Sellebeta Sustained-Release Tablet 50 mg (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”) Category | Severity | Without inhibitor | With inhibitor Renal impairment(1) | Mild | 50 mg | 25 mg Renal impairment(1) | Moderate | 50 mg | 25 mg Renal impairment(1) | Severe | 25 mg | Not recommended Hepatic impairment(2) | Mild | 50 mg | 25 mg Hepatic impairment(2) | Moderate | 25 mg | 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 who have allergies to the active ingredient or other ingredients. Furthermore, it should not be administered to patients with uncontrolled severe hypertension or severe heart disease, as it may worsen symptoms. Caution is required when administering to patients with a history of QT interval prolongation or those taking medications that can prolong the QT interval. It is not recommended for use in patients with end-stage renal disease or severe liver dysfunction. Patients with severe renal impairment or moderate liver dysfunction taking strong CYP3A4 inhibitors should also avoid using this medication. It should be administered cautiously to patients with bladder outlet obstruction or those taking antimuscarinic agents for the treatment of overactive bladder. Adverse effects such as tachycardia, urinary tract infection, and dry mouth have been reported in patients taking this medication during clinical trials, most of which were mild to moderate. Severe adverse effects, such as atrial fibrillation, may occur rarely, so caution is needed. This medication can elevate blood pressure and heart rate; therefore, patients with hypertension should regularly monitor their blood pressure and observe their condition. It is recommended that women who are pregnant or may become pregnant avoid using this medication, and nursing mothers should also refrain from administration. The safety and efficacy in children and adolescents under the age of 19 have not been established. In cases of overdose, increases in heart rate and blood pressure may occur; therefore, monitoring of heart rate, blood pressure, and electrocardiogram is necessary, and appropriate treatment should be provided. This medication should not be transferred to another container and must be stored out of reach of children. Finally, this medication may interact with some drugs, so if taking other medications, it is important to consult a physician or pharmacist.

• Tachycardia
• urinary tract infection
• atrial fibrillation
• palpitations
• increased blood pressure
• dyspepsia
• gastritis
• lip swelling
• urticaria
• rash

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, avoid extremely hot or cold places, and it is best to store it at room temperature between 1 degree and 30 degrees Celsius.

Appearance

Bright yellowish-brown to brown, oval-shaped film-coated sustained-release tablet

Package unit

90 tablets/box [10 tablets/PTP X 9], 10 tablets/box [10 tablets/PTP X 1]