Mirabegron Extended Release Tablet 50mg (Mirabegron)

Adult dose

For adults (including elderly patients), the recommended dose is 50mg orally once daily. This drug may be taken with or without food. Swallow with water; do not chew or crush. The following table shows the recommended daily doses for patients with renal or hepatic impairment, with or without a strong CYP3A inhibitor (see “Precautions for Use 5) Drug Interactions”). Renal impairment(1), mild: without strong CYP3A inhibitor 50 mg, with inhibitor 25 mg Renal impairment(1), moderate: without strong CYP3A inhibitor 50 mg, with inhibitor 25 mg Renal impairment(1), severe: without strong CYP3A inhibitor 25 mg, with inhibitor not recommended Hepatic impairment(2), mild: without strong CYP3A inhibitor 50 mg, with inhibitor 25 mg Hepatic impairment(2), moderate: without strong CYP3A inhibitor 25 mg, with inhibitor not recommended (1) Mild: GFR 60~89 mL/min/1.73m2; moderate: GFR 30~59 mL/min/1.73m2; severe: GFR 15~29 mL/min/1.73m2. (2) Mild: Child-Pugh Class A; moderate: Child-Pugh Class B. (3) For strong CYP3A inhibitors, see “5) Drug Interactions”.

This medication should not be used in patients with allergies to the active ingredient or other components. Patients with poorly controlled hypertension or severe heart disease should not be administered this drug as it may exacerbate their symptoms. Patients with heart diseases associated with prolonged QT interval or those taking medications that can prolong the QT interval should use this drug with special caution. It is not recommended for use in patients with end-stage kidney disease or severe liver impairment, and caution is required in patients with moderate kidney or liver impairment who are taking strong CYP3A4 inhibitors. Patients with bladder outlet obstruction or those on antimuscarinic agents for the treatment of overactive bladder may have a risk of side effects such as urinary retention when using this drug, hence it should be administered cautiously. Clinical trials and post-marketing studies have reported mainly mild to moderate side effects, with the most common being tachycardia and urinary tract infections. This medication may slightly increase blood pressure and heart rate, so it is important for patients with hypertension to regularly monitor their blood pressure. Pregnant women or those who may become pregnant are advised not to take this medication, and breastfeeding women should also avoid this drug for safety. The safety and efficacy of this medication in children and adolescents under 19 years of age have not been established. In cases of overdose, increased heart rate and elevated blood pressure may occur. If overdose is suspected, immediate consultation with healthcare providers is necessary, and monitoring of heart rate, blood pressure, and ECG should be performed. This drug does not significantly affect driving or operating machinery, but caution is necessary as it may vary by individual. This medication can interact with other drugs, so it is essential to inform healthcare providers if taking CYP3A4 inhibitors or medications that affect CYP2D6.

• tachycardia
• urinary tract infection
• atrial fibrillation
• elevated blood pressure
• dyspepsia
• gastritis
• lip swelling
• urticaria
• rash
• maculopapular rash

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance

Yellow oval film-coated extended release tablet

Package unit

30 tablets/box [10 tablets/PTP x 3]