U ka sebelisa Atorvastatin-Teva joang?

Foromo ea litekanyetso - matlapa a koahetsoeng ka filimi: hoo e ka bang e tšoeu kapa e tšoeu, e bopehile ka sekareleta, e ngotsoe ka mahlakoreng ka bobeli: ka lehlakoreng le leng - "93", ka lehlakoreng le leng - "7310", "7311", "7312" kapa "7313" (10 li-pcs ka blister, ka lebokoseng la mekotla e meraro kapa e 9.

Letlapa le le leng le na le:

ntho e sebetsang: calcium atorvastatin - 10,36 mg, 20,72 mg, 41.44 mg kapa 82.88 mg, e lekanang le 10 mg, 20 mg, 40 mg kapa 80 mg ea atorvastatin, ka ho latellana,
likarolo tse thusang: eudragit (E100) (Copolymer ea dimethylaminoethyl methacrylate, butyl methacrylate, methyl methacrylate), lactose monohydrate, alpha-tocopherol macrogol, povidone, croscarmellose sodium, sodium stearyl fumarate,
sebopeho sa koaelo ea lifilimi: opadry YS-1R-7003 (polysorbate 80, hypromellose 2910 3cP (E464), titanium dioxide, hypromellose 2910 5cP (E464), macrogol 400).

Matšoao a ho sebelisoa

heterozygous ea lelapa le e seng ea lelapa hypercholesterolemia, hypercholesterolemia ea mantlha le e kopaneng (e kopantsoeng) hyperlipidemia (mefuta ea IIa le IIb ho latela sehlopha sa Fredrickson) hammoho le lijo tse fokotsang lipid tse ikemiselitseng ho theola maemo a phahameng a cholesterol, low-density lipoprotein cholesterol high density lipoprotein cholesterol (HDL),
dysbetalipoproteinemia (mofuta oa III ho latela sehlopha sa Fredrickson), serum triglycerides (mofuta oa IV ho latela sehlopha sa Fredrickson) - ka kalafo ea phepo e sa sebetseng,
homozygous Famer hypercholesterolemia - ho theola cholesterol ea LDL le cholesterol e felletseng ka ts'ebeliso e sa lekanang ea kalafo ea ho ja le litlhare tse ling tse seng tsa meriana.

Contraindication

ho hloleha ha sebete (lihlopha tsa bana le bana tsa B),
li-pathologies tsa sebete tse sebetsang, ts'ebetso e eketsehileng ea li-enzyme tsa hepatic (e phahame makhetlo a 3 ho feta moeli o holimo oa tloaelehileng) oa tšimolohong e sa tsejoeng,
nako ea kemaro le kanyeso,
lilemo tse 18
hypersensitivity ho likarolo tsa moriana.

Ka tlhokomeliso, ho khothalletsoa hore Atorvastatin-Teva e ngolisoe ka nalane ea mafu a sebete, bakuli ba nang le khatello ea methapo, ho ts'etsoa joala, mathata a metabolic le endocrine, ho se leka-lekane ha methapo ea methapo, tšoaetso e mpe ea methapo (sepsis), maloetse a mesifa ea mokokotlo, lefu la sethoathoa le sa foleng. likotsi.

Tekanyetso le tsamaiso

Matlapa a nooa ka molomo nako e le ngoe ka letsatsi, ho sa tsotelehe lijo tse nang le lijo ka nako efe kapa efe ea letsatsi.

Ngaka e beha lethal dose ka bonngoe, ho nahanela boemo ba cholesterol ea pele ea LDL, sepheo sa kalafo le karabelo ea mokuli ho moriana.

Tsamaiso ea Atorvastatin-Teva e lokela ho tsamaisoa le ho hlahlojoa khafetsa (nako e le 'ngoe libeke tse ling le tse ling tse 2) ho lekola boemo ba lipids ka plasma ea mali, ho ipapisitse le lintlha tse fumanoeng, lokisa tekanyetso.

Phetoho ea moriana ha e ea lokela ho ba nako e le 'ngoe ho feta libeke tse 4.

Tekanyo e phahameng ea letsatsi le letsatsi ke 80 mg.

Khothaletso ea letsatsi le letsatsi e khothalletsoang:

heterozygous Familia hypercholesterolemia: lethal dose la pele ke 10 mg, ho etsa ntlafatso ea lethal dose ka mor'a libeke tse 4, butle-butle e lokela ho tlisoa ho 40 mg. Ha u phekoloa ka tekanyetso ea 40 mg, moriana o nooa o kopantsoe le li-acid tse 'meleng oa motsoako ka monotherapy.
hypercholesterolemia ea mantlha le hyperlipidemia e kopaneng (10), e le molao, lethal dose le fana ka taolo e hlokahalang ea maemo a lipid. Tšusumetso ea bohlokoa ea kliniki hangata e hlaha kamora libeke tse 4 mme e phehella tšebeliso ea nako e telele ea lithethefatsi,
homozygous Famer hypercholesterolemia: 80 mg.

Bakeng sa lefu la pelo le ho ba le kotsi e kholo ea mathata a pelo, phekolo e khothalletsoa ka lipheo tse latelang tsa khalemelo ea lipid: cholesterol e ka tlase ho 5 mmol / l (kapa ka tlase ho 190 mg / dl) le cholesterol ea LDL e ka tlase ho 3 mmol / l (kapa ka tlase ho 115 mg / dl).

Maemong a ho hloleha ha sebete, mokuli a ka hloka ho fana ka litekanyetso tse tlase kapa a tlohela moriana.

Ka ho se sebetse hantle ke pheko, ha ho hloke phetoho ea tekanyetso, hobane setlhare ha se fetole khatello ea mali ka hara plasma ea mali.

Litlamorao

ho tloha tsamaisong ea methapo ea kutlo: khafetsa - hlooho ea hlooho, khafetsa - tlolo ea maikutlo a tatso, ho tsekela, ho hloka boroko, paresthesia, amnesia, lits'oants'o tsa bosiu, hypesthesia, ka seoelo - peripheral neuropathy, frequency e sa tsejoeng - khatello ea maikutlo, tahlehelo ea memori kapa tahlehelo, ho sitisoa ha boroko,
ho tsoa sesole sa 'mele: khafetsa - karabelo, e sa tloaelehang haholo - ho tsitsipana ka anaphylactic, angioedema,
ho tsoa ka mpeng: hangata - ho nyekeloa, ho opa, lets'ollo, ho ruruha, ho sokela, ho sa lekana - bohloko ba ka mpeng, ho luma, pancreatitis, ho hlatsa,
ho tsoa ho tsamaiso ea masculoskeletal le tishu e sebetsanang: khafetsa - bohloko maotong, ho ruruha manonyeletsong, myalgia, bohloko ba morao, arthralgia, mesifa ea mesifa, hangata - mesifa ea mesifa, bohloko ba molala, ka seoelo - rhabdomyolysis, myopathy, myositis, tendonopathy ka ho phatloha ha tendon, frequency ha e tsejoe - immuno-mediated necrotizing myopathy,
ho tsoa ho hepatobiliary system: khafetsa - hepatitis, ka seoelo - cholestasis, ka seoelo - ho hloleha ha sebete,
ho tsoa ho tsamaiso ea methapo le tsamaiso ea mali: ka seoelo - thrombocytopenia,
ho tloha tsamaisong ea ho phefumoloha, sefuba le methapo ea methapo: hangata - nosebleeds, bohloko sebakeng sa pharyngeal-laryngeal, nasopharyngitis, maqhubu a sa tsejoeng - methapo ea methapo ea methapo,
matšoao a laboratori: khafetsa - keketseho ea tšebetso ea serum creatine kinase, hyperglycemia, hangata - hypoglycemia, leukocyturia, ts'ebetso e eketsehileng ea li-enzyme tsa sebete, khafetsa ha e tsejoe - keketseho ea boemo ba mahloriso a glycosylated hemoglobin,
lehlakoreng la setho se utloang, mathata a labyrinth: hangata - tinnitus, ka seoelo - tahlehelo ea kutlo.
karolong ea sebopeho sa pono: khafetsa - ho fokotseha hoa hlakileng hoa pono, ka seoelo - tlolo ea pono e bonoang,
dermatological reaction: khafetsa - ho hlohlona ha letlalo, lekhopho, alopecia, urticaria, ka seoelo - erythema multiforme, dermatitis e ngata, hangata - sesebelisoa sa chefo se bitsoang epidermal necrolysis, Stevens-Johnson,
ho tloha kemisong ea ho beleha: ka seoelo - gynecomastia, khaello e sa tsejoeng - ho se sebetse ka thobalano,
maloetse a akaretsang: khafetsa - bofokoli, asthenia, feberu, bohloko ba sefuba, edema ea ho potoloha, boima ba 'mele, lethargy, ho ipolaisa tlala.

Litaelo tse khethehileng

Pejana, hypercholesterolemia e lokela ho lekoa ho laola pheko ea lijo, ho eketsa ts'ebetso ea 'mele, le ho bakuli ba nang le botenya, ho theola boima ba' mele le kalafo ea maemo a mang.

Ts'ebeliso ea Atorvastatin-Teva e fana ka tlhokomeliso ea phepo e tloaelehileng ea hypocholesterol, e laetsoeng ke ngaka nako e le ngoe le sethethefatsi.

HMG-CoA reductase inhibitors e ka ama phetoho ea paramente ea biochemical ea ts'ebetso ea sebete ho pholletsa le kalafo. Ka hona, kalafo e lokela ho tsamaisana le ho lekola ts'ebetso ea sebete ka maqhubu a latelang: pele ho qala kalafo, kamora ho eketseha ha tekanyetso, ebe kamora libeke tse 6 le 12 kamora ho qala kalafo, ebe kamora likhoeli tse ling le tse ling tse tšeletseng. Bakuli ba nang le li-enzyme tse phahameng ba lokela ho beoa leihlo ke ngaka ho fihlela boemo bo khutlela ho bo tloaelehileng. Haeba litekanyetso tsa "aspartate aminotransferase" (AST) le alanine aminotransferase (ALT) li fetang makhetlo a 3 moeli o kaholimo oa tloaelo, tekanyo e lokela ho fokotsoa kapa e hlakotsoe.

Nts'etsopele ea myopathy e kanna ea ba phello e sa rateheng ea ho nka atorvastatin, matšoao a eona a kenyelletsa keketseho ea creatine phosphokinase (CPK) ea makhetlo a 10 kapa ho feta ha e bapisoa le moeli o ka holimo oa tloaelo o kopantsoeng le bohloko le bofokoli mesifa. Bakuli ba lokela ho tsebisoa ka tlhokahalo ea ho ea ngakeng hang-hang haeba ho e-ba le bohloko bo sa hlalosoang le bofokoli mesifa, bo tsamaeang le feberu le malaise. Phekolo e lokela ho khaotsa ha o ntse o boloka keketseho e boletsoeng ea ts'ebetso ea KFK kapa boteng ba belaelloang kapa bo netefalitsoeng ke myopathy.

Khahlano le nalane ea ts'ebeliso ea atorvastatin, nts'etsopele ea rhabdomyolysis ka ho hloleha ha reute haholo ka lebaka la myoglobinuria e khonahala. Haeba ho na le ts'oaetso e matla ea methapo, hypotension ea methapo, ts'ebetso e ngata, ts'enyo e kholo, metabolism e matla, endocrine le pherekano ea electrolyte, ho ts'oaroa ho sa laoleheng kapa ponahalo ea lintlha tse ling tsa kotsi bakeng sa ho se sebetse hantle ha nakong ea rhabdomyolysis, ho khothalletsoa ho tlohela kalafo ea Atorvastatin-Teva.

Ho nka moriana ona ha ho ame bokhoni ba mokuli ba ho khanna makoloi le mekhoa.

Ho sebelisana le lithethefatsi

Motsoako oa li-inhibitors tsa HMG-CoA reductase tse nang le li-fibrate, cyclosporine, lithibela-mafu tsa macrolide (ho kenyeletsa le erythromycin), nicotinic acid, li-antole antifungal e eketsa kotsi ea myopathy kapa e ka baka rhabdomyolysis, e tsamaellanang le ho hloleha ha phepelo e amanang le myoglobinuria. Ka hona, ho khothalletsoa hore ka mokhoa o leka-lekaneng, ho bapisa melemo le likotsi tsa kalafo, etsa qeto ea ho khethoa ha atorvastatin ka nako e le ngoe le lithethefatsi tsena.

Ka tlhokomeliso e fetelletseng, ho khothalletsoa ho fana ka litlhaloso hammoho le cyclosporine, li-inhibitors tsa HIV, li-macrolide, (ho kenyeletsa le erythromycin ,cacithromycin), lithethefatsi tsa azole antifungal, nefazodone le tse ling tse thibelang CYP3A4 isoenzyme, kaha ho ka etsahala ho eketsa mahloriso a matšoao a atorvastatin le plasma ea mali. .

Ka tšebeliso e tšoanang ea Atorvastatin-Teva:

cimetidine, ketoconazole, spironolactone le lithethefatsi tse ling tse fokotsang khoholeho ea lihormone tsa endidia, li eketsa menyetla ea ho fokotseha hoa boemo ba lihormone tsa endidia tsa steroid,
lithibela-pelehi tsa molomo tse nang le ethinyl estradiol le norethisterone haholo li eketsa bongata ba lintho tse sebetsang ho plasma ea mali,
Litšusumetso tse nang le aluminium hydroxide le magnesium li fokotsa (ka 35%) khatello ea atorvastatin ho plasma, ntle le ho fetola tekanyetso ea LDL,
digoxin e ka eketsa mahloriso a eona a plasma,
warfarin e baka ho fokotseha hanyane ha nako ea prothrombin qalong ea kalafo, matsatsing a 15 a tlang, letšoao le khutlisetsoa ho tloaelehileng,
cyclosporin le tse ling tsa P-glycoprotein inhibitors li ka eketsa bioavailability ea atorvastatin,
terfenadine ha e fetole khatello ea mali ka plasma ea mali.

Phekolo ea ho kopanya le colestipol e na le phello e boletsoeng ho lipids ho feta ho nka e le 'ngoe ea lithethefatsi ka thoko, leha boemo ba atorvastatin ka plasma ea mali bo fokotseha ka 25%.

Ts'ebeliso ea lero la morara ka nako ea kalafo e lokela ho fokotsoa, kaha lero le leholo le eketsa bongata ba atorvastatin ho plasma.

Setlhare sena ha se ame li-pharmacokinetics tsa phenazone le lithethefatsi tse ling tse entsoeng ka li-eyeenzymes tse tšoanang tsa cytochrome.

Litlamorao tsa rifampicin, phenazone, le litokisetso tse ling tsa CYP3A4 tse susumetsang isoenzyme ho Atorvastatin-Teva ha li e-so thehoe.

Monyetla oa ts'ebelisano e kholo ea tleliniki le tšebeliso ea lithethefatsi tsa sehlopha sa antiarrhythmic tsa klase (ho kenyeletsoa amiodarone) o lokela ho nahanoa.

Boithuto ha bo senole tšebelisano ea atorvastatin le cimetidine, amlodipine, lithethefatsi tsa antihypertensive.

Ts'ebetso ea pharmacological ea atorvastatin teva

Setlhare ke sa li-inhibitors tse khethiloeng tsa HMG-CoA reductase, tse thusang ho kopanya mevalonic acid, selelekela sa cholesterol le li-sterols tse ling.

Triacylglycerides (mafura) le k'holeseterole e ka har'a sebete e ea lipoprotein tse tlaase haholo, ho tloha moo li tsamaisoa ka mali ho ea mesifa le lithong tsa adipose. Tsena, nakong ea lipolysis, lipoproteins tse tlase (LDL) li thehiloe, tse felisitsoeng ke ho sebelisana le li-receptor tsa LDL.

Ketso ea sethethefatsi e etselitsoe ho fokotsa bongata ba mafura le cholesterol maling ka ho thibela ts'ebetso ea HMG-CoA reductase enzyme, cholesterol biosynthesis ka har'a sebete le ho eketsa palo ea li-receptor tsa LDL tse khothalletsang ts'ebetso le tšusumetso ea lipoprotein tse tlase tsa letsoalo.

Tšusumetso ea lithethefatsi e itšetleha ka tekanyo e nkuoeng 'me e kenyelletsa ho theola boemo ba lipoprotein tse tlaase ho bakuli ba nang le tlolo ea lefutso ea cholesterol metabolism (hypercholesterolemia), e ke keng ea fetoloa le lithethefatsi tse ling ho fokotsa lipids tsa mali.

Ho nwa moriana ho lebisa lerothong la:

Kakaretso ea k'holeseterole (30-46%),
cholesterol in LDL (41-61%),
apolipoprotein B (34-50%),
triacylglycerides (14-33%).

Ka nako e ts'oanang, boemo ba cholesterol ka sebopeho sa lipalo tse phahameng tsa methapo ea kutlo (HDL) le apolipoprotein A. Phello ena e ile ea bonoa ho bakuli ba nang le lefutso le mekhoa e fumanoeng ea hypercholesterolemia, dyslipidemia e kopaneng, le mofuta oa 2 lefu la tsoekere. Phello ea lithethefatsi tsa lithethefatsi e fokotsa menyetla ea lefu la pelo le ts'abo ea lefu ka lebaka la tsona.

Ho ea ka liphuputso tsa tliliniki, liphetho tsa ts'ebeliso ea lithethefatsi ho bakuli ba amanang le lilemo li ne li sa fapana ka polokeho le katleho ntlheng e mpe ho tsoa liphellong tsa kalafo ea bakuli ba lilemo tse ling.

Ntho ea lithethefatsi e kenella ka potlako ka mor'a taolo ea molomo. Khatello e phahameng ka ho fetisisa maling e tlalehiloe ka mor'a lihora tse 1-2. Ho ja hanyane ho fokotsa ho monya ha ntho e sebetsang, empa ha ho ame katleho ea ketso ea eona. Digestibility e sebetsang ke 12%. Ho ba le bioavailability ea ts'ebetso ea inhibitory e amanang le enzyme HMG-CoA reductase ke 30%, e bakoang ke tšimoloho ea metabolism ka har'a tšilo ea lijo le sebete. E amana le liprotheine tsa mali ka 98%.

Ntho e sebetsang e arotsoe ka metabolites (ortho- le para-hydroxylated derivatives, lihlahisoa tsa beta-oxidation) bakeng sa karolo e ngata ka ho fetisisa sebeteng. E biotransformed tlasa ts'ebetso ea isoenzymes CYP3A4, CYP3A5 le CYP3A7 ea cytochrome P450. Ts'ebetso ea inhibitory ea moemeli oa pharmacological e amanang le phepelo ea enzyme HMG-CoA ke 70% e itšetlehileng ka ketso ea metabolites e hlahisitsoeng.

Excretion ea metabolites ea ho qetela e etsahala haholo ka bile, e le karolo feela e sa bohlokoa (Matšoao a sebelisang atorvastatin teva

Thibelo ea maloetse a pelo le methapo ea pelo (lefu la pelo, ho otloa ke lefu la pelo, hammoho le mathata a tsona:

ho batho ba baholo sehlopheng se le seng kapa tse eketsehileng tse kotsing: ba tsofetseng, ba nang le khatello e matla ea maikutlo, ba tsubang, batho ba nang le HDL e fokolisitsoeng kapa lefutso le mpefatsang lefu la pelo le methapo,
ho bakuli ba mofuta oa 2 lefu la tsoekere le protheine, retinopathy, khatello e phahameng ea mali,
ho bakuli ba nang le lefu la pelo (ho qoba nts'etsopele ea mathata ").

Phekolo ea hyperlipidemia:

ka hypercholesterolemia ea mantlha (e fumanoeng le ea lefutso, ho kenyeletsoa homo- le heterozygous mefuta ea hypercholesterolemia ea malapa) - setlhare se sebelisoa e le sesebelisoa se ikemetseng hape e le karolo ea kalafo e rarahaneng ka mekhoa e meng e fokotsang lipid-LDL.
le dyslipidemia e tsoakiloeng,
ho bakuli ba nang le "triglycerides" e phahameng maling (mofuta oa IV ho ea ka Fredrickson),
ho bakuli ba nang le dysbetalipoproteinemia ea mantlha (mofuta oa Fredrickson III) ba nang le bothata ba kalafo ea phepo.

U ka e nka joang

Motsoako oa letsatsi le letsatsi o ipapisitse le boemo ba cholesterol ea pele mme o maemong a 10-80 mg. Pele, 10 mg e beoa hanngoe ka letsatsi ka nako efe kapa efe ea letsatsi, ntle le ho bua ka takatso ea lijo. Phetoho ea tekanyetso e ipapisitse le matšoao a k'holeseterole ea mali, e lokelang ho beoa leihlo pele e mong le e mong makhetlo a 2, ebe libeke tse ling le tse ling tse nne.

Litekanyetso tse tloaelehileng tsa letsatsi le letsatsi tsa lithethefatsi bakeng sa batho ba baholo:

ka hypercholesterolemia ea mantlha le hyperlipidemia e kopaneng: 10 mg hang ka letsatsi (phello e boletsoeng ea kalafo e tlalehiloe kamora matsatsi a 28 ho tloha qalong ea kalafo, ka kalafo ea nako e telele sephetho sena se tsitsitse)
le heterozygous hereditary hypercholesterolemia: 10 mg hang ka letsatsi (lethal dose la pele ka tokiso e eketsehileng le ho e tlisa ho 40 mg ka letsatsi),
le homozygous lefutso hypercholesterolemia: 80 mg e le 1 ka letsatsi.

Mafu a amanang le lefu la ramatiki ha a ame khatello ea ntho e sebetsang maling kapa katleho ea Atorvastatin-Teva. Ha ho na tlhoko ea phetoho ea litekanyetso ka lebaka la lefu la liphio. Tabeng ea ts'ebetso ea sebete e sa sebetseng hantle, ho hlokahala hore ho fetotsoe tokiso ea lethal dose ho latela ts'ebetso ea setho. Maemong a boima, kalafo ea lithethefatsi e hlakotsoe.