Mirasol XR 25

Indications:

Mirasol XR is indicated for the symptomatic treatment of urgency, increased micturition frequency, and urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.

Pharmacology:

Mirabegron, the first beta-3 adrenoceptor agonist, acts via dual mechanisms: direct action on bladder smooth muscle and sensory nervous system. It increases cyclic adenosine monophosphate (cyclic AMP), leading to detrusor smooth muscle relaxation during the urinary bladder fill-void cycle.

Dosage:

For adults including elderly patients, the recommended starting dose is Mirabegron 25 mg tablet once daily, with or without food. Depending on individual patient response, the dose may be increased to Mirabegron 50 mg tablet once daily. In patients with severe renal impairment (ClCr 15 to 29 mL/min or eGFR 15 to 29 mL/min/1.73 m²) or moderate hepatic impairment (Child-Pugh Class B), the daily dose should not exceed Mirabegron 25 mg tablet once daily. Mirabegron has not been studied in patients with end-stage renal disease or severe hepatic impairment (Child Pugh Class C) and is not recommended for use in these populations.

Administration:

Mirabegron tablets should be taken once daily, swallowed whole with liquids. They should not be chewed, divided, or crushed.

Interaction:

When co-administered with strong CYP3A inhibitors, dose adjustment to Mirabegron 25 mg once daily is recommended in patients with mild to moderate renal or hepatic impairment. No dose adjustment is necessary for Mirabegron when administered with CYP3A or P-gp inducers. Exercise caution when co-administering Mirabegron with drugs metabolized by CYP2D6.

Contraindications:

Mirabegron is contraindicated in patients with hypersensitivity to the active substance or any excipients, and in those with severe uncontrolled hypertension (systolic BP ≥180 mm Hg and/or diastolic BP ≥110 mm Hg).

Side Effects:

Common side effects include tachycardia and urinary tract infections. Serious adverse reactions may include atrial fibrillation (0.2%).

Pregnancy & Lactation:

Mirabegron is not recommended during pregnancy or breastfeeding due to limited safety data.

Precautions & Warnings:

Monitor renal function closely in patients with severe renal impairment. Use caution in patients with bladder outlet obstruction or QT prolongation.

Overdose Effects:

Symptoms of overdose may include palpitations and increased pulse rate. Monitoring of vital signs and ECG is recommended in case of overdose.

Therapeutic Class:

BPH/Urinary retention/Urinary incontinence.

Storage Conditions:

Store Mirasol XR in a cool, dry place, protected from light.