natgillin/translations-raw huggingface dataset:
All patients had at least 3 of the pre-defined cardiovascular risk factors: male gender, age ≥ 55 years, smoking, diabetes, history of CHD in a first-degree relative, TC: HDL-C > 6, peripheral vascular disease, left ventricular hypertrophy, prior cerebrovascular event, specific ECG abnormality, proteinuria/ albuminuria.
Vsi bolniki so imeli vsaj 3 od naslednjih, vnaprej določenih dejavnikov kardiovaskularnega tveganja: moški spol, starost ≥ 55 let, kajenje, diabetes, anamnezo koronarne bolezni pri sorodniku v prvem kolenu, razmerje trigliceridi: HDL > 6, periferno žilno bolezen, hipertrofijo levega prekata, predhoden cerebrovaskularni dogodek, specifične nenormalnosti EKG ali proteinurijo/ albuminurijo.
Patients were treated with anti-hypertensive therapy (either amlodipine or atenolol-based regimen) and either atorvastatin 10 mg daily (n=5,168) or placebo (n=5,137).
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).
Relative Risk
relativno
No. of Events (Atorvastatin
št. dogodkov
Absolute Risk
absolutno
vs Placebo)
tveganja (%)
Reduction1
primerjavi s
Event
dogodek
Fatal CHD plus non-fatal MI Total cardiovascular events and revascularization procedures Total coronary events
Skupno število ardiovaskularnih dogodkov in revaskularizacij
483
389 v primerjavi s 483
1
Skupno število koronarnih dogodkov 1
178 vs 247
178 v primerjavi s 247
CHD = coronary heart disease; MI = myocardial infarction.
Na podlagi razlike med okvirnim številom dogodkov v povprečnem obdobju spremljanja 3, 3 leta; CHD = koronarna bolezen; MI = miokardni infarkt.
82 events, p=0.51).
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).
In the subgroup analyses by gender (81% males, 19% females), a beneficial effect of atorvastatin was seen in males but could not be established in females possibly due to the low event rate in the female subgroup.
V analizi podskupin po spolu (81% moških, 19% žensk) so ugoden učinek atorvastatina na glavni opazovani dogodek potrdili pri moških, ne pa tudi pri ženskah, verjetno zato, ker je bila pogostost dogodkov v ženski podskupini manjša.
12), but this was not statistically significant.
Celotna umrljivost in kardiovaskularna umrljivost sta bili številčno večji pri ženskah (38 v primerjavi s 30 in 17 v primerjavi z 12), vendar to ni bilo statistično pomembno.
The primary endpoint (fatal CHD plus non-fatal MI) was significantly reduced by atorvastatin in patients treated with Amlodipine (HR 0.47 (0.32-0.69), p=0.00008), but not in those treated with Atenolol (HR 0.83 (0.59-1.17), p= 0.287).
Atorvastatin je pomembno zmanjšal pojavnost primarnega opazovanega dogodka (koronarna bolezen s smrtnim izidom in miokardni infarkt brez smrtnega izida) pri bolnikih, ki so se zdravili z amlodipinom (razmerje tveganja 0, 47 (0, 32- 0, 69), p=0, 00008), ne pa tudi pri tistih, ki so se zdravili z atenololom (razmerje tveganja 0, 83 (0, 59- 1, 17), p=0, 287).
The effect of atorvastatin on fatal and non-fatal cardiovascular disease was also assessed in a randomized, double-blind, multicenter, placebo-controlled trial, the Collaborative Atorvastatin Diabetes Study (CARDS) in patients with type 2 diabetes, 40-75 years of age, without prior history of
Učinek atorvastatina na kardiovaskularne bolezni s smrtnim izidom in brez njega so ocenili tudi v randomiziranem, dvojno slepem, multicentričnem, s placebom kontroliranem preskušanju CARDS (Collaborative Atorvastatin Diabetes Study), ki je vključevalo bolnike z diabetesom tipa 2, stare od 40 do 75 let, brez anamneze predhodne kardiovaskularne bolezni ter s koncentracijo holesterola LDL 4, 14 mmol/ l (160 mg/ dl) in trigliceridov ≤ 6, 78 mmol/ l (600 mg/ dl).
Patients were treated with either atorvastatin 10 mg daily (n=1428) or placebo (n=1410) for a median follow-up of 3.9 years.
Bolnike so zdravili bodisi z atorvastatinom 10 mg na dan (n=1428), bodisi s placebom (n=1410); povprečno spremljanje je trajalo 3, 9 leta.
(%)
placebom)
(%)
(%) vrednost p
Major cardiovascular events (fatal and non-fatal AMI, silent MI, acute CHD death, unstable angina, CABG, PTCA, revascularization, stroke)
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)
127
83 v primerjavi 127
MI (fatal and non-fatal AMI, silent MI)
MI (AMI s smrtnim izidom in brez njega, nemi MI)
38 vs 64
38 v
Strokes (Fatal and non-fatal) 1
Možganske kapi (s smrtnim izidom in brez njega) 1
21 vs.
21 v
39
primerjavi s 39
Based on difference in crude events rates occurring over a median follow-up of 3.9 years.
Na podlagi razlike med okvirnim številom dogodkov v povprečnem obdobju spremljanja 3, 9 leta.
AMI = acute myocardial infarction; CABG = coronary artery bypass graft; CHD = coronary heart disease; MI = myocardial infarction; PTCA = percutaneous transluminal coronary angioplasty.
22 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
There was no evidence of a difference in the treatment effect by patient’ s gender, age, or baseline LDL-C level.
Ni bilo dokazov, da bi se učinek zdravljenja razlikoval glede na spol bolnikov, njihovo starost ali izhodiščno koncentracijo holesterola LDL.
61 deaths in the atorvastatin group, p=0.0592).
Opažen je bil ugoden trend glede na stopnjo smrtnosti (82 smrti v skupini s placebom, 61 smrti v skupini z zdravljenjem, p=0, 0592).
The low systemic availability is attributed to presystemic clearance in gastrointestinal mucosa and/ or hepatic first-pass metabolism
Majhno sistemsko uporabnost pripisujejo predsistemskemu očistku v sluznici prebavil in/ ali jetrni presnovi prvega prehoda.
37 Distribution
Porazdelitev
Mean volume of distribution of atorvastatin is approximately 381 l.
Povprečni volumen distribucije atorvastatina je približno 381 litrov.
Atorvastatin is ≥ 98% bound to plasma proteins.
Atorvastatin je ≥ 98% vezan na beljakovine v plazmi.
Atorvastatin is metabolized by cytochrome P450 3A4 to ortho- and parahydroxylated derivatives and various beta-oxidation products.
Atorvastatin se s citokromom P450 3A4 presnavlja v orto - in parahidroksilirane derivate in različne betaoksidacijske produkte.
In vitro, inhibition of HMG-CoA reductase by ortho- and parahydroxylated metabolites is equivalent to that of atorvastatin.
Orto - in parahidroksilirani presnovki in vitro zavirajo HMG CoA reduktazo enako kot atorvastatin.
Atorvastatin is eliminated primarily in bile following hepatic and/ or extrahepatic metabolism.
Atorvastatin se po presnovi v jetrih in/ ali zunaj jeter eliminira predvsem z žolčem.
Special populations − Geriatric:
Posebne populacije – Starejši:
Plasma concentrations of atorvastatin and its active metabolites are higher in healthy elderly subjects than in young adults while the lipid effects were comparable to those seen in younger patient populations. − Paediatric:
Koncentracija atorvastatina in njegovih aktivnih presnovkov v plazmi je pri zdravih starejših osebah večja kot pri mladih odraslih, učinki na lipide pa so primerljivi tistim pri mlajših bolnikih. – Otroci:
Pharmacokinetic data in the paediatric population are not available. − Gender:
Farmakokinetičnih podatkov za otroke ni. – Spol:
10% lower for AUC).
Koncentracija atorvastatina in njegovih aktivnih presnovkov je pri ženskah drugačna kot pri moških (Cmax je pri ženskah približno 20% večja, AUC pa 10% manjša) kot pri moških.
These differences were of no clinical significance, resulting in no clinically significant differences in lipid effects among men and women. − Renal insufficiency:
Razlike niso klinično pomembne in učinek zdravila na lipide se med moškimi in ženskami klinično ne razlikuje. – Ledvična insuficienca:
Renal disease has no influence on the plasma concentrations or lipid effects of atorvastatin and its active metabolites. − Hepatic insufficiency:
Bolezen ledvic ne vpliva niti na koncentracijo atorvastatina in njegovih aktivnih presnovkov v plazmi niti na njihov učinek na lipide. – Jetrna insuficienca:
11-fold in AUC) in patients with chronic alcoholic liver disease (Childs-Pugh B).
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).
The maximum dose used was 63-fold higher than the highest human dose (80 mg/ day) on a mg/ kg body-weight basis and 8- to 16-fold higher based on AUC(0-24) values as determined by total inhibitory activity.
Največji uporabljeni odmerek je bil glede na mg/ kg telesne mase 63- krat večji od največjega odmerka pri človeku (80 mg/ kg), glede na vrednosti AUC( 0- 24) ugotovljene s celotnim zaviralnim delovanjem, pa 8 do 16- krat večji.
In a 2-year study in mice, incidences of hepatocellular adenoma in males and hepatocellular carcinomas in females were increased at the maximum dose used, and the maximum dose used was 250-fold higher than the highest human dose on a mg/ kg body-weight basis.
Med dveletno raziskavo na miših je ob največjem uporabljenem odmerku pri samcih porasla incidenca hepatocelularnega adenoma, pri samicah pa hepatocelularnega karcinoma; največji uporabljeni odmerek (v mg/ kg telesne mase) je bil 250- krat večji od največjega odmerka pri človeku.
Systemic exposure was 6-to 11-fold higher based on AUC(0-24).
Glede na AUC( 0- 24) je bila sistemska izpostavljenost od 6 - do 11- krat večja.
In animal studies atorvastatin had no effect on male or female fertility at doses up to 175 and 225 mg/ kg/ day, respectively, and was not teratogenic.
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.
Calcium carbonate Microcrystalline cellulose Lactose monohydrate Croscarmellose sodium Polysorbate 80 Hyprolose Magnesium stearate
kalcijev karbonat mikrokristalna celuloza laktoza monohidrat premreženi natrijev karmelozat polisorbat 80 hidroksipropilceluloza magnezijev stearat
Hypromellose Polyethylene glycol Titanium dioxide (E171) Talc Simethicone Stearate emulsifiers Sorbic acid Candelilla wax
hipromeloza makrogol 8000 titanov dioksid (E171) smukec simetikon stearatni emulgatorji sorbinska kislina kandelila vosek
The blisters consist of a forming film made of polyamide/ aluminum foil/ polyvinyl chloride and a backing made of either paper/ polyester/ aluminum foil/ vinyl heat-seal coating or aluminum foil/ vinyl heat-seal coating.
Folijsko- folijski pretisni omoti z enoodmernimi pretisnimi razdelki iz poliamida/ aluminijske folije/ polivinilklorida in podloga iz papirja/ poliestra/ aluminijske folije/ vinila za toplotno lepljenje oz. podlago iz aluminijske folije/ vinila za toplotno lepljenje.
6.6 Special precautions for disposal
6. 6 Navodila za uporabo in ravnanje z zdravilom
< [See Annex I - To be completed nationally] > [For referral procedures]
< [Glejte Dodatek I - Izpolni država članica] > [For referral procedures]
{Name and address }< {tel }> < {fax }> < {e-mail }>
{Ime in naslov} < {tel.} > < {fax} > < {e- mail} >
MARKETING AUTHORISATION NUMBER(S)
8 ŠTEVILKA DOVOLJENJA ZA PROMET
< {DD/MM/YYYY} > < {DD month YYYY} >
9 DATUM PRIDOBITVE DOVOLJENJA ZA PROMET
NAME OF THE MEDICINAL PRODUCT
25 1 IME ZDRAVILA
< [See Annex I - To be completed nationally] > [For referral procedures] {PRODUCT NAME} 40mg film-coated tablet
< [Glejte Dodatek I - Izpolni država članica] > [For referral procedures] {(Lastniško) ime} 20 mg filmsko obložene tablete
Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin calcium (trihydrate)).
1 filmsko obložena tableta vsebuje 20 mg atorvastatina (v obliki kalcijeve soli trihidrata).
Each {PRODUCT NAME} 40 mg film-coated tablet contains 131.22 mg lactose monohydrate.
Vsaka {(Lastniško) ime} 20 mg filmsko obložena tableta vsebuje 65. 61 mg laktoze monohidrata.
PHARMACEUTICAL FORM
4 KLINIČNI PODATKI
Film-coated tablet White elliptical, film-coated tablets debossed "40" on one side and "PD 157" on the other.
4. 1 Terapevtske indikacije
CLINICAL PARTICULARS
Hiperholesterolemija
4.1 Therapeutic indications
Preprečevanje kardiovaskularnih bolezni
Hypercholesterolaemia
4. 2 Odmerjanje in način uporabe
{PRODUCT NAME} is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in patients with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate.
Pred začetkom zdravljenja s {(Lastniško) ime} je treba bolniku predpisati standardno dieto za znižanje holesterola, ki jo mora nadaljevati tudi med zdravljenjem s {(Lastniško) ime}.
{PRODUCT NAME} is also indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e. g.
Odmerjanje je treba določiti posamezno glede na izhodiščno koncentracijo holesterola LDL, cilj zdravljenja in bolnikov odziv.
LDL apheresis) or if such treatments are unavailable.
Običajni začetni odmerek je 10 mg enkrat na dan.
Prevention of cardiovascular disease
26 Dnevni odmerek je treba zaužiti naenkrat, kadarkoli čez dan, s hrano ali brez nje.
Prevention of cardiovascular events in patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors.
Pri bolnikih z ugotovljeno koronarno boleznijo srca in drugih bolnikih, ki jih ogrožajo ishemični zapleti, sta cilj zdravljenja holesterol LDL < 3 mmol/ l (< 1, 15 mg/ ml) in celotni holesterol < 5 mmol/ l (< 1, 90 mg/ ml).
4.2 Posology and method of administration
Prirejeno po ‫״ ‬Prevention of coronary heart disease in clinical practice:
The patient should be placed on a standard cholesterol-lowering diet before receiving {PRODUCT NAME} and should continue on this diet during treatment with {PRODUCT NAME}.
Primarna hiperholesterolemija in kombinirana (mešana) hiperlipidemija
Dosage should be individualized according to baseline LDL-C levels, the goal of therapy, and patient response.
Odziv se med kroničnim zdravljenjem ohrani.
The usual starting dose is 10 mg once a day.
Zdravljenje je treba začeti z 10 mg {(Lastniško) ime} na dan.
Adjustment of dosage should be made at intervals of 4 weeks or more.
Odmerke je treba določiti posamezno in jih prilagajati vsake 4 tedne, do odmerka 40 mg na dan.
The maximum dose is 80 mg once a day.
Atorvastatin je bil uporabljen v odmerkih do 80 mg/ dan.
Each daily dose of atorvastatin is given all at once and may be given at any time of day with or without food.
Odmerjanje atorvastatina pri bolnikih s homozigotno familiarno hiperholesterolemijo je od 10 do 80 mg na dan.
41 For patients with established coronary heart disease or other patients at increased risk of ischemic events, the treatment goal is LDL-C < 3 mmol/ l (or < 115 mg/ dl) and total cholesterol < 5 mmol/ l (or < 190 mg/ dl).
Za doseganje ravni holesterola LDL, kakršne priporočajo trenutne smernice, bodo morda potrebni višji odmerki.
Adapted from “ Prevention of coronary heart disease in clinical practice:
Odmerjanje pri bolnikih z ledvično insuficienco
Recommendations of the Second Joint Task Force of European and Other Societies on Coronary Prevention” in Atherosclerosis 140 (1998) 199-270.
Bolezen ledvic ne vpliva niti na koncentracijo atorvastatina v plazmi niti na njegove učinke na lipide, zato odmerka ni treba prilagajati.
Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia
Pri bolnikih, starejših od 70 let, sta učinkovitost in varnost zdravila v priporočenih odmerkih podobna kot pri splošni populaciji.
The majority of patients are controlled with {PRODUCT NAME} 10 mg once a day.
Priporočeni začetni odmerek pri tej populaciji je 10 mg atorvastatina na dan.
A therapeutic response is evident within 2 weeks, and the maximum therapeutic response is usually achieved within 4 weeks.
Odmerek je mogoče glede na odziv in prenašanje zvečati do 80 mg na dan.
The response is maintained during chronic therapy.
Podatkov o varnosti za otrokov razvoj ni.
Heterozygous familial hypercholesterolaemia
4. 4 Posebna opozorila in previdnostni ukrepi
Patients should be started with {PRODUCT NAME} 10 mg daily.
Laboratorijske preiskave jetrne funkcije je treba narediti pred začetkom zdravljenja in jih redno izvajati med zdravljenjem.
Doses should be individualised and adjusted every 4 weeks to 40 mg daily.
Bolnike z zvišanimi vrednostmi transaminaz je treba nadzorovati, dokler nenormalnost( i) ne izgine( jo).
Thereafter, either the dose may be increased to a maximum of 80 mg daily or a bile acid sequestrant may be combined with 40 mg atorvastatin once daily.
{(Lastniško) ime} je treba previdno uporabljati pri bolnikih, ki uživajo veliko alkohola in/ ali imajo anamnezo o bolezni jeter.
Homozygous familial hypercholesterolaemia
Učinki na skeletne mišice
In a compassionate-use study of 64 patients there were 46 patients for whom confirmed LDL receptor information was available.
Pred zdravljenjem Atorvastatin je treba previdno dajati bolnikom, ki imajo predispozicijske dejavnike za rabdomiolizo.
From these 46 patients, the mean percent reduction in LDL-C was approximately 21%.
Če je vrednost CPK izhodiščno zelo velika (> 5- kratna ZNM), zdravljenja ne začnemo.
Atorvastatin was administered at doses up to 80 mg/ day.
28 – Če se takšni simptomi pojavijo med zdravljenjem z atorvastatinom, je treba določiti CPK.
The dosage of atorvastatin in patients with homozygous familial hypercholesterolemia is 10 to 80 mg daily.
Zato je treba natančno pretehtati koristi in tveganja sočasnega zdravljenja (glejte poglavje 4. 4).
Atorvastatin should be used as an adjunct to other lipid-lowering treatments (e. g.
Atorvastatin se presnavlja s citokromom P450 3A4.
LDL apheresis) in these patients or if such treatments are unavailable.
Med sočasno uporabo lahko koncentracija atorvastatina v plazmi poraste.
Prevention of cardiovascular disease
Zaviralci glikoproteina P
In the primary prevention trials, the dose was 10 mg/ day.
Atorvastatin in njegovi presnovki so substrati glikoproteina P.
Higher dosages may be necessary in order to attain (LDL-) cholesterol levels according to current guidelines.
Zaviralci glikoproteina P (npr. ciklosporin) lahko zvečajo biološko uporabnost atorvastatina.
Dosage in patients with renal insufficiency
Klaritromicin je povečal Cmax atorvastatina za 56% in njegovo AUC za 80%.
Renal disease has no influence on the atorvastatin plasma concentrations nor lipid effects of {PRODUCT NAME}; thus, no adjustment of dose is required.
Sočasna uporaba 40 mg atorvastatina in 200 mg itrakonazola na dan je povzročila 3- kratno zvečanje AUC atorvastatina.
Geriatric use
Zaviralci proteaze
Efficacy and safety in patients older than 70 using recommended doses is similar to that seen in the general population.
Sočasno uporabo atorvastatina in zaviralcev proteaz, ki so znani zaviralci citokroma P450 3A4, je spremljalo zvišanje koncentracije atorvastatina v plazmi.
Pediatric use
29 Grenivkin sok
Pediatric use should only be carried out by specialists.
Vsebuje eno ali več sestavin, ki zavirajo CYP3A4, in lahko zveča plazemsko koncentracijo zdravil, ki se presnavljajo s CYP3A4.
Experience in pediatrics is limited to a small number of patients (age 4 - 17 years) with severe dyslipidemias, such as homozygous familial hypercholesterolemia.
Zaužitje 240- ml kozarca grenivkinega soka je AUC atorvastatina zvečalo za 37%, AUC aktivnega ortohidroksi presnovka pa zmanjšalo za 20, 4%.
The recommended starting dose in this population is 10 mg of atorvastatin per day.
Vendar pa so velike količine zaužitega grenivkinega soka (več kot 1, 2 litra na dan pet dni) AUC atorvastatina zvečale za 2, 5- krat in AUC aktivnih zaviralcev HMG CoA reduktaze (atorvastatina in metabolitov) za 1, 3- krat.
The dose may be increased to 80 mg daily, according to the response and tolerability.
Zato ni priporočljivo, da bolnik med jemanjem atorvastatina pije veliko grenivkinega soka.
Developmental safety data in this population have not been evaluated.
Vpliv induktorjev citokroma P450 3A4 (npr. rifampicina ali fenitoina) na {(Lastniško) ime} ni znan.
4.3 Contraindications
Druga sočasna zdravila
42 {PRODUCT NAME} is contraindicated in patients: − with hypersensitivity to the active substance or to any of the excipients of this medication − with active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal − with myopathy − during pregnancy − while breast-feeding − in women of child-bearing potential not using appropriate contraceptive measures.
To bi lahko povzročilo zvišano koncentracijo atorvastatina v plazmi (glejte tudi poglavje 4. 4).
4.4 Special warnings and precautions for use
Bolnike, ki jemljejo digoksin, je treba ustrezno nadzorovati.
Liver effects
Pri določitvi odmerka peroralnih kontraceptivov je treba zvečanje upoštevati.
Liver function tests should be performed before the initiation of treatment and periodically thereafter.
Holestipol Če je bil holestipol uporabljen sočasno s {(Lastniško) ime}, so bile koncentracije atorvastatina in njegovih aktivnih presnovkov nižje za približno 25%.
Patients who develop any signs or symptoms suggestive of liver injury should have liver function tests performed.
Vendar pa je bil učinek na lipide večji, če sta bila {(Lastniško) ime} in holestipol uporabljena skupaj, kot če je bilo vsako zdravilo uporabljeno posebej.
Patients who develop increased transaminase levels should be monitored until the abnormality(ies) resolve.
Kljub temu je treba bolnike, ki dobivajo varfarin, po dodatku {(Lastniško) ime} v terapijo natančno nadzorovati.
Should an increase in transaminases of greater than 3 times the upper limit of normal persist, reduction of dose or withdrawal of {PRODUCT NAME} is recommended (see section 4.8).
Fenazon Sočasna uporaba večkratnih odmerkov {(Lastniško) ime} in fenazona je na očistek fenazona vplivala malo ali nič.
{PRODUCT NAME} should be used with caution in patients who consume substantial quantities of alcohol and/ or have a history of liver disease.
30 Cimetidin Raziskava interakcij cimetidina in {(Lastniško) ime} ni pokazala nobenega medsebojnega delovanja.
Skeletal muscle effects
4. 6 Nosečnost in dojenje
Atorvastatin, like other HMG-CoA reductase inhibitors, may in rare occasions affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis, a potentially life-threatening condition characterised by markedly elevated CPK levels (> 10 times ULN), myoglobinaemia and myoglobinuria which may lead to renal failure.
Varnost atorvastatina med nosečnostjo in dojenjem ni dokazana.
Before the treatment Atorvastatin should be prescribed with caution in patients with pre-disposing factors for rhabdomyolysis.
Izsledki raziskav na živalih kažejo, da lahko zaviralci HMG CoA reduktaze vplivajo na razvoj zarodka oz. ploda.
A creatine phosphokinase (CPK) level should be measured before starting statin treatment in the following situations: − Renal impairment − Hypothyroidism − Personal or familial history of hereditary muscular disorders − Previous history of muscular toxicity with a statin or fibrate − Previous history of liver disease and/ or where substantial quantities of alcohol are consumed − In elderly (age > 70 years), the necessity of such measurement should be considered, according to the presence of other predisposing factors for rhabdomyolysis
Če so breje samice dobivale atorvastatin v odmerkih nad 20 mg/ kg/ dan (klinična sistemska izpostavljenost), je bil razvoj mladičev upočasnjen, preživetje neposredno po rojstvu pa manjše.