Skip to Content

Mirabegron Dosage

Medically reviewed on September 11, 2017.

Applies to the following strengths: 25 mg; 50 mg

Usual Adult Dose for Urinary Incontinence

Monotherapy:
Initial dose: 25 mg orally once a day
Maintenance dose: 25 to 50 mg orally once a day based on individual patient efficacy and tolerability

Combination therapy with solifenacin (muscuranic antagonist)
Initial dose: 25 mg orally once a day plus solifenacin 5 mg orally once a day
-After 4 to 8 weeks, may increase mirabegron to 50 mg per day based on individual patient efficacy and tolerability
Maintenance dose: Mirabegron 25 to 50 mg orally once a day plus solifenacin 5 mg orally once a day

Comments:
-In clinical trials, mirabegron 25 mg was effective within 8 weeks, while the 50 mg dose showed efficacy within 4 weeks.
-In a clinical trial with combination mirabegron and solifenacin, combination therapy demonstrated greater improvements from baseline compared either drug alone; improvements were demonstrated at 3 months and maintained throughout the 1-year trial.

Uses: As monotherapy or in combination with a muscarinic antagonist (solifenacin) for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency

Usual Adult Dose for Urinary Frequency

Monotherapy:
Initial dose: 25 mg orally once a day
Maintenance dose: 25 to 50 mg orally once a day based on individual patient efficacy and tolerability

Combination therapy with solifenacin (muscuranic antagonist)
Initial dose: 25 mg orally once a day plus solifenacin 5 mg orally once a day
-After 4 to 8 weeks, may increase mirabegron to 50 mg per day based on individual patient efficacy and tolerability
Maintenance dose: Mirabegron 25 to 50 mg orally once a day plus solifenacin 5 mg orally once a day

Comments:
-In clinical trials, mirabegron 25 mg was effective within 8 weeks, while the 50 mg dose showed efficacy within 4 weeks.
-In a clinical trial with combination mirabegron and solifenacin, combination therapy demonstrated greater improvements from baseline compared either drug alone; improvements were demonstrated at 3 months and maintained throughout the 1-year trial.

Uses: As monotherapy or in combination with a muscarinic antagonist (solifenacin) for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency

Renal Dose Adjustments

-Mild to moderate renal impairment (CrCl 30 to 89 mL/min): No adjustment recommended
-Severe renal impairment (CrCl 15 to 29 mL/min): 25 mg orally once a day
-End stage renal disease (CrCl less than 15 mL/min): Not recommended

Liver Dose Adjustments

-Mild hepatic impairment (Child-Pugh A): No adjustment recommended
-Moderate hepatic impairment (Child-Pugh B): 25 mg orally once a day
-Severe hepatic impairment (Child-Pugh C): Not recommended

Precautions

CONTRAINDICATIONS:
-Hypersensitivity to the active substance or any product excipients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: Not recommended
Peritoneal dialysis: Data not available

Other Comments

Administration advice:
-Take orally with or without food
-Swallow whole with water; do not chew, divide, or crush

Missed dose: If you miss a dose, skip that dose and resume with next scheduled dose; do not take 2 doses on the same day

Monitor:
-Periodic blood pressure measurements, especially in patients with hypertension
-Monitor for urinary retention

Patient advice:
-Read the US FDA-approved Patient Information.
-Patients should be advised to contact their healthcare provider if they have a high blood pressure reading or if they are unable to empty their bladder.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide