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 β3‑adrenergic receptor agonist presented as an oral dosage form for oral use. It is indicated for the treatment of overactive bladder symptoms such as urinary urgency, frequency and urge incontinence in adults, and improves quality of life.

GNH India supplies Mirabegron Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory‑supported distribution across multiple regions, including compliance with EU pharmacopoeial specifications.

Manufacturer / TM Owner

Zentiva, K.S.

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Indications & Clinical Uses

Mirabegron is used to manage symptoms of the overactive bladder syndrome.

  • Overactive bladder: improves bladder capacity and reduces urgency and frequency episodes.
  • Urinary urgency: decreases the number of sudden urges to void.
  • Urge urinary incontinence: lessens 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, increasing bladder capacity and reducing involuntary contractions that cause urgency and frequency.

Side Effects

Mirabegron may be associated with several adverse reactions.

Common Side Effects

  • Hypertension: elevated blood pressure observed in some patients.
  • Nasopharyngitis: mild upper respiratory tract infection symptoms.
  • Headache: occasional mild to moderate headache.
  • Constipation: reduced bowel motility leading to hard stools.
  • Dry mouth: decreased salivary secretion.
  • Urinary tract infection: bacterial infection of the urinary system.

Serious or Rare Side Effects

  • Urinary retention: difficulty emptying the bladder.
  • Severe hypertension: markedly high blood pressure requiring medical attention.
  • Angioedema: swelling of face, lips, or throat.
  • Tachycardia: rapid heart rate.
  • Allergic reactions: rash, itching, or anaphylaxis.
  • Renal impairment: worsening kidney function in susceptible individuals.

Precautions & Warnings

Before prescribing Mirabegron, clinicians should consider several precautionary measures.

  • Assess blood pressure: measure baseline and monitor regularly.
  • Monitor for urinary retention: watch for signs of incomplete bladder emptying.
  • Evaluate renal function: adjust use in patients with impaired kidneys.
  • Use caution in uncontrolled hypertension: avoid initiation if blood pressure is not controlled.
  • Avoid in patients with known hypersensitivity to mirabegron or excipients.
  • Store at room temperature: keep in the original pack, protect from moisture and light.

Avoid Interactions

Mirabegron can interact with other medicines, requiring attention to potential effects.

Major Interactions (Avoid)

  • Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine): may increase mirabegron exposure.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may raise plasma concentrations.
  • Combined anticholinergics: risk of increased urinary retention.

Moderate Interactions (Monitor Closely)

  • Diuretics: additive effect on blood pressure.
  • Antihypertensives: potential for excessive blood pressure lowering.
  • NSAIDs: may affect renal function when used together.

Frequently Asked Questions

Mirabegron Zentiva is prescribed to treat overactive bladder symptoms, including urinary urgency, frequency, and urge urinary incontinence. It helps increase bladder capacity by relaxing the detrusor muscle, reducing the frequency of involuntary bladder contractions.

Mirabegron works by selectively activating β3‑adrenergic receptors in the bladder’s detrusor smooth muscle. This activation relaxes the muscle during the storage phase, allowing the bladder to hold more urine and decreasing episodes of urgency and leakage.

The specific dose of Mirabegron Zentiva is determined by the prescribing healthcare professional based on the patient’s condition, response, and any co‑existing medical issues. 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, and the decision must be made by a qualified healthcare provider.

To order Mirabegron Zentiva, submit an enquiry on the product page at gnhindia.com with 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 anticholinergic agents. It may be preferred when patients cannot tolerate anticholinergics or have contraindications.

Mirabegron Zentiva should be stored at room temperature, below 25 °C. Keep the product in its original packaging, protect it from moisture and direct light, and ensure the container is tightly closed to maintain stability.

Mirabegron Zentiva is taken orally, usually as a tablet, with or without food. The exact administration schedule is set by the prescriber, and patients should swallow the tablet whole with water and not crush or chew it.

Serious risks include significant hypertension, urinary retention, and rare allergic reactions such as angioedema. Patients should be monitored for elevated blood pressure and any signs of difficulty emptying the bladder, and they should seek immediate medical attention if severe symptoms develop.

Mirabegron should be avoided in individuals with known hypersensitivity to mirabegron or its excipients, in patients with uncontrolled hypertension, and in those who have severe urinary retention. A healthcare professional should evaluate suitability before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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