Boryeong Mirabegron Extended Release Tablets 50 mg

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. The following table shows the recommended daily doses for patients with renal or hepatic impairment, with or without strong CYP3A inhibitors (see “Precautions for Use, 5) Drug Interactions”). Category / Severity / Strong CYP3A inhibitor(3) absent / Strong CYP3A inhibitor(3) 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) For strong CYP3A inhibitors, see “5) Drug Interactions”.

This medication should not be used in individuals who are allergic to the active ingredient or any other component. It should not be administered to individuals with very high and uncontrolled blood pressure or severe heart disease, as this medication may worsen their condition. Patients with a history of prolonged QT interval related to heart rhythm or those taking medications that can prolong the QT interval should be cautious when using this drug. It is not recommended for patients with very poor kidney function or severe liver disease. Patients with severe kidney or moderate liver impairment who are taking strong CYP3A4 enzyme inhibitors should also avoid this medication. Patients with bladder outlet obstruction and those taking antimuscarinics for overactive bladder treatment should be cautious when using this medication. This drug contains certain dyes, so individuals allergic to these dyes should use it carefully. The most commonly reported side effects in clinical trials were rapid heartbeat or urinary tract infection, and some patients may experience serious side effects such as atrial fibrillation. In clinical trials involving Asians, dry mouth was reported relatively frequently, but it was not severe compared to other medications. This medication may slightly increase blood pressure, so it is important for hypertensive patients to monitor their blood pressure regularly. This drug is known not to have a significant impact on driving or operating machinery. Women who are pregnant or may become pregnant should avoid using this medication, and it is also safest for breastfeeding women to avoid it. Safety and efficacy have not been established in children under 19 years old, so it should not be used in this population. In cases of overdose, heart rate and blood pressure may increase, so immediate medical assistance should be sought, and cardiac condition monitoring may be necessary. This medication should be kept out of the reach of children and stored in its original container to maintain quality.

Tachycardia, urinary tract infection, atrial fibrillation, palpitations, hypertension, 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, confusional state, 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, diabetes exacerbation, cataract, glaucoma, cerebellar ataxia, spinal canal stenosis, fracture, hypertension, hypotension, pneumonia, pulmonary disease, peripheral edema, urinary disorders, urinary incontinence, dysuria, increased frequency of urination, decreased urine flow, chest pain, visual disturbances, nocturia, facial swelling, bladder discomfort, abnormal urine, back pain, asthenia, changes in temperature sensation, generalized edema, abdominal pain, colitis, glossitis, gastroesophageal reflux, gastritis, dry lips, periodontal destruction, thirst, dry eye, unspecified lipid metabolism disorder, weight loss, semen abnormalities, testicular pain, epididymitis, ejaculation dysfunction, inguinal hernia, prostatic hyperplasia, sensory disturbances, cognitive impairment, 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, palpitations, increased pulse rate

This medication should be stored in a sealed container to prevent exposure to air or moisture, preferably at room temperature between 1°C and 30°C. Storing it this way will help maintain the drug's efficacy for a long time.

Appearance

Yellow oval film-coated extended release tablets

Package unit

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