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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).


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NEWS HIGHLIGHTS

Published Studies Related to Ditropan XL (Oxybutynin)

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.

Patient-selected goals in overactive bladder: a placebo controlled randomized double-blind trial of transdermal oxybutynin for the treatment of urgency and urge incontinence. [2011.01]
CONCLUSIONS: In women with OAB, in comparison with placebo, transdermal oxybutynin 3.9 mg/day leads to significant objective improvements in urinary urgency, but with no significant difference observed in achievement of patients' own goals for therapy, or improvement in disease specific quality of life. (c) 2010 THE AUTHORS. JOURNAL COMPILATION (c) 2010 BJU INTERNATIONAL.

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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.

Botulinum Toxin Type A Versus Oral Oxybutynin ER in Spinal Cord Injured Patients With Neurogenic Detrusor Overactivity [Not yet 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).

Current treatment for incontinence in some SCI patients is clean intermittent self-catheterization (CIC). This is a procedure done by inserting a catheter (a soft, hollow tube) into the urethra into the bladder in order to empty the bladder. However, CIC can be associated with infection, which can make the urinary incontinence worse and can lead to kidney damage. There are drugs that may help with the incontinence but they are likely to cause dry mouth, constipation, and blurred vision.

BoNT-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 BoNT-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 one of two treatments. The treatment is determined by chance like the toss of a coin. There will be a 50-50 chance of receiving either treatment. The treatments are BoNT-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 2 years and involve 10 visits to the clinic. The risks of bladder BoNT-A injection are very small but include bleeding, infection, and the rare risk of spread of BoNT-A to other muscles causing weakness. Side effects of oxybutynin ER include dry mouth, constipation, and blurred vision. The potential benefits to the volunteer include improvement in the urinary incontinence symptoms, decrease in the number of required catheterizations, and an ease of the financial burden of buying protective garments.

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.

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Page last updated: 2013-02-10

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