Betmiga

Betmiga

mirabegron

Manufacturer:

Astellas Pharma

Distributor:

DKSH
Concise Prescribing Info
Contents
Mirabegron
Indications/Uses
Symptomatic treatment of urgency, increased micturition frequency &/or urgency incontinence as may occur in adult w/ overactive bladder (OAB) syndrome.
Dosage/Direction for Use
Adult including elderly 25 mg once daily, may be increased to 50 mg once 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
Known history of QT prolongation; clinically significant bladder outlet obstruction. Monitor BP at baseline & periodically during therapy. Concomitant use w/ drugs prolonging QT interval; antimuscarinic medications for OAB. Not recommended in end-stage renal disease, patients requiring haemodialysis, severe renal & moderate to severe hepatic impairment. Women of childbearing potential should use effective contraception. Not recommended during pregnancy. Not to be administered during lactation. Childn <18 yr.
Adverse Reactions
UTI; tachycardia; nausea, constipation, diarrhoea; headache, dizziness.
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, despiramine, digoxin. Potential P-gp inhibition of dabigatran. Thioridazine, type IC antiarrhythmics (eg, flecainide, propafenone), TCAs eg, imipramine, desipramine.
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
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