Interaksi Itrakonazol dan Silodosin

…that Affect Concomitant Drug Concentrations Concomitant Drug Within Class Prevention or Management Drug Interactions with TOLSURA that Increase Concomitant Drug Concentrations and May Increase Risk of Adverse Reactions Associated with the Concomitant Drug Alpha Blockers Alfuzosin Silodosin Tamsulosin Not recommended during and 2 weeks after TOLSURA treatment.

Severe renal impairment (CCr < 30 mL/min) Severe hepatic impairment (Child-Pugh score ≥ 10) Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir) [see DRUG INTERACTIONS (7.1) ] Patients with a history of hypersensitivity to silodosin or any of the ingredients in silodosin capsules…

Concomitant administration with strong Cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ketoconazole, clarithromycin, itraconazole, ritonavir).

Concomitant use of ketoconazole or other strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir) is therefore contraindicated [see DRUG INTERACTIONS (7.1) ].

Concomitant administration of strong CYP3A4 inhibitors and silodosin capsules is contraindicated [see CONTRAINDICATIONS (4) , WARNINGS AND PRECAUTIONS (5.4) and CLINICAL PHARMACOLOGY (12.3) ].

Pharmacokinetic Drug-Drug Interactions In a drug interaction study, co‑administration of a single 8 mg dose of silodosin capsules with 400 mg ketoconazole, a strong CYP3A4 inhibitor, caused a 3.8‑fold increase in maximum plasma silodosin concentrations and 3.2‑fold increase in silodosin exposure (i.e., AUC).