Betmiga

Betmiga

mirabegron

Manufacturer:

Astellas
Concise Prescribing Info
Contents
Mirabegron
Indications/Uses
Symptomatic treatment of urgency incontinence, urgency, nocturia & urinary frequency as may occur w/ overactive bladder (OAB) syndrome.
Dosage/Direction for Use
Adult (including elderly) 50 mg once daily. Renal impairment (in the absence & presence of strong CYP3A4 inhibitors) Mild & moderate: W/o inhibitor: 50 mg, w/ inhibitor: 25 mg. Severe w/o inhibitor: 25 mg. Hepatic impairment (absence & presence of strong CYP3A4 inhibitor) Mild: W/o inhibitor: 50 mg, w/ inhibitor: 25 mg. Moderate w/o inhibitor: 25 mg.
Administration
May be taken with or without food: Swallow whole w/ liqd, do not chew/divide/crush.
Contraindications
Special Precautions
Severe uncontrolled HTN. Known history of QT prolongation or taking medicines known to prolong QT interval; bladder outlet obstruction & taking antimuscarinic medications for OAB. End-stage renal disease (GFR 15-29 mL/min/1.73 m2), severe renal impairment; moderate (Child-Pugh Class B) & severe hepatic impairment (Child-Pugh Class C). Women of childbearing potential not using contraception. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Drug Interactions
Increased AUC w/ strong CYP3A/P-gp inhibitors eg, ketoconazole, itraconazole, ritonavir, clarithromycin. Decreased plasma conc by CYP3A/P-gp inducers. Increased Cmax & AUC of metoprolol, desipramine & digoxin. Thioridazine, type 1C antiarrhythmics (eg, flecainide, propafenone), TCAs. Potential P-gp inhibition of dabigatran.
ATC Classification
G04BD12 - mirabegron ; Belongs to the class of urinary antispasmodics.
Presentation/Packing
Form
Betmiga PR tab 25 mg
Packing/Price
3 × 10's
Form
Betmiga PR tab 50 mg
Packing/Price
3 × 10's
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