Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Efavirenz Teva

Efavirenz Teva 600 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 8–9

HOS-215276 · Präparat HOS-155418

8 Medicinal product by Effects on drug levels Recommendation concerning therapeutic areas Mean percent change in AUC, co-administration with (dose) Cmax, Cmin with confidence efavirenz intervals if availablea (mechanism) Not recommended as the exposure to both PIs is expected to be significantly decreased. Indinavir/efavirenz Indinavir: While the clinical significance of (800 mg q8h/200 mg once daily) AUC: ↓ 31% (↓ 8 to ↓47) decreased indinavir Cmin: ↓ 40% concentrations has not been A similar reduction in indinavir established, the magnitude of the exposures was observed when observed pharmacokinetic indinavir 1000 mg q8h was given interaction should be taken into with efavirenz 600 mg daily. consideration when choosing a (CYP3A4 induction) regimen containing both efavirenz and indinavir. Efavirenz: No clinically significant pharmacokinetic interaction Indinavir/ritonavir/efavirenz Indinavir: No dose adjustment is necessary (800 mg twice daily/100 mg twice AUC: ↓ 25% (↓ 16 to ↓32) b for efavirenz when given with daily/600 mg once daily) Cmax: ↓ 17% (↓ 6 to ↓ 26) b indinavir or indinavir/ritonavir. Cmin: ↓ 50% (↓ 40 to ↓ 59) b Efavirenz: See also ritonavir row below. No clinically significant pharmacokinetic interaction The geometric mean Cmin for indinavir (0.33 mg/l) when given with ritonavir and efavirenz was higher than the mean historical Cmin (0.15 mg/l) when indinavir was given alone at 800 mg q8h. In HIV-1 infected patients (n=6), the pharmacokinetics of indinavir and efavirenz were generally comparable to these uninfected volunteer data. Lopinavir/ritonavir soft capsules Substantial decrease in lopinavir With efavirenz, an increase of the or oral solution/ efavirenz exposure. lopinavir/ritonavir soft capsule or oral solution doses by 33% should Lopinavir/ritonavir tablets/ be considered (4 capsules/ efavirenz ~6.5 ml twice daily instead of 3 (400/100 mg twice daily/ 600 mg Lopinavir concentrations: ↓ 30-40% capsules/5 ml twice daily). once daily) Caution is warranted since this (500/125 mg twice daily/ 600 mg Lopinavir concentrations: similar to dose adjustment might be once daily) lopinavir/ritonavir 400/100 mg twice insufficient in some patients. The daily without efavirenz dose of lopinavir/ritonavir tablets should be increased to 500/125 mg twice daily when co-administered with efavirenz 600 mg once daily. See also ritonavir row below. Nelfinavir/efavirenz Nelfinavir: No dose adjustment is necessary (750 mg q8h/600 mg once daily) AUC: ↑ 20% (↑ 8 to ↑ 34) for either medicinal product. Cmax: ↑ 21% (↑ 10 to ↑ 33) The combination was generally well tolerated. Ritonavir/efavirenz Ritonavir: When using efavirenz with (500 mg twice daily/600 mg once Morning AUC: ↑ 18% (↑ 6 to ↑ 33) low-dose ritonavir, the possibility daily) Evening AUC: ↔ of an increase in the incidence of Morning Cmax: ↑ 24% (↑ 12 to ↑ 38) efavirenz-associated adverse Evening Cmax: ↔ events should be considered, due

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): indinavir (HOS-084518) lopinavir (HOS-086269) nelfinavir (HOS-084520) ritonavir (HOS-084521)