Europe — EMA
Mirabegron Zentiva
GNH USA supplies Mirabegron Zentiva (Mirabegron), a β3‑adrenergic receptor agonist for overactive bladder, urinary urgency, frequency and urge incontinence.
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What is Mirabegron?
Mirabegron, the active ingredient in Mirabegron Zentiva, is a β3‑adrenergic receptor agonist presented as an oral tablet for oral use. It treats overactive bladder symptoms, including urgency, frequency and urge incontinence, in adult patients. GNH USA supplies Mirabegron Zentiva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.
What is Mirabegron used for?
Mirabegron acts on the β3‑adrenergic pathway to improve bladder storage function. - Overactive bladder: increases bladder capacity and reduces urgency episodes. - Urinary urgency: lessens the frequency of sudden urges to void. - Urinary frequency: decreases the number of daily voids. - Urge urinary incontinence: lowers the occurrence of involuntary leakage.
What are the side effects of Mirabegron?
Adverse reactions may occur with Mirabegron use.
Common Side Effects: - Hypertension: elevated blood pressure observed in some patients. - Headache: mild to moderate headache reported. - Nasopharyngitis: upper respiratory tract infection symptoms. - Constipation: reduced bowel movements.
Serious or Rare Side Effects: - Urinary retention: difficulty emptying the bladder. - Severe hypertension: markedly high blood pressure requiring medical attention. - Angioedema: swelling of face, lips or throat. - Myocardial infarction: rare cardiac event. - Allergic reactions: rash, itching or anaphylaxis.
What precautions apply to Mirabegron?
Before prescribing Mirabegron, clinicians should consider several safety measures. - Blood pressure assessment: measure baseline and monitor regularly. - Renal function evaluation: adjust use in impaired kidney function. - Concomitant antihypertensive review: watch for additive blood‑pressure effects. - Uncontrolled hypertension: avoid or use with caution. - Store at ambient temperature: keep in the original pack, protect from moisture and light.
What does Mirabegron interact with?
Mirabegron may interact with other medicines, requiring careful management.
Major Interactions (Avoid): - Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine): may increase mirabegron exposure. - Monoamine oxidase inhibitors: risk of hypertensive crisis. - Drugs that lower blood pressure (e.g., alpha‑blockers): additive hypotensive effect.
Moderate Interactions (Monitor Closely): - CYP3A4 inhibitors (e.g., ketoconazole): may raise plasma levels modestly. - CYP3A4 inducers (e.g., rifampin): may reduce efficacy. - Diuretics: may enhance risk of hypertension when combined.
Frequently asked questions
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Product details
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