Europe — EMA
Mirabegron Zentiva
GNH USA supplies Mirabegron Zentiva (Mirabegron), a Beta-3 adrenergic receptor agonist for overactive bladder, urinary urgency and frequency.
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What is Mirabegron?
Mirabegron, the active ingredient in Mirabegron Zentiva, is a Beta-3 adrenergic receptor agonist presented as an oral dosage form for oral use. It is indicated for the treatment of overactive bladder symptoms such as urinary urgency, frequency and incontinence in adults. 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 lower urinary tract to improve storage symptoms associated with overactive bladder. - Overactive bladder: increases bladder capacity and reduces urgency episodes. - Urinary urgency: lessens the sudden need to void. - Urinary frequency: decreases the number of daily voids.
What are the side effects of Mirabegron?
Adverse reactions may vary in frequency and severity.
Common Side Effects: - Hypertension: increase in blood pressure, often mild to moderate. - Headache: transient, may resolve without intervention. - Nasopharyngitis: upper respiratory tract infection symptoms. - Urinary retention: difficulty initiating or maintaining urine flow. - Constipation: reduced bowel movements. - Dry mouth: decreased salivation.
Serious or Rare Side Effects: - Severe hypertension: marked elevation requiring medical attention. - Acute urinary retention: may lead to bladder over‑distension. - QT interval prolongation: potential cardiac arrhythmia risk. - Angioedema: swelling of face, lips, or airway. - Hepatic injury: abnormal liver function tests. - Anaphylactic reaction: severe allergic response.
What precautions apply to Mirabegron?
Before initiating therapy, clinicians should evaluate relevant patient factors and monitor for specific risks. - Assess cardiovascular status: monitor blood pressure before and during treatment. - Review renal function: dose adjustment may be required in severe impairment. - Avoid use in uncontrolled hypertension: contraindicated. - Caution with CYP2D6 inhibitors: may increase mirabegron exposure. - Pregnancy and lactation: safety not established; use only if benefit outweighs risk. - Store at ambient temperature: keep in the original container, protect from moisture and light.
What does Mirabegron interact with?
Mirabegron can influence the pharmacokinetics of several co‑administered drugs.
Major Interactions (Avoid): - Strong CYP2D6 inhibitors: may raise mirabegron plasma levels. - Antihypertensive agents: additive blood‑pressure‑lowering effect. - QT‑prolonging drugs: increased risk of cardiac arrhythmias.
Moderate Interactions (Monitor Closely): - Diuretics: may alter urinary symptom control. - Other β‑adrenergic agents: potential additive sympathomimetic effects. - Anticholinergics: may modify efficacy of bladder‑targeted therapy.
Frequently asked questions
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Product details
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