Ntụziaka maka ị drugsụ ọgwụ, analogues, nyocha

Mbadamba ihe eji etinye fim, 40 mg

Otu mbadamba ihe

ike ihe - kalịnti atorvastatin dị 41.44 mg (nke kwekọrọ na atorvastatin 40,00 mg)

n'imendị na-ebu ụzọ: povidone, sodium lauryl sulfate, carbon dioxide, microcrystalline cellulose, lactose monohydrate, ssumum croscarmellose, crospovidone, magnesium stearate,

shei: Opadry White Y-1-7000 (mejupụtara hypromellose, titanium dioxide (E 171) na macrogol 400)

Gburugburu mbadamba ụrọ kpuchie ya na ihe nkiri ịcha achacha, convex ubé

Ngwongwo ogwu

Atorvastatin na-agbaso ngwa ngwa mgbe nchịkwa ọnụ gasịrị, itinye uche ya na plasma ọbara ruru oke mgbe awa 1-2 gachara. Ogo nke nnabata na itinye uche nke atorvastatin na plasma ọbara na-abawanye na oke na nha. Ezigbo bioavailability nke atorvastatin dị ihe dị ka 14%, na sistemụ bioavailability usoro nke inhibitory na-emegide 3-hydroxy-3-methylglutaryl coenzyme A mbelata (HMG-CoA reductase) bụ ihe dịka 30%. Usoro bioavailability dị ala bụ n'ihi metabolism metabolism na akpụkpọ anụ mucous nke eriri afọ na / ma ọ bụ n'oge "ụzọ mbụ" site na umeji.

Nri jiri obere belata ogo na ogo nnabata nke ọgwụ (na 25% na 9%, dika nke ahụ gosipụtara site na nsonaazụ mkpebi siri ike nke Cmax na AUC), mana mbelata nke mkpụrụ obere lipoprotein cholesterol (LDL-C) yiri nke ahụ mgbe ị na-ewere atorvastatin na afọ efu. Ke ama akabiat atorvastatin ke mbubreyo, uto plasma esie osụhọde (Cmax ye AUC ke n̄kpọ nte 30%) akan ke ama eketie ke usenubọk. E gosipụtara mmekọrịta kwụụrụ n’etiti ogosi nke itinye uche na ogo nke ọgwụ ahụ.

Ogologo nha nke nkesa atorvastatin bụ ihe dịka 381 lita. Nkwukọrịta na protein plasma nke opekata mpe 98%. Erythrocyte / plasma atorvastatin ọdịnaya ruru 0.25, i.e. atorvastatin anaghị abanye n’ọbara ọbara nke ọma.

Atorvastatin bụ metabolized n'ụzọ dị ukwuu iji mepụta usoro ortho- na para-hydroxylated na ngwaahịa dị iche iche beta oxidation. Ihe metabolites Ortho- na para-hydroxylated metabolites nwere mmetụta mgbochi inhibitory na HMG-CoA reductase. Ihe dị ka 70% na-agbadata n'ọrụ HMG-CoA reductase na - apụta n'ihi ihe ndị na - emegharị metabolites na - arụ ọrụ. Cytochrome P450 3A4 nke imeju na-arụ ọrụ dị mkpa na metabolism nke atorvastatin: ịta nke atorvastatin na plasma ọbara mmadụ na-abawanye mgbe ị na-ewere erythromycin, nke bụ ihe na-egbochi isoenzyme a. Atorvastatin, n'aka nke ya, bụ ihe mgbochi na - adịghị ike nke cytochrome P450 3A4. Atorvastatin enweghị mmetụta dị ukwuu na-adakarị na plasma nke terfenadine, nke metabolized tumadi site cytochrome P450 3A4, ya mere, ọ bụ eleghi anya na atorvastatin nwere mmetụta dị ukwuu na ọgwụ ọgwụ nke ọgwụ ndị ọzọ na-eji cytochrome P450 3A4.

Atorvastatin na metabolites ya bụ ihe kachasị nke nwere ọrịa na-emetụta ya na hepatic na / ma ọ bụ extrahepatic metabolism (atorvastatin anaghị ata ahụhụ enterohepatic recirculation). Ọkara ọkara nke atorvastatin bụ ihe dị ka awa 14. Ọrụ mgbochi inhibido ihe megide HMG-CoA reductase na-adịgide ruo ihe dịka awa 20-30, n'ihi ọnụnọ nke metabolites na-arụ ọrụ. Mgbe nchịkwa ọnụ gasịrị, ihe na-erughị 2% nke atorvastatin bụ mmamịrị.

Ndị otu ọrịa pụrụ iche

Okenye: ihe plasma nwere nke atorvastatin n’etiti ndị gbara afọ iri isii na ise gbagowe elu (Cmax ihe dị ka 40%, AUC ihe dị ka 30%) karịa ndị ọrịa na-eto eto, ọdịiche n’ihe nchekwa, nrụpụta ọrụ ma ọ bụ nweta ebumnuche ọgwụgwọ egbugbere ọnụ nke ndị agadi na-elele ahughi onu ogugu.

ChildrenmụakaOnwe omumu ihe nke ndi dibia ogwu eji eme umuaka.

Okike: ịta nke atorvastatin na plasma ọbara na ụmụ nwanyị dị iche (Cmax ihe dịka 20% dị elu, na AUC site na 10% dị ala) na nke ahụ na ụmụ nwoke, agbanyeghị, enweghị ọdịiche dị oke egwu na mmetụta ọgwụ nwere na metabolism lipid n'ime ụmụ nwoke na ụmụ nwanyị.

Ọdịda ya: ọrịa akụrụ anaghị emetụta nsonaazụ nke atorvastatin na plasma ọbara ma ọ bụ ihe ọ na-eme na metabolism lipid, ya mere, mgbanwe mgbanwe dose na ndị ọrịa na arụ ọrụ ezigharị adịghị mkpa.

Ahụ ike: nleghara anya banyere akwara na-ebute oke mmụba nke atorvastatin, ebe ọgwụ nwere oke na protein plasma.

Imeju imeju: Atorvastatin itinye uche na-abawanye nke ukwuu (Cmax ihe dị ka ugboro iri na isii, AUC ihe dị ka ugboro 11) na ndị ọrịa nwere ọrịa imeju na-egbu egbu (Childe-Pugh B).

Mlọ ọgwụ

Atoris® bụ ọgwụ na-eme ka anwụ dị nro, ihe na - egbochi asọmpi HMG-CoA reductase, enzyme dị mkpa nke na - agbanwe 3-hydroxy-3-methylglutaryl-CoA na mevalonic acid, ihe na - ebute steroid, gụnyere cholesterol. N'ime ndị ọrịa na-arịa ụdị hypercholesterolemia na homozygous na heterozygous, na-abụghị nke ezinụlọ, hypercholesterolemia na-ejikọ aka na mmiri, Atoris® na-agbada cholesterol dị ala (Cs), obere protein lipoprotein dị ala na apolipoprotein B na-enwe ntakịrị lilalirol / triglycerides, na-akpata mmụba na-akwụsighi ike na chopoerol lipoprotein dị elu (HDL-C).

N'ime imeju, a na-etinye triglycerides na cholesterol na nchịkọta nke lipoproteins dị mkpụmkpụ (VLDL), banye na plasma ọbara ma zigara ya na akwara akụkụ. Ntọpụta lipoproteins dị ala (LDL) sitere na VLDL, nke a na-ejikọ ya site na mmekorita ya na ndị na-anabata LDL.

Atoris® na -ebelata mkpokọta cholesterol na lipoproteins na plasma ọbara, na-egbochi HMG-CoA reductase yana njikọ nke cholesterol na imeju na ịbawanye ọnụ ọgụgụ nke "imeju" LDL na-enweta ihe dị na sel, nke na-eduga n'ịba ụba na catabolism nke LDL cholesterol.

Ihe ngosi maka ojiji

- na mgbakwunye na nri iji gwọọ ndị ọrịa nwere nnukwu ụbara plasma nke cholesterol zuru oke, HDL-C, apolipoprotein B na triglycerides, na mmụba na HDL-C na ndị ọrịa nwere hypercholesterolemia (hytechozygous familial na ezinụlọ na-abụghị nke ezinụlọ), jikọtara (hyperliplestleralemia). IIa na IIb dị ka Frederickson si kwuo, ya na-abawanye ọdịnaya nke triglycerides na plasma ọbara (ụdị IV dị ka Frederickson) yana ndị ọrịa nwere dysbetalipoproteinemia (ụdị III dị ka Frederickson) si bụrụ na enweghị mmetụta zuru oke na di oterapii

- iji belata ọkwa plasma ọbara nke cholesterol mkpokọta na LDL-C n'ime ndị ọrịa nwere hyzycholesterolemia homozygous familial ezughi oke nke usoro ọgwụgwọ nri na usoro ọgwụgwọ ndị ọzọ na-abụghị ọgwụ ọgwụ.

- iji belata onwu nke ọrịa obi na akụrụngwa yana ihe ọghọm nke ịda myocardial infarction, angina pectoris, ọrịa strok na iji belata mkpa ịkpụgharị usoro ndị ọrịa nwere ọrịa obi na / ma ọ bụ dyslipidemia, yana ọ bụrụ na achọpụtaghị ọrịa ndị a, mana enwere ọ dịkarịa ala atọ ihe ndị dị ize ndụ maka mmepe nke ọrịa obi obi, dị ka afọ karịrị afọ 55, ise anwụrụ, oke mgbali akwara, plasma pere mpe nke HDL-C, yana ikpe nke mmalite mmalite nke ọrịa obi na akwara ndị ikwu.

- na mgbakwunye na nri iji gwọọ ụmụaka dị n’agbata afọ 10 ruo 17 ruo afọ na ịba ụba plasma ọdịnaya nke cholesterol ngụkọta, LDL-C na apolipoprotein B na heterozygous familial hypercholesterolemia, ọ bụrụ na mgbe ọgwụgwọ nri zuru oke larịị nke LDL-C na-anọgide> 190 mg / dl ma ọ bụ ọkwa nke LDL na-anọgide> 160 mg / dl, mana enwere ọnọdụ mbido mmalite nke ọrịa obi na ndị ikwu ma ọ bụ abụọ ma ọ bụ karịa ihe ndị ọzọ ga - ebute ọrịa obi na nwata.

Usoro onunu ogwu na nhazi

Tupu ịmalite ọgwụgwọ na Atoris®, ịkwesịrị ịgbalị ịchịkwa hypercholesterolemia site na nri, mmega ahụ na oke ibu na ndị ọrịa na-ebu oke ibu, yana ọgwụgwọ nke ọrịa na-akpata. Mgbe ị na-ede ọgwụ ahụ, onye ọrịa ahụ kwesịrị ikwu ezigbo usoro hypocholesterolemic, nke ọ ga-agbaso n'oge ọgwụgwọ.

A na-a drugụ ọgwụ ahụ n'oge ọ bụla n'ụbọchị, n'agbanyeghị nri a na-eri. Ọgwụ nke ọgwụ ahụ na-agbanwe site na 10 ruo 80 mg otu ugboro kwa ụbọchị, na-ahọpụta ya na-eburu n'uche ọdịnaya mbụ nke LDL-C, ebumnuche ọgwụgwọ na mmetụta onye ọ bụla. Na nmalite ọgwụgwọ na / ma ọ bụ n'oge mmụba nke dose nke Atoris®, ọ dị mkpa iji nyochaa ọdịnaya abụba dị na plasma ọbara kwa izu 2-4 ma dozie dose ahụ dabere.

Hypercholesterolemia nke mbu yana agwakọta (hyperlipidemia). maka ọtụtụ ndị ọrịa - 10 mg otu ugboro kwa ụbọchị, a na-egosipụta mmetụta ọgwụgwọ ahụ n'ime izu abụọ ma na-erukarị ogo karịa n'ime izu anọ, na ọgwụgwọ ogologo, mmetụta ahụ na-adịgide.

Homozygous familial hypercholesterolemia: 80 mg otu ugboro kwa ụbọchị (n'ọtụtụ oge, ọgwụgwọ mere ka mbelata ọdịnaya nke LDL-C site na 18-45%).

Nnukwu ọrịa dyslipidemia na ndị ọrịa ụmụaka: Usoro akwadoro ịmalite bụ 10 mg otu ugboro n'ụbọchị. Enwere ike ịbawanye ọgwụ ahụ ruo mg mg 80 kwa ụbọchị dabere na nzaghachi na nnabata. A ga-ahọrọ doses n’otu n’otu n’iburu n'uche ebumnuche ọgwụgwọ.

Jiri ndị ọrịa nwere ọrịa imeju: lee "Contraindications."

Usoro onunu ogwu na ndi oria na akwara itu Ọrịa akụrụ anaghị emetụta ịta nke Atoris® na plasma ọbara ma ọ bụ ogo nke mbelata nke ọdịnaya LDL-C, yabụ achọrọ ịmegharị ọgwụ ahụ.

Jiri ndị agadi: enweghị ọdịiche n'ihe nchekwa, nrụpụta ọrụ, ma ọ bụ mmezu nke ebumnuche nke ọgwụgwọ belata oke ọrịa n'ime ndị agadi ma e jiri ya tụnyere ndị mmadụ niile.

Nsonaazụ

mgbu na akpịrị na ogwooro, imi

dyspepsia, ọgbụgbọ, flatulence, erughi ala, belching, afọ ọsịsa

ọrịa ogbu na nkwonkwo, mgbu n’akwara, mgbu akwara, myalgia, myositis, myopathy

ndị na-adịghị ahụkebe na-egosi ọrụ imeju, ịba ụba serum creatine phosphokinase (CPK)

ike ahu, olu olu

ọrịa, ahụ ọkụ

Ọkpụkpụ mkpụrụ ndụ ọbara ọcha n’ime mmamịrị

Achọpụtala mmetụta ndị a na-eso na ọmụmụ ọmụmụ azụmaahịa:

Mmeghachi omume nfụkasị (gụnyere anaphylaxis)

I nweta ibu

hypesthesia, amnesia, dizziness, perversion uto

Stevens-Johnson syndrome, necrolysis na-egbu egbu, erythema multiforme, ihe ojoo

rhabdomyolysis, azụ mgbu

obi mgbu, akwara ọgụ, ike ọgwụgwụ

Ihe ngbanwe

ọgwụ mgbochi na akụkụ ọ bụla nke ọgwụ ahụ

ọrịa imeju na-arụ ọrụ ma ọ bụ ụbara ọbara transaminase na-arịwanye elu (karịa ugboro atọ ma e jiri ya tụnyere njedebe dị elu nke nkịtị) nke sitere na mmalite amabeghị

mụ nwanyị dị ime na ndị na-enye nwa ara, yana ụmụ nwanyị gbara afọ na-ejighi ụzọ dị mma nke igbochi

ndị ọrịa nwere ọrịa lactate e ketara eketa, ụkọ enzyme LAPP-lactase, glucose-galactose malabsorption

Mkparịta ụka ọgwụ ọjọọ

Ihe ọghọm nke imepụta myopathy na-abawanye n'oge ọgwụgwọ yana ndị na-egbochi HMG-CoA reductase inhibitors yana iji otu oge cyclosporin, ihe dị na fibric acid, nicotinic acid na cytochrome P450 3A4 inhibitors (erythromycin, ndị na-emegide antifungal metụtara azoles).

P450 3A4 Ndị na-egbochi ya: atorvastatin bụ metabolized site cytochrome P450 3A4. Oge atorvastatin na cytochrome P450 3A4 inhibitors nwere ike ime ka mmụba nke plasma nke atorvastatin. Ogo nke nmekorita na ike nke ihe a na-egosi dabere na mgbanwe nke ihe a na cytochrome P450 3A4.

Na-egbochi Ndị Na-egbochi: atorvastatin na metabolites ya nọchiri anya ndị na - ebugharị OATP1B1. Ndị na-egbochi OATP1B1 (dịka ọmụmaatụ, cyclosporine) nwere ike iwelie bioavailability nke atorvastatin. Ojiji nke 10 mg nke Atoris® na cyclosporine (5.2 mg / kg / ụbọchị) na-eduga n'ịbawanye na ikpughe atorvastatin site na oge 7.7.

Erythromycin / clarithromycin: n'iji atorvastatin na erythromycin (500 mg ugboro anọ n'ụbọchị) ma ọ bụ clarithromycin (500 mg ugboro abụọ n'ụbọchị), nke na-egbochi cytochrome P450 3A4, mmụba na mkpokọta nke atorvastatin na plasma ọbara.

Na-egbochi ndị na-egbochi gị: iji ihe atorvastatin mejuputa ya na ihe mgbochi nchebe nke a maara dika cytochrome P450 3A4 inhibitors tinyere mgbakwunye nke ndọta plasma nke atorvastatin.

Diltiazem hydrochloride: otu oge eji Atoris® (40 mg) na diltiazem (240 mg) na-eduga na mmụba nke mkpokọta atorvastatin na plasma ọbara.

Cimetidine: omumu banyere nmekorita nke atorvastatin na cimetidine ekpughere mmekorita di omimi nke ulo ogwu.

Itraconazole: n'otu oge eji Atoris® (20 mg-40 mg) na itraconazole (200 mg) na-eduga na mmụba na AUC nke atorvastatin.

Ihe ọ Juụpeụ mkpụrụ osisi Grape: nwere otu ma obu ihe abuo na egbochi oria CYP 3A4 ma nwekwaa ike itinye uche nke atorvastatin n’ime plasma obara, karie ma iribiga ihe oke nke mmanya nkpuru osisi (kariri 1.2 lita kwa ubochi)

Indoctors nke cytochrome P450 3A4: iji Atoris® mee ihe n'otu oge na cytochrome P450 3A4 inducers (efavirenz, rifampin) nwere ike ibute mbelata nke plasma nke atorvastatin. Nyere uzo abuo nke ihe nke rifampin (induction nke cytochrome P450 3A4 na mgbochi nke enzyme imeju OATP1B1), ekwesiri idebe Atoris® n'otu oge na rifampin, ebe obu na iburu Atoris® mgbe iwere rifampin na-eduga na mbelata nke oma na atorvastatin na plasma obara.

Antacids: n'otu ntinye nke nkwusioru nke nwere magnesium na alumini hydroxides belatara mkpocha nke atorvastatin na plasma obara site na 35%, agbanyeghị, ogo nke ibelata ọdịnaya nke LDL-C agbanweghi agbanwe.

Antipyrine: Atoris® emetụtaghị ọgwụ ọgwụ nke antipyrine, yabụ, mmekọrịta na ọgwụ ndị ọzọ metabolized site na otu cytochrome isoenzymes anaghị atụ anya.

Colestipol: n'iji colestipol na-emekọ ihe n'otu oge, mkpochapu nke atorvastatin na plasma ọbara belatara ihe dị ka 25%, agbanyeghị, mmetụta dị ala nke ngwakọta nke atorvastatin na colestipol karịrị nke ọgwụ ọ bụla n'otu n'otu.

Digoxin: Site na nchịkwa nke digoxin na atorvastatin ugboro ugboro na 10 mg, ikike itinye digoxin na plasma ọbara agbanweghị. Ka osi di, mgbe eji digoxin na atorvastatin na onwa 80 mg / ubochi, ntughari nke digoxin riri elu dika 20%. Ndị ọrịa na-anata digoxin yana Atoris® chọrọ nlekọta kwesịrị ekwesị.

Azithromycin: na ojiji nke atorvastatin (10 mg otu ugboro kwa ụbọchị) na azithromycin (500 mg otu ugboro n'ụbọchị), itinye uche nke atorvastatin na plasma agbanweghị.

Ogwu ogwula ogwu: site n'iji atorvastatin na oge onyunyo nke nwere norethindrone na ethinyl estradiol, enwere nnukwu ịrị elu na AUC nke norethindrone na ethinyl estradiol ihe dịka 30% na 20%, n'otu n'otu. E kwesịrị ịtụle mmetụta a mgbe ị na-ahọrọ ọgwụ mgbochi nwanyị maka nwanyị na-ewere Atoris®.

Warfarin: Enweghị mmekọrịta dị omimi nke atorvastatin na warfarin achọpụtara.

Amlodipine: na ojiji nke atorvastatin na amlodipine 10 mg, nke ọgwụ ọgwụ nke atorvastatin na steeti ohiha agbanwebeghị.

Fusidic acid: Emebeghi ihe omumu banyere nmekorita nke atorvastatin na fusidic acid, otu ekwuputala banyere rhabdomyolysis na otu ha ka ha siri mee na nzuko ahia. Ya mere, a ga-enyocha ndị ọrịa ma, ọ bụrụ na ọ dị mkpa, enwere ike kwụsịtụrụ ọgwụ Atoris® nwa oge.

Usoro ọgwụgwọ concomitant ndị ọzọ: mgbe ị na-eji atorvastatin na njikọ ndị na-egbochi ọgwụ na ọnụ mmiri, a hụghị mmekọrịta dị n'etiti ọgwụ na-adịghị mma.

Ntụziaka pụrụ iche

Imeju na imeju

Ka agwara ya na atorvastatin, ahuru ama (ihe kariri ugboro 3 ma e jiri ya tụnyere nke kachasị dị na mbụ) mmụba n'ọbara ọbara nke ọbara “imeju”.

Mmụba na ọrụ nke ọrịa ịba ọcha n'anya na-ejikọghị ya site na jaundice ma ọ bụ ngosipụta ndị ọzọ. Site na mbelata nke ọgwụ atorvastatin, ịkwụsịtụ ọgwụ ahụ ruo nwa oge ma ọ bụ kwụsịchaa, ọrụ ịba ọcha n'anya laghachiri na ọkwa mbụ ya. Imirikiti ndị ọrịa gara n'ihu na-ewere atorvastatin na ọgwụ dị ala na-enweghị nsogbu ọ bụla.

Ọ dị mkpa ileba anya n'ihe ngosipụta nke ọrụ umeji n'oge usoro ọgwụgwọ niile, ọkachasị mgbe ọ pụtara na akara ngosipụta akwara nke mmebi imeju. N'ihe banyere mmụba nke ọdịnaya hepatic transaminases, a ga-enyocha ọrụ ha ruo mgbe a ruru oke ụkpụrụ. Ọ bụrụ na mmụba na ọrụ AST ma ọ bụ nke ALT ihe karịrị ugboro 3 ma e jiri ya tụnyere oke nke ụkpụrụ ahụ ka ana-echekwa, a na-atụ aro ka ọ belata ma ọ bụ kagbuo dose ahụ.

Ọkpụkpụ akpụ akpụ akpụ

Mgbe ị na-edepụta Atoris® na usoro ọgwụ hypolipPs yana ngwakọta nke fibroic acid, erythromycin, immunosuppressants, ọgwụ azole antifungal ma ọ bụ nicotinic acid, dọkịta kwesịrị iji nlezianya tụlee uru na ihe ize ndụ nke ọgwụgwọ yana nyochaa ndị ọrịa mgbe niile iji chọpụta mgbu ma ọ bụ adịghị ike na akwara, karịsịa n'oge mbụ. ọnwa ọgwụgwọ na n'oge nke ịba ụba nke ọgwụ ọ bụla. N'ọnọdụ ndị dị otú ahụ, enwere ike ịkwado mkpebi nke oge ọrụ nke CPK, ọ bụ ezie na nlele dị otú ahụ anaghị egbochi mmepe nke myopathy siri ike. Atorvastatin nwere ike ibute mmụba n'ọrụ phosphokinase.

Mgbe ị na-eji atorvastatin, akọọla ikpe ikpe rhabdomyolysis na nnukwu akụrụ gbasara ọdịda nke myoglobinuria kọwara. Ekwesịrị ịhapụ Atoris® oge nwa oge ma ọ bụ kwụsị kpamkpam ma ọ bụrụ na e nwere ihe ịrịba ama nke myopathy enwere ike ma ọ bụ ihe dị ize ndụ maka mmepe nke ọdịda akwara n'ihi rhabdomyolysis (dịka ọmụmaatụ, ọrịa siri ike, hypotension, nnukwu ịwa ahụ, trauma, metabolic, endocrine na electrolyte ọgba aghara na enweghị nsogbu).

Ozi maka onye ọrịa: a kwesiri ịdọ ndị ọrịa aka na ntị na ha kwesịrị ịgakwuru dọkịta ozugbo ma ọ bụrụ na mgbu na-enweghị nkọwa ma ọ bụ adịghị ike na akwara ahụ pụtara, karịsịa ma ọ bụrụ na ha na-arịa ọrịa ịba ma ọ bụ ahụ ọkụ.

Jiri ịkpachara anya na ndị ọrịa na-a abuseụbiga mmanya ókè na / ma ọ bụ na-arịa ọrịa imeju (akụkọ ihe mere eme).

Ndị ọrịa na-enweghị ọrịa obi (CHD) nwere ọrịa strok na nso nso a ma ọ bụ trensient ischemic Attack (TIA) gosipụtara ọnụọgụ ọbara dị n'ọbara nke malitere ịnata atorvastatin na dose 80 mg ma e jiri ya tụnyere ndị ọrịa na-anata placebo. Ndị ọrịa nwere ọria ọbara na -egosi gosipụtara ka ọ nwekwuo ike ibute ọrịa strok. Agbanyeghị, ndị ọrịa na-a atụ atorvastatin 80 mg nwere ụdị strok ole ọ bụla na ụdị ọrịa obi na -ebi obere.

Ime na lactation

Mụ nwanyị nke afọ omumu kwesịrị iji ụzọ zuru oke nke mgbochi afọ n'oge ọgwụgwọ. Enwere ike ịgwa Atoris® ụmụ nwanyị toro afọ ịmụ nwa naanị ma ọ bụrụ na ịmụ nwa ga-adị obere, a na-emekwa ka onye ọrịa mara banyere ihe ọghọm o nwere ike ibute nwa ebu n’afọ n’oge ọgwụgwọ.

Pụrụ icheịdọ aka ná ntị filler

Atoris® nwere lactose. Ndị ọrịa nwere ọrịa ụbụrụ galactose ekweghị ibe nọrọ, ụkọ Lappase, ma ọ bụ ndị nwere glucose galactose malabsorption ekwesịghị ị thisụ ọgwụ a. Akụkụ nke nsonaazụ nke ọgwụ nwere ike ịkwọ ụgbọala na usoro ndị dị ize ndụ

N'inye nsogbu ndị dị na ọgwụ ahụ, akpachara anya kwesịrị ịkpachara anya mgbe ị na-anya ụgbọala na usoro ndị ọzọ nwere ike ibute.

Jiri nlezianya

Alcoholism, akụkọ banyere ọrịa imeju.
N'ime ndị ọrịa nwere ihe ndị dị ize ndụ maka rhabdomyolysis (nsị akụrụ, hypothyroidism, nkwarụ akwara nke hereditary na akụkọ onye ọrịa ma ọ bụ akụkọ ezinụlọ, mmerụ ahụ nke HMG-CoA reductase inhibitors nke statins ma ọ bụ fibrates na akwara anụ ahụ, akụkọ ihe mere eme nke ọrịa imeju na / / ma ọ bụ ndị ọrịa na-a amountsụbiga mmanya ókè, ndị ọrịa merela agadi karịa afọ 70, ọnọdụ ndị a na-atụ anya mmụba na plasma nke atorvastatin, dịka ọmụmaatụ, mmekọrịta na ọgwụ ndị ọzọ).

Jiri n’oge ime na n’oge a na-enye nwa ara

Atoris® bụ mgbochi ime na n’oge a na-enye nwa ara. Nnyocha ụmụ anụmanụ na-egosi na ihe ize ndụ nke nwa ebu n’afọ nwere ike karịa uru ọ bụla ọ ga-abara nne.
N'ime ụmụ nwanyị toro nwa na-ejighị usoro ịtụkwasị obi nke igbochi afọ ime, a gaghị akwado iji Atoris® mee ihe. Mgbe ị na-eme atụmatụ ịtụrụ ime, ịkwesịrị ịkwụsị iji Atoris® opekata mpe ọnwa 1 tupu ịtụrụ ime gị.
Onweghi ihe akaebe banyere ikenye atorvastatin nwere mmiri ara. Ka osi di, na ufodi umu anumanu n’oge a na-enye ara, of meju atorvastatin n’obara ọbara na mmiri ara. Ọ bụrụ na ọ dị mkpa ị Atụ ọgwụ Atoris® n'oge ara, iji zere ihe ize ndụ nke ihe ojoo na ụmụ ọhụrụ, a ga-akwụsị inye ara ya.

Usoro onunu ogwu na nhazi

Tupu ịmalite iji Atoris® ọgwụ ahụ, a ga-ebugharị onye ọrịa ahụ na nri nke na -ebelata mbelata lipids na plasma ọbara, nke a ga-ahụrịrị n'oge ọgwụgwọ ya dum. Tupu ịmalite usoro ọgwụgwọ, ị kwesịrị ịgbalị iji nweta nchịkwa nke hypercholesterolemia site na mmega ahụ na oke ibu na ndị ọrịa nwere oke ibu, yana ọgwụgwọ maka ọrịa na-akpata.
A na-ewere ọgwụ ọnụ site na ọnụ, n'agbanyeghị oge nri. Ọgwụ nke ọgwụ ahụ dịgasị site na 10 mg ruo 80 mg otu ugboro kwa ụbọchị ma ahọpụtara na-eburu n'uche itinye uche mbụ nke LDL-C na plasma ọbara, ebumnuche ọgwụgwọ na mmetụta ọgwụgwọ nke onwe ya.
Enwere ike iwere Atoris once otu oge n'oge ọ bụla n'ụbọchị, mana n'otu oge kwa ụbọchị. A na-achọpụta mmetụta ọgwụgwọ ahụ ka izu abụọ nke ọgwụgwọ gasịrị, na nsonaazụ kachasị na-etolite mgbe izu anọ gachara.
Na mbido ọgwụgwọ na / ma ọ bụ n'oge mmụba nke dose ahụ, ọ dị mkpa iji nyochaa mmụba nke lipids na plasma ọbara kwa izu 2-4 ma dozie dose ahụ dabere.
Hypercholesterolemia nke mbu yana agwakọta hyperlipidemia
Maka ọtụtụ ndị ọrịa, ọgwụ akwadoro nke Atoris® bụ 10 mg otu ugboro n'ụbọchị, ọgwụgwọ ọgwụgwọ na-egosipụta onwe ya n'ime izu abụọ ma na-erukarị ogo mgbe izu anọ gachara. Site n'ọgwụgwọ ruo ogologo oge, mmetụta ahụ na-adịgide.
Homozygous familial hypercholesterolemia
N'ọnọdụ ka ukwuu, a na-edozi 80 mg otu ugboro kwa ụbọchị (mbelata mkpokọta LDL-C na plasma site na 18-45%).
Heterozygous familial hypercholesterolemia
Ọgwụ izizi bụ 10 mg kwa ụbọchị. Ekwesịrị ịhọrọ dose ahụ n'otu n'otu ma nyochaa mkpa nke dose ahụ kwa izu anọ na mmelite ọ nwere ike iru 40 mg kwa ụbọchị. Mgbe ahụ, enwere ike ịbawanye dose ahụ ruo ogo 80 mg kwa ụbọchị, ma ọ bụ kwe omume ijikọta usoro nke bile acid na iji atorvastatin na dose 40 mg kwa ụbọchị.
Mgbochi Ọrịa Obi
Na nyocha nke mgbochi izizi, dose oforvastatin bụ 10 mg kwa ụbọchị. Mmụba nke dose nwere ike ịdị mkpa iji mezuo ụkpụrụ LDL-C kwekọrọ na ntuziaka ugbu a.
Jiri n'ime ụmụaka si na 10 ruo afọ 18 na heterozygous familial hypercholesterolemia
Usoro akwadoro ịmalite bụ 10 mg otu ugboro n'ụbọchị. Enwere ike ịbawanye ọgwụ ahụ ruo 20 mg kwa ụbọchị, dabere na nsonaazụ ụlọ ọgwụ. Ahụmịhe nwere ihe karịrị 20 mg (nke kwekọrọ na dose 0,5 mg / n'arọ) nwere mmachi.
Ekwesịrị ịhọrọ dose nke ọgwụ ahụ dabere na ebumnuche nke ọgwụgwọ Lipid. Ekwesịrị imeghari dose na oge nke oge 1 n'ime izu anọ ma ọ bụ karịa.
Imeju imeju
Ọ bụrụ na ọrụ imeju ezughi oke, a ga-ebelata oke nke Atoris®, yana ileba anya na mmemme nke “imeju” transminases: aspartate aminotransferase (AST) na alanine aminotransferase (ALT) na plasma ọbara.
Ọdịda ya
Ọrụ akụrụma anaghị arụ ọrụ emetụtaghị mkpokoro nke atorvastatin ma ọ bụ ogo mbelata mgbanye LDL-C na plasma, yabụ, achọrọ nhazigharị nke ọgwụ ahụ (lee mpaghara "Pharmacokinetics").
Ndị okenye na-arịa ọrịa
Enweghị ọdịiche dị iche iche na arụmọrụ ọgwụgwọ yana nchekwa nke atorvastatin na ndị ọrịa agadi etinyere na ọnụọgụ mmadụ, ọ dịghị mkpa ịgbanwe ndozi dose (lee ngalaba Pharmacokinetics).
Jiri na ọgwụ ndị ọzọ
Ọ bụrụ na ọ dị mkpa, ojiji nke oge ahụ na cyclosporine, telaprevir ma ọ bụ ngwakọta nke tipranavir / ritonavir, ọgwụ Atoris® nke ọgwụ ahụ agaghị agafe 10 mg / ụbọchị (lee akụkụ "ntuziaka pụrụ iche").
Ekwesịrị iji nlezianya mee ihe yana iji ọgwụ atorvastatin dị ala kachasị mma mgbe ejiri ya na ndị na-egbochi nje HIV, nje na-egbochi ọrịa hepatitis C (boceprevir), clarithromycin na itraconazole.
Ndụmọdụ nke Russian Society of Cardiology, National Society maka Ọmụmụ nke Atherosclerosis (NLA) na Russian Society of Cardiosomatic Rehabilitation na Secondary Prevention (RosOKR)
(V edegharị 2012)
Nlekọta kachasị mma nke LDL-C na LDL maka ndị ọrịa nwere nnukwu nsogbu bụ: ≤ 2.5 mmol / L (ma ọ bụ mg 100 mg / dL) na ≤ 4.5 mmol / L (ma ọ bụ ≤ 175 mg / dL), otu isi na maka ndị ọrịa nwere nnukwu ihe egwu: ≤ 1.8 mmol / l (ma ọ bụ ≤ 70 mg / dl) na / ma ọ bụ, ọ bụrụ na enweghị ike ịnweta ya, a na-atụ aro ka iwetu uche LDL-C site na 50% site na uru mbụ yana ≤ 4 mmol / l (ma ọ bụ ≤ 150 mg / dl), n'otu n'otu.

Mmetụta akụkụ

Ọrịa na nje
mgbe: nasopharyngitis.
Ọrịa site na ọbara na sistem lymphatic:
adịkarịghị: thrombocytopenia.
Ọrịa sistemụ immune:
mgbe: mmeghachi omume nfụkasị ahụ,
dị ụkọ: anaphylaxis.
Imebi metabolism na nri oriri:
ugboro ugboro: uru ibu, anorexia,
adịkarịghị ala: hyperglycemia, hypoglycemia.
Ọrịa uche:
mgbe: ọgba aghara ụra, nke gụnyere ehighị ụra nke ọma na nro “nke na-arọ nrọ”,
ugboro-amaghị: ịda mba.
Mmebi nke usoro ụjọ ahụ:
mgbe ọ bụla: isi ọwụwa, dizziness, paresthesia, ọrịa asthenic,
ugboro ugboro: neuropathy nsogbu, hypesthesia, uto isi, ọnwụ na ebe nchekwa.
Ọrịa ntị na ọgba aghara labyrinth:
ugboro ugboro: tinnitus.
Ọrịa sitere na akụkụ okuku ume, obi na akụkụ ahụ:
mgbe: akpịrị mgbu, imi,
Ugboro amaghị: ọrịa dịpụrụ adịpụ nke ọrịa ngụgụ na - agbakarị oge iji ya.
Ọrịa digestive:
mgbe mgbe: afọ ntachi, dyspepsia, ọgbụgbọ, afọ ọsịsa, flatulence (bloating), mgbu afọ,
ugboro ugboro: ọgbụgbọ, ọgbụgbọ.
Nmebi nke imeju na ọnya biliary:
adịkarịghị: ịba ọcha n'anya, cholestatic jaundice.
Ọkpụkpụ sitere na anụ ahụ yana anụ ahụ dị n'okpuru ala:
mgbe: akpukpo aru, itching,
ugboro ugboro: urticaria,
ọ dịkarịghị ala: angioedema, alopecia, njo na-egbu egbu, erythema multiforme, Stevens-Johnson syndrome, necrolysis na-egbu egbu.
Imebi akwara na uru ahụ:
mgbe: myalgia, ogbu na nkwonkwo, azụ mgbu, akụkụ nke nkwonkwo,
ugboro ugboro: myopathy, akwara olu,
adịkarịghị: myositis, rhabdomyolysis, tendopathy (n'ọnọdụ ụfọdụ nwere ọnya anụ ahụ),
ugboro amaghị: ikpe nke dịghịzi-onye ogbugbo necrotizing myopathy.
Nmebi nke akụrụ na akwara:
ugboro ugboro: nke abụọ gbasara akụrụngwa ọdịda.
Mmebi nke akụkụ anụ ahụ na mammary gland:
ugboro ugboro: dysfunction mmekọahụ,
adịkarịghị: gynecomastia.
Ọrịa na nkwarụ izugbe na saịtị ịgba ahụ:
ọtụtụ mgbe: akụkụ ụbụrụ na-apụ apụ,
ugboro ugboro: mgbu obi, ọrịa, ike ọgwụgwụ, ahụ ọkụ.
Laabu na akụrụngwa data:
ugboro ugboro: ụba ọrụ nke aminotransferases (AST, ALT), mụbara ọrụ nke serine creatine phosphokinase (CPK) na plasma ọbara,
ọ dịkarịghị ukwuu: ịba ụba nke glycosylated haemoglobin (HbA1).
Emebeghi mmekọrịta mmekọrịta nke mmetụta ụfọdụ na-adịghị mma site n'iji ọgwụ Atoris®, nke a na-ahụta "ihe dị ụkọ". Ọ bụrụ na mmetụta na-achọghị oke egosi, ekwesighi ịkwụsị Atoris®.

Mmekọrịta na ọgwụ ndị ọzọ

Ojiji nke atorvastatin nwere cyclosporine, ọgwụ nje (erythromycin, clarithromycin, chinupristine / dalphopristine), ndị na-egbochi nje HIV (indinavir, ritonavir), ndị ọrụ antifungal (fluconazole, itraconazole, ketoconazole) ma ọ bụ mmụba bara uru. na - eme ka ịbawanye myopathy na rhabdomyolysis na ọdịda akụrụ. Yabụ, n'iji Trymax erythromycin TCmax, atorvastatin na-abawanye 40%. Ọgwụ niile a na - egbochi CenP3A4 isoenzyme, nke na - etinye aka na metabolism nke atorvastatin na imeju. Mkparịta ụka yiri nke ahụ ga-ekwe omume na iji nke atorvastatin na-eme n'otu oge na fibrates na nicotinic acid na usoro onyalata egbugbere ọnụ (karịa 1 g kwa ụbọchị).
Ojiji ezetimibe nwere njikọ na mmepe nke mmeghachi omume ọjọọ, gụnyere rhabdomyolysis, site na usoro akwara. Ihe ọghọm nke mmeghachi omume ndị dị otú a na-abawanye site n’otu oge nke ezetimibe na atorvastatin. A na-atụ aro ka imechi anya maka ndị ọrịa a.
Ojiji nke atorvastatin na onodu 40 mg na diltiazem na onwa 240 mg na-eduga na mmụba nke mkpokọta atorvastatin na plasma ọbara.
CYP3A4 Isoenzyme Inductors
Ihe atorvastatin jikọtara ya na induzyme CYP3A4 dị ka ọmụmaatụ, efavirenz, rifampicin ma ọ bụ Hypericum perforatum nwere ike ibute mkpokọta atorvastatin na plasma ọbara. N'ihi usoro abụọ nke mkparịta ụka na rifampicin (inducer nke CYP3A4 isoenzyme na hepatocyte trans protein protein inhibitor OATP1B1), a na-atụ aro nchịkwa nke atorvastatin, ebe ọ bụ na ojiji nke atorvastatin na rifampicin na-eduga na mbelata dị ukwuu na mkpokọta atorvastatin na plasma ọbara. Enweghi ozi banyere mmetụta nke rifampicin na mkpokọta nke atorvastatin na hepatocytes, yabụ, ọ bụrụ na enweghị ike izere n'otu oge, ekwesịrị iji nlezianya nyochaa ịdị mma nke ngwakọta dị otú ahụ n'oge ọgwụgwọ.
Ebe ọ bụ na atorvastatin na-enweta metonolized site na isoenzyme CYP3A4, ojiji nke atorvastatin na-egbochi ya na ndị na-egbochi isoenzyme CYP3A4 nwere ike ibute mmụba nke atorvastatin na plasion ọbara.
OATP1B1 na-egbochi ndị na-egbochi protein (dịka ọmụmaatụ, cyclosporine) nwere ike iwelie bioavailability nke atorvastatin.
N'iji ọgwụ mgbochi oge (mgbochi nke magnesium hydroxide na aluminom hydroxide), ntinye nke atorvastatin na plasma ọbara na-ebelata.
Site na iji atorvastatin na oge nke colestipol, a na-ebelata mkpokoro atorvastatin na plasma ọbara site na 25%, mana ọgwụgwọ ọgwụgwọ nke njikọta ahụ dị elu karịa mmetụta nke atorvastatin naanị.
Ojiji atorvastatin na-ejikọ ọnụ na ọgwụ ndị na-ebelata mkpokọta homonụ steroid endogenous (gụnyere cimetidine, ketoconazole, spironolactone) na-amụba ohere nke belata homonụ steroid endogenous (ịkpachara anya kwesịrị igosipụta).
N'ime ndị ọrịa n'otu oge na-anata 80 mg nke atorvastatin na digoxin, mkpokọta digoxin na plasma ọbara na-abawanye ihe dị ka 20%, ya mere, a ga-enyocha ndị ọrịa dị otú ahụ.
Site n'iji atorvastatin n’otu oge yana ọgwụ mgbochi ime maka nchịkwa ọnụ (norethisterone na ethinyl estradiol), ọ ga-ekwe omume ịbawanye nnabata nke mgbochi ma bulie itinye uche ha na plasma ọbara. Ekwesịrị inyocha nhọrọ nke ọgwụ mgbochi na ụmụ nwanyị na-ewere atorvastatin.
Ojiji nke atorvastatin na warfarin n'oge gboo nwere ike ịbawanye uto nke warfarin na coagulation ọbara (mbelata oge prothrombin). Mmetụta a na-apụ n'anya mgbe ụbọchị iri nke ọgwụ ndị a na-eme n'otu oge.
N'agbanyeghị eziokwu ahụ bụ na emebeghị nnyocha banyere ojiji nke colchicine na atorvastatin, enwere akụkọ banyere mmepe nke myopathy na njikọ a. Iji otu oge atorvastatin na colchicine kwesiri ịkpachara anya.
Site na ojiji nke atorvastatin na terfenadine n'otu oge, achọpụtaghị mgbanwe dị ukwuu na ụlọ ọrụ ọgwụ nke terfenadine.
Atorvastatin anaghị emetụta ọgwụ ọgwụ nke phenazone.
Iji ihe ndị na-egbochi nchekwa na-eduga n'ịba ụba nke mkpokọta plasma nke atorvastatin.
Site n’otu oge eji atorvastatin na dose nke 80 mg na amlodipine na dose nke 10 mg, ọgwụ ọgwụ nke atorvastatin na steeti oruru agbanwe agbanwebeghị.
Enweela ikpe nke rhabdomyolysis n'ime ndị ọrịa na-eji atorvastatin na fusidic acid.
Usoro ọgwụgwọ na-agbanwe agbanwe
Mgbe ị na-eji atorvastatin na ndị na-ahụ maka ọgwụ mgbochi ọnụ na estrogens dị ka akụkụ nke usoro ọgwụgwọ nnọchi, enweghị akara nke mmekọrịta mmekọrịta dị oke mkpa na-achọghị.
Iji mkpụrụ osisi greepu n'oge Atoris® nwere ike ibute mmụba nke plasma nke atorvastatin. N'akụkụ a, ndị ọrịa na-a Atụ ọgwụ Atoris® kwesịrị izere ị juiceụ ihe ọ juiceụ graụ mkpụrụ osisi karịa 1.2 lita kwa ụbọchị.

Dodoụbiga ya ókè

Ọrịa: nsogbu ịbawanye ụba.

Ọgwụgwọ: enweghi ọgwụ mgbochi akọwapụtara maka ọgwụgwọ Atoris® overdose. N'ihe banyere ịdoụbiga mmanya ókè, a ga-ebu ọgwụgwọ Symptomatic ka ọ dị mkpa (dịka dọkịta gwara ya). Ebe ọgwụ a jikọtara ya na protein ndị dị na plasma, mmụba dị ukwuu na mkpochapụ Atoris n'oge ịba ọcha n'anya agaghị ele anya.

Mpempe akwụkwọ Mpempe akwụkwọ

Krka, dd, Novo Mesto, Slovenia

Adreesị nke nzukọ ahụ na-anabata ihe ndị na-azụ ahịa na-ekwu maka ịdị mma nke ngwaahịa (ngwongwo) na Republic of Kazakhstan

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

ụlọ 1 b, ụlọ nke abụọ, ọfịs 207

tel.: +7 (727) 311 08 09

faksị: +7 (727) 311 08 12

11.04.05

Ihe onyonyo 3D

Nkọwa nke ụdị usoro onunu ogwu

Mbadamba ụrọ, 10 na 20 mg: gburugburu, ubé biconvex, kpuchie ya na ihe nkiri ihe nkiri nke agba ọcha. Kink ele: acha uhie uhie ike ike uka na ịse fiimu nke na-acha ọcha ma ọ bụ fọrọ nke nta na agba.

Mbadamba ụrọ, 30 mg: gburugburu, ubé biconvex, kpuchie ya na ihe nkiri akpụkpọ ahụ nke na-acha ọcha ma ọ bụ ihe fọrọ nke nta ka ọ bụrụ ụcha, na bevel.

Mbadamba, 40 mg: okirikiri, biconvex dị ntakịrị, kpuchie ya na ihe nkiri ịke na-acha ọcha ma ọ bụ nke na-acha ọcha. Kink ele: acha uhie uhie ike ike uka na ịse fiimu nke na-acha ọcha ma ọ bụ fọrọ nke nta na agba.

Mlọ ọgwụ

Atorvastatin bụ ihe nnọchianya nke ahụ sitere na otu nke statins. Mainzọ kachasị mkpa nke atorvastatin bụ mgbochi nke ọrụ HMG-CoA reductase, enzyme nke na-egbochi ntụgharị nke HMG-CoA na mevalonic acid. Mgbanwe a bụ otu n'ime ụzọ izizi na njikọ nke Chs n'ime ahụ. Atorvastatin na-egbochi mkpokọta XC na-eduga n'ịbawanye ọrụ nke ndị na-anabata LDL na imeju, yana anụ ahụ extrahepatic. Ndị na-anabata ihe a na - ekekọta LDL ma wepụ ha na plasma ọbara, nke na - eduga n'ịbelata mkpokọta LDL-C n'ọbara.

Mmetụta antiatherosclerotic nke atorvastatin bụ nsonaazụ nke nsonaazụ ya na mgbidi nke arịa ọbara na akụkụ ọbara. Atorvastatin na-egbochi njikọ nke isoprenoids, nke bụ ihe na-eto eto nke mkpụrụ ndụ dị n’ime akwara ọbara. N'okpuru mmetụta nke atorvastatin, mmụba nke endothelium na-eme ka ọbara gbasaa, nsonye nke LDL-C, LDL (Apo-B), triglycerides (TG) na-ebelata, ntinye uche nke HDL-HDL na Apolipoprotein A (Apo-A) na-abawanye.

Atorvastatin na-ebelata viscosity nke plasma ọbara na ọrụ nke ụfọdụ ihe coagulation na nchịkọta platelet. N'ihi nke a, ọ na - eme ka hemodynamics na - adịwanye mma ma na - edozi ọnọdụ nke coagulation system. Ndị na-egbochi HMG-CoA reductase na-emetụta metabolism nke macrophages, na-egbochi ọrụ ha ma na-egbochi nbibi nke oghere atherosclerotic.

Dịka iwu, a na-achọpụta mmetụta ọgwụgwọ nke atorvastatin mgbe izu abụọ nke ọgwụgwọ gasịrị, mmetụta kachasị na-etolite mgbe izu anọ gachara.

Atorvastatin na nha nke 80 mg budata belata ihe ize ndụ nke nsogbu nsogbu ischemic (gụnyere ọnwụ site na infarction myocardial) site na 16%, ihe ize ndụ nke ịmaliteghachi n'ụlọ ọgwụ maka angina pectoris, yana ihe ịrịba ama nke ischemia myocardial, na 26%.

Mlọ ọgwụ

A na-enweta mmiri Atorvastatin dị elu, ihe dị ka 80% na-abanye na ngọngọ diges. Ogo nke nnabata na itinye uche na plasma ọbara na-abawanye na oke na nha. Ndi_max na nkezi awa 1-2. N'ime ụmụ nwanyị, T_max nke dị elu site na 20%, na AUC belata site na 10%. Ọdịiche dị na ọgwụ pharmacokinetics na ndị ọrịa site na afọ na okike adịghị mkpa na ha anaghị achọ mmezi dose.

N'ime ndị ọrịa nwere ịrụ mmanya nke imeju T_max 16 ugboro elu karịa nkịtị. Iri ura na -eme ka osisa lara ogwu ngwa ngwa (oge 25 na 9% dika nke ozo), ma mbelata nke itinye uche nke LDL-C yiri nke ahu na atorvastatin n’enweghi nri.

Atorvastatin bioavailability dị ala (12%), sistemụ bioavailability usoro nke inhibitory na-egbochi Htr-CoA reductase bụ 30%. Usoro bioavailability dị ala n'ihi sistem metabolism dị na eriri afọ mucosa na ụzọ izizi gafere.

Ọkara V_d atorvastatin - 381 l. Ihe karịrị 98% nke atorvastatin na-ejikọ protein protein. Atorvastatin anaghị agafe na BBB. Metabolized kachasị na imeju n'okpuru ọrụ nke isoenzyme CYP3A 4 nke cytochrome P450 na nguzobe nke metabolites na-arụ ọrụ metabolites (ortho- na para-hydroxylated metabolites, ngwaahịa nke oxidation beta), nke na-akpata ihe dị ka 70% nke ọrụ inhibitory megide HMG-CoA mbelata, ruo 20-30 awa .

Ndi_1/2 atorvastatin 14 h. A na - ewepụ ya naanị na bile (ọ bụghị n'ịnyịnya enterohepatic recirculation, a na - apụtaghị ya n'oge akwara hemodialysis). Ihe dịka 46% nke atorvastatin bụ nke eriri afọ na-erughị 2% site na akụrụ.

Ndị otu ọrịa pụrụ iche

Childrenmụaka. Enwere obere data na ọmụmụ ihe emepe izu asatọ nke ọgwụ pharmacokinetics na ụmụaka (afọ 6 - 17) na heterozygous familial hypercholesterolemia na ntinye mbụ nke LDL cholesterol ≥4 mmol / L, mesoro na atorvastatin n'ụdị nke 5 ma ọ bụ 10 mg chewable mbadamba ma ọ bụ mbadamba, ntem ke ndise, ke 10 m̀m, 20 mg ke ini ke usen, ke ukem. Naanị covariate dị mkpa na usoro ọgwụ pharmacokinetic nke ndị na-anata atorvastatin bụ ahụ. N sachapụ nke atorvastatin na ụmụaka adịghị iche na nke ndị okenye okenye, nwee ọ̀tụ̀tụ̀ allometric site na ịdị ya. N'ihe dị iche iche nke atorvastatin na o-hydroxyatorvastatin, a hụrụ mgbanwe na-agbanwe agbanwe na LDL-C na LDL.

Ndị okenye na-arịa ọrịa. C_max na plasma ọbara na AUC nke ọgwụ na ndị ọrịa agadi (karịa afọ 65) site na 40 na 30%, n'otu n'otu, dị elu karịa ndị ọrịa okenye na-eto eto. Enweghị ọdịiche dị iche na arụmọrụ yana nchekwa nke ọgwụ ma ọ bụ imezu ebumnuche nke ọgwụgwọ Lipid na-arịa ọrịa ndị agadi agadi ma e jiri ya tụnyere ọnụ ọgụgụ mmadụ niile.

Alrụ ọrụ na-arụ ọrụ na ụlọ. Renrụ ọrụ akụrụ na aka adịghị emetụta mkpocha atorvastatin na plasma ọbara ma ọ bụ ihe ọ na-eme na metabolism; ya mere, mgbanwe mgbanwe dose na ndị ọrịa arụ ọrụ ezughi oke ọrụ achọrọ.

Ọrụ imeju na-arụ ọrụ. Ntinye ọgwụ ahụ gbagotere nke ọma (C_max - ihe dị ka ugboro 16, AUC - ihe dị ka ugboro 11) na ndị ọrịa nwere ọrịa imeju na-egbu egbu (klas B dị ka nhazi nke ụmụaka-Pugh).

Ihe ngosi nke ogwu Atoris ®

- dịka mgbakwunye nri iji belata oke cholesterol, cholesterol-LDL, apo-B na TG na plasma ọbara na ndị ọrịa okenye, ndị na-eto eto na ụmụaka gbara afọ 10 ma ọ bụ karịa nwere nnukwu hypercholesterolemia, gụnyere ezinụlọ hypercholesterolemia (heterozygous) ma ọ bụ jikọtara ọnụ ( agwakọta) ọrịa hyperlipidemia (ụdị IIa na IIb, otu osi dị, dị ka nhazi nke Fredrickson), mgbe mmeghachi omume nri na usoro ọgwụgwọ ndị ọzọ anaghị adị,

- iji belata ngụkọta ngụkọta Chs, Chs-LDL na plasma n'ime ndị okenye nwere hyzycholesterolemia homozygous familial dị ka mgbakwunye na usoro ọgwụgwọ Lipid-wedata dị ala (dịka ọmụmaatụ, LDL apheresis), ma ọ bụ na usoro ọgwụgwọ dị otú ahụ adịghị.

Mgbochi ọrịa obi:

- mgbochi nke ihe gbasara obi na ndị ọrịa okenye n'ihe egwu dị elu nke ịmalite ihe gbasara ọrịa obi na mgbakwunye na mgbazi nke ihe ndị ọzọ dị ize ndụ,

- mgbochi nke ọrịa ụkwara akwara na ndị ọrịa nwere ọrịa obi (CHD) iji belata onwu, myocardial infarction, ọrịa strok, ịmalite ụlọ ọgwụ maka angina pectoris na mkpa nke ịmụgharị.

Ime na lactation

A na-egbochi ọgwụ Atoris ® n'oge afọ ime yana n'oge a na-enye nwa ara. Nnyocha ụmụ anụmanụ na-egosi na ihe ize ndụ nke nwa ebu n’afọ nwere ike karịa uru ọ bụla ọ ga-abara nne.

N'ime ụmụ nwanyị toro afọ ime, ndị na-ejighị ụzọ dị ịtụnanya nke igbochi afọ ime, a gaghị atụ aro iji Atoris ®. Mgbe ị na-eme atụmatụ ịtụrụ ime, ị ga-akwụsị iji Atoris ® opekata mpe ọnwa 1 tupu ịtụrụ ime gị.

Onweghi ihe akaebe banyere ikenye atorvastatin nwere mmiri ara. Agbanyeghị, itinye uche nke atorvastatin na ọbara ọbara na mmiri ara ehi nke ụmụ anụmanụ na-enye nkwado bụ otu ụdị anụmanụ. Ọ bụrụ na ọ dị mkpa iji ọgwụ Atoris ® n’oge ị breastụ ara, iji zere ihe ize ndụ nke ihe omume ụmụaka, a ga-akwụsị inye ụmụ ya ara.

Mpempe mwepụta

Mbadamba ihe eji etinye fim, 10 mg na 20 mg. 10 mbadamba na ngwungwu na agba (blister strip packaging) nke eji eji polyamide / aluminom foiluu / ihe mkpuchi nke PVC-aluminom (Cold na-eme OPA / Al / PVC-Al). 3 ma ọ bụ 9 bl. (blisters) na-etinye n'ime igbe kaadiodu.

Mbadamba ihe eji etinye fim, 30 mg. 10 mbadamba n ’ọnya mmiri nke polyamide / aluminom / PVC-aluminom foil. 3 bl. (blisters) na-etinye n'ime igbe kaadiodu.

Mbadamba ihe eji etinye fim, 40 mg. 10 mbadamba na ngwungwu na agba (blister strip packaging) nke eji eme ihe polyamide / aluminom foil / PVC-aluminom foil. 3 bl. (blisters) na-etinye n'ime igbe kaadiodu.

Emeputa

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

2. LLC KRKA-RUS, 143500, Russia, Moscow Region, Istra, ul. Moskovskaya, 50, na njiko na JSC “KRKA, dd, Novo mesto”, cmarješka cesta 6, 8501 Novo mesto, Slovenia.

Tẹ.: (495) 994-70-70, faksị: (495) 994-70-78.

Mgbe a na-eburu ya na / ma ọ bụ na-eburu ya n'ụlọ ọrụ Russia, a ga-egosi ya: "KRKA-RUS" LLC. 143500, Russia, Russia Mpaghara, Istra, ul. Moscow, 50.

Tẹ.: (495) 994-70-70, faksị: (495) 994-70-78.

CJSC Vector-Medica, 630559, Russia, Novosibirsk mpaghara, Novosibirsk district, r.p. Koltsovo, ụlọ 13, ulo 15.

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

Lọ ọrụ nnọchite anya nke Krka, dd, Novo mesto JSC na Russian Federation / nzukọ na-anabata mkpesa ndị ahịa: 125212, Moscow, Golovinskoye sh., 5, bldg. 1, ala 22.

Tẹ.: (495) 981-10-88, faksị (495) 981-10-90.

Nkọwa

Atoris ® bụ naanị ọnụọgụ atorvastatin nke nwere nnukwu ihe akaebe siri ike n'ihe banyere ịdịmma na nchekwa.

N'ọtụtụ ọmụmụ, enwetara data ndị a.

INTER-ARS nyocha. Ihe omumu ihe omumu nke mba nile nke Atoris ® (Krka) na atorvastatin mbu. Ọmụmụ ihe ahụ were izu 16 wee duzie ya na mba 3 (Slovenia, Poland na Czech Republic). Ọmụmụ ihe ahụ gụnyere ndị ọrịa 117 bụ ndị a na-ekeghị onwe ha ụzọ abụọ - otu otu natara ọgwụ Atoris ® (n = 57), nke ọzọ natara atorvastatin mbụ (n = 60). N'oge omumu ihe omumu, ihe omimi nke Atoris ® bu 16 mg. Ihe omumu a gosiputara nmekorita nke Atoris the na atorvastatin nke mbu site na idoghari ahihia. Atoris ® gosiputara mmetụta yiri ya na atorvastatin nke mbụ iji belata protein C-reactive. Profaịlụ nnabata nke Atoris ® bụ nke kwekọrọ na profaịlụ ndidi na mbụ atorvastatin.

ATLANTICA nyocha. Nyocha nke arụmọrụ na nchekwa nke Atoris the n'ọgwụgwọ ogologo oge nke ndị ọrịa nwere ọrịa dyslipidemia na nnukwu ihe ize ndụ nke ibute ọrịa obi. Ọmụmụ ihe ahụ gụnyere ndị ọrịa 655. E kewapụrụ ndị ọrịa ụzọ atọ.

Ndị ọrịa nọ na otu A (n = 216) natara Atoris ® na usoro nke 10 mg, ndị ọrịa nọ na Group B (n = 207) natara Atoris na dose 10 mg ruo 80 mg (nkezi usoro ịgwụ na njedebe nke ọmụmụ ahụ bụ 28.6 mg) ), ndị ọrịa nọ na otu C (n = 209) natara ọgwụgwọ ọkọlọtọ (mgbanwe ndụ, ọgwụgwọ ọgwụ gụnyere ọgwụgwọ ịbelata ala).

Mgbanwe kachasị dị na LDL-C (mbelata 42%), OXc (30% mbelata), TG (24% belata) mgbe izu 24 gachara na ndị ọrịa na-anata ọgwụgwọ ike na atorvastatin (otu B) ma e jiri ya tụnyere ndị ọrịa na-anata Atoris ® na onunu ogwu nke 10 mg, yana ndi oria na anata ogwu.Ọmụmụ ihe ahụ gosipụtara arụmọrụ yana nchekwa nke Atoris ® maka ọgwụgwọ ogologo oge nke ndị ọrịa nwere dyslipidemia ma nwekwuo nnukwu ọrịa obi.

Ọmụmụ nke ATOP. Nyocha nke arụmọrụ na nchekwa nke Atoris ® n'ọtụtụ ndị ọrịa (ndị ọrịa nwere ọrịa akwara ọbara, ọrịa metabolic, ọrịa shuga, na-arịa ọrịa nke akwara ndị na - adịghị ala ala). Oge ọmụmụ ihe ahụ bụ izu iri na abụọ. Ndị ọrịa (n = 334) natara Atoris ® na usoro onwa site na 10 ruo 40 mg. Nkezi ubochi nke Atoris ® na njedebe nke ihe omumu a bu 21.3 mg. Atoris ® ọgwụgwọ butere ọnụ ọgụgụ gbadara agbada na LDL-C site na 36% na OXc site na 26%. Ọmụmụ ihe ahụ gosipụtara na usoro ọgwụgwọ dị mma yana ezigbo nchekwa nchekwa nke Atoris ® n'ọtụtụ ndị ọrịa.

FARVATER nyocha. Nyocha banyere uru nke ọgwụ Atoris ® 10 na 20 mg na ọkwa nke lipids, protein C-reactive na fibrinogen na ndị ọrịa nwere ọrịa akwara na ọrịa dyslipidemia. Ọmụmụ ihe ahụ gụnyere ndị ọrịa 50, mgbe usoro ịgba, natara Atoris ® na usoro nke 10 ma ọ bụ 20 mg / ụbọchị. Ojiji Atoris ®, ma 10 na 20 mg / ụbọchị maka izu isii, jikọtara ọnụ na ịrị elu OXs, TG na Chs-LDL. N'ime ìgwè ndị ọrịa na-anata 10 mg / ụbọchị nke Atoris ®, mbelata a bụ 24.5% (OXc), 18.4% (TG), 34.9% (Chs-LDL), na ndị na-anata Atoris ® 20 mg / ụbọchị - 29,1% (OXc), 28.2% (TG), 40.9% (LDL-C), otu. Mgbe izu 12 gachara, ESA (vasodilation endothelium-based endoshelium) mụbara karịa 40.2% (10 mg / ụbọchị) yana 51.3% (20 mg / ụbọchị). Ogwe aka ike akwara kwụsịrị site na 23.4% (p = 0.008) na 25.7% (p = 0.002) n'ime otu 10 na 20 mg / ụbọchị, otu isi. Ọmụmụ ihe ahụ gosipụtara mbelata dị mma nke ọkwa lipid na mmetụta pleiotropic na ndị ọrịa nwere ọrịa akwara ọbara na hyperlipidemia.

Ọmụmụ OSCAR. Nyocha nke arụmọrụ na nchekwa nke Atoris ® na ezigbo ụlọọgwụ. Ọmụmụ ihe ahụ gụnyere ndị ọrịa 7098 natara atka nke ụlọ ọrụ Krka - Atoris ® (10 mg / ụbọchị). Mgbe izu asatọ nke Atoris treatment jiri ọgwụgwọ 8 mee ihe, ọkwa nke OX belatara site na 22.7%, Chs-LDL - site na 26.7% na TG - site na 24%. Mkpokọta akụrụngwa akụrụngwa ji pasent 33 belata. Ihe omumu a gosiputara odi nma na nchekwa nke Atoris real na ezi ulo ogwu.

1. Inter Ars. Data na faịlụ, KRKA d.d., Novo mesto.

2. ATLANTICA (Nrụpụta na nchekwa nke Atoris (atorvastatin, KRKA) na nsonaazụ ya n'ihe ọghọm nke ihe omume obi na ndị ọrịa nwere hyperlipidemia) - Belenkov Yu.N., Oganov R.G. Ngalaba Nkà Mmụta Ihe Ọmụma Sayensị nke Institute of Cardiology akpọrọ aha A.L. Myasnikova.- FGU RKNPK Rosmedtekhnologii. // Cardiology.- №11.- 2008.

3. ATP. Data na faịlụ, KRKA d.d., Novo mesto.

4. FARVATER (Nrụpụta nke Atorvastatin na mgbidi vaskụla na CRP) - A. Susekov, V. Kukharchuk.- FGU RKNPK Ministry of Health of the Russian Federation na SR Moscow.- 2006.- Cardiology .. Nke 9. 06. 06.- P.4-9 .

5. Shalnova SA, Deev AD Ihe omumu sitere na ihe omumu nke OSCAR - oria oria na oria nke ndi oria nwere nnukwu nsogbu na igba ogwu 2005-2006 // Usoro ogwu na mgbochi. - 2007.- 6 (1).

Homozygous hereditary hypercholesterolemia

Usoro ọgwụgwọ bụ otu ihe ahụ na ụdị hyperlipidemia ndị ọzọ.

A na-ahọrọ oge izizi iche iche dabere ogo ọrịa ahụ. N'ime ọtụtụ ndị ọrịa nwere hypercholesterolemia homozygous, a na-ahụ mmetụta kachasị mma site na iji ọgwụ ahụ na ọgwụ kwa ụbọchị nke 80 mg (otu oge). A na-eji Atoris® agwọ ọrịa na usoro ọgwụgwọ ndị ọzọ (plasmapheresis) ma ọ bụ dịka ọgwụgwọ bụ isi ọ bụrụ na ọgwụgwọ na ụzọ ndị ọzọ agaghị ekwe omume.

Jiri na ndị agadi

N'ime ndị ọrịa agadi na ndị ọrịa nwere ọrịa akụrụ, a gaghị agbanwe ọgwụ Atoris. Ọrụ akụrụma anaghị arụ ọrụ emetụtaghị mkpokọta atorvastatin na plasma ọbara ma ọ bụ ogo nke Mbelata nke ịta LDL-C site na iji atorvastatin, ya mere, a chọghị ịgbanwe ọgwụ a chọrọ.

Ọrụ imeju na-arụ ọrụ

N'ime ndị ọrịa nwere ọrụ imeju na-arụ ọrụ, ọ dị mkpa ịkpachara anya (n'ihi nkwụsị nke ọgwụ iji wepụ ahụ). N'ọnọdụ dị otú a, a ga-eji nlezianya nyochaa ụlọ ọgwụ na nyocha ụlọ nyocha (ị na-ahụ maka ọrụ nke aspartate aminotransferase (ACT) na alanine aminotransferase (ALT). Site na mmụba dị ukwuu na ọrụ nke ọrịa hepatic transaminases, a ga-ebelata dose nke Atoris ma ọ bụ kwụsị ọgwụgwọ.

Jiri n'oge ime na lactation

Atoris nọ n'afọ ime yana mgbe a na-enye nwa ara. Nnyocha ụmụ anụmanụ na-egosi na ihe ize ndụ nke nwa ebu n’afọ nwere ike karịa uru ọ bụla ọ ga-abara nne.

N’ime ụmụ nwanyị gbara ọmụmụ, ndị na-ejighị ụzọ a pụrụ ịtụkwasị obi nke igbochi afọ ime, a gaghị akwado iji Atoris mee ihe. Mgbe ị na-eme atụmatụ ịtụrụ ime, ikwesiri ịkwụsị iji Atoris opekata mpe ọnwa 1 tupu ịtụrụ ime gị.

Onweghi ihe akaebe banyere ikenye atorvastatin nwere mmiri ara. Agbanyeghị, n'ụfọdụ ụdị anụmanụ, nchịkọta nke atorvastatin n'ọbara ọbara yana mmiri ara nke ụmụ anụmanụ na-elekọta ụmụ. Ọ bụrụ na ọ dị mkpa iji ọgwụ Atoris mee ihe n’oge a na-enye nwa ara, iji zere ihe ize ndụ nke ịmalite ihe ọjọọ na ụmụ ọhụrụ, a ga-akwụsị inye ya ara.

Mkparịta ụka ọgwụ ọjọọ

Site na iji Atoris na diltiazem na-eme n'otu oge, enwere ike ịhụbawanye mkpokọta Atoris na plasma ọbara.

Ihe ọghọm nke nsogbu na-abawanye mgbe eji Atoris mee ihe na njikọ ya na fibrates, nicotinic acid, ọgwụ mgbochi, ndị na-egbochi antifungal.

Arụ ọrụ nke Atoris na-ebelata site na iji Rifampicin na Phenytoin n'otu oge.

Site na iji ọgwụ mgbochi antacid, nke gụnyere alumini na magnesium, a na-ahụta mbelata Atoris n'ọbara plasma ọbara.

Atchịkọta Atoris na mmiri mkpụrụ osisi greepu nwere ike ime ka ịba ụba nke ọgwụ na plasma ọbara. Ndị ọrịa na-ewere Atoris kwesịrị icheta na ị drinkingụ mmiri mkpụrụ osisi grape n'ime olu karịrị 1 liter kwa ụbọchị bụ ihe anabataghị.