BETMIGA 50/MG PR FC TAB 30/TAB

Indications

Approved Uses

Overactive bladder (OAB) in adults with symptoms of urgency, urinary frequency, and/or urge urinary incontinence.

Dosage & Administration

Dosing by Condition

Overactive Bladder (adults): Initial dose 25 mg once daily; may increase to 50 mg once daily after 4-8 weeks based on response and tolerability. Maximum dose: 50 mg once daily

Initial Dose

25 mg once daily orally

Maintenance Dose

25-50 mg once daily

Maximum Dose

50 mg once daily

Children's Dosage

Approved for neurogenic detrusor overactivity in children 3 years and older; dosage is based on body weight and administered as an oral suspension.

Dose Adjustment Notes

Severe renal impairment (eGFR 15-29 mL/min/1.73m²): do not exceed 25 mg once daily. Moderate hepatic impairment (Child-Pugh B): do not exceed 25 mg once daily. Severe hepatic impairment (Child-Pugh C): not recommended. Combination of severe renal impairment and moderate hepatic impairment: not recommended

Side Effects

Side Effect Frequency

Common (1-10%): hypertension, urinary tract infection, headache, nasopharyngitis; tachycardia is also reported (frequency varies by source but generally uncommon to common).

Safety & Warnings

Warnings & Precautions

May increase blood pressure-monitor periodically (especially if hypertensive); caution with bladder outlet obstruction and/or concomitant antimuscarinics due to urinary retention risk; discontinue if angioedema occurs; moderate CYP2D6 inhibitor-caution/monitor with CYP2D6 substrates (especially narrow therapeutic index); not recommended in severe hepatic impairment and in ESRD/dialysis

Age Restriction

Not approved under 3 years of age.

Drug Interactions

Food Interaction

No clinically relevant food restriction; may be taken with or without food.

Special Populations

Children

Approved for neurogenic detrusor overactivity in children 3 years and older; dosage is based on body weight and administered as an oral suspension.

Elderly

Standard adult dosing; no dose adjustment required based on age alone, but monitor blood pressure closely in elderly patients with cardiovascular comorbidities

Kidney Impairment

eGFR ≥30 mL/min/1.73m²: no adjustment; eGFR 15-29: max 25 mg once daily; eGFR <15 or on dialysis: not recommended

Liver Impairment

Mild hepatic impairment (Child-Pugh A): no adjustment; Moderate (Child-Pugh B): max 25 mg once daily; Severe (Child-Pugh C): not recommended

Storage & Patient Advice

Stopping the Medicine

Safe to stop anytime - no tapering required

Patient Counseling

Swallow the prolonged-release tablet whole (do not crush/chew/split); take once daily at the same time with or without food; benefits may take 4-8 weeks; monitor blood pressure; seek care for urinary retention (difficulty urinating) or signs of serious allergy/angioedema; tell clinicians about all medicines-especially digoxin and CYP2D6 substrates (e.g., metoprolol, flecainide/propafenone, thioridazine).

Pharmacology

Mechanism of Action

Selective β3-adrenoceptor agonist that relaxes detrusor smooth muscle during the bladder storage phase, increasing functional bladder capacity and reducing urgency/frequency/urge incontinence.

Onset of Action

Some improvement may be seen within ~4 weeks; assess full effect around 8 weeks.

Half-Life

Approximately 50 hours (terminal elimination half-life in adults).

Excretion

Approximately 55% excreted in urine and 34% in feces (after oral dosing; largely as metabolites with a minority as unchanged drug).

Protein Binding

Approximately 71%

Product Information

Available Dosage Forms

Prolonged-release (extended-release) film-coated tablet (50 mg) in blister pack.

Composition per Dose

Each prolonged-release film-coated tablet: 50 mg mirabegron

Generic Availability

No

Urological Condition

Overactive Bladder

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