API

Mirabegron (50mg)

Drug classification

Beta-3 adrenergic agonist; urinary antispasmodic.

Dosage form

Extended-release oral tablet containing 50 mg of mirabegron.

API strength per dosage

Dose

Mirabegron 50 mg is typically taken once daily in adults for overactive bladder. Dose adjustment may be needed in severe renal or moderate hepatic impairment; use is not recommended in end-stage renal disease or severe hepatic impairment. Safety and efficacy in children have not been established. Always consult product labeling for specific recommendations.

Mechanism of action

Mirabegron, the active ingredient in Megatas 50 Tablet ER, is a selective β3-adrenergic receptor agonist. It relaxes the detrusor smooth muscle in the bladder during the storage phase, increasing bladder capacity and reducing symptoms of overactive bladder such as urgency, frequency, and urge incontinence.

Indications

Treatment of Overactive bladder (OAB) symptoms

Side effects

Constipation Headache High blood pressure Nasal inflammation Urinary tract infection Fast heart rate Joint pain

Pregnancy category

Mirabegron should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus; human data are limited.

Precautions

Monitor blood pressure, use caution in patients with hypertension, urinary retention risk in bladder outlet obstruction, adjust dose in severe renal or hepatic impairment, potential for drug interactions (CYP2D6 substrates), monitor for angioedema, avoid in pregnancy unless clearly needed, assess efficacy and adverse effects regularly.

Contraindications

Hypersensitivity to mirabegron or excipients, severe uncontrolled hypertension, end-stage renal disease, severe hepatic impairment.