Europe — EMA
Mirabegron Teva
GNH USA supplies Mirabegron Teva (Mirabegron), a β3‑adrenergic receptor agonist for overactive bladder, urge urinary incontinence and urinary frequency.
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What is Mirabegron?
Mirabegron, the active ingredient in Mirabegron Teva, is a β3‑adrenergic receptor agonist presented as an oral dosage form for oral use. It is used to treat overactive bladder symptoms such as urgency, frequency, and urge urinary incontinence in adult patients.
GNH USA supplies Mirabegron Teva as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with distribution across EU and other regulated markets. The company ensures quality compliance with EU pharmacopeia standards.
What is Mirabegron used for?
Mirabegron is indicated for conditions affecting bladder storage function within the overactive bladder therapeutic area.
- Overactive bladder: reduces urgency episodes and increases bladder capacity. - Urge urinary incontinence: decreases frequency of involuntary urine loss. - Urinary frequency and urgency: lessens the number of daytime voids and urgency sensations.
What are the side effects of Mirabegron?
Mirabegron may be associated with several adverse reactions, which are categorized by frequency and severity.
Common Side Effects: - Hypertension: elevated blood pressure, often mild to moderate. - Headache: transient cranial pain. - Nasopharyngitis: inflammation of the nasal passages and throat. - Constipation: reduced bowel movements.
Serious or Rare Side Effects: - Severe hypertension: marked increase in blood pressure requiring medical intervention. - Urinary retention: difficulty emptying the bladder that may lead to acute retention. - Angioedema or anaphylaxis: swelling of the face, lips, or airway and severe allergic reaction.
What precautions apply to Mirabegron?
Before initiating Mirabegron therapy, clinicians should consider several precautionary measures to ensure patient safety.
- Blood pressure assessment: measure baseline and monitor regularly during treatment. - Cardiovascular risk evaluation: avoid in patients with uncontrolled hypertension. - Renal and hepatic function: adjust use in moderate to severe impairment. - Concomitant antihypertensives: monitor for additive blood pressure effects. - Urinary retention risk: assess for history of obstruction before use. - Store at ambient temperature: keep below 25 °C in original packaging, protect from moisture.
What does Mirabegron interact with?
Mirabegron can affect the pharmacokinetics of other medicines; awareness of key interactions helps manage therapy safely.
Major Interactions (Avoid): - Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine): may raise mirabegron plasma levels. - Potent CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): increase mirabegron exposure. - Drugs that raise blood pressure (e.g., sympathomimetics): may exacerbate hypertension.
Moderate Interactions (Monitor Closely): - CYP2D6 substrates (e.g., metoprolol, carvedilol): may have increased concentrations. - Digoxin: mirabegron can raise serum digoxin levels. - Diuretics: combined effect may alter fluid balance and blood pressure. - NSAIDs: may enhance risk of hypertension.
Frequently asked questions
What is Mirabegron Teva used for?+
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What is the usual dose of Mirabegron Teva?+
Is Mirabegron safe in pregnancy or breastfeeding?+
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Who should not use Mirabegron Teva?+
Product details
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