Betmiga

Betmiga

mirabegron

Manufacturer:

Astellas

Distributor:

Zuellig
Concise Prescribing Info
Contents
Mirabegron
Indications/Uses
Symptomatic treatment of urgency, increased micturition frequency &/or urgency incontinence as may occur in adult patients w/ overactive bladder (OAB) syndrome.
Dosage/Direction for Use
Adult 50 mg once daily. Renal impairment (w/o inhibitor) mild, moderate 50 mg, severe 25 mg; (w/ inhibitor) mild, moderate 25 mg. Hepatic impairment (w/o inhibitor) mild 50 mg, moderate 25 mg. (w/ inhibitor) mild 25 mg.
Administration
May be taken with or without food: Swallow whole, do not chew/divide/crush.
Contraindications
Hypersensitivity. Severe uncontrolled HTN (systolic BP ≥180 mmgHg &/or diastolic BP ≥110 mmHg).
Special Precautions
Patients w/ end stage renal disease (GFR <15 mL/min/1.73 m2 or requiring haemodialysis); severe renal impairment concomitantly receiving strong CYP3A inhibitors. Severe hepatic impairment (Child-Pugh class C); moderate hepatic impairment (Child-Pugh class C) concomitantly receiving strong CYP3A inhibitors. May increase BP. Measure BP periodically especially in hypertensive patients. History of QT prolongation or taking drugs known to prolong the QT interval. Patients w/ bladder outlet obstruction (BOO) & patients taking antimuscarinic medications for OAB. Women of childbearing potential. Pregnancy & lactation. Childn <18 yr.
Adverse Reactions
UTI; tachycardia; nausea, constipation, diarrhoea; headache, dizziness.
Drug Interactions
Increased exposure (AUC) w/ strong CYP3A inhibitor eg, itraconazole, ketoconazole, ritonavir & clarithromycin especially in patients w/ mild to moderate renal impairment or mild hepatic impairment. Increased AUC & Cmax of metoprolol, desipramine & digoxin. Caution in concomitant w/ drugs w/ narrow therapeutic index & significantly metabolized by CYP2D6 eg, thioridazine, type 1C antiarrhythmics (eg, flecainide, propafenone) & TCAs (eg, imipramine, desipramine). Potential P-gp inhibition of sensitive P-gp substrates eg, dabigatran.
ATC Classification
G04BD12 - mirabegron ; Belongs to the class of urinary antispasmodics.
Presentation/Packing
Form
Betmiga PR tab 50 mg
Packing/Price
30's (P1,950/box)
Form
Betmiga PR tab 25 mg
Packing/Price
30's (P1,950/box)
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