Mirabegron Controlled-release Tablet 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). Category / Severity / Strong CYP3A inhibitor(3), inhibitor absent / inhibitor present Renal impairment(1) / Mild / 50 mg / 25 mg Renal impairment(1) / Moderate / 50 mg / 25 mg Renal impairment(1) / Severe / 25 mg / Not recommended Hepatic impairment(2) / Mild / 50 mg / 25 mg Hepatic impairment(2) / Moderate / 25 mg / 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 certain patients. First, individuals who are allergic to the active ingredient or other components should avoid taking it. Additionally, patients with uncontrolled severe hypertension or significant heart disease may risk worsening symptoms if they take this medication. Caution is advised when administering this medication to patients with congenital or acquired conditions that can prolong the QT interval. Patients with a history of QT prolongation or those taking medications that can induce QT prolongation should pay special attention when taking this medication. It is not recommended for patients with end-stage renal disease or severe liver impairment, as the safety and effectiveness of this medication have not been thoroughly studied in these populations. Moreover, patients with severe renal impairment or moderate liver impairment who are taking strong CYP3A4 inhibitors should also avoid this medication. Patients with bladder outlet obstruction and those taking antimuscarinic agents for the treatment of overactive bladder should take caution due to the risk of side effects such as urinary retention when taking this medication. This medication contains Yellow No. 4 and Yellow No. 5 dyes, so caution is advised for individuals who are allergic to these ingredients. Common side effects include tachycardia and urinary tract infections. Rarely, abnormal cardiac responses such as atrial fibrillation have also been reported, and any such symptoms should prompt immediate consultation with medical personnel. This medication may increase blood pressure, so particularly hypertensive patients should regularly monitor their blood pressure and check their condition. It is advisable for women who are pregnant or may become pregnant, as well as breastfeeding women, to avoid taking this medication, as safety has not been established in individuals under 19 years of age. In case of overdose, increased heart rate and elevated blood pressure may occur, so immediate medical attention and monitoring should be sought if overdose is suspected. Finally, keep this medication out of reach of children and avoid transferring it to other containers.

tachycardia, urinary tract infection, atrial fibrillation, palpitations, elevated blood pressure, dyspepsia, gastritis, lip swelling, urticaria, rash, maculopapular rash, papular rash, itching, leukocytoclastic vasculitis, purpura, joint swelling, vulvar itching, cystitis, increased γ-GTP, increased SGOT, increased SGPT, dry mouth, urinary retention, nausea, constipation, diarrhea, angioedema, insomnia, confusion, dizziness, headache, pyuria, bladder stones, kidney stones, urinary tract obstruction, hematuria, malignant neoplasm of male genital organs, bladder carcinoma, malignant lymphoma, rectal carcinoma, diabetes mellitus, worsening of diabetes, cataract, glaucoma, cerebellar ataxia, spinal canal stenosis, fracture, hypertension, hypotension, pneumonia, pulmonary disease, peripheral edema, urinary disorders, urinary incontinence, dysuria, frequent urination, decreased urine flow, chest pain, back pain, asthenia, temperature sensation changes, generalized edema, abdominal pain, colitis, glossitis, gastroesophageal reflux, gastritis, dry lips, periodontal destruction, thirst, dry eyes, unspecified lipid metabolism disorder, weight loss, abnormal semen, testicular pain, epididymitis, loss of ejaculatory function, inguinal hernia, prostatic hyperplasia, visual disturbances, upper respiratory tract infection, pharyngitis, dyspnea, skeletal pain, fibromyalgia, arthropathy, orthostatic hypotension, erectile dysfunction, decreased libido, loss of appetite, cholelithiasis, fatty liver, acute urticaria, skin discoloration

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Yellow oval film-coated controlled-release tablet

Package unit

PTP - 90 tablets/box [10 tablets/PTP X 9], Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle