oxybutynin chloride

FDA Drug Profile — Oxybutynin Chloride, oxybutynin chloride

Drug Details

Generic Name
oxybutynin chloride
Brand Names
Oxybutynin Chloride, oxybutynin chloride
Application Number
ANDA075079
Sponsor
Strides Pharma Science Limited
NDC Codes
13
Dosage Forms
TABLET, TABLET, 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.