Selabetas-eong 25mg (Mirabegron Hydrochloride)

Adult dose

Adults (including elderly patients): The recommended dose is 50 mg orally once daily. This medicine may be taken with or without food and should be swallowed 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 a strong CYP3A inhibitor (see “Precautions for Use, 5. Drug Interactions”). Renal impairment(1), mild: strong CYP3A inhibitor absent, 50 mg; present, 25 mg Renal impairment(1), moderate: strong CYP3A inhibitor absent, 50 mg; present, 25 mg Renal impairment(1), severe: strong CYP3A inhibitor absent, 25 mg; present, not recommended Hepatic impairment(2), mild: strong CYP3A inhibitor absent, 50 mg; present, 25 mg Hepatic impairment(2), moderate: strong CYP3A inhibitor absent, 25 mg; present, 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 by patients with allergies to the active ingredient or other components. It should not be administered to patients with severely elevated or uncontrolled hypertension. Patients with severe heart disease should exercise caution as symptoms may worsen with this medication. It should be administered carefully to patients with a history of prolonged QT interval or those taking medications that prolong the QT interval. It is not recommended for patients with end-stage kidney disease or severe liver dysfunction. It is advisable not to administer it to patients with moderate liver impairment or severe kidney impairment who are taking strong CYP3A4 inhibitors. Care should be taken when administering this drug to patients with bladder outlet obstruction or those taking antimuscarinic agents for overactive bladder. This medication may increase heart rate and blood pressure, so patients with hypertension should regularly monitor their blood pressure. Commonly reported side effects in clinical trials include tachycardia and urinary tract infections, and rare cardiac adverse reactions such as atrial fibrillation may also occur. Side effects such as dry mouth, dyspepsia, rash, and pruritus have also been reported. Women who are pregnant or may become pregnant should avoid taking this medication, and breastfeeding women should also refrain from taking it. Safety and efficacy have not been established in children and adolescents under 19 years of age. In case of overdose, symptoms such as increased heart rate and blood pressure may occur; therefore, immediate consultation with healthcare professionals is advised if symptoms appear. This medication should be kept out of reach of children and should not be transferred to other containers. The effects on driving or operating machinery are minimal or negligible.

• tachycardia
• urinary tract infection
• atrial fibrillation
• hypertension
• dyspepsia
• gastritis
• lip swelling
• urticaria
• rash
• maculopapular rash

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. The appropriate storage temperature is room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's efficacy and safety.

Appearance

Brown egg-shaped film-coated sustained-release tablet

Package unit

90 tablets/box [(10 tablets/PTP x 9)], 10 tablets/box [(10 tablets/PTP)]