Mirabegron Extended-Release Tablets 50mg (Mirabegron)

Adult dose

In adults (including elderly patients), the recommended dose is 50 mg orally once daily. This medicine may be taken with or without food. It should be swallowed with water and must not be chewed or crushed. Recommended daily doses for patients with renal and hepatic impairment Renal impairment(1), mild: without a strong CYP3A inhibitor 50 mg, with a strong CYP3A inhibitor 25 mg Renal impairment(1), moderate: without a strong CYP3A inhibitor 50 mg, with a strong CYP3A inhibitor 25 mg Renal impairment(1), severe: without a strong CYP3A inhibitor 25 mg, with a strong CYP3A inhibitor not recommended Hepatic impairment(2), mild: without a strong CYP3A inhibitor 50 mg, with a strong CYP3A inhibitor 25 mg Hepatic impairment(2), moderate: without a strong CYP3A inhibitor 25 mg, with a strong CYP3A 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) See “5) Drug Interactions” for strong CYP3A inhibitors.

This drug should not be used in certain patients. Individuals who are allergic to this drug's active ingredient or other components should not take it. Additionally, patients with uncontrolled severe hypertension or severe heart disease should avoid this drug as symptoms may worsen. There are also patients for whom caution is required when administering this drug. Patients with prolonged QT interval or those taking drugs that can prolong the QT interval should be careful when using this medication. It is not recommended for patients with end-stage kidney disease or severe liver dysfunction. Moreover, patients with impaired kidney or liver function taking certain enzyme inhibitors should use this medication cautiously. Patients with bladder outlet obstruction or those taking antimuscarinic agents for overactive bladder should also be cautious. This medication contains yellow dye, which may cause an allergic reaction if the patient is sensitive to it. The possible side effects when taking this medication include rapid heart rate, urinary tract infection, dyspepsia, and skin rash. Rarely, cardiac arrhythmias such as atrial fibrillation have also been reported. In clinical trials involving Asians, dry mouth was common as a side effect; however, it was not severe. This drug may slightly raise heart rate and blood pressure; therefore, especially in hypertensive patients, blood pressure should be monitored regularly. Patients with a history of QT interval prolongation or those taking related medications should closely observe their cardiac status. Patients with bladder outlet obstruction or those taking antimuscarinic agents should use this drug cautiously as it may cause problems such as urinary retention. This drug may have drug interactions, so those taking other medications should inform their healthcare provider. Specifically, dose adjustment may be needed when combined with certain enzyme inhibitors. Additionally, some drug combinations may result in side effects such as increased heart rate. Pregnant women or those who could become pregnant, as well as lactating women, should avoid taking this medication. This drug can be excreted in breast milk and may affect the baby. The safety and effectiveness in pediatric patients under 19 years of age have not yet been established. In cases of overdose, symptoms such as increased heart rate and palpitations may occur, and in such cases, appropriate treatment should be given while monitoring blood pressure and heart status. This drug should be stored out of reach of children, and it is best not to transfer it into another container as this can prevent accidents and maintain the quality of the medication.

• Tachycardia
• urinary tract infection
• atrial fibrillation
• hypertension
• palpitations
• dyspepsia
• gastritis
• lip swelling
• urticaria
• rash

This drug should be stored in a tightly closed container to protect it from exposure to air and moisture, at a temperature between 1°C and 30°C at room temperature. This is to maintain the effectiveness of the medication and prevent deterioration.

Appearance

Yellow oval film-coated extended-release tablet

Package unit

PTP - 90 tablets/box [10 tablets/PTP X 9], Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle