Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Emtricitabine/Tenofovir disoproxil Krka

Emtricitabine/Tenofovir disoproxil Krka 200 mg/245 mg film-coated tablets · Abschnitt 4.5 · PDF-Seite 10–11

HOS-136584 · Präparat HOS-097888

Table 2: Interactions between emtricitabine/tenofovir disoproxil or its individual component(s) and other medicinal products IMedicinal product by therapeutic IEffects on drug levels 10 IRecommendation concerning co- I areas Mean percent change in AUC, administration with Cmax, Cmin with 90% confidence Emtricitabine/Tenofovir disoproxil intervals if available Krka (mechanism) (emtricitabine 200 mg, tenofovir disoproxil 245 mg) ANTI-INFECTIVES Antiretrovirals Protease inhibitors Atazanavir/Ritonavir/Tenofovir Atazanavir: No dose adjustment is recommended. disoproxil AUC: ↓ 25% (↓ 42 to ↓ 3) The increased exposure of tenofovir (300 mg q.d./100 mg q.d./245 mg Cmax: ↓ 28% (↓ 50 to ↑ 5) could potentiate tenofovir associated q.d.) Cmin: ↓ 26% (↓ 46 to ↑ 10) adverse events, including renal Tenofovir: disorders. Renal function should be AUC: ↑ 37% closely monitored (see section 4.4). Cmax: ↑ 34% Cmin: ↑ 29% Atazanavir/Ritonavir/Emtricitabine Interaction not studied. Darunavir/Ritonavir/Tenofovir Darunavir: No dose adjustment is recommended. disoproxil AUC: ↔ The increased exposure of tenofovir (300 mg q.d./100 mg q.d./245 mg Cmin: ↔ could potentiate tenofovir associated q.d.) Tenofovir: adverse events, including renal AUC: ↑ 22% disorders. Renal function should be Cmin: ↑ 37% closely monitored (see section 4.4). Darunavir/Ritonavir/Emtricitabine Interaction not studied. Lopinavir/Ritonavir/Tenofovir Lopinavir/Ritonavir: No dose adjustment is recommended. disoproxil AUC: ↔ The increased exposure of tenofovir (400 mg b.i.d./100 mg b.i.d/245 mg Cmax: ↔ could potentiate tenofovir associated q.d.) Cmin: ↔ adverse events, including renal Tenofovir: disorders. Renal function should be AUC: ↑ 32% (↑ 25 to ↑ 38) closely monitored (see section 4.4). Cmax: ↔ Cmin: ↑ 51% (↑ 37 to ↑ 66) Lopinavir/Ritonavir/Emtricitabine Interaction not studied. NRTIs Didanosine/Tenofovir disoproxil Co-administration of tenofovir Co-administration of disoproxil and didanosine results Emtricitabine/Tenofovir disoproxil in a 40-60% increase in systemic Krka and didanosine is not exposure to didanosine. recommended (see section 4.4). Didanosine/Emtricitabine Interaction not studied. Increased systemic exposure to didanosine may increase didanosine related adverse reactions. Rarely, pancreatitis and lactic acidosis, sometimes fatal, have been reported. Co-administration of tenofovir disoproxil and didanosine at a dose of 400 mg daily has been associated with a significant decrease in CD4 cell count, possibly due to an intracellular interaction increasing phosphorylated (i.e. active) didanosine. A decreased dosage of 250 mg didanosine co- administered with tenofovir disoproxil therapy has been associated with reports of high rates of virological failure within several tested combinations for the treatment of HIV- 1 infection.

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): tenofovir (HOS-088083) lopinavir (HOS-086269) atazanavir (HOS-086180) protease (HOS-085623) didanosine (HOS-085836) darunavir (HOS-086181) ritonavir (HOS-084521)