Product Overview
[Drug Name]
Generic Name: Mirabegron Extended-Release Tablets
Trade Name: BeiTanLi Mirabegron Extended-Release Tablets 50mg x 10 Tablets
Pinyin Code: BeiTanLi MiLaBeiLongHuanShiPian 50mg x 10 Tablets
[Main Ingredient]
Mirabegron.
[Properties]
This product is a yellow film-coated tablet that appears white or off-white after removal of the coating.
[Indications/Main Functions]
For the symptomatic treatment of urinary urgency, frequency, and/or urge incontinence in adult patients with overactive bladder (OAB).
[Specifications]
50mg x 10 tablets
[Dosage and Administration]
The recommended dose is 50mg, taken once daily after meals. Take with water. Since this is a sustained-release tablet, it should be swallowed whole and should not be chewed, broken, or crushed.
[Adverse Reactions]
The safety of mirabegron was evaluated in 8,433 patients with AAB in Phase II/II clinical trials. Of these, 5,648 patients received mirabegron at least once, and 622 patients received mirabegron for at least one year (365 days). Most adverse reactions were mild to moderate. In three 12-week, double-blind, placebo-controlled Phase IIII clinical trials, 88% of patients completed mirabegron treatment, and 4% discontinued due to adverse events. The most common adverse reactions in patients treated with mirabegron extended-release tablets (Bentanli) 50 mg were urinary tract infection and tachycardia. The incidence of urinary tract infection was 2.9%, and no patient discontinued the drug due to urinary tract infection. The incidence of tachycardia was 1.2%, and 0.1% of patients discontinued the drug due to tachycardia. Serious adverse reactions included atrial fibrillation (0.2%).
[Pediatric Use]
The safety and efficacy of mirabegron extended-release tablets (Bentanli) in children under 18 years of age have not been established. No relevant data are currently available.
[Pharmacology and Toxicology]
Pharmacological Action: Mirabegron is a selective β3-adrenergic receptor agonist that acts by targeting Bladder tissue, relaxes bladder smooth muscle. Toxicological studies: genetic toxicity; the results of the mirabegron Ames test, human peripheral blood lymphocyte chromosome aberration test, and rat micronucleus test were all negative. Reproductive toxicity: Mirabegron sustained-release tablets (Betanni) had no significant effect on fertility at sublethal dose levels (the corresponding human equivalent dose was 19 times higher than the maximum human recommended dose MRHD). Maternal toxicity (including death, reduced activity, fur staining, tearing, tremor, reduced body weight and food intake) and delayed estrus, reduced number of corpora lutea, number of implantations, and number of surviving fetuses were observed at a dose of 300 mg/kg.
