Wirkstoffe & Arzneimittelsicherheit

Wechselwirkungen · Aptivus

Aptivus 250 mg soft capsules · Abschnitt 4.5 · PDF-Seite 17

HOS-114835 · Präparat HOS-094169

Inhibition of CYP 3A4 by tipranavir/r. Oral contraceptives / Oestrogens Ethinyl oestradiol Ethinyl oestradiol Cmax ↓ 52% The concomitant administration 0.035 mg / Norethindrone Ethinyl oestradiol AUC ↓ 43% with Aptivus, co-administered 1.0 mg QD with low dose ritonavir, is not (TPV/r 750/200 mg BID) Mechanism unknown recommended. Alternative or additional contraceptive measures Norethindrone Cmax ↔ are to be used when oestrogen Norethindrone AUC ↑ 27% based oral contraceptives are co- administered with Aptivus and Tipranavir ↔ low dose ritonavir. Patients using oestrogens as hormone replacement therapy should be clinically monitored for signs of oestrogen deficiency (see sections 4.4 and 4.6). Phosphodiesterase 5 (PDE5) inhibitors Sildenafil Co-administration of tipranavir Particular caution should be used Vardenafil and low dose ritonavir with when prescribing the No interaction study PDE5 inhibitors is expected to phosphodiesterase (PDE5) performed substantially increase PDE5 inhibitors sildenafil or vardenafil concentrations and may result in in patients receiving Aptivus, co- an increase in PDE5 inhibitor- administered with low dose associated adverse events ritonavir. including hypotension, visual A safe and effective dose has not changes and priapism. been established when used with Aptivus, co-administered with CYP 3A4 inhibition by low dose ritonavir. There is tipranavir/ r increased potential for PDE5 inhibitor-associated adverse events (which include visual disturbances, hypotension, prolonged erection, and syncope). Co-administrationof Aptivus/ritonavir with sildenafil, when used to treat pulmonary arterial hypertension, is contraindicated.

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): norethindrone (HOS-088136) sildenafil (HOS-086162) ritonavir (HOS-084521) vardenafil (HOS-086163)