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 dosage form for oral use. It is indicated for the treatment of overactive bladder symptoms such as urinary urgency, frequency and incontinence in adults.
GNH India supplies Mirabegron Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Zentiva, K.S.

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Indications & Clinical Uses

Mirabegron acts on the lower urinary tract to improve storage symptoms associated with overactive bladder.

  • 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. This activation stimulates cyclic AMP formation, leading to relaxation of the detrusor during the storage phase, which expands functional bladder capacity and diminishes involuntary contractions that cause urgency and frequency.

Side Effects

Adverse reactions may vary in frequency and severity.

Common Side Effects

  • Hypertension: increase in blood pressure, often mild to moderate.
  • Headache: transient, may resolve without intervention.
  • Nasopharyngitis: upper respiratory tract infection symptoms.
  • Urinary retention: difficulty initiating or maintaining urine flow.
  • Constipation: reduced bowel movements.
  • Dry mouth: decreased salivation.

Serious or Rare Side Effects

  • Severe hypertension: marked elevation requiring medical attention.
  • Acute urinary retention: may lead to bladder over‑distension.
  • QT interval prolongation: potential cardiac arrhythmia risk.
  • Angioedema: swelling of face, lips, or airway.
  • Hepatic injury: abnormal liver function tests.
  • Anaphylactic reaction: severe allergic response.

Precautions & Warnings

Before initiating therapy, clinicians should evaluate relevant patient factors and monitor for specific risks.

  • Assess cardiovascular status: monitor blood pressure before and during treatment.
  • Review renal function: dose adjustment may be required in severe impairment.
  • Avoid use in uncontrolled hypertension: contraindicated.
  • Caution with CYP2D6 inhibitors: may increase mirabegron exposure.
  • Pregnancy and lactation: safety not established; use only if benefit outweighs risk.
  • Store at ambient temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Mirabegron can influence the pharmacokinetics of several co‑administered drugs.

Major Interactions (Avoid)

  • Strong CYP2D6 inhibitors: may raise mirabegron plasma levels.
  • Antihypertensive agents: additive blood‑pressure‑lowering effect.
  • QT‑prolonging drugs: increased risk of cardiac arrhythmias.

Moderate Interactions (Monitor Closely)

  • Diuretics: may alter urinary symptom control.
  • Other β‑adrenergic agents: potential additive sympathomimetic effects.
  • Anticholinergics: may modify efficacy of bladder‑targeted therapy.

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 patients achieve better control over their urinary habits.

Mirabegron selectively stimulates β3‑adrenergic receptors on the bladder’s detrusor muscle. This activation raises cyclic AMP levels, causing the muscle to relax during the filling phase, which expands bladder capacity and reduces involuntary contractions that trigger urgency.

The dosage of Mirabegron Zentiva is individualized by the prescribing clinician based on the patient’s condition, renal function, and response to therapy. Patients should follow the prescriber’s instructions and not adjust the dose without medical advice.

Safety data for mirabegron in pregnancy and lactation are limited. It should only be used if the potential benefit justifies any possible risk to the fetus or infant, and the decision must be made by a qualified healthcare professional.

To place an order, 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.

Antimuscarinic drugs such as oxybutynin reduce bladder contractions by blocking muscarinic receptors, often causing dry mouth and constipation. Mirabegron, a β3‑agonist, relaxes the detrusor muscle via a different pathway and typically has a lower incidence of anticholinergic side effects, offering an alternative for patients who cannot tolerate antimuscarinics.

Mirabegron Zentiva should be stored at ambient temperature, below 25 °C, in its original packaging to protect it from moisture and light. Keep the product out of reach of children and avoid storing it in humid or excessively hot environments.

The medication is taken orally, usually once daily, with or without food. Swallow the tablet whole with a glass of water; do not crush, chew, or split the tablet unless specifically instructed by a healthcare professional.

Serious adverse events include significant hypertension, acute urinary retention, and QT‑interval prolongation, which can predispose to cardiac arrhythmias. Patients should be monitored for elevated blood pressure and any signs of urinary obstruction, and an ECG may be considered in those with cardiac risk factors.

Mirabegron is contraindicated in patients with uncontrolled hypertension, severe hepatic impairment, or known hypersensitivity to mirabegron or any excipients. Caution is also advised for individuals taking strong CYP2D6 inhibitors or drugs that prolong the QT interval.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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