#特殊劑型：不建議磨粉、管灌藥品

Overactive bladder (OAB) as monotherapy or combine with solifenacin<20210405>
#仿單變更2021

Beta3 Agonist

Onset of action: Efficacy is seen within 8 weeks; steady state achieved within 7 daysDistribution: Vss: ~1670 L (following IV administration)Protein binding: ~71%; binds mainly to albumin and alpha1-acid glycoproteinMetabolism: Extensive metabolism via multiple pathways (eg, dealkylation, oxidation, glucuronidation, amide hydrolysis) via multiple enzymes (eg, UGT, esterase, CYP3A4, CYP2D6); two major pharmacologically inactive metabolites producedBioavailability: 29% to 35% (following 25 mg and 50 mg oral dosing, respectively); bioavailability is dose-dependent; Cmax and AUC are higher in females compared to malesHalf-life elimination: ~50 hoursTime to peak: ~3.5 hoursExcretion: Urine (radiolabeled drug: 55%; unchanged drug: ~25%); feces (radiolabeled drug: 34%; unchanged drug: 0%)

Hypersensitivity to mirabegron or any component of the formulation

Adverse effects have been observed in some animal reproduction studies.

It is not known if mirabegron is present in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

>10%: Cardiovascular: Hypertension (9% to 11%)1% to 10%:Cardiovascular: Tachycardia (2%)Central nervous system: Headache (2% to 4%), dizziness (1% to 3%)Gastrointestinal: Constipation (1% to 3%), xerostomia (4%), diarrhea (2%), abdominal pain (1%)Genitourinary: Urinary tract infection (3% to 6%), cystitis (2%)Infection: Influenza (3%)Neuromuscular & skeletal: Back pain (3%), arthralgia (2%)Respiratory: Nasopharyngitis (4%), sinusitis (3%)

Monotherapy: Initial 25 mg once daily; efficacy is observed within 8 weeks for 25 mg dose. May increase to 50 mg once daily based on individual patient efficacy and tolerability.
Concomitant use with solifenacin: Initial 25 mg once daily with solifenacin 5 mg once daily. May increase mirabegron dose to 50 mg once daily after 4 to 8 weeks.<20210405>

Safety and effectiveness of mirabegron are not established in pediatric patients

CrCl 30 to 89 mL/minute or eGFR 30 to 89 mL/minute/1.73 m2: No dosage adjustment necessary.CrCl 15 to 29 mL/minute or eGFR 15 to 29 mL/minute/1.73 m2: Do not exceed 25 mg once daily.CrCl <15 mL/minute or eGFR <15 mL/minute/1.73 m2: Not recommended (has not been studied).Hemodialysis: Not recommended (has not been studied).

Mild impairment (Child-Pugh class A): No dosage adjustment necessary.Moderate impairment (Child-Pugh class B): Do not exceed 25 mg once daily.Severe impairment (Child-Pugh class C): Not recommended (has not been studied).

Storage at 25°C; excursion permitted to 15°C to 30° C