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Ditropan XL (Oxybutynin Chloride Extended Release) - Summary

 
 



DITROPAN XL SUMMARY

DITROPAN XL®
(oxybutynin chloride)
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).


See all Ditropan XL indications & dosage >>

NEWS HIGHLIGHTS

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. [2014]
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. [2012]
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.

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Clinical Trials Related to Ditropan XL (Oxybutynin)

A Study Comparing the Efficacy and Safety of OROS® Oxybutynin to That of Ditropan® (Immediate-Release Oxybutynin) for the Treatment of Patients With Urge or Mixed Urinary Incontinence. [Completed]
The purpose of this study is to compare the efficacy and safety of OROS® oxybutynin to that of Ditropan® (immediate-release oxybutynin) for the treatment of patients with urge or mixed urinary incontinence. Oxybutynin is an antispasmodic, anticholinergic medication for the treatment of the symptoms of overactive bladder.

Fasting Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg [Completed]
The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (2 x 10 mg) dose under fasting conditions.

Food Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg [Completed]
The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (2 x 10 mg) dose under fed conditions.

Fed Study of Oxybutynin Chloride Extended-Release Tablets 10 mg and Ditropan XL® Tablets 10 mg [Completed]
The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (2 x 10 mg) dose under fed conditions.

Food Study of Oxybutynin Chloride Extended-Release Tablets 5 mg and Ditropan XL® Tablets 5 mg [Completed]
The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (4 x 5 mg) dose under fed conditions.

more trials >>


Page last updated: 2014-11-30

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