From the FDA Drug Label
2.2 Recommended Dosage for Adult Patients with OAB Mirabegron Monotherapy The recommended starting dosage of mirabegron extended-release tablets is 25 mg orally once daily. If needed, increase to the maximum dosage of mirabegron extended-release tablets 50 mg orally once daily after 4 to 8 weeks.
2.3 Recommended Dosage for Pediatric Patients Aged 3 Years and Older with NDO For pediatric patients 3 years of age and older, select the appropriate product (Mirabegron extended-release tablets and Mirabegron Granules) based on the patient's weight Pediatric Patients weighing 35 kg or more: Use mirabegron extended-release tablets The recommended starting dosage of mirabegron extended-release tablets is 25 mg orally once daily. If needed, increase to a maximum dosage of mirabegron extended-release tablets 50 mg orally once daily after 4 to 8 weeks.
The maximum dose of Myrbetriq (Mirabegron) is 50 mg orally once daily 1.
From the Research
Maximum Dose of Myrbetriq (Mirabegron)
The maximum dose of Myrbetriq (Mirabegron) can be determined based on the provided evidence.
- The therapeutic doses of mirabegron are between 25 and 100 mg in clinical trials 2, 3, 4.
- In Phase III clinical trials, mirabegron at daily doses of 25,50, and 100 mg demonstrated significant efficacy in treating symptoms of overactive bladder (OAB) 2.
- Mirabegron 50 mg once daily consistently significantly reduced urgency episodes and increased the volume of urine voided per micturition, generally in association with improved health-related quality of life (HR-QOL) and treatment satisfaction 3.
- The maximum dose of mirabegron used in the studies is 100 mg per day 2, 4.
- There is no evidence to suggest that doses higher than 100 mg per day were used or recommended in the provided studies.
Key Findings
- Mirabegron is an effective treatment for overactive bladder syndrome with a favorable tolerability profile 2, 3, 4, 5, 6.
- The most common adverse events observed with mirabegron in clinical trials were hypertension, nasopharyngitis, and urinary tract infection 2.
- Mirabegron 50 mg once daily carries a low risk of QT interval prolongation 3.