Lyberon Extended Release Tablet 50 mg (Mirabegron)

Adult dose

Adults (including elderly patients) should receive the recommended dose of 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. Category / Severity / Strong CYP3A inhibitor(3), no 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 certain patients. For example, patients who are allergic to the active ingredient or other components of this drug, those with uncontrolled very high blood pressure, and patients with severe heart disease may experience worsening symptoms if they take this medication. Additionally, it should be administered cautiously to patients with congenital or acquired abnormalities in cardiac electrical signals leading to prolonged QT interval. Although this drug is known not to significantly affect QT prolongation, the safety in patients with a history of QT prolongation or those taking drugs that cause QT prolongation is not guaranteed, so caution is required. The use of this medication is not recommended in patients with end-stage renal disease or severe liver dysfunction, as well as in patients with severe renal or liver impairment who are taking potent specific enzyme inhibitors. Patients with obstructive bladder or those currently on certain anticholinergic medications for overactive bladder should also use this medication with caution. Furthermore, patients who are allergic or hypersensitive to the yellow dye included in this drug should be administered it carefully. Taking this medication may cause an increase in heart rate or a slight rise in blood pressure; therefore, particularly hypertensive patients should monitor their blood pressure regularly and exercise caution. Some patients may experience side effects such as palpitations, urinary tract infections, dry mouth, indigestion, skin rashes, and, rarely, cardiac adverse reactions such as atrial fibrillation have been reported. It is recommended that women who are pregnant or may become pregnant avoid this medication, and nursing mothers should also refrain from using it. The safety and efficacy of this drug in children and adolescents under 19 years of age have not been sufficiently established. In case of overdose, an increase in heart rate and blood pressure may occur, so immediate medical attention should be sought. This drug may interact with other medications, particularly those that affect liver enzymes CYP3A4 or CYP2D6, thus consulting a physician or pharmacist is essential when taking them together. Finally, keep this drug out of the reach of children and avoid transferring it to another container.

tachycardia

This medication should be stored in a tightly closed container to protect it from air and moisture, at room temperature between 1°C and 30°C. Proper storage will help maintain the drug's effectiveness.

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