Europe — EMA
Iretig
GNH USA supplies Iretig (Mirabegron), a β3‑adrenergic receptor agonist for overactive bladder, urinary urgency and frequency.
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What is Mirabegron?
Mirabegron, the active ingredient in Iretig, is a β3‑adrenergic receptor agonist presented as an oral tablet for oral use. It is indicated for the treatment of overactive bladder symptoms such as urinary urgency, frequency, and urge incontinence in adults.
GNH USA supplies Iretig as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with distribution aligned to EU regulatory standards. The company ensures batch‑to‑batch consistency, proper labeling, and adherence to Good Manufacturing Practices. All shipments are handled with temperature‑controlled logistics where required.
What is Mirabegron used for?
Mirabegron is used to manage symptoms of the overactive bladder syndrome. - Overactive bladder: reduces urgency episodes, increases functional bladder capacity, and improves overall urinary control. - Urinary urgency: lessens the sudden, compelling need to void, allowing patients to postpone bathroom visits. - Urinary frequency: decreases the number of daytime voids, contributing to better quality of life. - Urge urinary incontinence: helps prevent involuntary leakage associated with sudden urges.
What are the side effects of Mirabegron?
Adverse reactions reported with mirabegron include both common and less frequent events.
Common Side Effects: - Headache: mild to moderate head pain that may appear within the first weeks of treatment. - Elevated blood pressure: increase in systolic or diastolic pressure, often monitored during therapy. - Nasopharyngitis: cold‑like symptoms such as sore throat, nasal congestion, and mild cough.
Serious or Rare Side Effects: - Severe hypertension: marked rise in blood pressure that can lead to cardiovascular complications and may require medication adjustment. - Acute urinary retention: sudden inability to void, potentially necessitating catheterisation or emergency medical care. - Anaphylactic reaction: rare systemic allergic response presenting with rash, swelling, difficulty breathing, and hypotension.
What precautions apply to Mirabegron?
Key safety considerations for mirabegron include the following precautions. - Assess cardiovascular status: measure baseline blood pressure and continue regular monitoring during therapy. - Review concomitant anticholinergic use: avoid additive urinary side effects and consider dose adjustments. - Evaluate renal function: adjust dosage or frequency in patients with moderate to severe renal impairment. - Evaluate hepatic function: use with caution in patients with moderate or severe liver disease. - Pregnancy and lactation: safety not established; prescribe only when potential benefit justifies potential risk. - Store at ambient temperature: keep in original container, protect from moisture and light, and do not expose to extreme heat.
What does Mirabegron interact with?
Mirabegron may interact with several medicines; the following interactions are recognised.
Major Interactions (Avoid): - Strong CYP2D6 inhibitors: may increase mirabegron plasma concentrations, raising risk of adverse effects. - Narrow‑gap antihypertensives (e.g., beta‑blockers): combined effect can lead to excessive blood pressure reduction. - QT‑prolonging agents: additive risk of cardiac arrhythmias.
Moderate Interactions (Monitor Closely): - Diuretics: may affect fluid balance and blood pressure, requiring closer observation. - Anticholinergic agents: may diminish therapeutic benefit on bladder symptoms. - Other β‑agonists: additive sympathomimetic effects may increase heart rate or blood pressure.
Frequently asked questions
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Product details
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