Miragron Extended-Release Tablets 50 mg (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. The following table shows the recommended daily doses for patients with renal or hepatic impairment, with or without a strong CYP3A inhibitor (see “5) Drug Interactions” under Precautions for Use). Renal impairment(1), mild: without a strong CYP3A inhibitor 50 mg, with 25 mg Renal impairment(1), moderate: without a strong CYP3A inhibitor 50 mg, with 25 mg Renal impairment(1), severe: without a strong CYP3A inhibitor 25 mg, with not recommended Hepatic impairment(2), mild: without a strong CYP3A inhibitor 50 mg, with 25 mg Hepatic impairment(2), moderate: without a strong CYP3A inhibitor 25 mg, with 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 medication should not be used in patients with known allergic reactions to the active ingredient or any other ingredients. Patients with severely uncontrolled hypertension or serious heart disease may experience worsening symptoms when taking this medication and should avoid it. Caution is needed for patients with a history of prolonged QT interval or those currently taking medications that can prolong the QT interval. The use of this medication is not recommended for patients with end-stage renal disease or severe liver impairment. It is particularly advisable not to administer this medication to patients with severe renal impairment or moderate liver impairment who are also taking strong CYP3A4 inhibitors. Patients with bladder outlet obstruction or those currently using anticholinergic agents for the treatment of overactive bladder should also exercise caution when using this medication. This medication contains Yellow No. 4 and Yellow No. 5 dyes, so it should be used carefully if there is an allergy to these ingredients. The most commonly reported side effects during treatment include rapid heartbeat and urinary tract infections, while serious adverse reactions such as atrial fibrillation may occur rarely. Dry mouth has also been reported, but this occurs at a lower frequency than other anticholinergics. Overdosage may lead to increased heart rate and blood pressure; symptoms should be promptly discussed with healthcare professionals. This medication can elevate blood pressure, so patients with high blood pressure should regularly monitor their blood pressure. It is advisable for women who are pregnant or may become pregnant to avoid taking this medication, and it is also safe not to use it while breastfeeding. The safety and efficacy in children and adolescents under 19 years of age have not been established. This medication does not significantly affect driving or operating machinery, but caution may be needed depending on the individual. There may be drug interactions, so if any other medications are being taken, it is essential to inform healthcare professionals, especially when using medications that may interact with CYP3A4 inhibitors or CYP2D6 metabolism.

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

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance

Yellow oval film-coated extended-release tablet

Package unit

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