Betmiga

Betmiga (mirabegron) is indicated for the treatment of overactive bladder (OAB) with symptoms of urgency incontinence, urgency, nocturia, and urinary frequency.

Posology: Adults (including elderly patients): The recommended dose is 50 mg once daily with or without food.
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.
The following table provides the daily dosing recommendations for subjects with renal or hepatic impairment in the absence and presence of strong CYP3A inhibitors.
Renal impairment (1) Mild: 50 mg (without inhibitor); 25 mg (with inhibitor)
Moderate: 50 mg (without inhibitor); 25 mg (with inhibitor)
Severe: 25 mg (without inhibitor); Not recommended (with inhibitor)
Hepatic impairment (2): Mild: 50 mg (without inhibitor); 25 mg (with inhibitor)
Moderate: 25 mg (without inhibitor); Not recommended (with inhibitor)
1. Mild: GFR 60 to 89 mL/min/1.73 m²; moderate: GFR 30 to 59 mL/min/1.73 m²; severe: GFR 15 to 29 mL/min/1.73 m².
2. Mild: Child-Pugh Class A; Moderate: Child-Pugh Class B.
3. Strong CYP3A inhibitors
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.

Hypersensitivity to the active substance or to any of the excipients.

Drugs for Bladder & Prostate Disorders

G04BD12 - mirabegron ; Belongs to the class of urinary antispasmodics.

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