Symptomatic treatment of urgency, increased micturition frequency, and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.
The recommended starting dose is 25 mg orally once daily, with or without food. 25 mg is effective within 8 weeks, and 50 mg is effective in treating the symptoms of OAB within 4 weeks. Based on individual efficacy and tolerability, the dose may be increased to 50 mg once daily. The tablet should be taken with water, swallowed whole, and should not be chewed, divided, or crushed.
Patients with Severe Renal Impairment or Moderate Hepatic Impairment: The maximum dose is 25 mg once daily.
Patients with End Stage Renal Disease (ESRD) or Severe Hepatic Impairment: Not recommended.
Mirabegron is contraindicated in patients with:
Hypersensitivity to the active substance or any of the excipients. Severe uncontrolled hypertension, defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg.
Mirabegron is an agonist of the human beta-3 adrenergic receptor (AR), as demonstrated by in vitro laboratory experiments using the cloned human beta-3 AR. Mirabegron relaxes the detrusor smooth muscle during the storage phase of the urinary bladder fill-void cycle by activation of beta-3 AR, which increases bladder capacity.
Cmax is achieved at approximately 3.5 hours.
The absolute bioavailability increases from 29% at a dose of 25 mg to 35% at a dose of 50 mg.
Steady-state concentrations are achieved within 7 days of once-daily dosing with Mirabegron.
After once-daily administration, plasma exposure of Mirabegron at steady state is approximately double that seen after a single dose.
Increased blood pressure
Common cold symptoms (nasopharyngitis)
Urinary tract infection
Headache
Increases in Blood Pressure: Mirabegron can increase blood pressure. Blood pressure should be measured at baseline and periodically during treatment with Mirabegron, especially in hypertensive patients.
Urinary Retention in Patients with Bladder Outlet Obstruction and in Patients Taking Antimuscarinic Drugs for Overactive Bladder: Administer with caution in these patients.
Patients Taking Drugs Metabolized by CYP2D6: It is a moderate inhibitor of CYP2D6. Appropriate monitoring is recommended, and dose adjustment may be necessary for a narrow therapeutic index CYP2D6 substrate.
Pregnancy Category C.
There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during treatment are encouraged to contact their physician.
Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture.
Medicine: Keep out of reach of children.
