Miraem Sustained Release 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 certain patients. For example, it should be avoided in patients allergic to the active ingredient or other ingredients, patients with uncontrolled severe hypertension, and those with serious heart conditions. Additionally, this medication should be administered with caution in patients with heart diseases that prolong the QT interval or who are taking medications that can prolong the QT interval. It is not recommended for patients with end-stage renal disease or severe liver impairment, and patients with severe renal or liver impairment taking strong CYP3A4 inhibitors should also avoid this medication. Caution is required when administering this medication to patients with bladder outlet obstruction or those who are taking other medications for the treatment of overactive bladder. Patients allergic to certain dye components should also use this medication carefully. Common side effects when taking this medication include rapid heartbeat and urinary tract infections, with reports of dry mouth. Rarely, abnormal cardiac responses such as atrial fibrillation, skin rashes, and symptoms like indigestion may occur. Blood pressure may increase, so patients with hypertension should check their blood pressure frequently, and these symptoms will resolve upon discontinuation of the medication. It is recommended that women who are pregnant or may become pregnant, as well as nursing mothers, do not use this medication. Safety and efficacy have not been established in children under 19 years of age. In case of overdose, there may be increases in heart rate and blood pressure; thus, monitoring of heart rate, blood pressure, and electrocardiogram is required to relieve symptoms. This medication should be kept out of the reach of children and should not be transferred to other containers. Finally, this medication may interact with other drugs, so it is important to consult a doctor or pharmacist, especially if taking CYP3A4 inhibitors or medications that affect CYP2D6 metabolism.

Tachycardia, urinary tract infection, atrial fibrillation, palpitations, increased blood pressure, indigestion, 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 stricture, hematuria, malignant neoplasm of male reproductive organs, bladder carcinoma, malignant lymphoma, rectal carcinoma, diabetes, worsening of diabetes, cataract, glaucoma, cerebellar ataxia, spinal canal stenosis, fracture, hypertension, hypotension, pneumonia, lung disorders, peripheral edema, urinary disorders, incontinence, dysuria, frequency of urination, decreased urine flow, nocturia, facial swelling, bladder discomfort, abnormal urination, chest pain, back pain, weakness, changes in temperature sensation, abdominal pain, colitis, stomatitis, gastroesophageal reflux, gastroenteritis, chapped lips, periodontal destruction, thirst, dry eyes, unspecified lipid metabolism disorder, weight loss, abnormal semen, testicular pain, epididymitis, loss of ejaculation function, inguinal hernia, prostatic hyperplasia, sensory abnormality, cognitive impairment, upper respiratory infection, pharyngitis, dyspnea, skeletal pain, myofascial pain, arthropathy, orthostatic hypotension, erectile dysfunction, decreased libido, appetite loss, cholelithiasis, fatty liver, acute urticaria, skin discoloration

This medication should be stored in a tightly closed container to prevent air or moisture ingress, and should be kept at room temperature between 1 and 30 degrees Celsius. This storage method helps maintain the medication's effectiveness over time.

Appearance

Yellow oval film-coated sustained-release tablet

Package unit

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