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GENITO URINARY SYSTEM AND SEX HORMONES › UROLOGICALS › UROLOGICALS › Drugs for urinary frequency and incontinence
mirabegron
G04BD12
Forms & Strengths
- Extended-release oral tablets: 25 mg
- Extended-release oral tablets: 50 mg
- Extended-release oral suspension: 8 mg/mL
Adult Dosing
- Overactive bladder: 25 mg orally once daily, increased after 4-8 weeks to 50 mg once daily if needed
- Neurogenic detrusor overactivity (pediatric formulation used in adults off-label or specific combos): 50 mg once daily
- Renal impairment (severe, eGFR 15-29 mL/min/1.73m2): Maximum 25 mg daily
- Hepatic impairment (moderate, Child-Pugh Class B): Maximum 25 mg daily
- Renal/Hepatic impairment (severe): Contraindicated
Pediatric Dosing
- Neurogenic detrusor overactivity (children 3 years and older): Weight-based dosing using extended-release suspension
- Children < 35 kg: Initial 1 mg/kg once daily, target 2 mg/kg once daily (max 50 mg/day)
- Children >= 35 kg: Initial 25 mg once daily, target 50 mg once daily
Indications
- Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency
- Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older
Mechanism of Action
- Selective beta-3 adrenergic receptor agonist
- Relaxes the detrusor smooth muscle during storage phase of urinary bladder fill by activation of beta-3 adrenoreceptors
- Increases bladder capacity and decreases frequency of contractions
Contraindications
- Hypersensitivity to mirabegron or any component
- Severe uncontrolled hypertension (systolic >= 180 mmHg and/or diastolic >= 110 mmHg)
- End-stage renal disease (ESRD) or severe hepatic impairment
Adverse Reactions
- Hypertension
- Nasopharyngitis
- Urinary tract infection
- Headache
- Tachycardia
- Constipation
- Dizziness
- Dry mouth
Drug Interactions
- CYP2D6 substrates: Moderate inhibitor of CYP2D6; may increase exposure of CYP2D6 substrates (e.g., metoprolol, desipramine)
- Digoxin: Co-administration may increase Cmax and AUC of digoxin; monitor serum digoxin levels
- CYP3A4 inducers/inhibitors: Strong inhibitors or inducers may alter mirabegron pharmacokinetics
Curated Content: Needs Vetting Before Put to Clinical Use