oxybutynin
Drug Details
- Generic Name
- oxybutynin
- Brand Names
- oxybutynin
- Application Number
- ANDA202332
- Sponsor
- NCS HealthCare of KY, LLC dba Vangard Labs
- NDC Codes
- 9
- Dosage Forms
- TABLET, FILM COATED, EXTENDED RELEASE
- Routes
- ORAL
- Active Ingredients
- OXYBUTYNIN CHLORIDE
Indications and Usage
INDICATIONS AND USAGE Oxybutynin chloride is indicated for the relief of symptoms of bladder instability associated with voiding in patients with uninhibited neurogenic or reflex neurogenic bladder (i.e., urgency, frequency, urinary leakage, urge incontinence, dysuria).
Warnings
WARNINGS Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.