Zitami Extended-Release Tablets 50 mg (Mirabegron)

Adult dose

Adults (including elderly patients): The recommended dose 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 (without strong CYP3A inhibitors): Mild renal impairment: 50 mg Moderate renal impairment: 50 mg Severe renal impairment: 25 mg Mild hepatic impairment: 50 mg Moderate hepatic impairment: 25 mg Recommended daily doses for patients with renal or hepatic impairment (with strong CYP3A inhibitors): Mild renal impairment: 25 mg Moderate renal impairment: 25 mg Severe renal impairment: Not recommended Mild hepatic impairment: 25 mg Moderate hepatic impairment: 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 administered to certain patients. For example, patients who are allergic to the active ingredient or other ingredients of this medication, those with uncontrolled severe hypertension, and patients with severe heart disease should not use this medication. Additionally, caution should be exercised when using this medication in patients with congenital or acquired prolonged QT interval, as prolonged QT can cause issues with heart rhythm. It is also not recommended for patients with end-stage renal disease, severe liver dysfunction, or those with moderate liver dysfunction or severe renal impairment when coadministered with strong CYP3A4 inhibitors. Patients with bladder outlet obstruction or those currently taking specific antimuscarinic agents for the treatment of overactive bladder should also take care when using this medication. This medication contains yellow dye, so patients allergic to this component should be cautious as well. This medication may cause side effects such as tachycardia or urinary tract infections, and rarely, cardiac abnormalities such as atrial fibrillation have been reported. Various adverse reactions may occur, including dry mouth, dyspepsia, skin rash, and itching, so consult with a healthcare professional immediately if symptoms appear. This medication can raise blood pressure, so patients with hypertension should monitor their blood pressure frequently. Furthermore, this medication may increase heart rate, so it is advisable to periodically check heart health. This medication is not recommended for use in pregnant women, nursing mothers, or children under 19 years of age. In case of overdose, increased heart rate and blood pressure may occur; seek immediate medical attention if an overdose is suspected. This medication may interact with other medications, so be sure to inform healthcare providers of any other drugs being taken. Finally, this medication should be kept out of the reach of children and should not be transferred to other containers for safety.

• Tachycardia
• urinary tract infection
• atrial fibrillation
• hypertension
• palpitations
• dyspepsia
• gastritis
• lip swelling
• urticaria
• rash

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to maintain storage temperatures between 1 and 30 degrees Celsius.

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