Myrbetriq
Loading...Myrbetriq Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
MYRBETRIQ® is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
History
There is currently no drug history available for this drug.
Other Information
Mirabegron is a beta-3 adrenergic agonist. The chemical name is 2-(2-aminothiazol-4-yl)-N-[4-(2-{[(2R)-2-hydroxy-2-phenylethyl]amino}ethyl)phenyl]acetamide having an empirical formula of C21H24N4O2S and a molecular weight of 396.51. The structural formula of mirabegron is:
Mirabegron is a white powder. It is practically insoluble in water (0.082 mg/mL). It is soluble in methanol and dimethyl sulfoxide.
Each MYRBETRIQ® extended-release tablet, for oral administration contains either 25 mg or 50 mg of mirabegron and the following inactive ingredients: polyethylene oxide, polyethylene glycol, hydroxypropyl cellulose, butylated hydroxytoluene, magnesium stearate, hypromellose, yellow ferric oxide, and red ferric oxide (25 mg tablet only).
Sources
Myrbetriq Manufacturers
-
Astellas Pharma Us, Inc.
![Myrbetriq (Mirabegron) Tablet, Film Coated, Extended Release [Astellas Pharma Us, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Myrbetriq | Astellas Pharma Us, Inc.
2.1 Dosing InformationThe recommended starting dose of MYRBETRIQ® is 25 mg once daily with or without food. MYRBETRIQ® 25 mg is effective within 8 weeks. Based on individual patient efficacy and tolerability the dose may be increased to 50 mg once daily [see Clinical Studies (14)].
MYRBETRIQ® should be taken with water, swallowed whole and should not be chewed, divided, or crushed.
2.2 Dose Adjustments in Specific PopulationsThe daily dose of MYRBETRIQ® should not exceed 25 mg once daily in the following populations:
• Patients with severe renal impairment (CL cr 15 to 29 mL/min or eGFR 15 to 29 mL/min/1.73 m 2) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. • Patients with moderate hepatic impairment (Child-Pugh Class B) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].MYRBETRIQ® is not recommended for use in patients with end stage renal disease (ESRD), or in patients with severe hepatic impairment (Child-Pugh Class C) [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3)].
Login To Your Free Account