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.
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 (Cat.C). Nursing mothers: not recommended.
May potentiate CYP2D6 substrates (eg, metoprolol, desipramine). Adjust dose and monitor esp. with narrow therapeutic index drugs metabolized by CYP2D6 (eg, thioridazine, flecainide, propafenone). Concomitant digoxin: use lowest digoxin dose initially (monitor and titrate).
Beta-3 adrenergic agonist.
Hypertension, nasopharyngitis, urinary tract infection, headache; angioedema.
Hepatic (CYP2D6, 3A4).
Tabs—30, 90, 100