Betaphrin Extended-Release Tablets 50mg (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. Mild renal impairment: 50 mg without a strong CYP3A inhibitor; 25 mg with a strong CYP3A inhibitor Moderate renal impairment: 50 mg without a strong CYP3A inhibitor; 25 mg with a strong CYP3A inhibitor Severe renal impairment: 25 mg without a strong CYP3A inhibitor; use with a strong CYP3A inhibitor is not recommended Mild hepatic impairment: 50 mg without a strong CYP3A inhibitor; 25 mg with a strong CYP3A inhibitor Moderate hepatic impairment: 25 mg without a strong CYP3A inhibitor; use with a strong CYP3A inhibitor is 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, individuals who are allergic to the active ingredient or other components, those with uncontrolled severe hypertension, and patients with severe heart disease should not be administered this medication. Additionally, it should be given cautiously to patients with a history of QT interval prolongation or those taking medications that may prolong the QT interval. This medication is not recommended for patients with end-stage renal disease or severe liver disease. Caution is needed when taken with certain enzyme inhibitors, and it should be used carefully in patients with bladder outlet obstruction or those taking antimuscarinic agents for the treatment of overactive bladder. Patients allergic to the colorant included in this medication should also be administered it with caution. Taking this medication may increase heart rate or blood pressure, thus hypertensive patients should monitor their blood pressure regularly. Some patients may experience side effects such as urinary tract infections or tachycardia; if any abnormal symptoms occur, consult a physician. Women who are pregnant or may become pregnant should avoid taking this medication, and breastfeeding women are also advised not to use this medication. Safety and efficacy in pediatric patients under 19 years of age have not been established. In cases of overdose, heart rate and blood pressure may increase, so if an overdose is suspected, seek medical attention immediately for appropriate treatment. This medication should be stored out of reach of children and not transferred to other containers. While it does not have a significant effect on driving or operating machinery, caution is advised in case of side effects occurring.

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

This medication may be sensitive to air or moisture, so it must be stored in a tightly closed container. It is best to maintain the storage temperature between 1 to 30 degrees Celsius at room temperature to safely preserve its 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