Symptomatic treatment of urgency, increased micturition frequency &/or urgency incontinence as may occur in adults w/ overactive bladder (OAB) syndrome.
End-stage renal disease, severe renal impairment; severe hepatic impairment (Child-Pugh Class C) & moderate hepatic impairment (Child-Pugh Class B); periodic BP monitoring; history of QT prolongation or taking medicines known to prolong QT interval; bladder outlet obstruction or taking antimuscarinics medications for OAB. Pregnancy & lactation.
In patients w/ mild to moderate renal impairment or mild hepatic impairment concomitantly receiving strong CYP3A inhibitors eg, itraconazole, ketoconazole, the recommended dose is 25 mg once daily. CYP3A/P-gp inducers decrease the plasma conc of mirabegron. Medicines w/ narrow therapeutic index & significantly metabolized by CYP2D6 eg, thioridazine, type 1C antiarrhythmics (eg, flecainide, propafenone) & TCAs (eg, imipramine, desipramine); individually dose-titrated CYP2D6 substrates. In combination w/ digoxin, the lowest dose for digoxin should be initially prescribed.
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