- Indications and Usage Mirabegron sustained-release tablets are indicated for the symptomatic treatment of overactive bladder (OAB) in adults, including symptoms of urinary urgency, frequency, and urge urinary incontinence.
- Dosage and Administration Recommended Dosage: The recommended dose is 50 mg taken orally once daily with water. Administration Details: Due to the sustained-release nature of the tablet, it must be swallowed whole and must not be chewed, broken, or crushed. Renal/Hepatic Impairment: For patients with severe renal impairment (GFR 15-29 mL/min/1.73 m²) not using strong CYP3A inhibitors, the dose should be reduced to 25 mg. It is not recommended for patients with end-stage renal disease (ESRD) or severe hepatic impairment (Child-Pugh Class C).
- Mechanism of Action Mirabegron is a selective beta-3 adrenergic receptor agonist. It acts by relaxing the detrusor smooth muscle of the bladder, thereby increasing functional bladder capacity and reducing uninhibited contractions.
- Safety and Warnings Hypertension and Tachycardia: Mirabegron may increase blood pressure and heart rate. Blood pressure should be monitored during treatment. It is contraindicated in patients with uncontrolled severe hypertension. Hypersensitivity: Serious hypersensitivity reactions, including angioedema, have been reported. Severe Hepatic/Renal Impairment: Not recommended for use in patients with end-stage renal disease or severe hepatic impairment.
- Adverse Reactions and Clinical Research Most Common Adverse Reactions: The most common adverse reactions are urinary tract infection and tachycardia. Other Common Reactions: Includes nausea, hypertension, abdominal pain, constipation, diarrhea, dizziness, and headache.
- Drug Interactions CYP2D6 Substrates: Mirabegron is a moderate inhibitor of CYP2D6. Concomitant use with narrow therapeutic index CYP2D6 substrates (e.g., flecainide, propafenone) requires dose monitoring and adjustment. CYP3A Inhibitors: Strong CYP3A inhibitors (e.g., ketoconazole, ritonavir) may increase mirabegron exposure, requiring dose reduction in patients with renal or hepatic impairment.
- Pharmaceutical Information Chemical Composition: Active ingredient is mirabegron. Appearance: Yellow film-coated tablets (50 mg strength), white or off-white inside. Storage: Store at controlled room temperature.
BeTanLi Mirabegron Sustained-release Tablets
Brand Name:贝坦利 ®（BeTanLi®）
Generic Name: Mirabegron Sustained-release
Strength: 50 mg per tablet, 10 tablets per box
Manufacturer: Avara Pharmaceutical Technologies Inc.
Marketing Authorization Holder: Astellas Pharma Europe B.V.
Approval Date in China: October 13, 2017
Registration Number: 国药准字HJ20171306
Storage: Seal tightly and store at 10–30°C, avoid high temperature and humidity. Refer to the full package insert for detailed storage specifications.
Price&Cost:Contact Us now for the best price of Mirabegron Sustained-release（BeTanLi）
Only logged in customers who have purchased this product may leave a review.
Reviews
There are no reviews yet.