Betagron Sustained Release Tablets 50 mg (Mirabegron)

Adult dose

The recommended dose for adults (including elderly patients) is 50 mg 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”). Renal impairment(1), mild: without a strong CYP3A inhibitor, 50 mg; with one, 25 mg Renal impairment(1), moderate: without a strong CYP3A inhibitor, 50 mg; with one, 25 mg Renal impairment(1), severe: without a strong CYP3A inhibitor, 25 mg; use with one is not recommended Hepatic impairment(2), mild: without a strong CYP3A inhibitor, 50 mg; with one, 25 mg Hepatic impairment(2), moderate: without a strong CYP3A inhibitor, 25 mg; use with one is 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 drug should not be used in patients who are allergic to the active ingredient or other components. It is also advisable not to administer this drug to patients with severely elevated and uncontrolled blood pressure. Patients with severe heart disease should exercise caution as this drug may worsen their symptoms. Patients with a history of prolonged QT interval or those taking medications that may prolong QT interval require careful monitoring when using this drug. This drug is not recommended for patients with severely impaired renal function or severe liver dysfunction. Particular caution should be exercised when administering this drug to patients with severe renal or liver impairment who are taking strong CYP3A4 inhibitors. Patients with urinary obstruction or those receiving antimuscarinics for overactive bladder should also be cautious when using this drug. This drug contains specific dyes; therefore, it should be administered cautiously to patients with allergies to these components. During treatment with this drug, heart rate and blood pressure may increase, so blood pressure should be regularly monitored and checked. In case of overdose, symptoms may include increased heart rate and elevated blood pressure; in this case, immediate consultation with medical personnel is necessary. Women who are pregnant or may become pregnant are advised not to use this drug, and breastfeeding women should also avoid its use. The safety and efficacy of this drug have not been established in children under 19 years of age; therefore, it is not used in this age group. This drug does not significantly affect the ability to drive or operate machinery, but caution is needed as this may vary by individual. Additionally, this drug can interact with various medications, so it is essential to consult with a doctor or pharmacist if taking other medications. Lastly, keep this drug out of the reach of children and store it 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, confusion, dizziness, headache, pyuria, bladder stones, kidney stones, urinary obstruction, hematuria, malignant male reproductive system neoplasm, bladder carcinoma, malignant lymphoma, rectal carcinoma, diabetes mellitus, worsening diabetes, cataract, glaucoma, cerebellar ataxia, spinal stenosis, fracture, hypertension, hypotension, pneumonia, pulmonary disease, peripheral edema, urinary disorders, urinary incontinence, dysuria, frequency of urination, decreased urine flow, nocturia, facial edema, bladder discomfort, abnormal urination, chest pain, back pain, asthenia, temperature sensation changes, general edema, abdominal pain, colitis, glossitis, gastroesophageal reflux, gastroenteritis, lip dryness, periodontal destruction, thirst, dry eyes, unspecified lipid metabolism disorder, weight loss, abnormal semen, testicular pain, epididymitis, ejaculation dysfunction, inguinal hernia, prostatic hyperplasia, visual disturbances, upper respiratory infection, pharyngitis, dyspnea, skeletal pain, fibromyalgia, arthropathy, orthostatic hypotension, erectile dysfunction, decreased libido, appetite loss, cholelithiasis, fatty liver, acute urticaria, skin pigmentation

This drug should be stored in a tightly closed container to prevent air or moisture from entering, and it is best kept at room temperature between 1 and 30 degrees Celsius. This storage method will help maintain the drug's effectiveness.

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