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 agonist presented as an oral tablet for oral use. It treats overactive bladder symptoms such as urinary urgency, frequency and urge incontinence in adult patients, improving bladder storage capacity and quality of life.

GNH India supplies Mirabegron Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The product conforms to EU regulatory standards and is manufactured under strict quality controls.

Manufacturer / TM Owner

Zentiva Pharma Uk Limited

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Indications & Clinical Uses

Mirabegron Zentiva is indicated for conditions involving detrusor overactivity within the overactive bladder disease spectrum.

  • Overactive bladder: reduces urinary urgency, frequency and episodes of urge incontinence.
  • Urinary urgency: provides relief by increasing bladder capacity and decreasing sudden urge sensations.
  • Urinary frequency: helps normalize voiding patterns and improves daily quality of life.

How It Works

  • Mirabegron activates β3‑adrenergic receptors located on the detrusor smooth muscle of the urinary bladder. Receptor stimulation leads to relaxation of the detrusor during the storage phase, thereby increasing functional 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: elevated blood pressure observed in some patients.
  • Headache: mild to moderate intensity.
  • Nasopharyngitis: upper respiratory tract infection symptoms.
  • Constipation: reduced bowel movements.
  • Dry mouth: decreased salivation.
  • Urinary retention: difficulty initiating or completing voiding.

Serious or Rare Side Effects

  • Severe hypertension: marked increase in blood pressure requiring medical intervention.
  • Tachycardia: rapid heart rate that may be symptomatic.
  • Angioedema: swelling of face, lips or throat.
  • Acute urinary retention leading to obstruction.
  • Allergic reactions: rash, pruritus or anaphylaxis.
  • QT interval prolongation: potential cardiac conduction disturbance.

Precautions & Warnings

Before initiating Mirabegron Zentiva, clinicians should consider the following precautions.

  • Monitor blood pressure: check baseline and periodic readings.
  • Assess renal function: dose adjustment may be needed in impairment.
  • Evaluate hepatic status: use with caution in severe liver disease.
  • Review concomitant antihypertensives: mirabegron may reduce their efficacy.
  • Avoid in uncontrolled hypertension: contraindicated in markedly elevated BP.
  • Store at below 25°C: keep in the original pack, protect from moisture.

Avoid Interactions

Mirabegron may interact with other medicines; interactions are classified by clinical significance.

Major Interactions (Avoid)

  • Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine): may increase mirabegron exposure.
  • Co‑administration with other β3‑adrenergic agonists: risk of additive cardiovascular effects.
  • Combined use with antihypertensive agents: may diminish blood pressure control.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): can raise mirabegron levels.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may lower mirabegron concentrations.
  • Diuretics: may potentiate hypertension when mirabegron raises blood pressure.

Frequently Asked Questions

Mirabegron Zentiva is prescribed to manage symptoms of overactive bladder, including urinary urgency, increased frequency of urination, and urge incontinence. By relaxing the bladder detrusor muscle, it helps increase bladder capacity and reduces involuntary contractions, improving daily comfort and quality of life for adult patients.

Mirabegron works by selectively activating β3‑adrenergic receptors on the bladder’s detrusor smooth muscle. This activation triggers a cascade that relaxes the muscle during the storage phase, allowing the bladder to hold a larger volume of urine and decreasing the frequency of sudden urges to void.

The appropriate dose of Mirabegron Zentiva is determined by the prescribing healthcare professional based on the patient’s medical condition, response to therapy, and any relevant clinical factors. The prescriber follows the product label and local regulatory guidance when selecting the dose.

Safety data for Mirabegron in pregnancy and lactation are limited. It should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss risks and alternatives with their healthcare provider.

To place an order, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams across international markets. After verification of trade or institutional credentials, the sales team will respond with pricing, availability, shipping details and any required import documentation.

Mirabegron belongs to the β3‑adrenergic agonist class, whereas antimuscarinics (e.g., oxybutynin, tolterodine) block muscarinic receptors. Mirabegron often has a lower incidence of dry mouth and constipation, common side effects of antimuscarinics, but may be associated with higher blood pressure. Choice of therapy depends on patient tolerance, comorbidities and physician judgment.

Mirabegron Zentiva tablets should be stored at temperatures below 25 °C, in their original packaging, and protected from moisture and direct sunlight. Do not store in bathrooms or near heat sources. Keep out of reach of children and dispose of any expired product according to local regulations.

Mirabegron Zentiva is taken orally, usually once daily. The tablet should be swallowed whole with a glass of water and can be taken with or without food. Patients should follow the dosing schedule prescribed by their healthcare professional and should not split, crush, or chew the tablet.

Serious risks include marked hypertension, tachycardia, severe urinary retention, angioedema, allergic reactions such as rash or anaphylaxis, and QT interval prolongation. Patients should seek immediate medical attention if they experience symptoms like a rapid or irregular heartbeat, significant blood pressure rise, swelling of the face or throat, or difficulty urinating.

Mirabegron is contraindicated in patients with uncontrolled hypertension, severe hepatic impairment, or known hypersensitivity to mirabegron or any of the tablet’s excipients. Caution is also advised for individuals with a history of urinary retention or bladder outlet obstruction. Clinicians should review the patient’s medical history before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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