natgillin/translations-raw huggingface dataset:
In such situations, the risk of treatment should be considered in relation to possible benefit, and clinical monitoring is recommended.
Pri podganah je bila koncentracija atorvastatina in njegovih aktivnih presnovkov v plazmi podobna kot v mleku.
If CPK levels are significantly elevated (> 5 times ULN) at baseline, treatment should not be started.
Ni znano, ali se to zdravilo ali njegovi presnovki pri ljudeh človeku izločajo v materinem mleku.
Creatine phosphokinase measurement Creatine phosphokinase (CPK) should not be measured following strenuous exercise or in the presence of any plausible alternative cause of CPK increase as this makes value interpretation difficult.
{(Lastniško) ime} ima zanemarljiv vpliv na sposobnost vožnje in upravljanja s stroji.
If CPK levels are significantly elevated at baseline (> 5 times ULN), levels should be remeasured within 5 to 7 days later to confirm the results.
Najpogosteje pričakovani neželeni učinki so predvsem prebavni, med drugim zaprtje, napenjanje, dispepsija in bolečine v trebuhu.
Whilst on treatment − Patients must be asked to promptly report muscle pain, cramps, or weakness especially if accompanied by malaise or fever.
V kliničnih raziskavah so zaradi neželenih učinkov, ki so jih pripisali {(Lastniško) ime}, zdravljenje prekinili pri manj kot 2% bolnikov.
43 − If such symptoms occur whilst a patient is receiving treatment with atorvastatin, their CPK levels should be measured.
Naslednja tabela prikazuje profil neželenih učinkov {(Lastniško) ime} na podlagi podatkov iz kliničnih raziskav in obsežnih postmarketinških izkušenj.
If these levels are found to be significantly elevated (> 5 times ULN), treatment should be stopped. − If muscular symptoms are severe and cause daily discomfort, even if the CPK levels are elevated to ≤ 5 x ULN, treatment discontinuation should be considered. − If symptoms resolve and CPK levels return to normal, then re-introduction of atorvastatin or introduction of an alternative statin may be considered at the lowest dose and with close monitoring. − Atorvastatin must be discontinued if clinically significant elevation of CPK levels (> 10 x ULN) occur, or if rhabdomyolysis is diagnosed or suspected.
Ocenjene pogostnosti neželenih učinkov so po dogovoru razvrščene, kot sledi: pogosti (≥ 1/ 100, < 1/ 10); občasni (≥ 1/ 1000, < 1/ 100); redki (≥ 1/ 10000, < 1/ 1000); zelo redki (≤ 1/ 10000).
Risk of rhabdomyolysis is increased when atorvastatin is administered concomitantly with certain medicaments such as: ciclosporin, erythromycin, clarithromycin, itraconazole, ketoconazole, nefazodone, niacin, gemfibrozil, other fibric acid derivates or HIV-protease inhibitors (see section 4.5 and section 4.8).
Občasno: anoreksija, bruhanje.
Patients with rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose- galactose malabsorption should not take this medicine.
Zelo redko: anafilaksija.
4.5 Interaction with other medicinal products and other forms of interaction
31 Bolezni endokrinega sistema
Therefore, the benefit and the risk of concurrent treatment should be carefully weighed (see section 4.4).
Občasno: alopecija, hiperglikemija, hipoglikemija, pankreatitis.
Inhibitors of cytochrome P450 3A4
Psihiatrične motnje
Atorvastatin is metabolized by cytochrome P450 3A4.
Občasno: amnezija.
Interaction may occur when {PRODUCT NAME} is administered with inhibitors of cytochrome P450 3A4 (e. g. ciclosporin, macrolide antibiotics including erythromycin and clarithromycin, nefazodone, azole antifungals including itraconazole and HIV protease inhibitors).
Pogosto: glavobol, omotica, parestezije, hipestezija Nepogoste: periferna nevropatija.
Concomitant administration can lead to increased plasma concentrations of atorvastatin.
Bolezni jeter, žolčnika in žolčevodov
Therefore, special caution should be exercised when atorvastatin is used in combination with such medicinal agents (see section 4.4).
Redko: hepatitis, holestatski ikterus.
44 Inhibitors of P-glycoprotein
Bolezni kože in podkožja
Atorvastatin and atorvastatin-metabolites are substrates of P-glycoprotein.
Občasno: urtikarija.
Inhibitors of the P- glycoprotein (e. g. ciclosporin) can increase the bioavailability of atorvastatin.
Zelo redko: angionevrotski edem, bulozni izpuščaji (vključno z multiformnim eritemom, Stevens - Johnsonovim sindromom in toksično epidermalno nekrolizo).
Erythromycin, clarithromycin
Ušesne bolezni, vključno z motnjami labirinta
Coadministration of atorvastatin 10 mg OD and erythromycin (500 mg QID), or atorvastatin 10 mg OD and clarithromycin (500 mg BID), known inhibitors of cytochrome P450 3A4, were associated with higher plasma concentrations of atorvastatin.
Občasno: miopatija.
Clarithromycin increased the Cmax and AUC of atorvastatin by 56% and 80% respectively.
Redko: miozitis, rabdomioliza.
Itraconazole
Splošne težave
Concomitant administration of atorvastatin 40 mg and itraconazole 200 mg daily resulted in a 3-fold increase in atorvastatin AUC.
Občasno: slabo počutje, zvečanje telesne mase.
Protease inhibitors
Preiskave
Coadministration of atorvastatin and protease inhibitors, known inhibitors of cytochrome P450 3A4, was associated with increased plasma concentrations of atorvastatin.
Te spremembe so ponavadi blage in prehodne ter zdravljenja zaradi njih ni treba prekiniti.
Grapefruit juice
32 4. 9 Preveliko odmerjanje
Contains one or more components that inhibit CYP3A4 and can increase plasma concentrations of medicinal products metabolized by CYP3A4.
Narediti je treba laboratorijske preiskave jetrne funkcije in nadzorovati raven CPK v serumu.
Intake of one 240 ml glass of grapefruit juice resulted in an increase in atorvastatin AUC of 37% and a decreased AUC of 20.4% for the active orthohydroxy metabolite.
Ker se atorvastatin v veliki meri veže na beljakovine v plazmi, ni pričakovati, da bi hemodializa pomembno zvečala njegov očistek.
However, large quantities of grapefruit juice (over 1.2 l daily for 5 days) increased AUC of atorvastatin 2.5 fold and AUC of active (atorvastatin and metabolites) HMG-CoA reductase inhibitors 1.3 fold.
5 FARMAKOLOŠKE LASTNOSTI
Concomitant intake of large quantities of grapefruit juice and atorvastatin is therefore not recommended.
Zveča tudi število jetrnih receptorjev LDL na površini celic in s tem vstopanje LDL v celico in njegovo razgradnjo.
Inducers of cytochrome P450 3A4
Ateroskleroza
The effect of inducers of cytochrome P450 3A4 (e. g. rifampicin or phenytoin) on {PRODUCT NAME} is unknown.
V skupini z atorvastatinom (n=253) ateroskleroza ni napredovala.
The possible interaction with other substrates of this isozyme is unknown but should be considered for other medicinal products with a narrow therapeutic index, for example, antiarrhythmic agents Class III including amiodarone.
V študiji niso raziskovali učinka intenzivnega nižanja lipidov na kardiovaskularni opazovani dogodek (tj. potrebo po revaskularizaciji, miokarden infarkt brez smrtnega izida, koronarno smrt).
Other concomitant therapy
Akutni koronarni sindrom
Gemfibrozil / fibric acid derivatives The risk of atorvastatin-induced myopathy may be increased with the concomitant use of fibric acid derivatives.
V raziskavi MIRACL so pri 3086 bolnikih (atorvastatin n=1538; placebo n=1548) z akutnim koronarnim sindromom (miokardni infarkt brez zobca Q in nestabilna angina pektoris) ovrednotili zdravljenje z atorvastatinom 80 mg.
According to results of in vitro studies the metabolic pathway of atorvastatin via glucuronidation is inhibited by Gemfibrozil.
Razlog za to je bilo predvsem 26- odstotno zmanjšanje števila ponovnih hospitalizacij zaradi angine pektoris z znaki ishemije miokarda (p=0, 018).
This may possibly lead to increased plasma levels of atorvastatin (see section 4.4).
Ostali sekundarni opazovani dogodki sami niso bili statistično pomembni (skupno: placebo 22, 2%, atorvastatin 22, 4%).
Digoxin When multiple doses of digoxin and 10 mg atorvastatin were coadministered, steady-state plasma digoxin concentrations were unaffected.
Bolnike so zdravili z antihipertenzivno terapijo (program na podlagi amlodipina ali atenolola) ter bodisi z 10 mg atorvastatina na dan (n=5168), bodisi s placebom (n=5137).
This interaction may be explained by an inhibition of the membrane transport protein, P-glycoprotein.
Celotna umrljivost in kardiovaskularna umrljivost se nista pomembno zmanjšali (185 dogodkov v primerjavi z 212, p=0, 17, in 74 dogodkov v primerjavi z 82, p=0, 51).
Patients taking digoxin should be monitored appropriately.
Opazili so pomembno interakcijo z zdravljenjem glede na izhodiščno antihipertenzivno terapijo.
45 Oral contraceptives Coadministration of {PRODUCT NAME} with an oral contraceptive produced increases in plasma concentrations of norethindrone and ethinyl oestradiol.
Vsi bolniki so imeli vsaj enega od naslednjih dejavnikov tveganja: hipertenzija, kajenje v času preskušanja, retinopatija, mikroalbuminurija ali makroalbuminurija.
These increased concentrations should be considered when selecting oral contraceptive doses.
Bolnike so zdravili bodisi z atorvastatinom 10 mg na dan (n=1428), bodisi s placebom (n=1410); povprečno spremljanje je trajalo 3, 9 leta.
Colestipol Plasma concentrations of atorvastatin and its active metabolites were lower (by approx.
(atorvastatin v
25%) when colestipol was coadministered with {PRODUCT NAME}.
tveganja (%)
However, lipid effects were greater when {PRODUCT NAME} and colestipol were coadministered than when either medicinal product was given alone.
Pomembni kardiovaskularni dogodki (AMI s smrtnim izidom in brez njega, nemi MI, akutna smrt zaradi koronarne bolezni, nestabilna angina pektoris, CABG, PTCA, revaskularizacija, možganska kap)
Antacid Coadministration of {PRODUCT NAME} with an oral antacid suspension containing magnesium and aluminium hydroxides decreased plasma concentrations of atorvastatin and its active metabolites approx.
Na podlagi razlike med okvirnim številom dogodkov v povprečnem obdobju spremljanja 3, 9 leta.
35%; however, LDL-C reduction was not altered.
35 AMI = akutni miokardni infarkt; CABG (coronary artery bypass graft) = obvodna operacija koronarne arterije; MI = miokardni infarkt; PTCA (percutaneous transluminal coronary angioplasty) = perkutana transluminalna koronarna angioplastika
Warfarin Coadministration of {PRODUCT NAME} and warfarin caused a small decrease in prothrombin time during the first days of dosing which returned to normal within 15 days of {PRODUCT NAME} treatment.
Ni bilo dokazov, da bi se učinek zdravljenja razlikoval glede na spol bolnikov, njihovo starost ali izhodiščno koncentracijo holesterola LDL.
Nevertheless, patients receiving warfarin should be closely monitored when {PRODUCT NAME} is added to their therapy.
Opažen je bil ugoden trend glede na stopnjo smrtnosti (82 smrti v skupini s placebom, 61 smrti v skupini z zdravljenjem, p=0, 0592).
Phenazone Coadministration of multiple doses of {PRODUCT NAME} and phenazone showed little or no detectable effect in the clearance of phenazone.
Absorpcija
Cimetidine An interaction study with cimetidine and {PRODUCT NAME} was conducted, and no interaction was seen.
Absolutna biološka uporabnost atorvastatina je približno 12%, sistemska uporabnost zaviralnega delovanja na HMG CoA reduktazo pa približno 30%.
Amlodipine Atorvastatin pharmacokinetics were not altered by the coadministration of atorvastatin 80 mg and amlodipine 10 mg at steady state.
Atorvastatin je ≥ 98% vezan na beljakovine v plazmi.
Other In clinical studies in which {PRODUCT NAME} was administered with antihypertensives or hypoglycaemic agents no clinically significant interactions were seen.
Poleg drugih poti poteka nadaljnja presnova teh produktov tudi z glukuronidacijo.
4.6 Pregnancy and lactation
Izločanje
{PRODUCT NAME} is contraindicated in pregnancy and while breast feeding.
Atorvastatin se po presnovi v jetrih in/ ali zunaj jeter eliminira predvsem z žolčem.
Women of child- bearing potential should use appropriate contraceptive measures.
Kot kaže, zdravilo nima pomembne enterohepatične recirkulacije.
The safety of atorvastatin in pregnancy and lactation has not yet been proven.
Povprečni eliminacijski razpolovni čas atorvastatina pri ljudeh je približno 14 ur.
There is evidence from animal studies that HMG-CoA reductase inhibitors may influence the development of embryos or foetuses.
Razlike niso klinično pomembne in učinek zdravila na lipide se med moškimi in ženskami klinično ne razlikuje. – Ledvična insuficienca:
The development of rat offspring was delayed and post-natal survival reduced during exposure of the dams to atorvastatin at doses above 20 mg/ kg/ day (the clinical systemic exposure).
Pri bolnikih s kronično alkoholno boleznijo jeter (Child- Pugh B) je koncentracija atorvastatina in njegovih aktivnih presnovkov v plazmi občutno zvečana (Cmax je približno 16- krat, AUC pa 11- krat večja).
In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk.
V 4 testih in vitro (s presnovno aktivacijo in brez nje) in 1 preskusu in vivo atorvastatin ni pokazal mutagenega ali klastogenega potenciala.
It is not known whether this medicinal product or its metabolites are excreted in human milk.
V raziskavah na živalih atorvastatin v odmerkih do 175 mg/ kg/ dan pri samcih in do 225 mg/ kg/ dan pri samicah ni vplival na plodnost in ni bil teratogen.
46 4.7 Effects on ability to drive and use machines
6. 1 Seznam pomožnih snovi
{PRODUCT NAME} has negligible influence on the ability to drive and use machines.
kalcijev karbonat mikrokristalna celuloza laktoza monohidrat premreženi natrijev karmelozat polisorbat 80 hidroksipropilceluloza magnezijev stearat
4.8 Undesirable effects
Filmska obloga
The most commonly expected adverse events are mainly gastrointestinal, including constipation, flatulence, dyspepsia, abdominal pain and usually ameliorate on continued treatment.
hipromeloza makrogol 8000 titanov dioksid (E171) smukec simetikon stearatni emulgatorji sorbinska kislina kandelila vosek
Less than 2% of patients were discontinued from clinical trials due to side effects attributed to {PRODUCT NAME}.
6. 2 Inkompatibilnosti
Based on data from clinical studies and extensive post-marketing experience, the following table presents the adverse event profile for {PRODUCT NAME}.
Navedba smiselno ni potrebna.
Estimated frequencies of events are ranked according to the following convention: common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (≤ 1/ 10,000).
Za shranjevanje zdravila niso potrebna posebna navodila.
Gastrointestinal disorders
6. 5 Vrsta ovojnine in vsebina
Common: constipation, flatulence, dyspepsia, nausea, diarrhoea.
Pretisni omoti s 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98 in 100 filmsko obloženimi tabletami.
Uncommon: anorexia, vomiting.
37 Na trgu ni vseh navedenih pakiranj.
Blood and lymphatic system disorders
6. 6 Navodila za uporabo in ravnanje z zdravilom
Uncommon: thrombocytopenia.
Ni posebnih zahtev.
Immune system disorders
[Izpolni država članica]
Common: allergic reactions.
{Ime in naslov} < {tel.} > < {fax} > < {e- mail} >
Very rare: anaphylaxis.
8 ŠTEVILKA DOVOLJENJA ZA PROMET
Endocrine disorders
[Izpolni država članica]
Uncommon: alopecia, hyperglycaemia, hypoglycaemia, pancreatitis.
9 DATUM PRIDOBITVE DOVOLJENJA ZA PROMET
Psychiatric
21. 11. 1996 / 31. 10. 2001
Common: insomnia.
10 DATUM ZADNJE REVIZIJE BESEDILA
Uncommon: amnesia.
38 1 IME ZDRAVILA
Nervous system disorders
2 KAKOVOSTNA IN KOLIČINSKA SESTAVA
Common: headache, dizziness, paraesthaesia, hypoesthesia.
1 filmsko obložena tableta vsebuje 40 mg atorvastatina (v obliki kalcijeve soli trihidrata).
Uncommon: peripheral neuropathy.
Pomožne snovi:
Hepato-biliary disorders
3 FARMACEVTSKA OBLIKA
Rare: hepatitis, cholestatic jaundice.
Filmsko obložena tableta Bela filmsko obložena tableta elipsaste oblike, ki ima na eni strani oznako "40" in na drugi strani oznako "PD 157".
Skin/ Appendages
4 KLINIČNI PODATKI
Skin rash, pruritus.
4. 1 Terapevtske indikacije
Uncommon: urticaria.
Hiperholesterolemija
Very rare: angioneurotic oedema, bullous rashes (including erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis).
{(Lastniško) ime} je indiciran tudi za znižanje zvišanega celotnega holesterola in holesterola LDL pri bolnikih s homozigotno obliko familiarne hiperholesterolemije kot dodatek drugim načinom terapevtskega zniževanja lipidov (npr. aferezi LDL) ali če takšni načini niso na voljo.
47 Ear and Labyrinth Disorders
Preprečevanje kardiovaskularnih bolezni
Uncommon: tinnitus
Preprečevanje kardiovaskularnih dogodkov pri bolnikih, za katere so ocenili, da pri njih obstaja visoko tveganje za prvi kardiovaskularni dogodek (glejte poglavje 5. 1), kot dodatek k obvladovanju ostalih dejavnikov tveganja.
Musculoskeletal disorders
4. 2 Odmerjanje in način uporabe
Common: myalgia, arthralgia.
Običajni začetni odmerek je 10 mg enkrat na dan.
Uncommon: myopathy.
Odmerjanje je treba prilagajati v presledku 4 tednov ali več.
Rare: myositis, rhabdomyolysis.
Največji odmerek je 80 mg enkrat na dan.
Reproductive system disorders
39 Dnevni odmerek je treba zaužiti naenkrat, kadarkoli čez dan, s hrano ali brez nje.
Uncommon: impotence.
Prirejeno po ‫״ ‬Prevention of coronary heart disease in clinical practice:
General disorders
Primarna hiperholesterolemija in kombinirana (mešana) hiperlipidemija
Common: asthenia, chest pain, back pain, peripheral oedema.
Terapevtski odziv je opazen že v 2 tednih, največji odziv pa se ponavadi pokaže v 4 tednih.
Uncommon: malaise, weight gain.
Odziv se med kroničnim zdravljenjem ohrani.
Investigations
Heterozigotna familiarna hiperholesterolemija
As with other HMG-CoA reductase inhibitors elevated serum transaminases have been reported in patients receiving {PRODUCT NAME}.
Zdravljenje je treba začeti z 10 mg {(Lastniško) ime} na dan.
These changes were usually mild, transient, and did not require interruption of treatment.
Odmerke je treba določiti posamezno in jih prilagajati vsake 4 tedne, do odmerka 40 mg na dan.
Clinically important (> 3 times upper normal limit) elevations in serum transaminases occurred in 0.8% patients on {PRODUCT NAME}.
Povprečno znižanje holesterola LDL pri teh 46 bolnikih je bilo približno 21%.
These elevations were dose related and were reversible in all patients.
Atorvastatin je bil uporabljen v odmerkih do 80 mg/ dan.
Elevated serum creatine phosphokinase (CPK) levels greater than 3 times upper limit of normal occurred in 2.5% of patients on {PRODUCT NAME}, similar to other HMG-CoA reductase inhibitors in clinical trials.
Atorvastatin je treba pri teh bolnikih uporabiti ali kot dodatek drugim načinom terapevtskega zniževanja lipidov (npr. aferezi LDL) ali če takšni načini niso na voljo.
Levels above 10 times the normal upper range occurred in 0.4% {PRODUCT NAME}-treated patients (see section 4.4).
Za doseganje ravni holesterola LDL, kakršne priporočajo trenutne smernice, bodo morda potrebni višji odmerki.
4.9 Overdose
Uporaba pri otrocih
Specific treatment is not available for {PRODUCT NAME} overdosage.
Otroke mora zdraviti specialist.
Should an overdose occur, the patient should be treated symptomatically and supportive measures instituted, as required.
Izkušnje z uporabo pri otrocih so omejene na maloštevilne bolnike (stare od 4 do 17 let) s hudimi dislipedamijami, npr. s homozigotno familiarno hiperholesterolemijo.
Liver function tests should be performed and serum CPK levels should be monitored.
Priporočeni začetni odmerek pri tej populaciji je 10 mg atorvastatina na dan.
Due to extensive atorvastatin binding to plasma proteins, haemodialysis is not expected to significantly enhance atorvastatin clearance.
Podatkov o varnosti za otrokov razvoj ni.
PHARMACOLOGICAL PROPERTIES
40 4. 3 Kontraindikacije
5.1 Pharmacodynamic properties
4. 4 Posebna opozorila in previdnostni ukrepi
Pharmacotherapeutic group:
Učinki na jetra
HMG-CoA-reductase inhibitors, ATC code:
Bolnike z zvišanimi vrednostmi transaminaz je treba nadzorovati, dokler nenormalnost( i) ne izgine( jo).
C10AA05
Učinki na skeletne mišice
Atorvastatin is a selective, competitive inhibitor of HMG-CoA reductase, the rate-limiting enzyme responsible for the conversion of 3-hydroxy-3-methyl-glutaryl-coenzyme A to mevalonate, a precursor of sterols, including cholesterol.
Tako kot drugi zaviralci HMG- CoA reduktaze, lahko tudi atorvastatin v redkih primerih prizadene skeletne mišice in povzroči mialgijo, miozitis in miopatijo, ki lahko napreduje v rabdomiolizo - ta je lahko smrtno nevarna, značilni zanjo pa so izrazito zvišanje vrednosti CPK (> 10- kratna ZNM) - mioglobinemija in mioglobinurija, ki lahko povzroči odpoved ledvic.
Triglycerides and cholesterol in the liver are incorporated into very low-density lipoproteins (VLDL) and released into the plasma for delivery to peripheral tissues.
Merjenje kreatin fosfokinaze Kreatin fosfokinaze (CPK) ne smemo meriti po naporni telesni dejavnosti ali v prisotnosti drugih verjetnih vzrokov za zvišanje CPK, kajti v takšnem primeru je tolmačenje vrednosti težavno.
Low- density lipoprotein (LDL) is formed from VLDL and is catabolized primarily through the receptor with high affinity to LDL (LDL receptor).
Če je vrednost CPK izhodiščno zelo velika (> 5- kratna ZNM), je treba CPK za potrditev izvida ponovno izmeriti čez 5 do 7 dni.
Atorvastatin lowers plasma cholesterol and lipoprotein serum concentrations by inhibiting HMG-CoA reductase and subsequently cholesterol biosynthesis in the liver and increases the number of hepatic LDL receptors on the cell surface for enhanced uptake and catabolism of LDL.
Tveganje za rabdomiolizo se zveča, če je atorvastatin uporabljen sočasno z določenimi zdravili, kakršna so npr.: ciklosporin, eritromicin, klaritromicin, itrakonazol, ketokonazol, nefazodon, niacin, gemfibrozil, drugi fibrati ali zaviralci HIV- proteaze (glejte poglavji 4. 5 in 4. 8).
48 Atorvastatin reduces LDL production and the number of LDL particles.
Atorvastatin se presnavlja s citokromom P450 3A4.
Atorvastatin produces a profound and sustained increase in LDL receptor activity coupled with a beneficial change in the quality of circulating LDL particles.
Medsebojno delovanje se lahko pojavi, če {(Lastniško) ime} uporabljamo sočasno z zaviralci citokroma P450 3A4 (npr. ciklosporinom, makrolidnimi antibiotiki, vključno z eritromicinom in klaritromicinom, nefazodonom, azolnimi antimikotiki vključno z itrakonazolom in zaviralci HIV proteaze).
Atorvastatin is effective in reducing LDL-C in patients with homozygous familial hypercholesterolaemia, a population that has not usually responded to lipid- lowering medication.
Zaviralci glikoproteina P (npr. ciklosporin) lahko zvečajo biološko uporabnost atorvastatina.
Atorvastatin has been shown to reduce concentrations of total-C (30% - 46%), LDL-C (41% - 61%), apolipoprotein B (34% - 50%), and triglycerides (14% - 33%) while producing variable increases in HDL-C and apolipoprotein A1 in a dose response study.
Sočasno uporabo 10 mg atorvastatina enkrat na dan in eritromicina (500 mg štirikrat na dan) oz. klaritromicina (500 mg dvakrat na dan) – oba sta znana zaviralca citokroma P450 3A4 – je spremljalo zvečanje koncentracije atorvastatina v plazmi.
These results are consistent in patients with heterozygous familial hypercholesterolaemia, nonfamilial forms of hypercholesterolaemia, and mixed hyperlipidaemia, including patients with noninsulin-dependent diabetes mellitus.
Sočasno uporabo atorvastatina in zaviralcev proteaz, ki so znani zaviralci citokroma P450 3A4, je spremljalo zvišanje koncentracije atorvastatina v plazmi.
Reductions in total-C, LDL-C, and apolipoprotein B have been proven to reduce risk for cardiovascular events and cardiovascular mortality.
Vsebuje eno ali več sestavin, ki zavirajo CYP3A4, in lahko zveča plazemsko koncentracijo zdravil, ki se presnavljajo s CYP3A4.
Mortality and morbidity studies with atorvastatin have not yet completed.
Zato ni priporočljivo, da bolnik med jemanjem atorvastatina pije veliko grenivkinega soka.
Atherosclerosis
Induktorji citokroma P450 3A4