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 tablet for oral use. It treats overactive bladder symptoms, including 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.

Manufacturer / TM Owner

Zentiva, K.S.

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Indications & Clinical Uses

Mirabegron acts on the β3‑adrenergic pathway to improve bladder storage function.

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

How It Works

  • Mirabegron selectively stimulates β3‑adrenergic receptors in detrusor smooth muscle, causing relaxation during the bladder storage phase. This relaxation expands functional bladder capacity, thereby reducing the sensation of urgency and the frequency of involuntary contractions that lead to incontinence.

Side Effects

Adverse reactions may occur with Mirabegron use.

Common Side Effects

  • Hypertension: elevated blood pressure observed in some patients.
  • Headache: mild to moderate headache reported.
  • Nasopharyngitis: upper respiratory tract infection symptoms.
  • Constipation: reduced bowel movements.

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.
  • Myocardial infarction: rare cardiac event.
  • Allergic reactions: rash, itching or anaphylaxis.

Precautions & Warnings

Before prescribing Mirabegron, clinicians should consider several safety measures.

  • Blood pressure assessment: measure baseline and monitor regularly.
  • Renal function evaluation: adjust use in impaired kidney function.
  • Concomitant antihypertensive review: watch for additive blood‑pressure effects.
  • Uncontrolled hypertension: avoid or use with caution.
  • Store at ambient temperature: keep in the original pack, protect from moisture and light.

Avoid Interactions

Mirabegron may interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine): may increase mirabegron exposure.
  • Monoamine oxidase inhibitors: risk of hypertensive crisis.
  • Drugs that lower blood pressure (e.g., alpha‑blockers): additive hypotensive effect.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., ketoconazole): may raise plasma levels modestly.
  • CYP3A4 inducers (e.g., rifampin): may reduce efficacy.
  • Diuretics: may enhance risk of hypertension when combined.

Frequently Asked Questions

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

Mirabegron selectively activates β3‑adrenergic receptors located in the detrusor muscle of the bladder. This activation relaxes the muscle during the storage phase, allowing the bladder to hold a larger volume of urine and reducing involuntary contractions that cause urgency and leakage.

The dosage of Mirabegron Zentiva is determined by the prescribing healthcare professional based on the individual’s clinical condition, renal function and concomitant medications. 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 any possible risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their healthcare provider.

To request 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.

The primary alternative for overactive bladder is the antimuscarinic class (e.g., oxybutynin, tolterodine). Antimuscarinics block muscarinic receptors, often causing dry mouth and constipation, whereas Mirabegron works via β3‑adrenergic stimulation and has a different side‑effect profile, making it suitable for patients who cannot tolerate antimuscarinics.

Mirabegron Zentiva tablets should be stored at ambient temperature, preferably below 25 °C. Keep them in the original packaging to protect from moisture and light, and ensure the container is tightly closed when not in use.

Mirabegron is taken orally as a tablet. Patients should swallow the tablet whole with water, and it may be taken with or without food. Consistency in timing each day helps maintain stable drug levels.

Serious adverse events include significant hypertension, urinary retention, angioedema, and rare cardiac events such as myocardial infarction. Patients should be monitored for sudden increases in blood pressure, difficulty urinating, or signs of an allergic reaction and seek medical attention promptly if they occur.

Mirabegron is contraindicated in patients with uncontrolled hypertension, severe hepatic impairment, or known hypersensitivity to the drug. Caution is also advised for individuals taking strong CYP2D6 inhibitors or those with conditions that could be worsened by increased blood pressure.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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