Product image of Mirabegron supplied by GNH India

Mirabegron

Active Ingredient:
Mirabegron
Origin:
EU

Mirabegron

Mirabegron, the active ingredient in Mirabegron, is a β3‑adrenergic receptor agonist presented as a tablet for oral use. It treats overactive bladder with symptoms of urgency, frequency, and urge urinary incontinence in adult patients, helping to improve bladder capacity and quality of life.

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

Manufacturer / TM Owner

Adalvo Limited

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Indications & Clinical Uses

  • Mirabegron is indicated for conditions within the overactive bladder disease spectrum, where it improves bladder function.
  • Overactive bladder: reduces urgency, frequency, and urge urinary incontinence episodes.
  • Urge urinary incontinence: decreases the number of incontinence events.
  • Frequency of urination: lowers daytime urinary frequency.

How It Works

  • Mirabegron selectively stimulates β3‑adrenergic receptors located in the detrusor smooth muscle of the bladder. Activation of these receptors raises cyclic adenosine monophosphate (cAMP) levels, causing relaxation of the detrusor muscle during the storage phase. This relaxation expands bladder capacity, diminishes involuntary contractions, and consequently reduces urgency and frequency of voiding.

Side Effects

Mirabegron may be associated with a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Hypertension: elevated blood pressure observed in some patients.
  • Nasopharyngitis: mild upper respiratory tract infection.
  • Urinary tract infection: increased incidence reported.
  • Headache: occasional mild to moderate headache.
  • Constipation: reduced bowel movements.
  • Dry mouth: decreased salivation.

Serious or Rare Side Effects

  • Severe hypertension: marked increase in blood pressure requiring medical attention.
  • Urinary retention: difficulty emptying the bladder.
  • Tachycardia: rapid heart rate episodes.
  • Angioedema: swelling of face, lips, or throat.
  • Myocardial infarction: rare cardiac event.
  • Acute renal failure: sudden loss of kidney function.

Precautions & Warnings

  • When prescribing Mirabegron, clinicians should consider several safety precautions to minimize risk.
  • Assess blood pressure before initiating therapy: baseline measurement recommended.
  • Monitor for hypertension during treatment: check blood pressure regularly.
  • Evaluate renal function: adjust dose in severe impairment.
  • Use caution in hepatic impairment: consider dose reduction.
  • Avoid use in uncontrolled hypertension: contraindicated.
  • Store at ambient temperature: keep in the original pack, protect from moisture.

Avoid Interactions

Mirabegron can affect the pharmacokinetics of other medicines, requiring attention to potential drug‑drug interactions.

Major Interactions (Avoid)

  • Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine): may increase Mirabegron exposure.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may raise plasma levels.
  • Concomitant antihypertensive agents: may reduce their efficacy, leading to uncontrolled blood pressure.

Moderate Interactions (Monitor Closely)

  • Anticholinergic agents: may increase anticholinergic burden.
  • Diuretics: may enhance risk of hypertension.
  • CYP2D6 substrates (e.g., metoprolol): may have altered plasma concentrations.

Frequently Asked Questions

Mirabegron is prescribed to manage overactive bladder, a condition characterized by urinary urgency, increased frequency, and urge urinary incontinence. By improving bladder storage capacity, it helps reduce the number of sudden urges and accidental leaks experienced by patients.

Mirabegron works by selectively activating β3‑adrenergic receptors in the bladder’s detrusor muscle. This activation raises intracellular cAMP, leading to muscle relaxation during the storage phase, which expands bladder capacity and lessens involuntary contractions that cause urgency.

The dose of Mirabegron is determined by a qualified prescriber based on the individual’s clinical condition and response. Typical prescribing starts at a low dose and may be adjusted, but the exact regimen should always follow the healthcare professional’s recommendation.

Safety data for Mirabegron during pregnancy and lactation are limited. It should only be used when the potential benefit to the mother outweighs any possible risk to the fetus or infant, and the decision must be made by a qualified healthcare provider.

To order Mirabegron, 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.

Mirabegron belongs to a different drug class than antimuscarinics; it targets β3‑adrenergic receptors rather than muscarinic receptors. This mechanism often results in fewer dry‑mouth and constipation side effects, making it a useful alternative or adjunct for patients who cannot tolerate antimuscarinic therapy.

Mirabegron tablets should be stored at ambient temperature, below 25 °C, in their original packaging. Keep the container tightly closed, protect it from moisture and direct sunlight, and store out of reach of children.

Mirabegron is taken orally as a tablet. Patients should swallow the tablet whole with water, and it may be taken with or without food. The exact timing and frequency are set by the prescribing clinician.

The most serious risks include significant hypertension, urinary retention, and rare cardiovascular events such as tachycardia or myocardial infarction. Patients should monitor blood pressure regularly and seek medical attention if they experience severe headache, chest pain, or difficulty urinating.

Mirabegron should be avoided in patients with uncontrolled hypertension, severe renal impairment, or known hypersensitivity to the drug. It is also contraindicated in individuals where the risk of urinary retention outweighs the therapeutic benefit.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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