August 28, 2015

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:

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 Astellas logo, 325 Astellas 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 25oC (77oF) with excursions permitted from 15oC to 30oC (59oF to 86oF) {see USP controlled Room Temperature}.

Manufactured by: Astellas Pharma Technologies, Inc., Norman, Oklahoma 73072. Marketed and Distributed by: Astellas Pharma US, Inc., Northbrook, Illinois 60062. Revised: July 2015.

Last reviewed on RxList: 8/27/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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