Betmiga Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

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 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.

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Overdosage

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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).

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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 B); 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.

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Use In Pregnancy & Lactation

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Adverse Reactions

UTI; tachycardia; nausea, constipation, diarrhoea; headache, dizziness.

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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 & C_max 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 when combined w/ sensitive P-gp substrates eg, dabigatran.

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Storage

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Description

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Action

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MIMS Class

Drugs for Bladder & Prostate Disorders

ATC Classification

G04BD12 - mirabegron ; Belongs to the class of urinary antispasmodics.

Regulatory Classification

Presentation/Packing

Form

Betmiga PR tab 25 mg

Packing/Price

30's

Form

Betmiga PR tab 50 mg

Packing/Price

30's

Betmiga

mirabegron

Manufacturer:

Astellas

Distributor:

Zuellig