24 HR Myrbetriq 50 MG Extended Release Tablet
1 INDICATIONS AND USAGE MYRBETRIQ is a 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, either alone or in combination with the muscarinic antagonist solifenacin succinate. ( 1.1 ) • Neurogenic detrusor overactivity (NDO) in pediatric patients aged 3 years and older and weighing 35 kg or more. ( 1.2 ) MYRBETRIQ Granules is a beta-3 adrenergic agonist indicated for the treatment of NDO in pediatric patients aged 3 years and older. ( 1.2 ) 1.1 Adult Overactive Bladder (OAB) MYRBETRIQ Monotherapy MYRBETRIQ ® is indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. MYRBETRIQ Combination Therapy with Solifenacin Succinate MYRBETRIQ, in combination with the muscarinic antagonist solifenacin succinate, is indicated for the treatment of OAB in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency. 1.2 Pediatric Neurogenic Detrusor Overactivity (NDO) MYRBETRIQ Granules MYRBETRIQ ® Granules is indicated for the treatment of NDO in pediatric patients aged 3 years and older. MYRBETRIQ MYRBETRIQ is indicated for the treatment of NDO in pediatric patients aged 3 years and older and weighing 35 kg or more.
Astellas Pharma US, Inc.
OVAL YELLOW Astellas logo 355
Astellas logo 355 OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 MYRBETRIQ (
MIRABEGRON extended-release tablets) MYRBETRIQ is supplied as oval, film-coated, extended-release tablets, available in bottles as follows: Strength 25 mg 50 mg Shape/Color oval/brown oval/yellow Branding on Tablet logo, 325 logo, 355 Bottles of 30 NDC 0469-2601-30 NDC 0469-2602-30 Bottles of 90 NDC 0469-2601-90 NDC 0469-2602-90 Store and Dispense Store at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. logo.jpg logo.jpg 16.2 MYRBETRIQ Granules (
MIRABEGRON for extended-release oral suspension) MYRBETRIQ Granules (
MIRABEGRON for extended-release oral suspension) is supplied as granules in bottles with a child-resistant cap packaged in an aluminum pouch with desiccant. Each bottle is filled with approximately 8.3 g of yellowish white granules, which contain 830 mg of
MIRABEGRON. After reconstitution with 100 mL water, the oral suspension is pale brownish yellow to yellow with 8 mg/mL of
MIRABEGRON. 1 Carton Containing 1 Bottle NDC 0469-5020-99 Store and Dispense Store MYRBETRIQ Granules at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store the reconstituted suspension at 20°C to 25°C (68°F to 77°F) for up to 28 days. Discard the unused portion after 28 days.
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