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Betmiga

Betmiga

mirabegron

Manufacturer:

Astellas Pharma

Distributor:

Zuellig Pharma
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.
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Dosage/Direction for Use
Adult (including elderly) 50 mg once daily. Renal impairment (in the absence & presence of strong CYP3A inhibitors) Mild & moderate: W/o inhibitor: 50 mg; w/ inhibitor: 25 mg. Severe w/o inhibitor: 25 mg. Hepatic impairment (absence & presence of strong CYP3A inhibitor) Mild: W/o inhibitor: 50 mg; w/ inhibitor: 25 mg. Moderate w/o inhibitor: 25 mg.
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Overdosage
View Betmiga overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food: Swallow whole, do not chew/divide/crush.
Contraindications
Hypersensitivity.
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Special Precautions
ESRD (GFR <15 mL/min/1.73 m2 or requiring hemodialysis). Severe renal impairment (GFR 15-29 mL/min/1.73 m2) concomitantly receiving strong CYP3A inhibitors. Severe (Child-Pugh C), & moderate (Child-Pugh B) hepatic impairment concomitantly receiving strong CYP3A inhibitors. Severe uncontrolled HTN (systolic BP ≥180 mmHg &/or diastolic BP ≥110 mmHg). Perform periodic BP measurements. Known history of QT prolongation & taking drugs known to prolong QT interval. Patients w/ bladder outlet obstruction & taking antimuscarinics for OAB. Pregnancy & lactation. Childn <18 yr.
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Adverse Reactions
UTI, tachycardia, nausea.
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Drug Interactions
Increased exposure w/ strong CYP3A/P-gp inhibitors eg, ketoconazole. Decreased plasma conc w/ CYP3A/P-gp inducers. Drugs w/ narrow therapeutic index & metabolized by CYP2D6 eg, thioridazine, type 1C antiarrhythmics (eg, flecainide, propafenone) & TCAs (eg, imipramine, desipramine); sensitive P-gp substrates eg, dabigatran. Increase Cmax & AUC of digoxin.
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Caution For Usage
For caution against possible variation of physical aspect of medicine... Click to view Betmiga detailed prescribing information
Storage
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Description
View Betmiga description for details of the chemical structure and excipients (inactive components).
Action
View Betmiga mechanism of action for pharmacodynamics and pharmacokinetics details.
MIMS Class
Drugs for Bladder & Prostate Disorders
ATC Classification
G04BD12 - mirabegron ; Belongs to the class of urinary antispasmodics.
Presentation/Packing
Form
Betmiga PR tab 50 mg
Packing/Price
30's
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