Hyubegron Prolonged Release Tablet 50 mg (Mirabegron)

Adult dose

The recommended dose for adults (including elderly patients) is 50mg 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. Recommended daily doses for patients with renal or hepatic impairment, with or without strong CYP3A inhibitors: Renal impairment(1) mild — Without inhibitor: 50 mg, With inhibitor: 25 mg Renal impairment(1) moderate — Without inhibitor: 50 mg, With inhibitor: 25 mg Renal impairment(1) severe — Without inhibitor: 25 mg, With inhibitor: Not recommended Hepatic impairment(2) mild — Without inhibitor: 50 mg, With inhibitor: 25 mg Hepatic impairment(2) moderate — Without inhibitor: 25 mg, With 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) For strong CYP3A inhibitors, see ‘5) Drug interactions’

This medication should not be used in certain patients. For example, individuals who are allergic to the active ingredient or other excipients, those with severe uncontrolled hypertension, and patients with severe heart disease should avoid taking this medication. Additionally, caution should be exercised when using this medication in patients with congenital or acquired QT interval prolongation. QT interval prolongation can affect heart rhythm, so it is important to consult a doctor before taking this medication. The use of this medication is not recommended in patients with end-stage renal disease or severe liver dysfunction. Caution should also be taken when used in conjunction with certain enzyme inhibitors; careful administration is required for patients with bladder outlet obstruction or those using antimuscarinic agents for overactive bladder treatment. This medication contains yellow dye, and individuals with a history of allergy to this dye should confirm the absence of allergic reactions before taking this medication. The most commonly reported side effects in clinical trials were tachycardia and urinary tract infections, and most side effects were mild to moderate. Rarely, serious cardiac side effects such as atrial fibrillation were reported. In clinical trials involving Asians, dry mouth was a common side effect, but it was reported at a similar or lower frequency than in the placebo group or compared to the active comparator. It is important to periodically monitor blood pressure and heart rate while taking this medication. Especially for patients with hypertension, it is crucial to closely observe blood pressure changes. Pregnant or breastfeeding women are advised to avoid this medication as its safety has not been sufficiently established, and safety and effectiveness in pediatric patients under 19 years of age have not been established. In case of overdose, heart rate and blood pressure may increase; in such cases, it is essential to visit a healthcare facility immediately for appropriate care. This medication should be kept out of reach of children, and it is advisable not to transfer it to other containers to maintain quality. Finally, this medication may interact with other drugs, so if you are taking other medications, consult with your doctor or pharmacist for safe use.

Tachycardia, urinary tract infection, atrial fibrillation, palpitations, hypertension, dyspepsia, gastritis, lip swelling, urticaria, rash, maculopapular rash, papular rash, pruritus, leukocytoclastic vasculitis, petechiae, 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, ureteral stricture, hematuria, malignant neoplasm of the male reproductive system, bladder cancer, malignant lymphoma, rectal carcinoma, diabetes mellitus, worsening of diabetes, 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 urinary flow, nocturia, facial swelling, bladder discomfort, urinary abnormalities, chest pain, back pain, asthenia, altered temperature sensation, generalized edema, abdominal pain, colitis, stomatitis, gastroesophageal reflux, gastroenteritis, lip dryness, periodontal destruction, thirst, dry eye, unspecified lipid metabolism disorder, weight loss, abnormal semen, testicular pain, epididymitis, ejaculation dysfunction, inguinal hernia, prostatic hyperplasia, visual disturbances, upper respiratory tract infection, pharyngitis, dyspnea, skeletal pain, myofascial pain, arthropathy, orthostatic hypotension, erectile dysfunction, decreased libido, decreased appetite, cholelithiasis, fatty liver, acute urticaria, skin discoloration

This medication must be stored in a tightly closed container to protect it from air and moisture. The appropriate storage temperature is room temperature between 1°C and 30°C. Storing it this way will help maintain the drug's effectiveness over time.

Appearance

Yellow oval film-coated prolonged release tablet

Package unit

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