Miralons Sustained 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. Mild renal impairment: without a strong CYP3A inhibitor 50 mg, with an inhibitor 25 mg Moderate renal impairment: without a strong CYP3A inhibitor 50 mg, with an inhibitor 25 mg Severe renal impairment: without a strong CYP3A inhibitor 25 mg, with an inhibitor not recommended Mild hepatic impairment: without a strong CYP3A inhibitor 50 mg, with an inhibitor 25 mg Moderate hepatic impairment: without a strong CYP3A inhibitor 25 mg, with an inhibitor 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 by patients who are allergic to the active ingredient or any other components. It is safe not to administer to patients with severely elevated or uncontrolled hypertension. Patients with severe heart disease should take caution as this medication may worsen their symptoms. Patients with a history of QT interval prolongation or those taking medications that may prolong the QT interval should be administered this drug carefully. Its use is not recommended for patients with end-stage renal disease or severe liver dysfunction. It is also advisable not to prescribe to patients with severe renal impairment or moderate liver impairment who are taking specific enzyme inhibitors. Patients with bladder outlet obstruction or those currently taking certain medications for the treatment of overactive bladder should be cautious when using this drug. This medication contains certain pigments, and patients allergic to those components should use it with caution. During treatment, heart rate and blood pressure may increase, so regular monitoring is necessary to check for abnormalities. Side effects such as dry mouth, tachycardia, urinary tract infections may occur, and patients should consult healthcare providers if symptoms arise. Pregnant women or those who may become pregnant are recommended not to take this medication, and breastfeeding women should also avoid its use. It is not used in children under the age of 19 as safety and efficacy have not been established. In case of overdose, heart rate and blood pressure may increase; if overdose is suspected, immediate medical attention should be sought for appropriate treatment. This medication should be kept out of reach of children and not transferred to another container.

Tachycardia, urinary tract infection, atrial fibrillation, palpitations, increased blood pressure, dyspepsia, gastritis, lip swelling, urticaria, rash, maculopapular rash, papular rash, itching, leukopenic vasculitis, purpura, joint swelling, pruritus of the external genitals, 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 male reproductive system neoplasm, 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, urination disorders, urinary incontinence, dysuria, increased urinary frequency, decreased urine flow, chest pain, visual disturbances, facial swelling, bladder discomfort, urinary abnormalities, back pain, weakness, changes in temperature sensation, abdominal pain, colitis, glossitis, gastroesophageal reflux, gastritis, lip dryness, periodontal destruction, thirst, dry eye, unspecified lipid metabolism disorder, weight loss, abnormal semen, testicular pain, epididymitis, erectile dysfunction, inguinal hernia, prostatic hyperplasia, sensory abnormalities, cognitive impairment, upper respiratory tract infection, pharyngitis, dyspnea, skeletal pain, muscle fiber pain, arthropathy, orthostatic hypotension, erectile dysfunction, decreased libido, appetite loss, cholelithiasis, fatty liver, acute urticaria, skin pigmentation

This medication should be stored in a tightly closed container to protect it from air and moisture and should be kept at room temperature between 1 to 30 degrees Celsius. Storing in this manner helps maintain the efficacy and safety of the drug.

Appearance

Yellow oval-shaped film-coated sustained release tablet

Package unit

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