Yuav siv Atorvastatin Teva li cas?
Dosage form - cov yeeb yaj kiab-xaum xim: yuav luag dawb lossis dawb, zoo li lub tshuaj ntsiav, kos rau ob sab: ntawm ib sab - "93", nyob rau lwm qhov - "7310", "7311", "7312" lossis "7313" (10 pcs hauv lub hlwv, hauv daim ntawv qhwv ntawm 3 los yog 9 lub hlwv).
1 ntsiav tshuaj muaj:
- cov tshuaj nquag: atorvastatin calcium - 10.36 mg, 20.72 mg, 41.44 mg lossis 82.88 mg, uas yog sib npaug ntawm 10 mg, 20 mg, 40 mg lossis 80 mg ntawm atorvastatin, ntsig txog,
- Cov khoom siv pabcuam: eudragit (E100) (copolymer ntawm dimethylaminoethyl methacrylate, butyl methacrylate, methyl methacrylate), lactose monohydrate, alpha-tocopherol macrogol succinate, povidone, croscarmellose sodium, sodium stearyl fumarate,
- zaj duab xis txheej muaj pes tsawg leeg: opadry YS-1R-7003 (polysorbate 80, hypromellose 2910 3cP (E464), titanium dioxide, hypromellose 2910 5cP (E464), macrogol 400).
Kev ntsuas rau siv
- heterozygous tsev neeg thiab tsis-tsev neeg hypercholesterolemia, thawj hypercholesterolemia thiab sib xyaw (ua ke) hyperlipidemia (hom IIa thiab IIb raws li Fredrickson kev faib tawm) hauv kev sib xyaw nrog lipid-txo cov zaub mov tsom rau kev txo qis kom tag nrho cov roj (cholesterol), cov roj lipoprotein tsawg (LDL, I-lipid,) cov roj lipoprotein ntau heev (HDL),
- dysbetalipoproteinemia (hom III raws li Fredrickson kev faib tawm), kom cov ntshiab triglycerides (hom IV raws Fredrickson kev faib tawm) - nrog rau kev kho kev noj haus tsis muaj txiaj ntsig,
- homozygous tsev neeg hypercholesterolemia - kom txo qis ntawm LDL cov roj (cholesterol) thiab cov roj (cholesterol) tag nrho nrog cov tsis muaj txiaj ntsig ntawm kev noj zaub mov noj thiab lwm yam kev kho mob tsis muaj tshuaj.
Cov Yuav Tsum Muaj
- daim siab ua rau lub siab (Cov Me Nyuam Pugh chav A thiab B),
- nquag lub siab pathologies, nce kev ua si ntawm hepatic enzymes (ntau dua 3 zaug siab dua qhov tsis pub dhau lub zog ntawm ib txwm) ntawm cov keeb kwm tsis paub,
- lub caij nyoog ntawm cev xeeb tub thiab pub niam mis,
- hnub nyoog txog 18 xyoo
- ua kom lub cev tsis haum rau cov tshuaj ntawm cov tshuaj.
Nrog kev ceev faj, nws pom zoo tias Atorvastatin-Teva tau sau tseg nrog keeb kwm ntawm cov kab mob siab, cov neeg mob txoj hlab ntshav hauv lub cev, kev quav dej cawv, cov teeb meem ntawm lub cev metabolic thiab endocrine, kev siv ntshav electrolyte tsis txaus, kev mob hnyav sai (sepsis), mob pob txha mob, tsis tuaj yeem tswjhwm, mob vwm, thiab kev phais mob ntau ntxiv kev raug mob.
Tsuas tshuaj thiab tswj hwm
Cov ntsiav tshuaj tau noj ntawm qhov ncauj 1 zaug hauv ib hnub, tsis hais noj zaub mov thaum lub sijhawm twg los tau nruab hnub.
Tus kws kho mob tau sau ntawv rau noj ib lub zuj zus, suav mus rau theem pib ntawm LDL cov roj cholesterol, lub hom phiaj ntawm txoj kev kho thiab tus neeg mob teb rau cov tshuaj.
Kev tswj hwm ntawm Atorvastatin-Teva yuav tsum nrog ua ke (1 zaug txhua 2-4 lub lis piam) soj ntsuam txog qib ntawm lipids hauv cov ntshav ntshav, raws li cov ntaub ntawv tau txais, kho lub koob tshuaj.
Kev hloov koob tshuaj yuav tsum ua tsis pub ntau tshaj 1 zaug hauv 4 lub lis piam.
Qhov nyiaj pab ntau tshaj txhua hnub yog 80 mg.
Pom zoo kom noj tshuaj txhua hnub:
- heterozygous tsev neeg hypercholesterolemia: thawj koob tshuaj yog 10 mg, ua ib koob tshuaj hloov kho txhua 4 lub lis piam, nws yuav tsum maj mam nqa mus rau 40 mg. Thaum kho nrog lub koob tshuaj ntawm 40 mg, cov tshuaj raug muab coj los ua ke nrog cov tshuaj tiv thaiv cov kua tsib kua qaub, nrog cov tshuaj monotherapy, qhov koob tshuaj tau nce ntxiv rau 80 mg,
- thawj hypercholesterolemia thiab sib xyaw (sib xyaw) hyperlipidemia: 10 mg, raws li txoj cai, koob tshuaj muab cov kev tswj hwm tsim nyog ntawm qib lipid. Cov kev kho mob tseem ceeb feem ntau tshwm sim tom qab 4 lub lis piam thiab tawm tsam ntev heev ntawm kev siv tshuaj,
- homozygous tsev neeg hypercholesterolemia: 80 mg.
Txog kev mob plawv thiab muaj feem yuav muaj mob plawv, kev kho mob yog pom zoo nrog cov hom phiaj hauv qab no rau kev kho lipid: tag nrho cov roj (cholesterol) tsawg dua 5 mmol / l (lossis qis dua 190 mg / dl) thiab LDL roj tsawg dua 3 mmol / l (lossis qis dua 115 mg / dl).
Yog tias lub siab ua haujlwm rau lub siab, tus neeg mob yuav tsum tau sau ntawv noj tshuaj kom qis dua lossis tsum tsis pub noj ntxiv.
Nrog lub raum tsis ua haujlwm, qhov kev hloov kho tshuaj tsis tas yuav tsum tau ua, vim tias cov tshuaj tsis hloov pauv qhov siab hauv cov ntshav ntshav.
Sab sij huam
- los ntawm cov leeg hlwb: feem ntau - mob taub hau, tsis xws luag - ua txhaum saj tsis hnov tsw, kiv taub hau, pw tsaug zog, paresthesia, amnesia, npau suav phem, hypesthesia, tsis tshua - peripheral neuropathy, tsis paub ntau zaus - kev nyuaj siab, nco ploj lossis ploj, pw tsaug zog,
- los ntawm kev tiv thaiv kab mob: feem ntau - kev tawm tsam tsis haum, tsis tshua muaj tshwm sim - anaphylactic shock, angioedema,
- los ntawm kev mob plab hnyuv: feem ntau - xeev siab, dyspepsia, raws plab, mob plab, cem quav, ua tsis xws luag - mob plab, ntuav, mob caj pas, ntuav,
- los ntawm cov leeg ua haujlwm thiab cov nqaij sib txuas: feem ntau - mob ntawm nqaj, o rau cov pob qij txha, mob myalgia, mob nraub qaum, mob caj dab, mob leeg, tsis nco qab - leeg tsis muaj zog, mob caj dab, tsis tshua muaj mob - rhabdomyolysis, myopathy, myositis, tendonopathy nrog cov leeg txhaws, qhov ntau zaus tsis paub zoo - immuno-mediated necrotizing myopathy,
- los ntawm cov kab mob hepatobiliary: ntuag - kab mob siab, tsis tshua muaj - cholestasis, muaj tsawg - kab mob siab,
- los ntawm cov lymphatic system thiab cov ntshav system: tsis tshua muaj - thrombocytopenia,
- los ntawm cov kab mob ua pa, hauv siab thiab mediastinal plab hnyuv siab raum: feem ntau - txhaws ntswg, mob hauv thaj av pharyngeal-laryngeal, nasopharyngitis, zaus tsis paub - mob ntsws ntawm lub ntsws,
- lub cim ntsuas: feem ntau - kev nce ntxiv ntawm cov ntshav creatine kinase kev ua si, hyperglycemia, ua tsis tau - hypoglycemia, leukocyturia, kev ua si ntawm daim siab enzymes, qhov ntau zaus tsis paub - kev nce qib ntawm glycosylated hemoglobin concentration,
- ntawm ib feem ntawm cov khoom hnov, hauv kev tsis sib haum: tsis xws luag - tinnitus, tsis tshua muaj - hnov lus tsis zoo,
- nyob rau ib feem ntawm cov khoom hauv nruab nrog ntawm kev tsis pom kev: tsis xws luag - txo qis ntawm qhov pom tseeb ntawm lub zeem muag, tsis tshua muaj - kev ua txhaum ntawm kev pom kev pom,
- dermatological tshua: ua tsis xws luag - tawv nqaij ua pob khaus, xoo pob liab vog, alopecia, urticaria, tsis tshua muaj - erythema multiforme, dermatitis ua rau tawv nqaij, tsis tshua muaj mob - lom kabmob ua paug tsis sib luag, Stevens-Johnson syndrome,
- los ntawm kev muaj me nyuam: tsis tshua muaj - gynecomastia, zaus tsis paub - kev sib deev,
- cov teeb meem dav dav: tsis ua haujlwm - tsis muaj zog, asthenia, kub taub hau, mob hauv siab, peripheral edema, hnyav ntxiv, qaug zog, tsis nco qab.
Cov lus qhia tshwj xeeb
Sij hawm dhau los, hypercholesterolemia yuav tsum tau sim tswj kev noj haus, ua kom lub cev muaj zog, thiab hauv cov neeg mob rog rog, poob phaus thiab kho lwm yam mob.
Kev siv Atorvastatin-Teva muab rau kev saib xyuas ntawm kev noj zaub mov hypocholesterol, uas yog kws kho mob tau sau tseg nrog cov tshuaj.
HMG-CoA reductase inhibitors tuaj yeem cuam tshuam kev hloov pauv hauv biochemical cov kab mob siab ua haujlwm thoob plaws txoj kev kho. Yog li, kev kho mob yuav tsum tau nrog kev saib xyuas lub siab ua haujlwm nrog cov zaus hauv qab no: ua ntej pib txoj kev kho, tom qab txhua koob nce, tom qab 6 thiab 12 lub lis piam tom qab pib kho, tom qab ntawd txhua rau lub hlis. Cov neeg mob uas muaj qhov nce siab ntawm cov enzymes yuav tsum tau saib xyuas los ntawm tus kws kho mob kom txog thaum rov qab zoo li qub. Yog tias aspartate aminotransferase (AST) thiab alanine aminotransferase (ALT) qhov tseem ceeb tshaj li 3 zaug ntawm qhov tsis pub dhau ntawm qhov kev cai, qhov tshuaj yuav tsum raug txo lossis raug muab tso tseg.
Txoj kev loj hlob ntawm myopathy tej zaum yuav tsis muaj qhov xav tau ntawm kev noj atorvastatin, nws cov tsos mob suav nrog kev nce ntawm creatine phosphokinase (CPK) ntawm 10 zaug lossis ntau dua piv nrog qhov kev txwv sab sauv ntawm txoj cai ua ke nrog qhov mob thiab tsis muaj zog hauv cov leeg. Cov neeg mob yuav tsum paub txog qhov xav tau tam sim ntawd sab laj nrog kws kho mob yog tias tsis hnov mob thiab tsis muaj zog hauv cov leeg, nrog rau mob ua npaws thiab mob siab. Txoj kev kho yuav tsum tsis ua mus ntxiv thaum tswj hwm qhov muaj tseeb los ntawm KFK cov haujlwm lossis qhov pom tias muaj tus mob myopathy.
Tawm tsam keeb kwm yav dhau los ntawm kev siv atorvastatin, kev txhim kho ntawm rhabdomyolysis nrog mob raum tsis ua haujlwm vim myoglobinuria yog ua tau. Thaum muaj mob hnyav, mob ntshav tawm ntshav, kev phais mob ntau ntxiv, raug mob, teeb meem loj ntawm lub cev, mob endocrine thiab hluav taws xob tsis zoo, tsis nco qab qhov mob lossis qhov tshwm sim ntawm lwm yam kev pheej hmoo rau lub raum tsis ua haujlwm thaum rhabdomyolysis, nws raug nquahu kom tsum tsis txhob Atorvastatin-Teva kev kho.
Kev noj cov tshuaj tsis cuam tshuam rau tus neeg mob lub peev xwm ntawm kev tsav tsheb thiab lub tshuab.
Yeeb tshuaj sib cuam tshuam
Kev sib xyaw ntawm HMG-CoA reductase inhibitors nrog cov tshuaj fibrates, cyclosporine, cov tshuaj tua kab mob macrolide (suav nrog erythromycin), nicotinic acid, azole antifungal tus neeg sawv cev nce myopathy lossis tuaj yeem ua rau mob rhabdomyolysis, nrog cov myoglobinuria ntsig txog lub raum tsis ua haujlwm. Yog li, nws raug nquahu tias kom sib npaug, sib piv cov txiaj ntsig thiab kev pheej hmoo ntawm kev kho, txiav txim siab txog kev teem caij ntawm atorvastatin ib txhij nrog cov tshuaj no.
Nrog rau kev ceev faj, nws raug nquahu kom muab tshuaj nrog cyclosporine, HIV protease inhibitors, tshuaj tua kab mob macrolide (suav nrog erythromycin, clarithromycin), azole antifungal tshuaj, nefazodone thiab lwm yam tshuaj tiv thaiv ntawm CYP3A4 isoenzyme, vim tias nws muaj peev xwm nce qhov kev nce siab ntawm atorvastatin hauv cov ntshav ntshav. Cov.
Nrog tib lub sijhawm siv ntawm Atorvastatin-Teva:
- cimetidine, ketoconazole, spironolactone thiab lwm yam tshuaj uas txo cov kev ua kom zoo ntawm cov tshuaj hormones endogenous steroid, nce qhov kev pheej hmoo ntawm txo qis hauv qib ntawm cov tshuaj hormones endogenous steroid,
- qhov ncauj tiv thaiv kab mob muaj ethinyl estradiol thiab norethisterone ua rau kom cov tshuaj lom ntau ntxiv hauv cov ntshav ntshav,
- kev txwv tsis pub muaj aluminium hydroxide thiab magnesium txo (li ntawm 35%) qhov kev sib xyaw ntawm atorvastatin hauv ntshav, yam tsis muaj kev hloov pauv qhov kev txo qis hauv LDL,
- digoxin tuaj yeem ua rau nws ntshav ntxiv,
- warfarin ua rau lub sijhawm prothrombin pib me ntsis thaum pib kho, dhau 15 hnub tom ntej, qhov ntsuas tau rov qab zoo li qub,
- cyclosporin thiab lwm yam tshuaj P-glycoprotein inhibitors yuav ua rau kom muaj kev nyab xeeb ntawm atorvastatin,
- terfenadine tsis hloov pauv cov ntshav hauv cov ntshav ntshav.
Kev sib xyaw ua ke nrog colestipol muaj cov txiaj ntsig ntawm lipids ntau dua li noj txhua yam ntawm cov tshuaj cais, txawm hais tias theem ntawm atorvastatin hauv cov ntshav ntshav txo qis li 25%.
Kev noj cov txiv kab ntxwv kua txiv thaum lub sij hawm kho yuav tsum tau txwv, vim tias cov kua txiv kom ntau ntxiv cov tshuaj atorvastatin hauv ntshav.
Cov tshuaj tsis cuam tshuam rau pharmacokinetics ntawm phenazone thiab lwm yam tshuaj metabolized los ntawm tib lub cytochrome isoenzymes.
Qhov cuam tshuam ntawm rifampicin, phenazone, thiab lwm yam CYP3A4 inducing isoenzyme npaj ntawm Atorvastatin-Teva tseem tsis tau tsim.
Tau qhov sib cuam tshuam ntawm chaw khomob muaj txiaj ntsig nrog kev siv cov tshuaj III tshuaj tiv thaiv kab mob (nrog rau amiodarone) yuav tsum raug txiav txim siab.
Cov kev tshawb fawb tsis tau qhia txog kev cuam tshuam ntawm atorvastatin nrog cimetidine, amlodipine, tshuaj tiv thaiv kev tsis txaus siab.
Pharmacological kev txiav txim ntawm atorvastatin teva
Cov tshuaj yog rau kev xaiv sib tw inhibitors ntawm cov enzyme HMG-CoA reductase, uas catalyzes cov kev sib txuas ntawm mevalonic acid, ib txheej ua ntej ntawm cov roj cholesterol thiab lwm yam sterols.
Triacylglycerides (rog) thiab cov roj (cholesterol) hauv cov nplooj siab khi rau cov lipoproteins uas tsis tshua muaj siab, los ntawm qhov chaw uas lawv thauj los ntawm cov ntshav mus rau cov leeg thiab cov nplais adipose. Ntawm cov no, thaum lub sijhawm lipolysis, cov lipoproteins tsawg (LDL) yog tsim, uas yog kev sib cais los ntawm kev sib cuam tshuam nrog LDL receptors.
Qhov kev txiav txim ntawm cov tshuaj yog pab txo cov rog thiab cov roj cholesterol hauv cov ntshav los ntawm kev txwv cov haujlwm ntawm HMG-CoA reductase enzyme, cov roj ntsha biosynthesis hauv lub siab thiab nce cov LDL receptors uas txhawb kev nce siab thiab catabolism ntawm lipoproteins tsawg.
Cov nyhuv ntawm cov tshuaj yog nyob ntawm lub koob tshuaj uas tau coj thiab muaj nyob hauv qis qis ntawm cov tshuaj lipoproteins tsawg hauv cov neeg mob ua rau muaj kev tsis sib haum ntawm cov roj metabolism (hypercholesterolemia), uas tsis tuaj yeem hloov kho nrog lwm cov tshuaj los txo cov ntshav lipids.
Kev noj cov tshuaj ua rau qhov txo qis hauv qib:
- tag nrho cov roj (30-46%),
- cov roj (cholesterol) hauv LDL (41-61%),
- apolipoprotein B (34-50%),
- triacylglycerides (14-33%).
Nyob rau tib lub sijhawm, cov theem ntawm cov roj (cholesterol) nyob rau hauv kev sib xyaw ntawm high lipoproteins (HDL) thiab apolipoprotein A nce. Cov nyhuv no tau pom hauv cov neeg mob uas muaj keeb kwm thiab tau txais cov ntawv hypercholesterolemia, cov ntawv sib xyaw ua ke dyslipidemia, nrog rau hom 2 ntshav qab zib mellitus. Cov nyhuv pharmacological ntawm cov tshuaj txo cov kev pheej hmoo ntawm cov hlab ntsha pathologies thiab kev hem thawj ntawm kev tuag hauv kev sib txuas nrog lawv.
Raws li kev tshawb fawb soj ntsuam, cov txiaj ntsig ntawm kev siv tshuaj nyob rau hauv cov neeg muaj hnub nyoog tsis txawv hauv kev nyab xeeb thiab kev ua tau zoo nyob rau hauv kev qhia tsis zoo los ntawm cov txiaj ntsig ntawm kev kho mob ntawm cov neeg mob ntawm lwm lub hnub nyoog.
Cov tshuaj yeeb tshuaj yog nqus sai sai tom qab kev tswj hwm qhov ncauj. Qhov siab tshaj plaws hauv cov ntshav tau sau cia tom qab 1-2 teev. Noj ib nyuag mentsis nqes rau qhov nqus ntawm qhov nquag, tab sis tsis cuam tshuam rau qhov ua tau zoo ntawm nws cov haujlwm. Kev siv zom zaub mov yog 12%. Lub bioavailability ntawm lub inhibitory kev ua si txheeb ze rau enzyme HMG-CoA reductase yog 30%, uas yog tshwm sim los ntawm kev hloov ua ntej hauv cov khoom noj hauv lub plab thiab lub siab. Nws khi rau cov ntshav protein li 98%.
Cov tshuaj ua kom nquag plias raug faib ua cov metabolites (ortho- thiab para-hydroxylated derivatives, beta-oxidation khoom lag luam) rau feem ntau hauv daim siab. Nws yog biotransformed nyob rau hauv qhov kev txiav txim ntawm isoenzymes CYP3A4, CYP3A5 thiab CYP3A7 ntawm cytochrome P450. Cov kev tiv thaiv kev cuam tshuam ntawm tus neeg sawv cev pharmacological txheeb ze rau enzyme HMG-CoA reductase yog 70% nyob ntawm kev txiav txim ntawm cov metabolites uas tau tshwm sim.
Kev nqhis dej ntawm cov metabolites kawg tshwm sim feem ntau los ntawm cov kua tsib, tsuas yog ib feem tsis tseem ceeb (Kev ntsuas rau kev siv atorvastatin teva
Kev tiv thaiv kab mob ntawm cov hlab plawv hlab plawv (mob plawv, mob hlab ntsha tawg, mob myocardial infarction), nrog rau lawv cov teeb meem:
- nyob rau hauv cov laus hauv ib lossis ntau pawg muaj kev pheej hmoo: cov laus, cov neeg mob ntshav siab, haus luam yeeb, cov neeg muaj HDL tsawg dua lossis ua rau muaj kev nyuaj siab rau cov kab mob plawv thiab leeg ntshav,
- hauv cov neeg mob uas muaj hom 2 mob ntshav qab zib mellitus nrog proteinuria, retinopathy, kub siab,
- hauv cov neeg mob uas muaj mob plawv (tiv thaiv kom tsis txhob muaj kev txhim kho ntawm cov teeb meem).
Kev kho mob ntawm hyperlipidemia:
- nrog thawj hypercholesterolemia (tau txais thiab muaj keeb, nrog rau homo- thiab heterozygous cov ntaub ntawv ntawm tsev neeg hypercholesterolemia) - cov tshuaj siv yog qhov cuab yeej ywj pheej thiab ua ib feem ntawm txoj kev kho mob nrog lwm txoj lipid-txo txoj kev (LDL apheresis),
- nrog xyaw dyslipidemia,
- nyob rau hauv cov neeg mob uas nce triglycerides hauv cov ntshav (hom IV raws li Fredrickson),
- nyob rau hauv cov neeg mob uas muaj thawj dysbetalipoproteinemia (Fredrickson hom III) nrog kev kho kev noj haus tsis muaj txiaj ntsig.
Yuav noj li cas
Kev noj tshuaj txhua hnub yog nyob ntawm qib pib ntawm cov roj (cholesterol) thiab yog nyob hauv thaj tsam li 10-80 mg. Thaum pib, 10 mg yog tau sau tseg ib hnub ib zaug nyob rau txhua lub sijhawm ntawm hnub, yam tsis muaj kev cuam tshuam txog kev noj zaub mov. Kev hloov koob tshuaj nyob ntawm tus neeg cov cim ntawm cov ntshav roj, uas yuav tsum tau saib xyuas ua ntej txhua 2, tom qab ntawd txhua 4 asthiv.
Cov qauv tshuaj txhua hnub rau cov neeg laus:
- nrog thawj hypercholesterolemia thiab sib xyaw hyperlipidemia: 10 mg ib hnub ib zaug (muaj cov nyhuv hais tawm tom qab 28 hnub txij li hnub pib kho, nrog kev kho mob ntev ntev cov txiaj ntsig no ruaj khov)
- nrog rau qhov mob heterozygous cov kab mob hypercholesterolemia: 10 mg ib hnub ib zaug (pib koob nrog kho ntxiv thiab nqa nws mus rau 40 mg ib hnub twg),
- nrog homozygous kab mob hypercholesterolemia: 80 mg 1 lub sijhawm ib hnub.
Cov mob raum tsis muaj kev cuam tshuam cov kev ua ntawm cov tshuaj nquag hauv cov ntshav lossis cov txiaj ntsig ntawm Atorvastatin-Teva. Tsis tas yuav tsum tau muab kev hloov kho ntau ntxiv vim yog mob raum. Yog tias daim siab ua haujlwm tsis zoo, yuav tsum tau txhaj tshuaj kho raws li qhov ua haujlwm hauv nruab nrog cev. Nyob rau hauv cov mob loj, kev kho tshuaj kho mob raug muab tso tseg.