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These brands contain the same active ingredient (Mirabegron). Strength and form may differ — confirm substitution with your doctor or pharmacist before switching.
Indications & Uses
Megron ER tablet is used to relieve symptoms of overactive bladder (OAB) in adults, including urgency, frequent urination and urgency incontinence.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
For adults, including elderly patients, the recommended starting dose is one Mirabegron 25 mg tablet taken once daily, with or without food. Depending on how well the individual patient responds and tolerates the medicine, the dose may be increased to one Mirabegron 50 mg tablet once daily. In patients with renal or hepatic impairment, those 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) should not receive more than 25 mg of Mirabegron once daily. Mirabegron has not been studied in patients with end stage renal disease (GFR below 15 mL/min/1.73 m2, or patients requiring haemodialysis) or severe hepatic impairment (Child Pugh Class C), so its use is not recommended in these patient groups. No dose adjustment is required based on gender. In the paediatric population, the safety and efficacy of Mirabegron in children under 18 years of age have not yet been established. The Mirabegron tablet should be taken once daily with liquid, swallowed whole, and should not be chewed, divided, or crushed.
Side Effects
Tachycardia (fast heart rate) and urinary tract infections were the side effects most often reported with Megron ER 50 mg across three 12-week phase 3 trials, which were double-blind and placebo-controlled. Tachycardia occurred in 1.2% of patients on Megron ER 50 mg and caused 0.1% to stop treatment. Urinary tract infections occurred in 2.9% of patients on Megron ER 50 mg, but did not cause anyone to discontinue treatment. Among serious reactions, atrial fibrillation was reported in 0.2% of patients.
Cautions & Contraindications
Warnings & Precautions
Renal impairment: Megron ER has not been studied in patients with end stage renal disease, defined as a GFR below 15 mL/min/1.73 m2 or those requiring haemodialysis, and it is therefore not recommended for this group. Information is also limited for patients with severe renal impairment (GFR 15 to 29 mL/min/1.73 m2); a pharmacokinetic study supports reducing the dose to 25 mg in these patients. Megron ER is not recommended for patients with severe renal impairment who are also taking strong CYP3A inhibitors. Hepatic impairment: Megron ER has not been studied in patients with severe hepatic impairment (Child Pugh Class C), so it is not recommended for this group. It is also not recommended for patients with moderate hepatic impairment (Child Pugh Class B) who are taking strong CYP3A inhibitors at the same time. Hypertension: Megron ER can raise blood pressure. Blood pressure should be checked before starting treatment and monitored periodically during treatment, particularly in patients who already have hypertension. Data are limited for patients with stage 2 hypertension, meaning a systolic reading of 160 mm Hg or higher or a diastolic reading of 100 mm Hg or higher. Patients with QT prolongation: Megron ER should be used with caution in patients who have congenital or acquired QT prolongation. Patients with bladder outlet obstruction (BOO) and patients on antimuscarinic medicines for OAB: A controlled clinical safety study in patients with bladder outlet obstruction (BOO) did not show an increase in urinary retention among those treated with Megron ER. Even so, Megron ER should be given with caution to patients who have clinically significant bladder outlet obstruction (BOO), and the same caution applies when it is given to patients who are taking antimuscarinic medicines for overactive bladder (OAB).
Contraindications
Mirabegron should not be used by anyone who is hypersensitive to the active substance or to any of its excipients. It is also contraindicated in patients with severe, uncontrolled hypertension, defined as a systolic blood pressure of 180 mmHg or higher and/or a diastolic blood pressure of 110 mmHg or higher.