natgillin/translations-raw huggingface dataset:
The inhibitory effect of ritonavir (with or without other protease inhibitors) on P-gp activity may decrease over time (eg digoxin and fexofenadine-see table “ Ritonavir effects on non-antiretroviral drugs” below).
Zaviralni učinek ritonavirja (z drugimi zaviralci proteaz ali brez njih) na aktivnost P- gp se lahko sčasoma zmanjša (npr. digoksin in feksofenadin – glejte spodnjo tabelo “ Učinki ritonavirja na neretrovirusna zdravila ”).
Ritonavir may induce glucuronidation and oxidation by CYP1A2, CYP2C8, CYP2C9 and CYP2C19 thereby increasing the biotransformation of some medicinal products metabolised by these pathways, and may result in decreased systemic exposure to such medicinal products, which could decease or shorten their therapeutic effect.
Ritonavir lahko inducira glukuronidacijo in oksidacijo s CYP1A2, CYP2C8, CYP2C9 in CYP2C19 in tako lahko poveča
Important information regarding drug interactions when ritonavir is used as a pharmacokinetic enhancer is also contained in the Summary of Product Characteristics of the co-administered protease inhibitor.
Pomembne informacije o medsebojnem delovanju zdravil med uporabo ritonavirja kot farmakokinetičnega stopnjevalca vsebuje tudi povzetek glavnih značilnosti sočasno uporabljenega zaviralca proteaz.
Drugs that affect ritonavir levels
Zdravila, ki vplivajo na koncentracijo ritonavirja
Serum levels of ritonavir can be reduced by concomitant use of herbal preparations containing St John’ s wort (Hypericum perforatum).
Sočasna uporaba zeliščnih pripravkov, ki vsebujejo šentjanževko (Hypericum perforatum), lahko zmanjša koncentracijo ritonavirja v serumu, ker šentjanževka inducira encime, ki presnavljajo zdravila.
This is due to the induction of drug metabolising enzymes by St John’ s wort.
Zeliščnih pripravkov s šentjanževko se zato ne sme uporabljati v kombinaciji z ritonavirjem.
Herbal preparations containing St John’ s wort must not be used in combination with ritonavir.
Če bolnik že jemlje šentjanževko, njeno jemanje prekinite in, če je mogoče, kontrolirajte raven virusov.
If a patient is already taking St John’ s wort, stop St John’ s wort and if possible check viral levels.
Koncentracija ritonavirja se lahko po prenehanju jemanja šentjanževke zveča.
Ritonavir levels may increase on stopping St John’ s wort.
Potrebna utegne biti prilagoditev odmerka ritonavirja.
The inducing effect may persist for at least 2 weeks after cessation of treatment with St John’ s wort (see section 4.3).
Indukcijski učinek lahko traja še vsaj 2 tedna po opustitvi šentjanževke (glejte poglavje 4. 3).
Serum levels of ritonavir may be affected by select co-administered medicinal products (eg delavirdine, efavirenz, phenytoin and rifampicin).
Določena sočasno uporabljana zdravila (npr. delavirdin, efavirenz, fenitoin in rifampicin) lahko vplivajo na koncentracijo ritonavirja v serumu.
These interactions are noted in the drug interaction tables below.
Ta medsebojna delovanja so navedena v spodnjih tabelah interakcij.
9 Drugs that are affected by the use of ritonavir
Zdravila, na katera vpliva uporaba ritonavirja
Interactions between ritonavir and protease inhibitors, antiretroviral agents other than protease inhibitors and other non-antiretroviral drugs are listed in the tables below.
Medsebojna delovanja med ritonavirjem in zaviralci proteaz, protiretrovirusnimi zdravili razen zaviralcev proteaz in neretrovirusnimi zdravili so našteta v spodnjih tabelah.
Drug Interactions – Ritonavir with Protease Inhibitors
Medsebojno delovanje zdravil – ritonavir z zaviralci proteaz
Co-
Sočasno
Dose of NORVIR
Odmerek sočasno Odmerek
Drug
Ocenjena
administered Drug
uporabljeno zdravilo
(mg)
uporabljenega zdravila (mg)
(mg)
NORVIRJA (mg)
Assessed
zdravila
↑ 64%
Amprenavir2 ↑ 64% Amprenavir
↑ 5 fold
↑ 5- krat
For further information, physicians should refer to the Agenerase Summary of Product Characteristics.
Za dodatne informacije glejte povzetek glavnih značilnosti zdravila Agenerase.
↑ 86%
Atazanavir ↑ 86% Atazanavir1 ↑ 2- krat
↑ 3-7 fold
↑ 11- krat ↑ 3 - do 7- krat
For further information, physicians should refer to the Reyataz Summary of Product Characteristics.
Za dodatne informacije glejte povzetek glavnih značilnosti zdravila Reyataz.
Darunavir 600, single 100 q12h Darunavir
Darunavir 600, posamičen 100 na 12 ur Darunavir
↑ 14 fold
↑ 14- krat
Ritonavir increases the serum levels of darunavir as a result of CYP3A inhibition.
Ritonavir zavira CYP3A in tako zviša koncentracijo darunavirja v serumu.
For further information, refer to the Summary of Product Characteristics for Prezista.
Za dodatne informacije glejte povzetek glavnih značilnosti zdravila Prezista.
700 q12h
700 na 12 ur
Amprenavir
Amprenavir ↑ 2, 4- krat
↑ 2.4 fold
↑ 11- krat
For further information, physicians should refer to the Telzir Summary of Product Characteristics.
Za dodatne informacije glejte povzetek glavnih značilnosti zdravila Telzir.
400 q12h
400 na 12 ur 10
100 q12h
100 na 12
Nelfinavir 1250 q12h 100 q12h Nelfinavir
Nelfinavir 1250 na 12 ur 100 na 12 ur Nelfinavir
↑ 20to39%
↑ 20- 39%
Saquinavir
Sakvinavir4 ↑ 15- krat Sakvinavir
↑ 5-fold ↔
↑ 5- krat ↔
400 q12h
400 na 12 ur 400 na 12 ur
400 q12h
ND
Ritonavir 100 mg twice daily with saquinavir 1000 mg twice daily provides saquinavir systemic exposure over 24 hours similar to or greater than those achieved with saquinavir 1200 mg three times daily without ritonavir.
Ritonavir 100 mg dvakrat na dan s sakvinavirjem 1000 mg dvakrat na dan zagotavlja 24- urno sistemsko izpostavljenost sakvinavirju, ki je podobna ali večja, kot je dosežena s 1200 mg sakvinavirja trikrat na dan brez ritonavirja.
10 In a clinical study investigating the interaction of rifampicin 600 mg once daily and saquinavir 1000 mg with ritonavir 100 mg twice daily in healthy volunteers, severe hepatocellular toxicity with transaminase elevations up to > 20-fold the upper limit of normal after 1 to 5 days of co-administration was noted.
V klinični študiji, s katero so pri zdravih prostovoljcih raziskali medsebojno delovanje 600 mg rifampicina enkrat na dan ter 1000 mg sakvinavirja s 100 mg ritonavirja dvakrat na dan, so po 1 do 5 dneh sočasne uporabe zabeležili hude toksične učinke na jetrne celice z zvišanjem transaminaz do > 20- kratno zgornjo mejo normalnih vrednosti.
Due to the risk of severe hepatoxicity, saquinavir/ritonavir should not be given together with rifampicin.
Zaradi tveganja za hepatotoksične učinke sakvinavirja/ ritonavirja ne smete dajati skupaj z rifampicinom.
For further information, physicians should refer to the Invirase or Fortovase Summary of Product Characteristics.
Fortovase.
↑ 11 fold
Tipranavir ↑ 11- krat Ritonavir ↓ 40%
↑ 29 fold
↑ 29- krat ND
For further information, physicians should refer to the Aptivus Summary of Product Characteristics.
Za dodatne informacije glejte povzetek glavnih značilnosti zdravila Aptivus.
Not determined.
Ni določeno.
Drug Interactions – Ritonavir with Antiretroviral Agents Other Than Protease Inhibitors Co-
Medsebojno delovanje zdravil – ritonavir s protiretrovirusnimi zdravili razen zaviralcev proteaz Ocenjena Sočasno
Dose of Co-
Odmerek sočasno
Dose of NORVIR (mg)
Odmerek NORVIRJA
Drug
zdravila
administered Drug (mg)
uporabljenega zdravila (mg)
Assessed
(mg)
600 q12h 2 h later
600 na 12 ur 2 uri pozneje
↔
13% ↔
As ritonavir is recommended to be taken with food and didanosine should be taken on an empty stomach, dosing should be separated by 2.5 h.
Zato mora med uporabo enega in drugega miniti 2, 5 ure.
400 q8h
400 na 8 ur
↑ 50%
Ritonavir ↑ 50% ↑ 75%
↔ ↑ 75%
↔
A higher frequency of adverse events (eg, dizziness, nausea, paraesthesia) and laboratory abnormalities (elevated liver enzymes) have been observed when efavirenz is co-administered with ritonavir dosed as an antiretroviral agent.
Med sočasno uporabo efavirenza z ritonavirjem, odmerjanim kot protiretrovirusnim zdravilom, so opažali večjo pogostnost neželenih učinkov (npr. omotico, navzejo, parestezije) in laboratorijskih nepravilnosti (zvišanje jetrnih encimov).
Maraviroc
11 Maravirok
100 q12h 100 q12h
100 na 12 ur 100 na 12 ur
Maraviroc ↑161%
Maravirok ↑ 161% ↑ 28%
For further information, refer to the Summary of Product Characteristics for Celsentri.
Za dodatne informacije glejte povzetek glavnih značilnosti zdravila Celsentri.
Co-administration of ritonavir with nevirapine does not lead to clinically relevant changes in the pharmacokinetics of either nevirapine or ritonavir.
Sočasna uporaba ritonavirja z nevirapinom ne povzroči klinično pomembnih sprememb v farmakokinetiki nevirapina ali ritonavirja.
200 q8h
200 na 8 ur
ND
Zidovudin ↓ 25% ND
Not determined 1.
Ni določeno 1.
Ritonavir effects on Non-antiretroviral Co-administered Drugs Co-administered Drug
Učinki ritonavirja na sočasno uporabljena neretrovirusna zdravila Sočasno uporabljeno zdravilo
Dose of Co- administered Drug (mg)
Odmerek sočasno
Effect on Co- administered Drug AUC
Vpliv na AUC sočasno
Effect on Co- administered Drug Cmax
Vpliv na Cmax sočasno
Dose of Co- administered Drug (mg)
uporabljenega
Dose of NORVIR (mg)
(mg)
Effect on Co- administered Drug AUC
uporabljenega
Effect on Co- administered Drug Cmax
uporabljenega
Ritonavir co-administration is likely to result in increased plasma concentrations of alfuzosin and is therefore contraindicated (see section 4.3).
Sočasna uporaba ritonavirja ponavadi zviša koncentracijo alfuzosina v plazmi in je zato kontraindicirana (glejte poglavje 4. 3).
Amphetamine Derivatives Amphetamine
Derivati amfetamina Amfetamin
Careful monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with antiretroviral doses of ritonavir (see section 4.4).
Med sočasno uporabo teh zdravil in protiretrovirusnih odmerkov ritonavirja je priporočljivo natančno nadziranje terapevtskih in neželenih učinkov (glejte poglavje 4. 4).
Analgesics Buprenorphine Norbuprenorphine Glucuronide metabolites
Analgetiki Buprenorfin Norbuprenorfin Presnovki glukuronida
Meperidine, piroxicam, propoxyphene
Meperidin, piroksikam, propoksifen
Ritonavir co-administration is likely to result in increased plasma concentrations of meperidine, piroxicam, and propoxyphene and is therefore contraindicated (see section 4.3).
Sočasna uporaba ritonavirja ponavadi zviša koncentracijo meperidina, piroksikama in propoksifena v plazmi in je zato kontraindicirana (glejte poglavje 4. 3).
Fentanyl
Odmerek NORVIRJA
Careful monitoring of therapeutic and adverse effects is recommended when fentanyl is concomitantly administered with ritonavir.
Vpliv na Cmax sočasno
Methadone1
uporabljenega
5, single dose
zdravila (mg)
500 q12h,
zdravila
↓ 36%
zdravila
Increased methadone dose may be necessary when concomitantly administered with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer due to induction of glucuronidation.
Ritonavir, odmerjan kot farmakokinetični stopnjevalec ali kot protiretrovirusno zdravilo, zavira CYP3A4, zato je treba pričakovati, da zviša koncentracijo fentanila v plazmi.
Dose adjustment should be considered based on the patient’s clinical response to methadone therapy.
Med sočasno uporabo fentanila in ritonavirja je priporočljivo natančno nadziranje terapevtskih in neželenih učinkov.
Morphine
Metadon1
Morphine levels may be decreased due to induction of glucuronidation by co-administered ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer.
5, posamičen 500 na 12 ur, ↓ 36% ↓ 38% odmerek Zaradi indukcije glukuronidacije utegne biti med sočasno uporabo metadona in ritonavirja, odmerjanega kot protiretrovirusno zdravilo ali farmakokinetični stopnjevalec, potreben večji odmerek metadona.
Antiarrthymics Amiodarone, bepridil, encainide, flecanide, propafenone, quinidine
Morfin
Ritonavir co-administration is likely to result in increased plasma concentrations of amiodarone, bepridil, encainide, flecanide, propafenone, and quinidine and is therefore contraindicated (see section 4.3).
Koncentracija morfina se lahko zviša zaradi glukuronidacije, ki jo inducira sočasna uporaba ritonavirja, odmerjanega kot protivirusno zdravilo ali farmakokinetični stopnjevalec.
12 Ritonavir effects on Non-antiretroviral Co-administered Drugs Co-administered Drug
Antiaritmiki Amiodaron, bepridil, enkainid, flekanid, propafenon, kinidin
Dose of Co- administered Drug (mg)
Sočasna uporaba ritonavirja ponavadi zviša koncentracijo bepridila, enkainida, flekanida, propafenona in kinidina kontraindicirana (glejte poglavje 4. 3).
Dose of NORVIR (mg)
amiodarona, v plazmi in je zato
0.5 single IV dose 0.4 single oral dose
0, 5, posamičen 300 na 12 h, 3 ↑ 86% i. v. odmerek dni
300 q12h, 3 days 200 q12h, 13 days
ND
↑ 86% ↑ 22%
0, 4, posamičen 200 na 12 h, ↑ 22% peroralen 13 dni odmerek
This interaction may be due to modification of P-glycoprotein mediated digoxin efflux by ritonavir dosed as an antriretroviral agent or as a pharmacokinetic enhancer.
Interakcija je morda posledica tega, da ritonavir, odmerjan kot protiretrovirusno zdravilo ali farmakokinetični stopnjevalec, spremeni s P- glikoproteinom posredovani iztok digoksina.
Increased digoxin levels observed in patients receiving ritonavir may lessen over time as induction develops (see section 4.4).
Zvišana koncentracija digoksina, ugotovljena pri prejemnikih ritonavirja, se lahko sčasoma zmanjša, ko se pojavi indukcija (glejte poglavje 4. 4).
Antiasthmatic Theophylline1
Antiastmatik Teofilin1
500 q12h
3 mg/ kg na 8 ur 500 na 12 ur
An increased dose of theophyline may be required when co- administered with ritonavir, due to induction of CYP1A2.
Zaradi indukcije CYP1A2 utegne biti med sočasno uporabo z ritonavirjem potreben večji odmerek teofilina.
Anticancer agents Vincristine, vinblastine
Zdravila proti raku Vinkristin, vinblastin
Serum concentrations may be increased when co-administered with ritonavir resulting in the potential for increased incidence of adverse events.
Sočasna uporaba z ritonavirjem lahko poveča koncentracijo v serumu in posledično tudi pojavljanje neželenih učinkov.
Anticoagulant Warfarin S-Warfarin R-Warfarin
Antikoagulant Varfarin
5, single dose
5, posamičen
Induction of CYP1A2 and CYP2C9 lead to decreased levels of R- warfarin while little pharmacokinetic effect is noted on S- warfarin when co-administered with ritonavir.
Indukcija CYP1A2 in CYP2C9 povzroči znižanje koncentracije R - varfarina, medtem ko na farmakokinetiko S- varfarina sočasna uporaba ritonavirja vpliva le malo.
Anticonvulsants Carbamazepine
Odmerek sočasno
Divalproex, lamotrigine, phenytoin
Odmerek NORVIRJA
Phenytoin may decrease serum levels of ritonavir.
Vpliv na AUC sočasno
13 Ritonavir effects on Non-antiretroviral Co-administered Drugs Co-administered Drug
Vpliv na Cmax sočasno
Antidepressants
zdravila (mg)
Amitriptyline, fluoxetine, imipramine, nortriptyline, paroxetine, sertraline
Antidepresivi Amitriptilin, fluoksetin, imipramin, nortriptilin, paroksetin, sertralin
Ritonavir dosed as an antiretroviral agent is likely to inhibit CYP2D6 and as a result is expected to increase concentrations of desipramine, imipramine, amitriptyline, nortriptyline, fluoxetine, paroxetine or sertraline.
Ritonavir, odmerjan kot protiretrovirusno zdravilo, verjetno zavira CYP2D6, zato je treba pričakovati, da zviša koncentracijo dezipramina, imipramina, amitriptilina, nortriptilina, fluoksetina, paroksetina in sertralina.
100 single oral dose 500 q12h ↑ 145% ↑ 22% The AUC and Cmax of the 2-hydroxy metabolite were decreased 15 and 67%, respectively.
100, posamičen 500 na 12 ur ↑ 145% ↑ 22% peroralni odmerek AUC 2- hidroksi presnovka se je zmanjšala za 15%, njegova Cmax pa za 67%.
50, single dose
50, posamičen 200 na 12 ur odmerek
↑ 2.4-fold
↑ 2, 4- krat
An increase in the incidence in trazodone-related adverse events was noted when co-administered with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer.
Med sočasno uporabo trazodona z ritonavirjem, odmerjanim kot protiretrovirusno zdravilo ali farmakokinetični stopnjevalec, so opažali večjo incidenco neželenih učinkov, povezanih s trazodonom.
Antihistamines Astemizole, terfenadine
Antihistaminiki Astemizol, terfenadin
Ritonavir co-administration is likely to result in increased plasma concentrations of astemizole and terfenadine and is therefore contraindicated (see section 4.3).
Sočasna uporaba ritonavirja ponavadi zviša koncentracijo astemizola in terfenadina v plazmi in je zato kontraindicirana (glejte poglavje 4. 3).
Ritonavir may modify P-glycoprotein mediated fexofenadine efflux when dosed as an antriretroviral agent or as a pharmacokinetic enhancer resulting in increased concentrations of fexofenadine.
Ritonavir, odmerjan kot protiretrovirusno zdravilo ali farmakokinetični stopnjevalec, lahko spremeni s P- glikoproteinom posredovani iztok feksofenadina in tako zviša koncentracijo feksofenadina.
14 Ritonavir effects on Non-antiretroviral Co-administered Drugs Co-administered Drug
14
Due to the large increase in rifabutin AUC, the concomitant use of rifabutin with ritonavir dosed as an antiretroviral agent is contraindicated (see section 4.3).
Sočasna uporaba rifabutina in ritonavirja, odmerjanega kot protiretrovirusno zdravilo, je kontraindicirana zaradi velikega povečanja AUC rifabutina (glejte poglavje 4. 3).
200 q12h 400 q12h ↓ 82% ↓ 66% 200 q12h 100 q12h ↓ 39% ↓ 24% Concomitant use of ritonavir dosed as an antiretroviral agent and voriconazole is contraindicated due to reduction in voriconazole concentrations (see section 4.3).
200 na 12 ur 400 na 12 ur ↓ 82% ↓ 66% 200 na 12 ur 100 na 12 ur ↓ 39% ↓ 24% Sočasna uporaba ritonavirja, odmerjanega kot protiretrovirusno zdravilo, in vorikonazola je kontraindicirana zaradi zmanjšane kocentracije vorikonazola (glejte poglavje 4. 3).
500 q12h, 200 q8h ↑ 77% ↑ 31%
500 na 12 ur, 200 na 8 ur ↑ 77% ↑ 31%
14-OH clarithromycin metabolite
presnovek 14- OH klaritromicin
Clarithromycin doses greater than 1 g per day should not be co- administered with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer.
Hkrati z ritonavirjem, odmerjanim kot protiretrovirusno zdravilo ali farmakokinetični stopnjevalec, ne smete uporabljati odmerkov klaritromicina, večjih od 1 g na dan.
For patients with renal impairment, a clarithromycin dose reduction should be considered: for patients with creatinine clearance of 30 to 60 ml/min the dose should be reduced by 50%, for patients with creatinine clearance less than 30 ml/min the dose should be reduced by 75%.
Pri bolnikih z okvaro ledvic pride v poštev zmanjšanje odmerka klaritromicina: bolnikom z očistkom kreatinina od 30 do 60 ml/ min je treba odmerek zmanjšati za 50%, tistim z očistkom kreatinina manj kot 30 ml/ min pa za 75%.
Erythromycin, itraconazole
15 Učinki ritonavirja na sočasno uporabljena neretrovirusna zdravila Sočasno uporabljeno zdravilo
Ritonavir dosed as a pharmacokinetic enhancer or as an antiretroviral agent inhibits CYP3A4 and as a result is expected to increase the plasma concentrations of erythromycin and itraconazole.
Odmerek sočasno
Ketoconazole
Odmerek NORVIRJA
200 daily 500 q12h ↑ 3.4-fold ↑ 55%
Vpliv na AUC sočasno
15 Ritonavir effects on Non-antiretroviral Co-administered Drugs Co-administered Drug
Vpliv na Cmax sočasno
Ritonavir inhibits CYP3A-mediated metabolism of ketoconazole.
Eritromicin, itrakonazol
Due to an increased incidence of gastrointestinal and hepatic adverse events, a dose reduction of ketoconazole should be considered when co- administered with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer.
Med sočasno uporabo ketokonazola in ritonavirja, odmerjanega kot protiretrovirusno zdravilo ali farmakokinetični stopnjevalec, pride zaradi večje incidence neželenih učinkov na prebavila in jetra v poštev zmanjšanje odmerka ketokonazola.
Sulfamethoxazole/Trimethoprim2
Sulfametoksazol/ Trimetoprim2
800/160, single dose
800/ 160, posamičen odmerek
Dose alteration of sulfamethoxazole/trimethoprim during concomitant ritonavir therapy should not be necessary.
Med sočasnim zdravljenjem z ritonavirjem odmerka kombinacije sulfametoksazol/ trimetoprim praviloma ni treba spreminjati.
Antipsychotics/Neuroleptics Clozapine, pimozide
Antipsihotiki/ Nevroleptiki Klozapin, pimozid
Ritonavir co-administration is likely to result in increased plasma concentrations of clozapine or pimozide and is therefore contraindicated (see section 4.3).
Sočasna uporaba ritonavirja ponavadi zviša koncentracijo klozapina in pimozida v plazmi in je zato kontraindicirana (glejte poglavje 4. 3).
Careful monitoring of therapeutic and adverse effects is recommended when these medicines are concomitantly administered with antiretroviral doses of ritonavir (see section 4.3).
Med sočasno uporabo teh zdravil in protiretrovirusnih odmerkov ritonavirja je priporočljivo natančno nadziranje terapevtskih in neželenih učinkov (glejte poglavje 4. 3).
Calcium channel antagonists Amlodipine, diltiazem, nifedipine
Antagonisti kalcijevih kanalčkov Amlodipin, diltiazem, nifedipin
Ergot Derivatives
Derivati ergot alkaloidov Dihidroergotamin, ergonovin, ergotamin, metilergonovin
Ritonavir co-administration is likely to result in increased plasma concentrations of ergot derivatives and is therefore contraindicated (see section 4.3).
Sočasna uporaba ritonavirja ponavadi zviša koncentracijo derivatov ergot alkaloidov v plazmi in je zato kontraindicirana (glejte poglavje 4. 3).
Ritonavir co-administration is likely to result in increased plasma concentrations of cisapride and is therefore contraindicated (see section 4.3).
Sočasna uporaba ritonavirja ponavadi zviša koncentracijo cisaprida v plazmi in je zato kontraindicirana (glejte poglavje 4. 3).
16 Ritonavir effects on Non-antiretroviral Co-administered Drugs Co-administered Drug
16 Učinki ritonavirja na sočasno uporabljena neretrovirusna zdravila Sočasno uporabljeno zdravilo
HMG Co-A Reductase Inhibitors
Zaviralci reduktaze HMG- CoA
HMG-CoA reductase inhibitors which are highly dependent on CYP3A metabolism, such as lovastatin and simvastatin, are expected to have markedly increased plasma concentrations when co-administered with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer.
Pri zaviralcih reduktaze HMG- CoA, ki so zelo odvisni od presnove s CYP3A (npr. lovastatin in simvastatin), je treba med sočasno uporabo z ritonavirjem, odmerjanem kot protiretrovirusno zdravilo ali farmakokinetični stopnjevalec, pričakovati izrazito zvišanje njihove koncentracije v plazmi.
Since increased concentrations of lovastatin and simvastatin may predispose patients to myopathies, including rhabdomyolysis, the combination of these medicinal products with ritonavir is contraindicated (see section 4.3).
Ker lahko zvišana koncentracija lovastatina in simvastatina povzroči nagnjenost k miopatijam, vključno z rabdomiolizo, je sočasna uporaba teh zdravil z ritonavirjem kontraindicirana (glejte poglavje 4. 3).
If treatment with an HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended.
Če je indicirano zdravljenje z zaviralcem reduktaze HMG- CoA, sta priporočljiva pravastatin ali fluvastatin.
Hormonal contraceptive Ethinyl estradiol
Hormonski kontraceptivi Etinilestradiol
50 µg single dose
50 µg, posamičen odmerek
Ritonavir is likely to change the uterine bleeding profile and reduce the effectiveness of estradiol-containing contraceptives (see section 4.4).
Verjetno je, da bo ritonavir spremenil profil maternične krvavitve in zmanjšal učinkovitost kontraceptivov, ki vsebujejo estradiol (glejte poglavje 4. 4).
Immunosupressants Cyclosporine, tacrolimus, everolimus
Imunosupresivi Ciklosporin, takrolimus, everolimus
Phosphodiesterase inhibitors Sildenafil
Inhibitorji fosfodiesteraze Sildenafil
100, single dose
100, posamičen 500 na 12 ur odmerek
↑ 11-fold
↑ 11- krat
↑ 4-fold
↑ 4- krat
Concomitant use of sildenafil with ritonavir dosed as an antiretroviral agent or as a pharmacokinetic enhancer is not recommended and in no instance should sildenafil doses exceed 25 mg in 48 hours (see also section 4.4).
V nobenem primeru ne sme odmerek sildenafila preseči 25 mg v 48 urah (glejte tudi poglavje 4. 4).
Concomitant use of sildenafil with ritonavir is contraindicated in pulmonary arterial hypertension patients.
Sočasna uporaba sildenafila in ritonavirja je kontraindicirana pri bolnikih s pljučno arterijsko hipertenzijo.
20, single dose
20, posamičen 200 na 12 ur odmerek