Generic
Mirabegron
21 brands available in the market
At a glance
Mirabegron is a beta-3 receptor agonist used for the treatment of overactive bladder symptoms.
Description
Mirabegron is a beta-3 adrenergic receptor agonist that relaxes the detrusor smooth muscle of the urinary bladder and increases bladder capacity.
Indications
- Overactive bladder (OAB)
- Urinary urgency
- Increased urinary frequency
- Urinary incontinence
Therapeutic class
BPH/ Urinary retention/ Urinary incontinence
Pharmacological class
Beta-3 Adrenergic Receptor Agonist
Pharmacology
Mirabegron activates beta-3 adrenergic receptors increasing cyclic AMP and relaxing detrusor smooth muscle.
Mechanism of action
Relaxes bladder muscle to increase urine storage capacity and reduce urinary frequency.
Dosage
Adult Dose (Oral):
- Initial Dose: 25 mg once daily
- Maintenance Dose: 25-50 mg once daily
- Hepatic Impairment (Moderate): Not to exceed 25 mg/day
- Renal Impairment (Severe): Not to exceed 25 mg/day
Administration
- May be taken with or without food
- Swallow tablet whole; do not chew or crush
- Take at the same time each day
Missed dose
Not applicable (missed dose information not available)
Side effects
Common Side Effects:
- Hypertension
- Headache
- Nasopharyngitis
- Urinary tract infection
- Constipation
- Tachycardia
Precautions & warnings
- Monitor blood pressure regularly
- Contraindicated in severe uncontrolled hypertension
- Not recommended in severe hepatic impairment
- Caution in pregnancy and lactation
Contraindications
- Hypersensitivity
- Severe uncontrolled hypertension
Drug interactions
- Strong CYP3A/P-gp Inhibitors: Increased AUC
- CYP3A/P-gp Inducers: Decreased plasma concentration
- Metoprolol, Desipramine, Digoxin: Increased Cmax and AUC
Food interactions
Caution advised when consuming alcohol with Mirabegron.
Use in pregnancy
Use in Pregnancy: Possibly unsafe. Animal studies show reproductive toxicity.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Probably unsafe. May be excreted in breast milk.
Pediatric use
Safety and efficacy not established in children under 18 years.
Geriatric use
No specific dose adjustment for elderly.
Renal / hepatic impairment
Renal Impairment: Severe (CrCl 15-29 mL/min): Not to exceed 25 mg/day; ESRD: Not recommended.
Hepatic Impairment: Moderate (Child-Pugh B): Not to exceed 25 mg/day; Severe (Child-Pugh C): Not recommended.
Overdose effects
Overdose may cause palpitations and increased heart rate (>100 bpm).
Storage conditions
Store in a cool and dry place protected from light.
Chemical structure
Mirabegron