boceprevir, ho khothalletsoa ho sebelisa Atoris® ka tekanyo e tlase ea pele mme o etsa tlhahlobo ea bongaka. Nakong ea tšebeliso e kopaneng le boceprevir, lethal dose la letsatsi le letsatsi la atorvastatin ha lea lokela ho feta 20 mg.

Litlaleho tse sa tloaelehang haholo tsa immuno-Mediated necrotizing myopathy (OSI) li tlalehiloe nakong ea kalafo le ka mor'a eona le li-statins, ho kenyeletsoa le atorvastatin. OSI e tsebahala ka ho fokola ha mesifa ea mesifa le boemo bo phahameng ba serum creatine kinase, bo ntseng bo tsoela pele ho sa tsotelloe kalafo ea statin.

P450 3A4 Inhibitors: atorvastatin e hlahisitsoe ka cytochrome P450 3A4. Ho sebelisoa ka nako e le 'ngoe ha Atoris le cytochrome P450 3A4 inhibitors ho ka lebisa ho eketseha ha khatello ea atorvastatin ho plasma ea mali. Bophahamo ba tšebelisano le matla a phello e ipapisitse le phapang ea ketso ho cytochrome P450 3A4.

Tšebeliso e le 'ngoe li-inhibitors tse matlaP450 3A4(mohlala, cyclosporine, telithromycin ,cacithromycin, delavirdine, styripentol, ketoconazole, voriconazole, itraconazole, posaconazole le li-inhibitors tsa HIV.ho kenyelletsa ritonavir, lopinavir, atazanavir, indinavir, darunavir, jj..) e lokela ho qojoa ka hohle kamoo ho ka khonehang. Maemong moo tšebeliso ea lithethefatsi tsena ka nako e tšoanang li ke keng tsa qojoa, ho khothalletsoa ho fana ka tekanyetso e tlase le e phahameng ea atorvastatin, hammoho le ho etsa tlhahlobo e nepahetseng ea boemo ba mokuli.

Lithibelo tse itekanetsengP450 3A4 (mohlala. erythromycin, diltiazem, verapamil le fluconazole) e ka eketsa likhahla tsa plasma tsa atorvastatin. Ha o sebelisa erythromycin hammoho le li-statins, ho na le kotsi e eketsehileng ea myopathy. Lithuto tsa tšebelisano tse hlahlobang litlamorao tsa amiodarone kapa verapamil ho atorvastatin ha li e-so tšoaroe. Ka bobeli amiodarone le verapamil li thibela ts'ebetso ea P450 3A4, 'me ts'ebeliso ea bona e kopaneng le atorvastatin e ka lebisa ho pepeseha ha atorvastatin. Kahoo, ka tšebeliso e tšoanang ka li-inhibitors tsa P450 3A4 tse leka-lekaneng, ho khothalletsoa ho fana ka tekanyetso e tlase ea atorvastatin le ho etsa tlhahlobo e nepahetseng ea kliniki ho mokuli. Tlhokomelo e loketseng ea kliniki e khothalletsoa kamora ho qalisoa ha kalafo kapa ka mor'a tokiso ea litekanyetso ea inhibitor.

Li-inhibitors tsa Transporter: atorvastatin le metabolites ea eona ke likarolo tse ling tsa transporter ea OATP1B1. Li-inhibitors tsa OATP1B1 (mohlala, cyclosporine) li ka eketsa bioavailability ea atorvastatin. Ts'ebeliso e ts'oanang ea 10 mg ea atorvastatin le cyclosporine (5.2 mg / kg / letsatsi) e lebisa keketseho ea tlhahiso ea atorvastatin ka makhetlo a 7.7.

Ka tšebeliso e tšoanang ea atorvastatin le inhibitors ea CYP3A4 isoenzyme kapa liprotheine tse tsamaisang, ho eketseha ha khatello ea atorvastatin ho plasma ea mali le kotsi e eketsehileng ea myopathy ho khonahala. Kotsi e kanna ea eketseha ka tšebeliso e tšoanang ea atorvastatin e nang le lithethefatsi tse ling tse ka bakang myopathy, tse kang li-derivatives tsa fibroic acid le ezetimibe.

Erythromycin / clarithromycin: ka ts'ebeliso e le 'ngoe ea atorvastatin le erythromycin (500 mg makhetlo a mane ka letsatsi) kapa clarithromycin (500 mg habeli ka letsatsi), e thibelang cytochrome P450 3A4, keketseho ea khatello ea atorvastatin maling a mali.

Protease Inhibitors: Ts'ebeliso e kopanetsoeng ea atorvastatin e nang le li-inhibitors tsa cytochrome P450 3A4 e ne e tsamaisana le keketseho ea plasma ea atorvastatin.

Diltiazem hydrochloride: tšebeliso ea nako e le 'ngoe ea atorvastatin (40 mg) le diltiazem (240 mg) e lebisa keketseho ea khatello ea atorvastatin plasma ea mali.

Cimetidine: thuto e ile ea etsoa mabapi le tšebelisano ea atorvastatin le cimetidine, ha ho litšebelisano tsa bohlokoa tsa kliniki tse fumanoeng.

Itraconazole: ts'ebeliso e le 'ngoe ea atorvastatin (20 mg-40 mg) le itraconazole (200 mg) e lebisa hoketsong ea AUC ea atorvastatin.

Lero la Morara: e na le karolo e le 'ngoe kapa tse peli tse thibelang CYP 3A4 mme e ka eketsa bongata ba atorvastatin ho plasma ea mali, haholo-holo ka tšebeliso e feteletseng ea lero la morara (ho feta lilithara tse 1,2 ka letsatsi).

Inductors ea cytochrome P450 3A4: tšebeliso ea nako e tšoanang ea atorvastatin e nang le li-inducers tsa cytochrome P450 3A4 (efavirenz, rifampin le litokisetso tsa wort tsa St. John) li ka lebisa ho fokotseha hoa khatello ea atorvastatin ho plasma ea mali. Ha ho fanoa ka mokhoa o kopanetsoeng oa ts'ebetso ea rifampin (ho kenella ha cytochrome P450 3A4 le thibelo ea enthanme ea phetisetso ea OATP1B1 sebeteng), ho kgothaletsoa ho fana ka Atoris® ka nako e le ngoe le rifampin, kaha ho nka Atoris ka mor'a ho nka rifampin ho lebisa ho fokotseha ho hoholo hoa boemo ba atorvastatin maling.

Li-antacid: ho kenella ka nako e le 'ngoe ho emisoeng ho nang le magnesium le aluminium hydroxides ho fokotsitse khatello ea atorvastatin ka plasma ea mali ka 35%, leha ho le joalo, tekanyo ea ho fokotseha ha litaba tsa LDL-C e lula e sa fetohe.

Antipyrine: atorvastatin ha e ame li-pharmacokinetics tsa antipyrine, ka hona, ho sebelisana le lithethefatsi tse ling tse lokiselitsoeng ke cytochrome isoenzymes e sa lebelloang.

Gemfibrozil / fibroic acid e tsoang ho: monotherapy ka li-fibrate maemong a mang e tsamaisana le litlamorao tse sa rateheng tse tsoang mesifa, ho kenyelletsa le rhabdomyolysis. Kotsi ea liketsahalo tsena e ka eketseha ka tsamaiso e ts'oanang ea lits'oaetso tsa fibroic acid le atorvastatin. Haeba tšebeliso ea nako e tšoanang e ke ke ea qojoa, ho fihlela sepheo sa kalafo, litekanyetso tse tlase tsa atorvastatin li lokela ho sebelisoa mme bakuli ba lokela ho betoa leihlo ka nepo.

Ezetimibe: Ezetimibe monotherapy e tsamaisana le litlamorao tse bohloko tse tsoang mesifa, ho kenyelletsa le rhabdomyolysis. Ka lebaka leo, menyetla ea liketsahalo tsena e ka eketseha ka tsamaiso e ts'oanang ea ezetimibe le atorvastatin. Ho hlahlojoa ka nepo ho khothalletsoa ho bakuli bana.

Colestipol: ka tšebeliso e tšoanang ea colestipol, khatello ea atorvastatin e plasma ea mali e fokotsehile ka 25%, leha ho le joalo, phello e fokotsang lipid ea ho kopanya ha atorvastatin le colestipol e ne e feta ea lithethefatsi ka bomong.

Digoxin: Tsamaiso ea khafetsa ea digoxin le atorvastatin ka tekanyo ea 10 mg, mokokotlo oa tekano ea digoxin ka plasma ea mali ha oa ka oa fetoha. Leha ho le joalo, ha digoxin e ne e sebelisoa hammoho le atorvastatin ka tekanyo ea 80 mg / ka letsatsi, khatello ea "digoxin" e eketsehile ka hoo e ka bang 20%. Bakuli ba fumanang digoxin hammoho le atorvastatin ba hloka ho hlahlojoa ka nepo.

Azithromycin: ka tšebeliso e tšoanang ea atorvastatin (10 mg hang ka letsatsi) le azithromycin (500 mg hang ka letsatsi), khatello ea atorvastatin ho plasma ha e ea fetoha.

Lithibela-mafu tsa molomo: ka ts'ebeliso e ts'oanang ea atorvastatin le lithibela-pelehi tsa molomo tse nang le norethindrone le ethinyl estradiol, ho bile le keketseho e kholo ho AUC ea norethindrone le ethinyl estradiol ka 30% le 20%, ka ho latellana. Tšusumetso ena e lokela ho nahanoa ha u khetha lithibela-pelehi tsa molomo bakeng sa mosali ea noang atorvastatin.

Warfarin: Phuputsong ea bongaka ho bakuli ba fumanang kalafo ea nako e telele ea warfarin, tšebeliso e kopaneng ea atorvastatin ka tekanyo ea 80 mg ka letsatsi le warfarin e bakile ho fokotseha hanyane hoa nako ea prothrombin ka metsotsoana e 1.7 nakong ea matsatsi a 4 a kalafo, e ileng ea khutlela ho tloaelehileng matsatsing a 15 a kalafo atorvastatin. Le ha ho tlalehiloe maemo a sa tloaelehang haholo a ts'ebelisano ea bohlokoahali le li-anticoagulants, ho bakuli ba nkang li-anticoagulants, nako ea prothrombin e lokela ho khethoa pele e qala kalafo ka atorvastatin mme hangata e lekana mehatong ea pele ea kalafo ho etsa bonnete ba hore ha ho na liphetoho tse kholo tsa nako ea prothrombin. Hang ha nako e tsitsitseng ea prothrombin e se e tlalehiloe, e ka hlahlojoa hangata hangata e khothalletsoang bakuli ba fumanang li-anticoagulants tsa coumarin. Ts'ebetso e ts'oanang e lokela ho phetoa ha u fetola tekanyetso ea atorvastatin kapa ho hlakoloa ha eona. Phekolo ea Atorvastatin e ne e sa tsamaee le maemo a ho tsoa mali kapa liphetoho tsa nako ea prothrombin ho bakuli ba seng

Warfarin: Ha ho ts'ebelisano e kholo ea ts'ebelisano ea atorvastatin le warfarin e fumanoeng.

Amlodipine: ka tšebeliso e tšoanang ea atorvastatin 80 mg le amlodipine 10 mg, pharmacokinetics ea atorvastatin e maemong a lekanang ha ea ka ea fetoha.

Colchicine: Leha lithuto tsa ts'ebelisano ea atorvastatin le colchicine li sa etsoa, linyeoe tsa myopathy li tlalehiloe ka tšebeliso e kopaneng ea atorvastatin le colchicine.

Fusidic asiti: lithuto mabapi le tšebelisano ea atorvastatin le fusidic acid ha lia ka tsa etsoa, leha ho le joalo, linyeoe tsa rhabdomyolysis ka ts'ebeliso ea bona e ts'oanang li tlalehiloe lithutong tsa morao-rao tsa ho bapatsa. Ka hona, bakuli ba lokela ho hlahlojoa mme ha ho hlokahala, kalafo ea Atoris e ka emisoa ka nakoana.

Pheko e 'ngoe e kopaneng: lithutong tsa kliniki, atorvastatin e sebelisitsoe hammoho le lithethefatsi tsa antihypertgency le estrogens, tse neng li fanoe ka morero oa ho nka sebaka, ho ne ho se na matšoao a ts'ebelisano ea bohlokoa ka kliniki e sa hlokahaleng.

Ketso ho sebete

Kamora kalafo le atorvastatin, keketseho e kholo (e fetang makhetlo a 3 ha e bapisoa le moeli o kaholimo o tloaelehileng) keketseho ea serum ea "transaminase" ea "sebete" e hlokometsoe.

Keketseho ea tšebetso ea li-transaminase tsa hepatic hangata e ne e sa tsamaee le jaundice kapa lipontšo tse ling tsa kliniki. Ka ho fokotseha ha tekanyetso ea atorvastatin, ho khaotsa ka nakoana ea lithethefatsi, ts'ebetso ea li-transaminase tsa hepatic e khutletse boemong ba eona ba pele. Boholo ba bakuli ba ile ba tsoela pele ho nka atorvastatin ka tekanyo e fokotsoang ntle le litlamorao.

Hoa hlokahala ho lekola matšoao a ts'ebetso ea sebete nakong eohle ea kalafo, haholo ha ho bonahala matšoao a kalafo ea tšenyo ea sebete. Tabeng ea keketseho ea litaba tsa transpase tsa hepatic, tšebetso ea bona e lokela ho beoa leihlo ho fihlela meeli ea se tloaelehileng e fihlelle. Haeba keketseho ea ts'ebetso ea AST kapa ALT ka makhetlo a fetang a 3 ha e bapisoa le moeli o kaholimo oa tloaelo e bolokiloe, ho khothalletsoa hore tekanyo e fokotsoe kapa e hlakoloe.

Ketso ea mesifa ea masapo

Ha ho fana ka atorvastatin ho litekanyetso tsa hypolipidemic hammoho le lintlha tse tsoang ho li-fibroic acid, erythromycin, immunosuppressants, lithethefatsi tsa azole antifungal kapa acid ea nicotinic, ngaka e lokela ho lekanya melemo le likotsi tsa kalafo tse lebelletsoeng le ho hlahloba bakuli khafetsa ho tseba bohloko kapa bofokoli mesifa, haholoholo likhoeling tsa pele. kalafo le nakong ea litekanyetso tse ntseng li eketseha tsa moriana o mong le o mong. Maemong a joalo, boikemisetso ba nako le nako ba ts'ebetso ea CPK bo ka khothaletsoa, leha ho ba leihlo joalo ho sa thibele nts'etsopele ea myopathy e matla. Atorvastatin e ka baka keketseho ea ts'ebetso ea creatine phosphokinase.

Ha u sebelisa atorvastatin, ho hlalositsoe liketsahalo tse sa tloaelehang tsa rhabdomyolysis ka lebaka la ho hloleha ha renal ka lebaka la myoglobinuria le myoglobinemia. Phekolo ea Atorvastatin e lokela ho khaoloa ka nakoana kapa ho khaoloe ka botlalo haeba ho na le matšoao a myopathy a ka khonehang kapa lebaka la kotsi la ho ba le ho se sebetse ha methapo ka lebaka la rhabdomyolysis (mohlala, ts'oaetso e matla ea methapo, khatello ea maikutlo ea methapo, ts'ebetso e matla ea mmele, ts'oaetso ea metabolic, endocrine le electrolyte le ho ts'oaroa ho sa laoleheng.

Tlhahisoleseling bakeng sa mokuli: bakuli ba lokela ho lemosoa hore ba lokela ho ea ngakeng hang-hang haeba ho utloahala bohloko kapa bofokoli mesifa, haholo ha bo tsamaisana le malaise kapa feberu.

Sebelisa ka hloko ho bakuli ba sebelisang joala hampe le / kapa ba nang le lefu la sebete (nalane).

Tlhahlobo ea boithuto ba bakuli ba 4731 ba se nang lefu la pelo (CHD) ba neng ba tšoeroe ke lefu la stroke kapa la nakoana nakoana likhoeling tse 6 tse fetileng mme ba ileng ba qala ho nka atorvastatin 80 mg ba senola liperesente tse phahameng tsa methapo ea hemorrhagic sehlopheng se nkile 80 mg ea atorvastatin ha e bapisoa le placebo ( 55 ho atorvastatin bapisoa le 33 ho placebo). Bakuli ba nang le lefu la hemorrhagic ba bontšitse kotsi e eketsehileng ea ho tšoaroa khafetsa (7 ho atorvastatin le 2 ho placebo). Leha ho le joalo, bakuli ba nkang atorvastatin 80 mg ba ne ba e-na le lichapo tse fokolang tsa mofuta ofe kapa ofe (265 bapisoa le 311) le lefu la pelo le fokolang.

Lefu la matšoafo a matšoafo

Ka tšebeliso ea li-statins tse itseng, haholo-holo ka kalafo ea nako e telele, ho tlalehiloe mafu a sa tloaelehang haholo a lefu la matšoafong a pakeng. Liponahatso li ka kenyelletsa dyspnea, khohlela e sa beheng, le bophelo bo botle (mokhathala, ho theola boima ba 'mele le feberu). Haeba ho e-na le lipelaelo tsa mokuli ea nang le lefu la matšoafong a ka hare, kalafo ea "statin" e lokela ho emisoa.

Bopaki bo bong bo fana ka maikutlo a hore li-statins, joalo ka sehlopha, li eketsa tsoekere ea mali mme ho bakuli ba bang ba nang le kotsi e kholo ea ho ba le lefu la tsoekere nakong e tlang, ba ka lebisa ho hyperglycemia, moo ho leng bohlale ho qala kalafo ea lefu la tsoekere. Leha ho le joalo, kotsi ena e fetisoa ke melemo ea ho fokotsa kotsi ho methapo ea mali ka li-statin, ka hona ha ea lokela ho ba lebaka la ho emisa kalafo ea statin. Bakuli ba kotsi (glucose e potlakileng ea 5.6-6.9 mmol / l, BMI> 30 kg / m2, triglycerides e phahameng, khatello e phahameng ea mali)

e lokela ho beoa leihlo ka bobeli litleliniking le litekanyetsong ho latela tataiso ea naha.

Bokhachane le pelehi

Basali ba lilemo tsa ho ba le bana ba lokela ho sebelisa mekhoa e lekaneng ea ho thibela pelehi nakong ea kalafo. Atorvastatin e ka fuoa basali ba lilemo tsa ho ba le bana ha feela monyetla oa ho ima o le tlase haholo, 'me mokuli a tsebisoa ka kotsi e ka bang teng ho lesea nakong ea kalafo.

Tlhokomeliso e khethehileng mabapi le ba tlisoang Atoris® e na le lactose. Bakuli ba nang le ts'oaetso ea lefutso ea galactose e fumanehang ka seoelo, khaello ea Lappase ea lactase, kapa glucose-galactose malabsorption ha baa lokela ho nka meriana ena. Lintlha tsa phello ea lithethefatsi ho bokhoni ba ho khanna koloi le mekhoa e ka bang kotsi

Ka lebaka la litlamorao tsa lithethefatsi, tlhokomeliso e lokela ho sebelisoa ha ho khannoa likoloi le mekhoa e meng e ka bang kotsi.

Setifikeiti sa ho ingolisa

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