Generic name: MIRABEGRON 25mg
Dosage form: tablet, film coated, extended release
Medically reviewed on April 24, 2018.
The recommended starting dose of MYRBETRIQ is 25 mg once daily with or without food. MYRBETRIQ 25 mg is effective within 8 weeks. Based on individual patient efficacy and tolerability the dose may be increased to 50 mg once daily [see Clinical Studies (14.1)].
MYRBETRIQ should be taken with water, swallowed whole and should not be chewed, divided, or crushed.
Combination with Muscarinic Antagonist Solifenacin Succinate
The recommended starting doses for combination treatment are MYRBETRIQ 25 mg once daily and solifenacin succinate 5 mg once daily. Based on individual patient efficacy and tolerability, the MYRBETRIQ dose may be increased to 50 mg once daily after 4 to 8 weeks [see Clinical Studies (14.2)].
MYRBETRIQ and solifenacin succinate can be taken together with or without food.
Dose Adjustments in Specific Populations
The daily dose of MYRBETRIQ should not exceed 25 mg once daily in the following populations:
- Patients with severe renal impairment (CLcr 15 to 29 mL/min or eGFR 15 to 29 mL/min/1.73 m2) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
- Patients with moderate hepatic impairment (Child-Pugh Class B) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
MYRBETRIQ is not recommended for use in patients with End-Stage Renal Disease (ESRD), or in patients with severe hepatic impairment (Child-Pugh Class C) [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3)].
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