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)
Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity. [2009.10]
PURPOSE: We evaluated the efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity... CONCLUSIONS: Transdermal oxybutynin was a well tolerated and effective alternative to oral oxybutynin in treating neurogenic detrusor overactivity in children who previously tolerated oxybutynin.
Efficacy and safety of oxybutynin chloride topical gel for overactive bladder: a randomized, double-blind, placebo controlled, multicenter study. [2009.04]
PURPOSE: We assessed the efficacy and safety of oxybutynin chloride topical gel vs placebo in adults with overactive bladder... CONCLUSIONS: Oxybutynin chloride topical gel was efficacious in improving overactive bladder symptoms and was well tolerated in adult patients.
Efficacy and safety of extended-release oxybutynin in combination with tamsulosin for treatment of lower urinary tract symptoms in men: randomized, double-blind, placebo-controlled study. [2008.09]
OBJECTIVE: To evaluate the efficacy and tolerability of extended-release oxybutynin in combination with the alpha1-blocker tamsulosin in reducing lower urinary tract symptoms in men... CONCLUSION: In men with substantial storage symptoms, combination therapy with tamsulosin and extended-release oxybutynin demonstrated greater efficacy than and comparable safety and tolerability to tamsulosin monotherapy.
Intravesical oxybutynin for children with poorly compliant neurogenic bladder: a systematic review. [2008.09]
PURPOSE: Children with neurogenic bladder and poor bladder compliance are usually treated with bladder catheterization and oral anticholinergic medication. They may become nonresponders to the drug or present with severe side effects. We evaluated the effectiveness and tolerability of intravesical oxybutynin in children with poorly compliant neurogenic bladder... CONCLUSIONS: Adjunctive intravesical oxybutynin therapy increased mean maximum bladder capacity and decreased bladder pressure in children with neurogenic bladder. However, identified studies offered a low level of evidence, with most being poorly reported retrospective case series with potential biases. Although the incidence of side effects was lower with the intravesical route, side effects are still possible and should be discussed with patients and families. The evidence available is insufficient to recommend this therapy. Research of more sound study design such as a randomized controlled trial should be conducted to assess the efficacy and side effects of intravesical oxybutynin in children.
Intravesical Oxybutynin for Children With Poorly Compliant Neurogenic Bladder: A Systematic Review. [2008.07.17]
PURPOSE: Children with neurogenic bladder and poor bladder compliance are usually treated with bladder catheterization and oral anticholinergic medication. They may become nonresponders to the drug or present with severe side effects. We evaluated the effectiveness and tolerability of intravesical oxybutynin in children with poorly compliant neurogenic bladder... CONCLUSIONS: Adjunctive intravesical oxybutynin therapy increased mean maximum bladder capacity and decreased bladder pressure in children with neurogenic bladder. However, identified studies offered a low level of evidence, with most being poorly reported retrospective case series with potential biases. Although the incidence of side effects was lower with the intravesical route, side effects are still possible and should be discussed with patients and families. The evidence available is insufficient to recommend this therapy. Research of more sound study design such as a randomized controlled trial should be conducted to assess the efficacy and side effects of intravesical oxybutynin in children.
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.
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