Betamiga Extended Release 25 mg (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. Recommended daily doses for patients with renal or hepatic impairment, with or without potent CYP3A inhibitors 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 administered to certain patients. For example, patients who are allergic to the active ingredient or other components of this medication, those with uncontrolled severe hypertension, and patients with severe heart disease should not use this medication. Additionally, patients with a history of QT interval prolongation or those taking medications that can prolong the QT interval should use this medication with caution. It is not recommended for patients with end-stage renal disease or severe liver impairment, as well as those with renal or liver impairment receiving certain medications. When taking this medication, heart rate and blood pressure may increase, so especially patients with hypertension should measure their blood pressure regularly. Patients with bladder outlet obstruction or those taking antimuscarinic agents for overactive bladder also need to be cautious. This medication is not recommended for pregnant women, nursing mothers, or children under 19 years of age, as safety has not been established. It should be avoided during pregnancy, and it is advisable not to administer it while nursing. In case of overdose, heart rate and blood pressure may increase, so if symptoms appear, consult a healthcare professional immediately for appropriate treatment. This medication can interact with various drugs, so if you are taking other medications, be sure to consult your physician or pharmacist. Special caution is necessary when used with CYP3A4 inhibitors or drugs that affect CYP2D6 metabolism. Finally, keep this medication out of the reach of children, and take care not to transfer it to another container.

• Tachycardia
• urinary tract infection
• atrial fibrillation
• elevated blood pressure
• indigestion
• 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 recommended to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature.

Appearance

Brown oval film-coated extended-release tablet

Package unit

90 tablets/box [10 tablets/PTPx9]