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 β3‑adrenergic receptor agonist presented as an oral dosage form for oral use. It is indicated for the management of overactive bladder symptoms such as urinary urgency, frequency and incontinence in adults.
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 acts on the β3‑adrenergic pathway to improve bladder storage function.

  • Overactive bladder: increases bladder capacity and reduces urgency episodes.
  • Urinary urgency: lessens the sudden need to void.
  • Urinary frequency: decreases the number of daily voids.

How It Works

  • Mirabegron selectively activates β3‑adrenergic receptors located on the detrusor smooth muscle of the bladder. Receptor activation raises intracellular cyclic AMP, leading to relaxation of the detrusor during the storage phase, thereby expanding functional bladder capacity and reducing involuntary contractions.

Side Effects

Adverse reactions may vary in frequency and severity.

Common Side Effects

  • Hypertension: elevated blood pressure observed in some patients.
  • Nasopharyngitis: mild upper respiratory tract infection symptoms.
  • Headache: transient cranial discomfort.
  • Constipation: reduced bowel motility.
  • Dry mouth: decreased salivary flow.
  • Urinary retention: difficulty initiating voiding.

Serious or Rare Side Effects

  • Severe hypertension: marked rise in blood pressure requiring medical attention.
  • Acute urinary retention leading to bladder outlet obstruction.
  • Tachycardia: rapid heart rate episodes.
  • Angioedema: swelling of face, lips or airway.
  • Allergic reactions: rash, pruritus or anaphylaxis.
  • Renal impairment: worsening kidney function in susceptible individuals.

Precautions & Warnings

Before initiating therapy, several safety considerations should be reviewed.

  • Cardiovascular assessment: evaluate baseline blood pressure and heart rate.
  • Monitor blood pressure: check regularly during treatment, especially after dose changes.
  • Renal function: assess creatinine clearance in patients with kidney disease.
  • Hepatic impairment: use caution and consider dose adjustment in moderate to severe liver dysfunction.
  • Uncontrolled hypertension: avoid use 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 through metabolic pathways or additive pharmacologic effects.

Major Interactions (Avoid)

  • Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine): may increase Mirabegron exposure.
  • Potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): can raise plasma concentrations.
  • Anticholinergic agents used for bladder control: may reduce therapeutic benefit.

Moderate Interactions (Monitor Closely)

  • CYP2D6 substrates (e.g., metoprolol, desipramine): monitor for enhanced effects.
  • Diuretics (e.g., furosemide): watch for additive blood pressure changes.
  • Antihypertensives (e.g., ACE inhibitors, ARBs): may require dose adjustment of blood pressure medication.

Frequently Asked Questions

Mirabegron Stada is prescribed for adults with overactive bladder, specifically to reduce urinary urgency, frequency, and episodes of urge incontinence by increasing bladder capacity.

The drug selectively stimulates β3‑adrenergic receptors on bladder detrusor muscle, raising cyclic AMP levels, which relaxes the muscle during the storage phase and allows the bladder to hold more urine without involuntary contractions.

The appropriate dose is determined by the prescribing healthcare professional based on the patient’s clinical condition, renal function, and response to therapy. Patients should follow the prescriber’s instructions exactly.

Safety data in pregnancy and lactation are limited. The product should only be used if the potential benefit justifies any potential risk to the fetus or infant, and the decision must be made by a qualified clinician.

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 required import documentation.

Mirabegron belongs to a different class (β3‑adrenergic agonist) and does not carry the anticholinergic side‑effects such as dry mouth or constipation. It may be chosen when patients cannot tolerate anticholinergics or need an alternative mechanism of action.

Store the product at ambient temperature, below 25 °C, in the original packaging. Keep it away from moisture, heat and direct sunlight to maintain product stability.

Mirabegron Stada is taken orally, usually once daily, with or without food, as directed by the prescribing clinician. Swallow the tablet whole with a glass of water.

Serious concerns include significant hypertension, acute urinary retention that may require catheterisation, and rare allergic reactions such as angioedema. Patients should seek immediate medical attention if they experience severe headache, rapid heartbeat, or swelling of the face or throat.

Individuals with uncontrolled high blood pressure, severe hepatic impairment, or known hypersensitivity to Mirabegron or any excipients should avoid this medication. A healthcare professional should evaluate suitability before prescribing.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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