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. It is indicated for the treatment of overactive bladder symptoms such as urinary urgency, frequency and urge incontinence in adults.

GNH India supplies Mirabegron Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality and regulatory compliance across global markets.

Manufacturer / TM Owner

Zentiva, K.S.

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Indications & Clinical Uses

Mirabegron is a β3‑adrenergic receptor agonist used in the management of overactive bladder and related urinary symptoms.

  • Overactive bladder: improves bladder storage capacity and reduces urgency episodes.
  • Urinary urgency: lessens the frequency of sudden urges to void.
  • Urinary frequency: decreases daytime voiding episodes.
  • Urge incontinence: reduces episodes of involuntary leakage.

How It Works

  • Mirabegron selectively activates β3‑adrenergic receptors located in the detrusor smooth muscle of the bladder. Activation triggers a cascade that relaxes the detrusor during the storage phase, thereby increasing bladder capacity and reducing involuntary contractions that cause urgency and frequency.

Side Effects

Adverse reactions reported with Mirabegron Zentiva are categorized by frequency.

Common Side Effects

  • Hypertension: increase in blood pressure observed in some patients.
  • Headache: mild to moderate headache may occur.
  • Nasopharyngitis: inflammation of the nasal passages and throat.
  • Constipation: reduced bowel movements reported.

Serious or Rare Side Effects

  • Acute urinary retention: inability to void requiring medical intervention.
  • Severe hypertension: marked rise in blood pressure needing urgent care.
  • Tachycardia: rapid heart rate that may be symptomatic.
  • Angioedema or allergic reaction: swelling of face, lips or airway.

Precautions & Warnings

When prescribing Mirabegron Zentiva, clinicians should observe the following precautions.

  • Monitor blood pressure: check regularly due to risk of hypertension.
  • Assess renal function: evaluate before initiation and adjust if impaired.
  • Evaluate hepatic function: use caution in patients with severe liver disease.
  • Review concomitant medications: avoid strong CYP2D6 inhibitors and potent CYP3A4 inducers.
  • Store at ambient temperature: keep below 25°C, in the original pack, protect from moisture.

Avoid Interactions

Mirabegron may interact with other medicines; awareness of interaction severity guides clinical decisions.

Major Interactions (Avoid)

  • Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine): may increase Mirabegron exposure.
  • Potent CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce efficacy.
  • Co‑administration with other β3‑adrenergic agonists: additive pharmacologic effect.

Moderate Interactions (Monitor Closely)

  • Diuretics: may enhance hypotensive effect when blood pressure falls.
  • Antihypertensive agents: monitor for additive blood‑pressure lowering.
  • NSAIDs: may increase risk of renal impairment, especially in susceptible patients.

Frequently Asked Questions

Mirabegron Zentiva is prescribed for adults with overactive bladder, including symptoms such as urinary urgency, increased daytime frequency, and urge incontinence. It helps to improve bladder storage capacity and reduce the frequency of sudden urges to void.

Mirabegron selectively stimulates β3‑adrenergic receptors in the detrusor muscle of the bladder. This activation relaxes the muscle during the storage phase, allowing the bladder to hold more urine and decreasing involuntary contractions that cause urgency and frequency.

The dosage of Mirabegron Zentiva is determined by the prescribing healthcare professional based on the individual’s clinical condition, renal function, and response to therapy. Patients should follow the prescriber’s instructions and not adjust the dose without medical guidance.

Safety data for Mirabegron during pregnancy and lactation are limited. The drug should only be used if the potential benefit justifies any potential risk to the fetus or infant, and the decision should be made by a qualified healthcare provider.

To place an order, submit an enquiry on the Mirabegron Zentiva 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 (e.g., oxybutynin) reduce bladder contractions by blocking muscarinic receptors, often causing dry‑mouth and constipation. Mirabegron works via a different β3‑adrenergic pathway and typically has a lower incidence of anticholinergic side effects, making it a useful alternative or add‑on therapy for patients who cannot tolerate antimuscarinics.

Store Mirabegron Zentiva at ambient temperature, below 25 °C. Keep the tablets in the original packaging, protect them from moisture and direct sunlight, and ensure the container is tightly closed to maintain product stability.

Mirabegron Zentiva is taken orally, usually with or without food, as directed by the prescriber. Swallow the tablet whole with a glass of water and do not crush, chew, or split the tablet unless specifically instructed.

Serious adverse events include acute urinary retention, severe hypertension, tachycardia, and rare allergic reactions such as angioedema. Patients experiencing difficulty urinating, a sudden rise in blood pressure, rapid heartbeat, or signs of an allergic response should seek immediate medical attention.

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 with significant renal dysfunction or those taking strong CYP2D6 inhibitors.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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