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Mirabegron

Active Ingredient:
Mirabegron
Origin:
EU

Mirabegron

Mirabegron, the active ingredient in Mirabegron, is a β3‑adrenergic receptor agonist presented as an oral tablet for systemic use. It is indicated for the management of overactive bladder in adults, helping to reduce urinary urgency, frequency and urge urinary incontinence by increasing bladder capacity and relaxing the detrusor muscle during the storage phase.

GNH India supplies Mirabegron as a licensed, GDP‑compliant international pharmaceutical supplier, providing the product to hospitals, pharmacies and clinics worldwide and ensuring regulatory compliance in each market.

Manufacturer / TM Owner

Adalvo Limited

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Indications & Clinical Uses

Mirabegron is used to treat conditions related to overactive bladder, a disorder of urinary storage.

  • Overactive bladder: Improves bladder capacity and reduces episodes of urgency and incontinence.
  • Urinary urgency: Decreases the frequency of sudden, compelling urges to void.
  • Urinary frequency: Lowers the number of daytime voids.
  • Urge urinary incontinence: Reduces involuntary leakage associated with sudden urges.

How It Works

  • Mirabegron selectively activates β3‑adrenergic receptors located on the detrusor smooth muscle of the bladder. This activation stimulates a cyclic AMP–mediated signaling cascade that leads to relaxation of the detrusor during the storage phase, thereby increasing functional bladder capacity and reducing involuntary contractions associated with overactive bladder. The drug does not significantly affect α‑adrenergic or muscarinic pathways, allowing it to act without anticholinergic side effects.

Side Effects

Mirabegron may cause 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 symptoms.
  • Headache: Persistent or intermittent head pain.
  • Constipation: Reduced bowel movement frequency.
  • Dry mouth: Decreased salivary secretion.
  • Dizziness: Light‑headed sensation, especially on standing.

Serious or Rare Side Effects

  • Cardiovascular events: Tachycardia, arrhythmia, or angina.
  • Urinary retention: Difficulty initiating or maintaining urine flow.
  • Severe hypersensitivity: Rash, angioedema, or anaphylaxis.
  • Angle‑closure glaucoma: Acute increase in intra‑ocular pressure (rare).

Precautions & Warnings

Before initiating Mirabegron therapy, clinicians should consider several safety aspects.

  • Assess blood pressure: Monitor baseline and periodically due to risk of hypertension.
  • Review cardiovascular status: Use cautiously in patients with uncontrolled hypertension or severe cardiac disease.
  • Evaluate renal function: Dose adjustment may be needed in severe renal impairment.
  • Consider hepatic function: Use with caution in moderate to severe hepatic impairment.
  • Pregnancy and lactation: Safety not established; avoid unless benefit outweighs risk.
  • Store at ambient temperature: Keep below 25 °C, in original packaging, protected from moisture and light.

Avoid Interactions

Mirabegron can interact with other medicines, requiring attention to avoid reduced efficacy or increased toxicity.

Major Interactions (Avoid)

  • Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine): May increase mirabegron exposure and risk of adverse effects.
  • Antihypertensive agents (e.g., beta‑blockers): May attenuate the blood‑pressure‑lowering effect of concomitant therapy.

Moderate Interactions (Monitor Closely)

  • Diuretics: Potential additive increase in blood pressure.
  • Anticholinergic agents: May increase risk of urinary retention.
  • Digoxin: May raise serum digoxin concentrations, requiring monitoring.
  • NSAIDs: May enhance risk of hypertension when used together.

Frequently Asked Questions

Mirabegron is prescribed for adults with overactive bladder, specifically to reduce urinary urgency, urinary frequency, and urge urinary incontinence. By increasing bladder capacity, it helps patients achieve better control over bladder storage and diminish episodes of involuntary leakage.

Mirabegron selectively activates β3‑adrenergic receptors on the detrusor muscle of the bladder. This activation triggers a cyclic AMP cascade that relaxes the muscle during the storage phase, allowing the bladder to hold more urine and decreasing involuntary contractions that cause urgency and incontinence.

The exact dose of Mirabegron is determined by the prescribing healthcare professional based on the individual’s medical condition, renal and hepatic function, and concomitant medications. Patients should follow the prescriber’s instructions and not adjust the dose without medical guidance.

Safety data for Mirabegron in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and under close medical supervision.

To request 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.

Unlike anticholinergics, Mirabegron does not block muscarinic receptors, so it typically avoids dry mouth, constipation and blurred vision. It offers an alternative mechanism by relaxing the detrusor muscle via β3‑adrenergic activation, which can be advantageous for patients who cannot tolerate anticholinergic side effects.

Mirabegron tablets should be stored at ambient temperature, below 25 °C. Keep them in the original blister pack or container, protect from moisture and direct light, and ensure they are out of reach of children.

Mirabegron is taken orally as a tablet, usually with or without food, according to the prescriber’s directions. The tablet is swallowed whole with a glass of water and should not be crushed, chewed, or split unless specifically instructed by a healthcare professional.

Serious risks include significant hypertension, cardiovascular events such as tachycardia or arrhythmia, urinary retention, and rare severe allergic reactions like anaphylaxis. Patients should promptly report any sudden increase in blood pressure, chest pain, difficulty urinating, or signs of an allergic response.

Mirabegron should be avoided in patients with uncontrolled hypertension, severe cardiac disease, or known hypersensitivity to the drug. Caution is also advised for individuals with severe renal or hepatic impairment, and it is not recommended for use during pregnancy or breastfeeding unless clearly justified.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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