Drug Interaction Report

MONITOR: Coadministration with inhibitors of CYP450 2D6 and/or 3A4 may increase the plasma concentrations of cevimeline, which is metabolized by these isoenzymes.

MANAGEMENT: Dosage adjustments and clinical monitoring may be appropriate whenever a CYP450 2D6 and/or 3A4 inhibitor is added to or withdrawn from therapy. Patients should be advised to notify their physician if they experience excessive adverse cholinergic effects of cevimeline such as nausea, vomiting, diarrhea, sweating, salivation, urinary frequency, visual disturbance, confusion, tremor, palpitations, or irregular heartbeat.

Food reduces the oral absorption and bioavailability of mirabegron. According to the product labeling, administration of a 50 mg tablet with a high-fat meal decreased mirabegron peak plasma concentration (Cmax) and systemic exposure (AUC) by 45% and 17%, respectively, whereas administration with a low-fat meal decreased mirabegron Cmax and AUC by 75% and 51%, respectively. In phase 3 clinical studies demonstrating both safety and efficacy, mirabegron was administered without regards to food content and intake. Therefore, mirabegron can be taken with or without food at the recommended dosage.