Product image of Mirabegron Al (Mirabegron) supplied by GNH India

Mirabegron Al

Active Ingredient:
Mirabegron
Origin:
EU

Mirabegron Al (Mirabegron)

Mirabegron, the active ingredient in Mirabegron Al, is a β3‑adrenergic receptor 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.
GNH India supplies Mirabegron Al as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Aliud Pharma Gmbh

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Indications & Clinical Uses

Mirabegron is indicated for conditions related to overactive bladder, a disorder of urinary storage function.

  • Overactive bladder: improves bladder capacity and reduces urgency episodes.
  • Urinary urgency: lessens the sudden, strong need to void.
  • Urinary frequency: decreases the number of daytime voids.
  • Urge urinary incontinence: reduces involuntary leakage episodes.

How It Works

  • Mirabegron selectively activates β3‑adrenergic receptors located on detrusor smooth muscle. Activation triggers a cascade that increases cyclic AMP, leading to relaxation of the detrusor during the bladder filling phase. This relaxation expands functional bladder capacity, thereby reducing the frequency of involuntary contractions that cause urgency and incontinence.

Side Effects

Adverse reactions may vary in frequency and severity.

Common Side Effects

  • Hypertension: elevated blood pressure readings.
  • Nasopharyngitis: mild upper‑respiratory tract infection symptoms.
  • Urinary tract infection: dysuria or cloudy urine.
  • Headache: mild to moderate intensity.
  • 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 initiating or maintaining urine flow.
  • Allergic reactions: rash, pruritus or anaphylaxis.
  • Myocardial infarction: rare cardiac event.

Precautions & Warnings

Before prescribing Mirabegron, clinicians should evaluate cardiovascular status and renal function.

  • Blood pressure assessment: measure baseline and monitor regularly.
  • Cardiovascular monitoring: watch for tachycardia or hypertension during therapy.
  • Renal impairment: use caution in patients with severe renal dysfunction.
  • Hepatic impairment: consider dose adjustment in moderate to severe liver disease.
  • Concomitant CYP2D6 inhibitors: review other medicines that may increase mirabegron exposure.
  • Store at room temperature: keep in the original pack, protect from moisture and direct sunlight.

Avoid Interactions

Mirabegron can alter the pharmacokinetics of several drug classes; careful review is advised.

Major Interactions (Avoid)

  • Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine): may increase mirabegron plasma levels.
  • Sympathomimetic agents (e.g., epinephrine): additive increase in blood pressure.
  • Antihypertensive drugs (e.g., beta‑blockers): may reduce antihypertensive efficacy.

Moderate Interactions (Monitor Closely)

  • Diuretics: monitor electrolytes and volume status.
  • Anticholinergic agents: assess for additive urinary retention risk.
  • Moderate CYP3A4 inhibitors (e.g., ketoconazole): may modestly raise mirabegron exposure.

Frequently Asked Questions

Mirabegron Al is prescribed for adults with overactive bladder, including symptoms such as urinary urgency, increased daytime frequency and urge urinary incontinence. It helps relax the bladder muscle during filling, thereby increasing storage capacity and reducing unwanted bladder contractions.

Mirabegron selectively stimulates β3‑adrenergic receptors on detrusor smooth muscle. This activation raises intracellular cyclic AMP, causing the muscle to relax during the bladder‑filling phase. The relaxed detrusor allows the bladder to hold a larger volume before the urge to void occurs.

The specific dose of Mirabegron Al is determined by the prescribing clinician based on the patient’s medical history, renal function and response to therapy. Dosage adjustments may be required for certain populations, and the prescriber will provide individualized instructions.

Safety data for Mirabegron Al in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. Healthcare providers should weigh potential benefits against possible risks before prescribing to pregnant or nursing women.

To request Mirabegron Al, 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 class (β3‑adrenergic agonist) than anticholinergics, which block muscarinic receptors. Mirabegron often has a lower incidence of dry mouth and constipation, common anticholinergic side effects, but may raise blood pressure, requiring cardiovascular monitoring.

Mirabegron Al should be stored at room temperature, below 25 °C, in its original packaging. Keep the product away from moisture, direct sunlight and excessive heat to maintain stability throughout its shelf life.

Mirabegron Al is taken orally, usually once daily, with or without food. The tablet is swallowed whole with a glass of water. Patients should follow the dosing schedule prescribed by their healthcare professional.

Serious risks include significant hypertension, tachycardia, angioedema and urinary retention. Patients should seek immediate medical attention if they experience a rapid rise in blood pressure, severe chest pain, swelling of the face or throat, or inability to urinate.

Mirabegron Al is contraindicated in patients with uncontrolled hypertension, severe hepatic impairment, or known hypersensitivity to mirabegron or any excipients. Caution is also advised for individuals taking strong CYP2D6 inhibitors or other medications that may increase cardiovascular risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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