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 (including elderly) 50 mg once daily. Renal impairment (w/o strong CYP3A inhibitor) mild, moderate 50 mg daily, severe 25 mg daily; (w/ strong CYP3A inhibitor) mild, moderate 25 mg daily. Hepatic impairment (w/o strong CYP3A inhibitor) mild 50 mg daily, moderate 25 mg daily; (w/ strong CYP3A inhibitor) mild 25 mg daily.
Administration
May be taken with or without food: Swallow whole, do not chew/divide/crush.
Contraindications
Hypersensitivity. Severe uncontrolled HTN (systolic BP ≥180 mmHg &/or diastolic BP ≥110 mmHg).
Special Precautions
May increase BP. Measure BP at baseline & periodically especially in hypertensive patients. Patients w/ history of QT prolongation or who are taking medicinal products known to prolong the QT interval. Patients w/ bladder outlet obstruction & patients taking antimuscarinic medications for OAB. Not recommended in patients w/ ESRD (GFR <15 mL/min/1.73 m2 or requiring haemodialysis); severe renal impairment (GFR 15-29 mL/min/1.73 m2) concomitantly receiving strong CYP3A inhibitors; severe hepatic impairment (Child-Pugh class C); moderate hepatic impairment (Child-Pugh class B) concomitantly receiving strong CYP3A inhibitors. Not recommended during pregnancy & in women of childbearing potential not using contraception. Not to be administered during 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 co-administration w/ medicinal products w/ narrow therapeutic index & significantly metabolised by CYP2D6 eg, thioridazine, type 1C antiarrhythmics (eg, flecainide, propafenone) & TCAs (eg, imipramine, desipramine); CYP2D6 substrates that are individually dose titrated. Potential P-gp inhibition when combined w/ sensitive P-gp substrates eg, dabigatran.
MIMS Class
Drugs for Bladder & Prostate Disorders
ATC Classification
G04BD12 - mirabegron ; Belongs to the class of urinary antispasmodics.
Presentation/Packing
Form
Betmiga PR tab 25 mg
Packing/Price
30's
Form
Betmiga PR tab 50 mg
Packing/Price
30's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Sign in