United States - English - NLM (National Library of Medicine)

mylan institutional inc. - oxybutynin chloride (unii: l9f3d9renq) (oxybutynin - unii:k9p6mc7092) - oxybutynin chloride 5 mg - oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). oxybutynin chloride extended-release tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. oxybutynin chloride extended-release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. there have been reports of hypersensitivity reactions, including anaphylaxis and angioedema. there are no adequate and well-controlled studies using oxybutynin chloride extended-release tablets in pregnant

United States - English - NLM (National Library of Medicine)

american health packaging - oxybutynin chloride (unii: l9f3d9renq) (oxybutynin - unii:k9p6mc7092) - oxybutynin chloride 5 mg - oxybutynin chloride tablets are 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). oxybutynin chloride is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. oxybutynin chloride is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.

United States - English - NLM (National Library of Medicine)

avpak - oxybutynin chloride (unii: l9f3d9renq) (oxybutynin - unii:k9p6mc7092) - oxybutynin chloride 5 mg - oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). oxybutynin chloride extended-release tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. oxybutynin chloride extended-release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. there have been reports of hypersensitivity reactions, including anaphylaxis and angiodema. pregnancy category b. there are no adequate and well-controlled studies using oxybutynin chloride extended-releas

United States - English - NLM (National Library of Medicine)

nucare pharmaceuticals, inc. - oxybutynin chloride (unii: l9f3d9renq) (oxybutynin - unii:k9p6mc7092) - oxybutynin chloride 10 mg - oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). oxybutynin chloride extended-release tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. oxybutynin chloride extended-release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. there have been reports of hypersensitivity reactions, including anaphylaxis and angiodema. pregnancy category b. there are no adequate and well-controlled studies using oxybutynin chloride extended-releas

United States - English - NLM (National Library of Medicine)

ncs healthcare of ky, inc dba vangard labs - oxybutynin chloride (unii: l9f3d9renq) (oxybutynin - unii:k9p6mc7092) - oxybutynin chloride 5 mg - oxybutynin chloride is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. oxybutynin chloride extended-release tablets, usp are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). oxybutynin chloride extended-release tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. oxybutynin chloride extended-release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. there have been reports of hypersensitivity reactions, including anaphylaxis and angioedema. there are no adequate and well-controlled studies using oxybutynin chloride extended-release tablets in pregnant women. oxybutynin ch

United States - English - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - oxybutynin chloride (unii: l9f3d9renq) (oxybutynin - unii:k9p6mc7092) - oxybutynin chloride 5 mg - oxybutynin chloride extended-release tablets are  a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. oxybutynin chloride extended release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). oxybutynin chloride extended release tablets  are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. oxybutynin chloride extended release tablets  are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.  there have been reports of hypersensitivity reactions, including anaphylaxis and angioedema. risk summary there are no adequate data on oxybutynin chloride extended-release tablets use in pregnant wome

United States - English - NLM (National Library of Medicine)

ncs healthcare of ky, inc dba vangard labs - oxybutynin chloride (unii: l9f3d9renq) (oxybutynin - unii:k9p6mc7092) - oxybutynin chloride 15 mg - oxybutynin chloride extended release tablets are a once-daily controlled-release tablet indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. oxybutynin chloride extended release tablets are 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). oxybutynin chloride extended release tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. oxybutynin chloride extended release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - oxybutynin chloride (unii: l9f3d9renq) (oxybutynin - unii:k9p6mc7092) - oxybutynin chloride 5 mg - oxybutynin chloride tablets usp are 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). oxybutynin chloride is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. oxybutynin chloride is also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product.

United States - English - NLM (National Library of Medicine)

american health packaging - oxybutynin chloride (unii: l9f3d9renq) (oxybutynin - unii:k9p6mc7092) - oxybutynin chloride 5 mg - oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). oxybutynin chloride extended-release tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. oxybutynin chloride extended-release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. there have been reports of hypersensitivity reactions, including anaphylaxis and angioedema. risk summary there are no adequate data on oxybutynin chloride extended-release tablets use in pregnant wome

United States - English - NLM (National Library of Medicine)

mckesson corporation dba sky packaging - oxybutynin chloride (unii: l9f3d9renq) (oxybutynin - unii:k9p6mc7092) - oxybutynin chloride 5 mg - oxybutynin chloride extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. oxybutynin chloride extended-release tablets are also indicated for the treatment of pediatric patients aged 6 years and older with symptoms of detrusor overactivity associated with a neurological condition (e.g., spina bifida). oxybutynin chloride extended-release tablets are contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. oxybutynin chloride extended-release tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug substance or other components of the product. there have been reports of hypersensitivity reactions, including anaphylaxis and angioedema. pregnancy category b. there are no adequate and well-controlled studies using oxybutynin chloride extended-release tablets in pregnant women. oxybutynin chloride extended-release tablets should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. women who become pregnant during oxybutynin chloride extended-release tablets treatment are encouraged to contact their physician. risk summary based on animal data, oxybutynin is predicted to have a low probability of increasing the risk of adverse developmental effects above background risk. animal data reproduction studies with oxybutynin chloride in the mouse, rat, hamster, and rabbit showed no evidence of impaired fertility or harm to the animal fetus. it is not known whether oxybutynin is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when oxybutynin chloride extended-release tablets are administered to a nursing woman. the safety and efficacy of oxybutynin chloride extended-release tablets were studied in 60 children in a 24-week, open-label, non-randomized trial. patients were aged 6 to 15 years, all had symptoms of detrusor overactivity in association with a neurological condition (e.g., spina bifida), all used clean intermittent catheterization, and all were current users of oxybutynin chloride. study results demonstrated that administration of oxybutynin chloride extended-release tablets 5 to 20 mg/day was associated with an increase from baseline in mean urine volume per catheterization from 108 ml to 136 ml, an increase from baseline in mean urine volume after morning awakening from 148 ml to 189 ml, and an increase from baseline in the mean percentage of catheterizations without a leaking episode from 34% to 51%. urodynamic results were consistent with clinical results. administration of oxybutynin chloride extended-release tablets resulted in an increase from baseline in mean maximum cystometric capacity from 185 ml to 254 ml, a decrease from baseline in mean detrusor pressure at maximum cystometric capacity from 44 cm h 2 o to 33 cm h 2 o , and a reduction in the percentage of patients demonstrating uninhibited detrusor contractions (of at least 15 cm h 2 o) from 60% to 28%. the pharmacokinetics of oxybutynin chloride extended-release tablets in these patients were consistent with those reported for adults [see clinical pharmacology ( 12.3)] . oxybutynin chloride extended-release tablets are not recommended in pediatric patients who cannot swallow the tablet whole without chewing, dividing, or crushing, or in children under the age of 6. the rate and severity of anticholinergic effects reported by patients less than 65 years old and those 65 years and older were similar. the pharmacokinetics of oxybutynin chloride extended-release tablets were similar in all patients studied (up to 78 years of age). there were no studies conducted with oxybutynin chloride extended-release tablets in patients with renal impairment. there were no studies conducted with oxybutynin chloride extended-release tablets in patients with hepatic impairment.