Generic name: MIRABEGRON 25mg
Dosage form: tablet, film coated, extended release
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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)].
MYRBETRIQ® should be taken with water, swallowed whole and should not be chewed, divided, or crushed.
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)].