May 28, 2017
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Myrbetriq

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Myrbetriq




Indications
Dosage
How Supplied

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

Dosing Information

The 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].

MYRBETRIQ® should be taken with water, swallowed whole and should not be chewed, divided, or crushed.

Dose Adjustments In Specific Populations

The daily dose of MYRBETRIQ® should not exceed 25 mg once daily in the following populations:

hepatic impairment (Child-Pugh Class B) [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

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 and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

MYRBETRIQ® extended-release tablets are supplied in two different strengths as described below:

  • 25 mg oval, brown, film coated tablet, debossed with the (Astellas logo) and “325”
  • 50 mg oval, yellow, film coated tablet, debossed with the(Astellas logo) and “355”

Storage And Handling

MYRBETRIQ® is supplied as oval, film coated extended-release tablets, available in bottles and blister units as follows:

Strength 25 mg 50 mg
Color brown yellow
Debossed logo, 325 logo, 355
Bottle of 30 NDC 0469-2601-30 NDC 0469-2602-30
Bottle of 90 NDC 0469-2601-90 NDC 0469-2602-90
Unit dose pack of 100 NDC 0469-2601-71 NDC 0469-2602-71

Store at 25°C (77°F) with excursions permitted from 15 °C to 30°C (59 °F to 86°F) {see USP controlled Room Temperature}.

Marketed and Distributed by: Astellas Pharma US, Inc., Northbrook, Illinois 60062. Revised: Dec 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 8/29/2016

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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