Generic Name and Formulations:
Mirabegron 25mg, 50mg; ext-rel tabs.
Astellas Pharma US, Inc.
Indications for MYRBETRIQ:
Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency, as monotherapy or in combination with solifenacin.
Swallow whole. Initially 25mg once daily; may increase to 50mg once daily as needed or tolerated. Severe renal impairment or moderate hepatic impairment: max 25mg once daily. ESRD or severe hepatic impairment: not recommended.
Severe uncontrolled hypertension: not recommended. Monitor blood pressure periodically. Significant bladder outlet obstruction, patients taking antimuscarinic drugs for OAB: risk of urinary retention. Discontinue and treat if angioedema of the tongue, hypopharynx, or larynx occurs. Pregnancy. Nursing mothers.
May potentiate CYP2D6 substrates (eg, metoprolol, desipramine); adjust dose and monitor esp. with narrow therapeutic index drugs (eg, thioridazine, flecainide, propafenone). Concomitant digoxin: use lowest digoxin dose initially (monitor and titrate).
Beta-3 adrenergic agonist.
Hypertension, nasopharyngitis, urinary tract infection, headache; also with solifenacin: dry mouth, constipation, tachycardia; angioedema.
Hepatic (CYP2D6, 3A4).