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

Mirabegron Zentiva

Active Ingredient:
Mirabegron
Origin:
EU

Mirabegron Zentiva (Mirabegron)

Mirabegron, the active ingredient in Mirabegron Zentiva, is a beta‑3 adrenergic receptor agonist presented as an oral tablet for oral use. Approved in the European Union, it treats overactive bladder symptoms—including urgency, frequency and urge urinary incontinence—in adult patients.

GNH India supplies Mirabegron Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier, providing the product to hospitals, pharmacies and clinics worldwide under strict quality standards. The company supports global procurement, regulatory compliance and reliable logistics for institutional buyers, ensuring timely delivery and product integrity.

Manufacturer / TM Owner

Zentiva Pharma Gmbh

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Indications & Clinical Uses

Mirabegron acts on the beta‑3 adrenergic pathway to improve bladder storage function in overactive bladder conditions.

  • 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 beta‑3 adrenergic receptors located in the detrusor smooth muscle of the bladder. Activation of these receptors increases cyclic adenosine monophosphate (cAMP) levels, leading to relaxation of the detrusor during the storage phase. This relaxation expands functional bladder capacity, diminishes involuntary contractions, and thereby reduces urgency, frequency and urge incontinence.

Side Effects

Mirabegron may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Hypertension: mild increase in blood pressure.
  • Headache: transient head pain.
  • Nasopharyngitis: symptoms of upper respiratory tract infection.
  • Urinary retention: difficulty emptying the bladder.
  • Dry mouth: reduced salivation.

Serious or Rare Side Effects

  • Severe hypertension: marked elevation of blood pressure requiring medical attention.
  • Acute urinary retention leading to bladder outlet obstruction.
  • Allergic reactions: rash, swelling, or anaphylaxis.

Precautions & Warnings

Before initiating Mirabegron therapy, clinicians should consider several safety precautions.

  • Assess cardiovascular status: measure baseline blood pressure and monitor regularly during treatment.
  • Review renal function: adjust use in patients with severe renal impairment as recommended.
  • Evaluate for urinary retention risk: avoid in individuals with known bladder outlet obstruction.
  • Consider drug interactions: avoid concomitant use with strong CYP2D6 inhibitors without dose adjustment.
  • Pregnancy and lactation: use only if potential benefit justifies potential risk, as safety data are limited.
  • Store below 25°C: keep in the original packaging, protect from moisture and heat.

Avoid Interactions

Mirabegron can affect the pharmacokinetics of several medicines, requiring attention to avoid adverse outcomes.

Major Interactions (Avoid)

  • Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): may increase mirabegron plasma concentrations.
  • Antihypertensive agents (e.g., beta‑blockers, ACE inhibitors): additive blood‑pressure‑lowering effect may require monitoring.

Moderate Interactions (Monitor Closely)

  • Diuretics: may alter fluid balance and affect blood pressure control.
  • Nitrates: combined use can enhance hypotensive response.
  • Other beta‑3 agonists: additive pharmacodynamic effect may increase risk of urinary retention.

Frequently Asked Questions

Mirabegron Zentiva is prescribed to manage symptoms of overactive bladder, including urinary urgency, increased frequency of daytime voids, and urge urinary incontinence in adult patients. It helps improve bladder storage capacity and reduces the need for frequent bathroom trips.

Mirabegron selectively activates beta‑3 adrenergic receptors in the bladder’s detrusor muscle. This activation raises intracellular cAMP levels, causing the muscle to relax during the bladder‑filling phase, which increases functional bladder capacity and lessens involuntary contractions that trigger urgency and leakage.

The prescribed dose of mirabegron is determined by the treating clinician based on the patient’s condition, response, and any concomitant therapies. The prescriber will select the appropriate starting dose and may adjust it according to therapeutic goals and tolerability.

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 the decision should be made in consultation with a healthcare professional.

To place an order, submit an enquiry on the product page at gnhindia.com specifying the required quantity of Mirabegron Zentiva. 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—beta‑3 adrenergic agonists—whereas antimuscarinics block muscarinic receptors. Mirabegron often has a lower incidence of dry mouth and constipation, common side effects of antimuscarinics, but may be associated with higher rates of hypertension. Choice of therapy depends on patient tolerance, comorbidities and physician preference.

Store Mirabegron Zentiva below 25 °C in its original packaging, protecting it from moisture and direct heat. Keep the container tightly closed and out of reach of children. No special refrigeration is required for this oral tablet formulation.

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

Serious risks include marked hypertension, acute urinary retention that may require catheterisation, and severe allergic reactions such as rash, swelling or anaphylaxis. Patients should seek immediate medical attention if they experience sudden high blood pressure, inability to urinate, or signs of a severe allergic response.

Mirabegron should be avoided in individuals with uncontrolled hypertension, severe urinary retention or known bladder outlet obstruction, and in patients with a documented hypersensitivity to mirabegron or any excipients in the tablet. Caution is also advised for those taking strong CYP2D6 inhibitors.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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