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

Mirabegrón Stada

Active Ingredient:
Mirabegron
Origin:
EU

Mirabegrón Stada (Mirabegron)

Mirabegron, the active ingredient in Mirabegrón Stada, is a β3‑adrenergic receptor agonist presented as an oral tablet for oral use. It treats overactive bladder symptoms—including urinary urgency, frequency and urge urinary incontinence—in adult patients. The medication works by relaxing the detrusor muscle, thereby increasing bladder capacity and reducing involuntary contractions.

GNH India supplies Mirabegrón Stada as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, offering batch‑specific certificates of analysis and supporting import‑export compliance.

Manufacturer / TM Owner

Laboratorio Stada, S.L.

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Indications & Clinical Uses

  • Mirabegron is indicated for conditions within the overactive bladder disease spectrum, where it improves bladder storage function.
  • Overactive bladder: reduces urgency episodes and increases bladder capacity.
  • Urinary urgency: lessens the frequency of sudden urges to void.
  • Urge urinary incontinence: decreases the number of incontinence episodes.

How It Works

  • Mirabegron selectively activates β3‑adrenergic receptors located on the detrusor smooth‑muscle cells of the bladder. This activation stimulates a cyclic AMP‑mediated signaling cascade that relaxes the detrusor muscle during the storage phase, thereby increasing functional bladder capacity and reducing involuntary contractions that cause urgency and incontinence.

Side Effects

Common Side Effects

  • Hypertension: elevated blood pressure observed in some patients.
  • Nasopharyngitis: mild upper‑respiratory tract infection symptoms.
  • Urinary tract infection: increased incidence reported.
  • Headache: mild to moderate intensity.
  • Dry mouth: reduced salivation.
  • Constipation: decreased bowel motility.

Serious or Rare Side Effects

  • Urinary retention: difficulty emptying the bladder.
  • Tachycardia: rapid heart rate episodes.
  • Severe hypertension: markedly high blood pressure requiring medical attention.
  • Angioedema: swelling of face, lips, or throat.
  • Allergic reactions: rash, pruritus, or anaphylaxis.
  • Myocardial infarction: rare cardiac event.

Precautions & Warnings

Before initiating therapy, consider the following precautions:

  • Cardiovascular assessment: monitor blood pressure regularly.
  • Renal function evaluation: adjust use in severe renal impairment.
  • Urinary retention risk: avoid in patients with significant bladder outlet obstruction.
  • Concomitant antihypertensives: be aware of possible additive blood‑pressure effects.
  • Drug‑interaction review: assess for CYP2D6 inhibitors or inducers.
  • Store at ambient temperature: keep below 25°C, protect from moisture and light.

Avoid Interactions

Mirabegron may interact with several drug classes; review patient medication lists carefully.

Major Interactions (Avoid)

  • Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine): may increase mirabegron exposure.
  • Combined anticholinergics: heightened risk of urinary retention.
  • Antihypertensive agents: possible reduction in blood‑pressure control.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin): may lower mirabegron levels.
  • NSAIDs: may exacerbate hypertension.
  • Diuretics: potential additive effect on blood‑pressure regulation.

Frequently Asked Questions

Mirabegrón Stada is prescribed for adults with overactive bladder, including symptoms such as urinary urgency, increased frequency of urination, and urge urinary incontinence. It helps improve bladder storage capacity and reduces involuntary bladder contractions.

Mirabegron selectively stimulates β3‑adrenergic receptors on the detrusor muscle of the bladder. This activation triggers a cyclic AMP pathway that relaxes the muscle during the storage phase, allowing the bladder to hold more urine and decreasing urgency and incontinence episodes.

The appropriate dose of Mirabegrón 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 in pregnancy and lactation are limited. It should only be used if the potential benefit justifies the potential risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss risks and alternatives with their healthcare provider.

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) and does not have the anticholinergic side‑effects such as dry mouth or constipation that are common with anticholinergics. Clinical studies show comparable efficacy in reducing urgency episodes, and mirabegron may be preferred when anticholinergic tolerance is an issue.

Store Mirabegrón Stada at ambient temperature, preferably below 25 °C (77 °F). Keep the tablets in the original packaging, protect them from moisture, heat and direct sunlight to maintain product stability.

Mirabegrón 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 adverse reactions, although rare, can include severe hypertension, urinary retention, tachycardia, angioedema and myocardial infarction. Patients should seek immediate medical attention if they experience symptoms such as a sudden rise in blood pressure, difficulty urinating, rapid heartbeat, swelling of the face or throat, or chest pain.

Mirabegron Stada is contraindicated in patients with uncontrolled hypertension, severe urinary retention, or known hypersensitivity to mirabegron or any tablet excipients. Caution is also advised for individuals with significant cardiovascular disease, severe renal impairment, or those taking strong CYP2D6 inhibitors.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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