Lablon Sustained 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. Mild renal impairment(1): without strong CYP3A inhibitors 50 mg, with inhibitors 25 mg Moderate renal impairment(1): without strong CYP3A inhibitors 50 mg, with inhibitors 25 mg Severe renal impairment(1): without strong CYP3A inhibitors 25 mg, with inhibitors Not recommended Mild hepatic impairment(2): without strong CYP3A inhibitors 50 mg, with inhibitors 25 mg Moderate hepatic impairment(2): without strong CYP3A inhibitors 25 mg, with inhibitors 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 medicine should not be used in patients who are allergic to the active substance or any other constituents. It is also advisable to avoid using it in patients with very high blood pressure or severe heart disease. Particularly, patients with a history of prolonged QT interval or those taking medications that can prolong the QT interval should be cautious when using this drug. This medication is not recommended for patients with severely impaired kidney function or serious liver dysfunction. As this drug can interact with certain enzyme inhibitors, it is advisable not to administer it to patients with severe renal or hepatic impairment who are taking potent CYP3A4 inhibitors. Patients with bladder outlet obstruction or those taking antimuscarinic agents for the treatment of overactive bladder should also exercise caution when using this drug. This tablet contains specific dyes; patients who are hypersensitive or have a history of allergies to these substances should use it with caution. The most commonly reported side effects in clinical trials were increased heart rate or urinary tract infection, most of which were mild to moderate. The types and severity of side effects did not significantly differ in patients taking the medication for an extended period. Dry mouth may occur in some patients, but it is generally less than with other treatments. This medication may elevate blood pressure; therefore, especially in patients with hypertension, it is important to regularly measure and manage blood pressure. In cases of overdose, symptoms such as increased heart rate and elevation of blood pressure may occur, and immediate consultation with medical staff and monitoring of heart rate and blood pressure is necessary. Women who are pregnant or may become pregnant should avoid using this drug, and breastfeeding women should also refrain from using this medication for safety reasons. It is not to be used in children under 19 years old as safety and efficacy have not been established. This drug is known not to significantly affect driving or operating machinery, but caution may still be needed depending on the individual. There may be interactions with other medications while taking this drug, so anyone who is currently taking other medications must inform their healthcare provider. Particularly, caution is required when taking CYP3A4 inhibitors or medications that affect CYP2D6 metabolism together with this drug. This medication should be stored out of reach of children and should not be transferred to other containers.

Tachycardia, urinary tract infection, atrial fibrillation, increased blood pressure, palpitations, dyspepsia, gastritis, lip swelling, urticaria, rash, maculopapular rash, papular rash, itching, leukocytoclastic vasculitis, purpura, joint swelling, vulvar pruritus, 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 genital organs, bladder carcinoma, malignant lymphoma, rectal carcinoma, diabetes mellitus, worsening of diabetes, cataract, glaucoma, cerebellar ataxia, spinal stenosis, fracture, hypertension, hypotension, pneumonia, lung disease, peripheral edema, urological disorders, urinary incontinence, dysuria, frequency of urination, decreased urine flow, chest pain, visual disturbances, facial edema, bladder discomfort, abnormal urination, back pain, weakness, changes in temperature sensation, generalized edema, abdominal pain, colitis, glossitis, gastroesophageal reflux, gastritis, chapped lips, periodontal destruction, thirst, dry eye, unspecified lipid metabolism disorder, weight loss, abnormal semen, testicular pain, epididymitis, loss of ejaculation function, inguinal hernia, prostatic hyperplasia, sensory disturbances, cognitive impairment, upper respiratory tract infection, pharyngitis, dyspnea, skeletal pain, fibromyalgia, arthropathy, orthostatic hypotension, erectile dysfunction, decreased libido, anorexia, cholelithiasis, fatty liver, acute urticaria, skin discoloration

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain storage temperature between 1 and 30 degrees Celsius to ensure the safety and effectiveness of the medication.

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