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 a tablet for oral use. It treats 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. The product complies with EU marketing authorisation requirements and is manufactured under strict quality standards. It is available for bulk distribution to meet the needs of healthcare systems across multiple regions.

Manufacturer / TM Owner

Zentiva, K.S.

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Indications & Clinical Uses

  • Mirabegron is used to manage conditions within the overactive bladder disease family.
  • Overactive bladder: improves bladder capacity and reduces urgency episodes.
  • Urinary urgency: decreases the frequency of sudden urges to void.
  • Urge urinary incontinence: lowers the number of incontinence episodes.

How It Works

  • Mirabegron selectively activates β3‑adrenergic receptors located in the detrusor smooth muscle of the bladder. Activation leads to relaxation of the detrusor during the storage phase, thereby increasing functional bladder capacity and reducing involuntary contractions that cause urgency and incontinence.

Side Effects

Adverse reactions reported with Mirabegron Zentiva are categorized by frequency.

Common Side Effects

  • Hypertension: elevated blood pressure readings.
  • Nasopharyngitis: mild upper respiratory tract infection symptoms.
  • Urinary tract infection: signs of bladder infection.
  • Headache: mild to moderate head pain.
  • Constipation: reduced bowel movements.
  • Dry mouth: decreased salivation.

Serious or Rare Side Effects

  • Severe hypertension: markedly high blood pressure requiring medical attention.
  • Tachycardia: rapid heart rate that may be symptomatic.
  • Angioedema: swelling of face, lips or throat.
  • Urinary retention: difficulty emptying the bladder.
  • Allergic reactions: rash, itching or anaphylaxis.
  • Myocardial infarction: rare occurrence of heart attack.

Precautions & Warnings

  • When prescribing Mirabegron, clinicians should consider several safety measures.
  • Assess blood pressure before initiating: monitor regularly during therapy.
  • Review cardiovascular history: use with caution in patients with uncontrolled hypertension.
  • Evaluate renal function: dose adjustment may be needed in severe impairment.
  • Consider drug interactions: avoid concomitant use with strong CYP2D6 inhibitors.
  • Store at ambient temperature: keep in original container, protect from moisture and heat.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine): can increase mirabegron exposure.
  • MAO inhibitors: risk of hypertensive events.
  • Anticholinergic agents used for bladder control: may reduce efficacy.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., ketoconazole): may raise plasma levels.
  • CYP3A4 inducers (e.g., rifampin): may lower effectiveness.
  • Antihypertensive drugs: mirabegron may attenuate blood‑pressure‑lowering effect.

Frequently Asked Questions

Mirabegron Zentiva is prescribed to treat symptoms of overactive bladder, including urinary urgency, increased frequency of urination, and urge urinary incontinence. It helps improve bladder storage capacity and reduces involuntary bladder contractions.

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 the frequency of sudden urges to void.

The prescribed dose is determined by the treating clinician based on the patient’s condition and response. A common starting regimen is 25 mg taken once daily, which may be increased to 50 mg once daily if needed, but exact dosing must follow the prescriber’s instructions.

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 should be made in consultation with a healthcare professional.

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.

Mirabegron belongs to a different class (β3‑adrenergic agonist) and does not have the anticholinergic side‑effects such as dry mouth and constipation that are common with antimuscarinic agents. It may be used alone or in combination with antimuscarinics to enhance symptom control while offering an alternative safety profile.

Store the tablets at ambient temperature, preferably below 25 °C (77 °F). Keep them in the original packaging, protect from moisture and direct sunlight, and ensure the container is tightly closed to maintain product stability.

Mirabegron Zentiva is taken orally as a whole tablet with or without food. The tablet should be swallowed whole with a glass of water and taken at the same time each day to maintain consistent blood levels.

Serious adverse events include severe hypertension, tachycardia, angioedema, urinary retention, and rare cases of myocardial infarction. Patients should be monitored for significant increases in blood pressure or heart rate and advised to seek medical attention if these occur.

Mirabegron is contraindicated in patients with uncontrolled hypertension, severe hepatic impairment, or known hypersensitivity to mirabegron or any tablet excipients. Caution is also advised for individuals taking strong CYP2D6 inhibitors or those with significant cardiovascular disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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