Betamiga Sustained Release Tablet 50mg (Mirabegron)

Adult dose

The recommended dose for adults (including elderly patients) is 50mg orally once daily. This medicine may be taken with or without food. Swallow it with water; do not chew or crush it. The following table shows the recommended daily doses for patients with renal or hepatic impairment, with or without potent CYP3A inhibitors (see “Precautions for Use, 5. Interactions”). Renal impairment(1) mild: no inhibitor 50 mg, with inhibitor 25 mg Renal impairment(1) moderate: no inhibitor 50 mg, with inhibitor 25 mg Renal impairment(1) severe: no inhibitor 25 mg, with inhibitor not recommended Hepatic impairment(2) mild: no inhibitor 50 mg, with inhibitor 25 mg Hepatic impairment(2) moderate: no 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) See “5) Interactions” for potent CYP3A inhibitors.

This medication should not be used in patients with hypersensitivity to the active ingredient or other components. It is also not safe to administer to patients with severe uncontrolled hypertension or serious heart disease. Caution is needed for patients with a history of prolonged QT interval or those taking drugs with a risk of QT prolongation. It is not recommended for patients with end-stage kidney disease or severe liver impairment, and those receiving certain enzyme inhibitors who have severe kidney or liver impairment. Patients with bladder outlet obstruction or those taking antimuscarinic agents for overactive bladder should use this medication with caution. This medication may increase heart rate and blood pressure, so regularly monitoring blood pressure and heart rate during administration is necessary. After administration, various adverse reactions, such as urinary tract infection, tachycardia, dyspepsia, and rash may rarely occur, and severe symptoms should be discussed with a healthcare professional. Use is not recommended for pregnant women, women who may become pregnant, breastfeeding women, and children under 19. In case of overdose, heart rate and blood pressure may rise, requiring immediate appropriate treatment at a medical institution. Keep this medication out of reach of children and do not transfer it to another container to maintain the safety and quality of the medicine. This medication does not significantly affect driving or machinery operation, but caution is needed if adverse reactions occur.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1°C and 30°C. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance

Yellow oval film-coated sustained release tablet

Package unit

90 tablets/box [10 tablets/PTPx9]