Product image of Iretig (Mirabegron) supplied by GNH India

Iretig

Active Ingredient:
Mirabegron
Origin:
EU

Iretig (Mirabegron)

Mirabegron, the active ingredient in Iretig, is a β3‑adrenergic receptor agonist presented as an oral tablet for oral use. It works by relaxing the detrusor muscle, thereby increasing bladder capacity and reducing symptoms of overactive bladder such as urinary urgency, frequency and urge incontinence in adult patients.

GNH India supplies Iretig as a licensed, GDP‑compliant international pharmaceutical supplier, providing the product to hospitals, pharmacies and clinics throughout worldwide markets with adherence to quality standards, regulatory requirements and reliable logistics support.

Manufacturer / TM Owner

Zentiva, K.S.

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Indications & Clinical Uses

Mirabegron is indicated for conditions affecting bladder storage function in the overactive bladder disease family.

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

How It Works

  • Mirabegron selectively stimulates β3‑adrenergic receptors located on detrusor smooth‑muscle cells in the bladder. Activation of these receptors increases intracellular cyclic adenosine monophosphate (cAMP), leading to relaxation of the detrusor during the storage phase. The resulting reduction in bladder muscle tone expands functional bladder capacity and diminishes involuntary contractions that cause urgency and incontinence. Additionally, the drug’s selectivity minimizes activation of β1 and β2 receptors, reducing cardiovascular side effects.

Side Effects

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

Common Side Effects

  • Hypertension: increased blood pressure.
  • Headache: mild to moderate head pain.
  • Nasopharyngitis: inflammation of the nasal passages and throat.
  • Constipation: reduced bowel movements.

Serious or Rare Side Effects

  • Severe hypertension: markedly elevated blood pressure requiring medical intervention.
  • Urinary retention: difficulty emptying the bladder.
  • Angioedema or anaphylaxis: rapid swelling of face, lips, tongue or severe allergic reaction.

Precautions & Warnings

When prescribing Mirabegron, clinicians should consider several precautionary measures to ensure patient safety.

  • Monitor blood pressure: check baseline and periodic measurements during therapy.
  • Assess cardiovascular status: avoid use in patients with uncontrolled hypertension or recent cardiac events.
  • Evaluate renal function: dose adjustment may be needed in severe renal impairment.
  • Review hepatic function: consider dose reduction in moderate to severe liver disease.
  • Caution with drug interactions: avoid concomitant strong CYP2D6 inhibitors without dose adjustment.
  • Store at room temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

Mirabegron can affect the pharmacokinetics of several co‑administered medicines, leading to clinically relevant interactions.

Major Interactions (Avoid)

  • Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine): may increase mirabegron plasma levels.
  • Antihypertensive agents (e.g., β‑blockers, ACE inhibitors): mirabegron may reduce their blood‑pressure‑lowering effect.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin): may modestly raise mirabegron concentrations.
  • CYP3A4 inducers (e.g., rifampicin, carbamazepine): may lower mirabegron exposure.
  • Digoxin: mirabegron can increase digoxin serum levels.
  • NSAIDs: combined use may enhance risk of hypertension.

Frequently Asked Questions

Iretig contains mirabegron and is prescribed to manage symptoms of overactive bladder, including urinary urgency, increased daytime frequency, and urge urinary incontinence. It helps patients achieve better bladder control by increasing functional bladder capacity.

Mirabegron selectively activates β3‑adrenergic receptors on detrusor smooth‑muscle cells. This activation raises intracellular cAMP levels, causing the muscle to relax during the storage phase of the bladder cycle, which expands capacity and reduces involuntary contractions that trigger urgency.

The appropriate dose of Iretig is determined by the prescribing healthcare professional based on the individual’s clinical condition, renal and hepatic function, and concomitant medications. Patients should follow the prescriber’s instructions and not adjust the dose on their own.

Safety data for mirabegron in pregnancy and lactation are limited. The drug 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 pregnancy, or breastfeeding should discuss alternatives with their clinician.

To order Iretig, 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.

The primary alternative to mirabegron is the antimuscarinic class (e.g., oxybutynin, tolterodine). Antimuscarinics reduce bladder contractions by blocking muscarinic receptors, often causing dry‑mouth and constipation. Mirabegron, a β3‑agonist, tends to have a lower incidence of anticholinergic side effects but may raise blood pressure, requiring monitoring.

Iretig should be stored at room temperature, below 25 °C, in its original packaging. Keep the tablets away from moisture, direct sunlight and excessive heat. Do not store in the bathroom or near a kitchen sink to maintain product stability.

Iretig is taken orally as a tablet. Patients should swallow the tablet whole with a glass of water, preferably at the same time each day. It can be taken with or without food, but consistency helps maintain steady drug levels.

Serious adverse events include marked hypertension, urinary retention that may require catheterisation, and rare allergic reactions such as angioedema or anaphylaxis. Patients should seek immediate medical attention if they experience a sudden rise in blood pressure, inability to urinate, or signs of severe allergic response.

Iretig 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 with significant renal dysfunction, recent urinary retention, or those taking strong CYP2D6 inhibitors without dose adjustment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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