GEMTESA Film-coated tablet Ref.[50992] Active ingredients: Vibegron

Source: FDA, National Drug Code (US)  Revision Year: 2021 

1. Indications and Usage

GEMTESA is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

2. Dosage and Administration

2.1 Recommended Dosage

The recommended dosage of GEMTESA is one 75 mg tablet orally, once daily with or without food. Swallow GEMTESA tablets whole with a glass of water.

In adults, GEMTESA tablets also may be crushed, mixed with a tablespoon (approximately 15 mL) of applesauce and taken immediately with a glass of water [see Clinical Pharmacology (12.3)].

10. Overdosage

There is no experience with inadvertent GEMTESA overdosage. In case of suspected overdose, treatment should be symptomatic and supportive.

16.2. Storage and Handling

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Keep this and all medications out of sight and reach of children.

Dispose unused medication via a take-back option if available; otherwise follow FDA instructions for disposal in the household trash. See www.fda.gov/drugdisposal for more information.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.