What is MIRABEGRON used for?

1 INDICATIONS AND USAGE Mirabegron extended-release tablets are beta-3 adrenergic agonist indicated for the treatment of: Overactive bladder (OAB) in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1.1 ) 1.1 Adult Overactive Bladder (OAB) Mirabegron Extended-Release Tablets Monotherapy Mirabegron extended-release tablets are indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and

How does MIRABEGRON work?

11 DESCRIPTION Mirabegron extended-release tablet for oral use is a beta-3 adrenergic agonist.

What pharmaceutical form is MIRABEGRON available in?

MIRABEGRON: Tabletki o przedłużonym uwalnianiu 25 mg (doustna)

Is MIRABEGRON OTC or prescription only?

MIRABEGRON requires a doctor's prescription.

What are the side effects of MIRABEGRON?

6 ADVERSE REACTIONS Most commonly reported adverse reactions with mirabegron monotherapy in adult patients with OAB (> 2% and > placebo) were hypertension, nasopharyngitis, urinary tract infection, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions are discussed in more detail in other sections of the labeling. Hypertension [see Warni

Who should NOT take MIRABEGRON?

4 CONTRAINDICATIONS Hypersensitivity to mirabegron or any inactive ingredients. ( 4 ) Mirabegron extended-release tablets are contraindicated in patients with known hypersensitivity reactions to mirabegron or any inactive ingredients of the tablet [see Adverse Reactions ( 6.1 , 6.2 )] .

Does MIRABEGRON interact with other medications?

7 DRUG INTERACTIONS Drugs Metabolized by CYP2D6 : Mirabegron is a CYP2D6 inhibitor and, when used concomitantly with drugs metabolized by CYP2D6, especially narrow therapeutic index drugs, appropriate monitoring and possible dose adjustment of those drugs may be necessary. ( 5.4 , 7.1 , 12.3 ) Digoxin : When initiating a combination of mirabegron and digoxin, use the lowest dose of digoxin; monitor serum digoxin concentrations to titrate digoxin dose to desired clinical effect.

Can MIRABEGRON be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no studies with the use of mirabegron in pregnant women or adolescents to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. Mirabegron administration to pregnant animals during organogenesis resulted in reversible skeletal variations (in rats) at 22-fold (via AUC) the maximum recommended human dose (MRHD) of 50 mg/day and decreased fetal body weights (in r

What precautions should be taken with MIRABEGRON?

• Caution should be exercised in patients with history of liver or kidney disease, uncontrolled high blood pressure, weak urine stream, who are taking other medications, during pregnancy and breastfeeding. • It may cause dizziness, do not drive a car or operate machinery while taking this medication.

Who manufactures MIRABEGRON?

Astellas Pharma Europe B.V. (Holandia)

What ATC class does MIRABEGRON belong to?

MIRABEGRON: ATC G04BD12. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

MIRABEGRON

25 mg, Tabletki o przedłużonym uwalnianiu

INN: Mirabegronum

Available in:

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Form

Tabletki o przedłużonym uwalnianiu

Dosage

25 mg

Route

doustna

Storage

—

About This Product

Manufacturer

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