Product image of Mirabegron Stada (Mirabegron) supplied by GNH India

Mirabegron Stada

Active Ingredient:
Mirabegron
Origin:
EU

Mirabegron Stada (Mirabegron)

Mirabegron, the active ingredient in Mirabegron Stada, is a Beta-3 adrenergic receptor agonist presented as an oral formulation for systemic use. It is indicated for the management of overactive bladder symptoms such as urgency, frequency and urge incontinence in adult patients.
GNH India supplies Mirabegron Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

Mirabegron is used to treat conditions related to overactive bladder and its associated symptoms.

  • Overactive bladder: increases bladder capacity and reduces urgency episodes.
  • Urinary urgency: lessens the frequency of sudden, compelling urges to void.
  • Urge urinary incontinence: decreases the number of involuntary leakage episodes.

How It Works

  • Mirabegron selectively stimulates β3‑adrenergic receptors in the detrusor smooth muscle of the bladder. Activation of these receptors leads to relaxation of the detrusor muscle during the storage phase, thereby increasing functional bladder capacity and reducing involuntary contractions that cause urgency and incontinence.

Side Effects

Adverse reactions may occur with Mirabegron therapy.

Common Side Effects

  • Hypertension: elevated blood pressure observed in some patients.
  • Nasopharyngitis: mild upper respiratory tract infection symptoms.
  • Urinary tract infection: bacterial infection of the urinary system.
  • Headache: mild to moderate head pain.

Serious or Rare Side Effects

  • Angioedema: swelling of deep skin layers that can affect breathing.
  • Severe hypertension: markedly high blood pressure requiring medical attention.
  • Urinary retention: difficulty emptying the bladder.
  • Bladder rupture: rare but serious injury to bladder wall.

Precautions & Warnings

Before initiating Mirabegron, several safety considerations should be observed.

  • Blood pressure assessment: measure baseline and monitor regularly.
  • Cardiovascular monitoring: watch for signs of tachycardia or arrhythmia.
  • Renal function evaluation: adjust use in patients with impaired kidney function.
  • Concomitant medication review: avoid combining with strong CYP2D6 or CYP3A4 inhibitors.
  • Uncontrolled hypertension avoidance: do not start in patients with markedly elevated blood pressure.
  • Store at ambient temperature: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Mirabegron may interact with other medicines, requiring attention to avoid adverse outcomes.

Major Interactions (Avoid)

  • Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): may increase Mirabegron exposure.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): can raise plasma concentrations.
  • Monoamine oxidase inhibitors: risk of hypertensive crisis.
  • Anticholinergic agents: may exacerbate urinary retention.

Moderate Interactions (Monitor Closely)

  • Diuretics: potential additive effect on blood pressure.
  • Antihypertensive drugs: may require dose adjustment.
  • NSAIDs: increased risk of renal impairment.

Frequently Asked Questions

Mirabegron Stada is prescribed for adults with overactive bladder, including symptoms such as urinary urgency, increased frequency of urination, and urge urinary incontinence. It helps relax the bladder muscle, allowing it to store more urine and reduce sudden urges.

Mirabegron selectively activates β3‑adrenergic receptors located in the detrusor smooth muscle of the bladder. This activation causes the muscle to relax during the filling phase, which expands bladder capacity and diminishes involuntary contractions that trigger urgency and leakage.

The specific dose of Mirabegron Stada is determined by the prescribing healthcare professional based on the patient’s medical condition, response to therapy, and any concomitant medications. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Safety data for Mirabegron Stada in pregnancy and lactation are limited. Healthcare providers should weigh the potential benefits against possible risks before prescribing to pregnant or nursing women, and discuss alternative options when appropriate.

To place an order, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Mirabegron belongs to a different class (β3‑adrenergic agonist) than anticholinergics, which block muscarinic receptors. Mirabegron often has a lower incidence of dry mouth and constipation, common anticholinergic side effects, but may be associated with higher blood pressure. Choice depends on patient tolerance and comorbidities.

Mirabegron Stada should be stored at ambient temperature, below 25 °C. Keep the product in its original packaging, protect it from moisture, and store away from direct sunlight to maintain stability.

Mirabegron Stada is taken orally, usually once daily, with or without food. The tablet should be swallowed whole with a glass of water. Patients should follow the dosing schedule prescribed by their healthcare professional.

Serious risks include severe hypertension, angioedema, urinary retention, and rare cases of bladder rupture. Patients should seek immediate medical attention if they experience sudden swelling, very high blood pressure, difficulty urinating, or severe abdominal pain.

Mirabegron Stada is contraindicated in patients with uncontrolled hypertension, known hypersensitivity to mirabegron or any excipients, and those taking strong CYP2D6 or CYP3A4 inhibitors that cannot be discontinued. Clinicians should assess each patient’s medical history before prescribing.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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