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‑adrenoceptor agonist presented as a tablet for oral use. It relaxes the detrusor muscle of the urinary bladder, increasing capacity and reducing symptoms of overactive bladder such as urgency, frequency, and urge incontinence in adult patients.

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‑approved batches for global distribution, with full traceability and batch‑release documentation.

Manufacturer / TM Owner

Zentiva, K.S.

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Indications & Clinical Uses

Mirabegron is indicated for conditions related to overactive bladder, a disorder characterized by involuntary detrusor contractions.

  • Overactive bladder: reduces urgency episodes and increases bladder capacity.
  • Urinary urgency: improves control over sudden urges to void.
  • Urinary frequency: decreases daytime voiding frequency.

How It Works

  • Mirabegron selectively activates β3‑adrenergic receptors located in the detrusor smooth muscle of the urinary bladder. Receptor activation stimulates cyclic AMP production, leading to relaxation of the detrusor muscle during the storage phase of the micturition cycle. This relaxation increases functional bladder capacity and diminishes involuntary contractions, thereby alleviating symptoms of urgency, frequency, and urge incontinence associated with overactive bladder.

Side Effects

Adverse reactions reported with mirabegron can be grouped by frequency.

Common Side Effects

  • Increased blood pressure: mild elevations observed in some patients.
  • Nasopharyngitis: upper respiratory tract infection symptoms.
  • Headache: mild to moderate intensity.
  • Dry mouth: reduced salivation.

Serious or Rare Side Effects

  • Hypertension: significant rise in blood pressure requiring medical attention.
  • Urinary retention: difficulty initiating or maintaining urine flow.
  • Severe allergic reaction: rash, swelling, or anaphylaxis.

Precautions & Warnings

When prescribing mirabegron, clinicians should consider several precautionary measures.

  • Blood pressure monitoring: check baseline and periodically during therapy.
  • Cardiovascular assessment: evaluate patients with known heart disease before initiating.
  • Renal function evaluation: adjust use in severe renal impairment.
  • Concomitant β‑agonists: avoid combining with other β‑adrenergic agents without supervision.
  • Store at ambient temperature: keep below 25 °C, retain in original packaging, protect from moisture.

Avoid Interactions

Mirabegron may interact with other medicines, altering their plasma concentrations or pharmacodynamic effects.

Major Interactions (Avoid)

  • CYP2D6 substrates (e.g., metoprolol): increased exposure; may require dose reduction.
  • Antihypertensives (e.g., ACE inhibitors): additive blood pressure effects; monitor closely.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., ketoconazole): may raise mirabegron levels.
  • Diuretics: enhanced risk of hypertension.
  • Anticholinergics: potential additive urinary retention.

Frequently Asked Questions

Mirabegron Zentiva is prescribed to manage symptoms of overactive bladder, including urinary urgency, increased frequency of urination, and urge incontinence. By improving bladder storage capacity, it helps adult patients achieve better control over bladder function.

Mirabegron activates β3‑adrenergic receptors in the detrusor muscle of the bladder. This activation raises cyclic AMP levels, causing the muscle to relax during the storage phase of the urinary cycle, which increases bladder capacity and reduces involuntary contractions.

The dosage of Mirabegron Zentiva is individualized by the prescribing healthcare professional based on the patient’s condition, response, and any comorbidities. Patients should follow the dose and schedule provided by their prescriber.

Safety data for mirabegron in pregnancy and lactation are limited. It is classified as a pregnancy category with unknown risk, so clinicians should weigh potential benefits against possible risks and discuss options with the patient.

To request Mirabegron Zentiva, 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‑adrenoceptor agonist) and does not have the anticholinergic side‑effects such as dry mouth and constipation that are common with antimuscarinic drugs. It can be used alone or in combination with antimuscarinics for additive efficacy, depending on the patient’s profile.

Store Mirabegron Zentiva at ambient temperature, preferably below 25 °C. Keep the tablets in the original container, protect them from moisture and direct sunlight, and ensure the packaging remains sealed until use.

Mirabegron Zentiva is taken orally, usually once daily, with or without food. The tablet should be swallowed whole with a glass of water and not chewed or crushed.

Serious risks include significant hypertension, urinary retention that may require medical intervention, and rare severe allergic reactions such as rash, swelling or anaphylaxis. Patients should seek immediate medical attention if they experience any of these symptoms.

Mirabegron is contraindicated in patients with uncontrolled hypertension, severe renal impairment, or known hypersensitivity to mirabegron or any of its excipients. Caution is also advised for individuals taking other β‑adrenergic agents.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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