Posology: Adults (including elderly patients): The recommended starting dose is 25 mg once daily with or without food. Betmiga 25mg is effective within 8 weeks. Based on individual patient efficacy and tolerability the dose may be increased to 50 mg once daily. Betmiga should be taken with water, swallowed whole and should not be chewed, divided, or crushed.
Special populations: Renal and hepatic impairment: Betmiga has not been studied in patients with end stage renal disease (GFR < 15 mL/min/1.73 m2 or patients requiring haemodialysis) or severe hepatic impairment (Child-Pugh Class C) and it is therefore not recommended for use in these patient populations (see Precautions and Pharmacology: Pharmacokinetics under Actions).
The following table provides the daily dosing recommendations for subjects with renal or hepatic impairment in the absence and presence of strong CYP3A inhibitors (see Precautions, Interactions and Pharmacology: Pharmacokinetics under Actions). (See Table 4.)
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Gender: No dose adjustment is necessary according to gender.
Paediatric population: The safety and efficacy of mirabegron in children below 18 years of age have not yet been established. No data are available.
Method of administration: The tablet is to be taken once daily, with liquids, swallowed whole and is not to be chewed, divided, or crushed.