DITROPAN XL SUMMARY
Extended Release Tablets
DITROPAN XL® (oxybutynin chloride) is an antispasmodic, anticholinergic agent. Each DITROPAN XL Extended Release Tablet contains 5 mg, 10 mg, or 15 mg of oxybutynin chloride USP, formulated as a once-a-day controlled-release tablet for oral administration. Oxybutynin chloride is administered as a racemate of R- and S-enantiomers.
DITROPAN XL® (oxybutynin chloride) is a once-daily controlled-release tablet indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
DITROPAN XL is also indicated in the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida).
Published Studies Related to Ditropan XL (Oxybutynin)
A phase 2, randomized, double-blind, efficacy and safety study of oxybutynin
vaginal ring for alleviation of overactive bladder symptoms in women. 
vaginal ring in women with overactive bladder... CONCLUSIONS: The oxybutynin vaginal ring appears to be an effective and safe once
Desmopressin and oxybutynin in monosymptomatic nocturnal enuresis: a randomized,
double-blind, placebo-controlled trial and an assessment of predictive factors. 
evaluated... CONCLUSIONS: Our findings highlight that anticholinergic agents may play an
Efficacy of oral extended-release oxybutynin in cognitively impaired older nursing home residents with urge urinary incontinence: a randomized placebo-controlled trial. [2011.11]
OBJECTIVES: To determine the efficacy of oral extended-release oxybutynin for urge urinary incontinence in older female nursing home residents with mild to severe cognitive impairment... CONCLUSION: Extended-release oxybutynin 5 mg per day for 4 weeks in older cognitively impaired female nursing home residents did not significantly reduce urinary incontinence and urinary frequency or achieve dryness. Participants with mild to moderate cognitive and/or physical impairment were no more likely to benefit from oxybutynin than more severely impaired individuals in an exploratory analysis but further research in a larger population and perhaps using a larger dose is needed. Copyright (c) 2011 American Medical Directors Association. Published by Elsevier Inc. All rights reserved.
Tolerability of solifenacin and oxybutynin immediate release in older (> 65 years) and younger (</= 65 years) patients with overactive bladder: sub-analysis from a Canadian, randomized, double-blind study. [2011.02]
CONCLUSIONS: Solifenacin 5 mg/day was better tolerated than oxybutynin IR 15 mg/day in younger (</= 65 years) and older (> 65 years) subgroups. Solifenacin was equally well tolerated in both age subgroups. Limitations of the analysis were that the study was not preplanned to perform post-hoc subgroup analysis, patients knew that dry mouth was a primary outcome, and the study used fixed doses of each drug.
[Comparisons of efficacy and safety of tolterodine and oxybutynin in children with idiopathic overactive bladder]. [2011.01]
OBJECTIVE: To compare the efficacy and safety of tolterodine and oxybutynin in the treatment of idiopathic overactive bladder in children... CONCLUSIONS: Tolterodine has a similar efficacy to oxybutynin in the treatment of idiopathic overactive bladder in children, with better safety in pharmacotherapy.
Clinical Trials Related to Ditropan XL (Oxybutynin)
OnabotulinumtoxinA (onaBoNT-A) Versus Oral Oxybutynin ER [Recruiting]
Overactive bladder is a condition associated with symptoms of feeling the urge to urinate,
urinating often, and may or may not be accompanied by leakage of urine. A patient who has a
spinal cord injury (SCI) often suffers from an overactive bladder which often leads to
urinary incontinence (UI - an unwanted leakage of urine).
OnaBoNT-A bladder injections have been studied in clinical research trials. The results
have shown an improvement in urinary symptoms by reducing how often urine leakage occurs and
by increasing the amount of urine the bladder can hold.
This purpose of this clinical trial is to see if onaBoNT-A is safe and effective when
injected into the bladder for the treatment of UI and if it works better than a drug that is
taken by mouth. A second purpose of the study is to perform research tests on the urine
samples provided by the volunteers. Urine presents a rich source of information for bladder
diseases and the biomarkers (the chemical make-up of the urine cells) will be examined to
learn if there are yet undiscovered reasons for urinary diseases. These tests would be very
beneficial because the results would lead to better treatment of the urinary diseases.
Volunteers will be randomized to either: ARM 1: onaBoNT-A 200 U bladder injection and
placebo oral capsule daily or ARM 2: Placebo bladder injection (saline) and oxybutynin ER
15mg capsule daily.
The treatments are onaBoNT-A bladder injection and a placebo oral capsule once a day or
placebo bladder injection and oxybutynin ER (like Ditropan) capsule once a day. Placebo
contains no active medicine. Participation in this study will be about 6-7 months and
involve 5 visits to the clinic. The risks of bladder onaBoNT-A
Fesoterodine and Oxybutynin XL for Overactive Bladder Syndrome in Children [Enrolling by invitation]
Desloratadine With Oxybutynin for the Treatment of Seasonal Allergic Rhinitis and Post-Nasal Drip (Study P04258)(COMPLETED) [Completed]
This was a 1-week study of desloratadine (DL) plus oxybutynin (OXY) at two dose levels in
the treatment of post-nasal drip in participants with seasonal allergic rhinitis.
Participants received either desloratadine twice a day, oxybutynin twice a day,
desloratadine plus lower-dose oxybutynin twice a day, desloratadine plus higher-dose
oxybutynin twice a day, or placebo for 7 days.
Use of Oxybutynin for Treating Hyperhidrosis: A Placebo-control Study [Completed]
Video-assisted thoracic sympathectomy (VATS) provides excellent resolution of palmar and
axillary hyperhidrosis but is associated with compensatory hyperhidrosis. Low doses of
Oxybutynin can be used to treat palmar hyperhidrosis with fewer side effects.
Treatment of Hyperhidrosis With Oxybutynin [Completed]