Mirabegron Teva (Mirabegron)

Mirabegron is indicated for conditions affecting bladder storage function within the overactive bladder therapeutic area.

• Overactive bladder: reduces urgency episodes and increases bladder capacity.
• Urge urinary incontinence: decreases frequency of involuntary urine loss.
• Urinary frequency and urgency: lessens the number of daytime voids and urgency sensations.

• Mirabegron selectively activates β3‑adrenergic receptors located in the detrusor smooth muscle of the urinary bladder. Activation triggers cyclic AMP accumulation, leading to relaxation of the detrusor muscle during the storage phase. This relaxation increases functional bladder capacity and diminishes involuntary contractions, thereby alleviating urgency, frequency, and urge incontinence associated with overactive bladder.

Mirabegron may be associated with several adverse reactions, which are categorized by frequency and severity.

Common Side Effects

• Hypertension: elevated blood pressure, often mild to moderate.
• Headache: transient cranial pain.
• Nasopharyngitis: inflammation of the nasal passages and throat.
• Constipation: reduced bowel movements.

Serious or Rare Side Effects

• Severe hypertension: marked increase in blood pressure requiring medical intervention.
• Urinary retention: difficulty emptying the bladder that may lead to acute retention.
• Angioedema or anaphylaxis: swelling of the face, lips, or airway and severe allergic reaction.

Before initiating Mirabegron therapy, clinicians should consider several precautionary measures to ensure patient safety.

• Blood pressure assessment: measure baseline and monitor regularly during treatment.
• Cardiovascular risk evaluation: avoid in patients with uncontrolled hypertension.
• Renal and hepatic function: adjust use in moderate to severe impairment.
• Concomitant antihypertensives: monitor for additive blood pressure effects.
• Urinary retention risk: assess for history of obstruction before use.
• Store at ambient temperature: keep below 25 °C in original packaging, protect from moisture.

Mirabegron can affect the pharmacokinetics of other medicines; awareness of key interactions helps manage therapy safely.

Major Interactions (Avoid)

• Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine): may raise mirabegron plasma levels.
• Potent CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): increase mirabegron exposure.
• Drugs that raise blood pressure (e.g., sympathomimetics): may exacerbate hypertension.

Moderate Interactions (Monitor Closely)

• CYP2D6 substrates (e.g., metoprolol, carvedilol): may have increased concentrations.
• Digoxin: mirabegron can raise serum digoxin levels.
• Diuretics: combined effect may alter fluid balance and blood pressure.
• NSAIDs: may enhance risk of hypertension.