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 tablet for oral use. It is indicated for the treatment 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. The company adheres to stringent quality standards and provides regulatory‑approved batches to meet global demand.

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

Mirabegron is used to manage conditions related to overactive bladder and urinary storage dysfunction.

  • Overactive bladder: improves bladder capacity and reduces urgency episodes.
  • Urinary urgency: decreases the frequency of sudden urges to void.
  • Urinary frequency: lowers the number of daytime voids.
  • Urge urinary incontinence: reduces involuntary leakage episodes.

How It Works

  • Mirabegron selectively stimulates β3‑adrenergic receptors located in the detrusor smooth muscle of the urinary bladder. Activation of these receptors raises intracellular cyclic AMP, causing relaxation of the detrusor during the storage phase, which expands bladder capacity and diminishes involuntary contractions. The drug does not block muscarinic receptors, providing an alternative mechanism to antimuscarinic agents.

Side Effects

Adverse reactions reported with mirabegron use are categorized by frequency and severity.

Common Side Effects

  • Hypertension: increase in blood pressure.
  • Nasopharyngitis: inflammation of the nasal passages and throat.
  • Headache: mild to moderate head pain.
  • Constipation: reduced bowel movements.
  • Dry mouth: decreased salivation.

Serious or Rare Side Effects

  • Urinary retention: difficulty emptying the bladder.
  • Tachycardia: rapid heart rate.
  • Angioedema: swelling of face, lips, or airway.
  • Severe hypertension: markedly elevated blood pressure.
  • Allergic reactions: rash, itching, or anaphylaxis.

Precautions & Warnings

Before initiating mirabegron therapy, several safety considerations should be reviewed.

  • Blood pressure monitoring: check baseline and periodically during treatment.
  • Cardiovascular disease: use caution in patients with uncontrolled hypertension or arrhythmias.
  • Drug interactions: review concomitant medications that affect adrenergic pathways.
  • Renal impairment: adjust therapy based on renal function assessment.
  • Pregnancy and lactation: avoid use unless benefits outweigh potential risks.
  • Store at ambient temperature: keep below 25 °C in original packaging, protect from moisture and light.

Avoid Interactions

Mirabegron may alter the pharmacokinetics of several co‑administered drugs, requiring attention to interaction potential.

Major Interactions (Avoid)

  • Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine): may increase mirabegron exposure.
  • Antihypertensive agents (e.g., beta‑blockers, ACE inhibitors): additive blood pressure effects.

Moderate Interactions (Monitor Closely)

  • CYP2D6 substrates (e.g., metoprolol, tramadol): may have increased plasma levels.
  • Diuretics: potential for enhanced blood pressure changes.
  • Anticholinergic bladder agents: combined effect on urinary symptoms.

Frequently Asked Questions

Mirabegron Stada is prescribed to treat symptoms of overactive bladder, including urinary urgency, increased frequency of daytime voids, and urge urinary incontinence. By improving bladder storage capacity, it helps patients achieve better control over urinary function.

Mirabegron selectively activates β3‑adrenergic receptors in the detrusor smooth muscle of the bladder. This activation raises cyclic AMP levels, leading to muscle relaxation during the storage phase, which expands bladder capacity and reduces involuntary contractions.

The appropriate dose of mirabegron is determined by the prescribing healthcare professional based on the patient’s medical condition, response to therapy, and any relevant regulatory labeling. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Safety data for mirabegron during pregnancy and lactation are limited. It should only be used when the potential benefit to the mother outweighs any possible risk to the fetus or infant, and this decision must be made by a qualified healthcare provider.

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

The primary alternative for overactive bladder is the antimuscarinic class, which blocks muscarinic receptors to reduce bladder contractions. Mirabegron works via a different mechanism—β3‑adrenergic receptor activation—offering an option for patients who cannot tolerate antimuscarinics or who experience their side effects.

Mirabegron Stada tablets should be stored at ambient temperature, preferably below 25 °C. Keep them in the original packaging, protect from moisture and direct light, and ensure they are out of reach of children.

Mirabegron Stada is taken orally, usually as a whole tablet swallowed with water. It can be taken with or without food, but patients should follow the specific instructions provided by their prescriber.

Serious risks include significant hypertension, urinary retention that may require catheterisation, and rare allergic reactions such as angioedema or anaphylaxis. Patients should seek immediate medical attention if they experience severe headache, chest pain, difficulty breathing, or sudden inability to urinate.

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

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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