Miragon 25 | 1 Strip

Miragon Tablet (Mirabegron)

Indications

Symptomatic treatment of overactive bladder (OAB) with features such as:

Urgency

Increased urinary frequency

Urgency incontinence

Pharmacology

Class: First β3-adrenoceptor agonist.

Mechanism of Action:

Activates β3-adrenoceptors in the bladder → increases cAMP levels.

Relaxes detrusor smooth muscle during the storage phase of the fill-void cycle.

Enhances bladder capacity.

Works through both direct smooth muscle action and modulation of the sensory nervous system.

Dosage & Administration

Adults (including elderly):

Start with 25 mg once daily, with or without food.

May increase to 50 mg once daily depending on response and tolerability.

Renal/Hepatic Impairment:

Severe renal impairment (CrCl 15–29 mL/min) or moderate hepatic impairment (Child-Pugh B): Do not exceed 25 mg/day.

End-stage renal disease (GFR <15 mL/min/1.73 m² or dialysis): Not recommended.

Severe hepatic impairment (Child-Pugh C): Not recommended.

Pediatric Use: Not established (<18 years).

Administration: Swallow whole with liquids; do not chew, crush, or divide.

Drug Interactions

Enzyme inhibitors (CYP3A/P-gp):

Ketoconazole, itraconazole, ritonavir, clarithromycin ↑ Mirabegron exposure.

Use 25 mg daily in patients with mild/moderate renal or hepatic impairment.

Enzyme inducers (rifampicin, others): ↓ Mirabegron levels; no dose adjustment required.

CYP2D6 substrates (metoprolol, desipramine, flecainide, tricyclic antidepressants): Mirabegron moderately inhibits CYP2D6 → ↑ plasma levels. Use with caution.

Digoxin (P-gp substrate): ↑ digoxin exposure; start digoxin at lowest dose and monitor serum levels.

No significant interactions with solifenacin, tamsulosin, warfarin, metformin, or oral contraceptives.

Contraindications

Hypersensitivity to Mirabegron or excipients.

Severe, uncontrolled hypertension (≥180/110 mmHg).

Side Effects

Common: Tachycardia (1.2%), urinary tract infections (2.9%).

Serious: Rare cases of atrial fibrillation (0.2%).

Other possible effects: headache, hypertension, palpitations, dizziness, constipation, or nasopharyngitis.

Precautions & Warnings

Hypertension: Monitor BP at baseline and periodically.

Renal & hepatic impairment: Dose adjustment or avoidance required as per severity.

QT prolongation: Use cautiously in patients with congenital/acquired QT prolongation.

Bladder outlet obstruction & antimuscarinic use: Use with caution due to risk of urinary retention.

Use in Pregnancy & Lactation

Pregnancy: Limited human data; animal studies show reproductive toxicity → not recommended.

Lactation: Likely excreted in breast milk → avoid use during breastfeeding.

Fertility: No adverse effects observed in animals; human data not available.

Overdose Effects

Doses up to 400 mg caused palpitations and tachycardia.

Multiple doses up to 300 mg/day increased heart rate and blood pressure.

Management: Supportive and symptomatic; monitor ECG, BP, and pulse.

Therapeutic Class

Drugs for urinary incontinence / OAB / BPH.

Storage

Store in a cool, dry place, protected from light.

Keep out of reach of children.