Betamiras 50mg Extended-Release Tablet (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). Category / Severity / Strong CYP3A inhibitor(3), inhibitor absent / inhibitor 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) See “5) Drug Interactions” for strong CYP3A inhibitors.

This medication should not be used in patients with allergies to the active ingredient or other ingredients. In particular, patients with uncontrolled severe hypertension or severe heart disease may experience worsening of symptoms if they take this medication and should not be administered. Patients with certain conditions related to heart rhythm or a history of prolonged QT interval should use this medication with caution. This medication is not recommended for patients with end-stage renal disease or severe liver dysfunction. Caution is also needed when taken with strong specific enzyme inhibitors. Patients with bladder outlet obstruction or those taking antimuscarinic agents for overactive bladder should also use this medication with caution. This medication contains certain dyes, and those who have allergic reactions to them should be cautious. Side effects such as rapid heartbeat or urinary tract infections may occur when taking this medication, and severe adverse reactions such as atrial fibrillation have been reported infrequently. Dry mouth may commonly occur, but this is less than with other similar medications. This medication may increase blood pressure, so patients with hypertension should regularly monitor their blood pressure. Patients with bladder outlet obstruction or those taking antimuscarinic agents may experience urinary retention issues, so caution is advised. It is recommended that women who are pregnant or may become pregnant do not take this medication, and nursing women should also avoid its use. Safety and efficacy have not been established in children under 19 years of age. In case of overdose, increased heart rate and elevated blood pressure may occur, so consult medical personnel immediately in the event of an overdose and monitor heart condition. This medication should be stored in a safe place out of reach of children, and should not be transferred to another container. Additionally, this medication may affect the metabolism of certain enzymes and drugs, so be sure to inform medical personnel if you are taking other medications. There is little effect on driving or operating machinery, but this may vary by individual, so caution is necessary.

Tachycardia, urinary tract infection, atrial fibrillation, palpitations, increased blood pressure, dyspepsia, gastric inflammation, lip swelling, urticaria, rash, maculopapular rash, papular rash, itching, leukopenic 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 strictures, hematuria, malignant neoplasm of the male reproductive system, bladder carcinoma, malignant lymphoma, rectal carcinoma, diabetes mellitus, worsening of diabetes, cataract, glaucoma, cerebellar ataxia, spinal canal stenosis, fracture, hypertension, hypotension, pneumonia, lung disease, peripheral edema, urination disorders, urinary incontinence, dysuria, frequent urination, decreased urine flow, chest pain, visual disturbances, nocturia, facial edema, bladder discomfort, abnormal urination, back pain, asthenia, temperature sensation changes, generalized edema, abdominal pain, colitis, glossitis, gastroesophageal reflux, gastroenteritis, dry 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 infection, pharyngitis, dyspnea, skeletal pain, fibromyalgia, arthropathy, orthostatic hypotension, erectile dysfunction, decreased libido, loss of appetite, cholelithiasis, fatty liver, acute urticaria, skin discoloration

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Yellow oval film-coated extended-release tablet

Package unit

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