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Ditropan Xl® • Central Nervous System (CNS) effects: CNS effects have been reported HIGHLIGHTS OF PRESCRIBING INFORMATION with oxybutynin. If patient experiences anticholinergic CNS effects, These highlights do not include all the information needed to use consider dose adjustment or discontinuation of DITROPAN XL®. (5.2) DITROPAN XL® safely and effectively. See full prescribing information • Use with caution due to aggravation of symptoms: for DITROPAN XL®. Pre-existing dementia in patients treated with cholinesterase o inhibitors (5.2), DITROPAN XL® (oxybutynin chloride) Extended Release Tablets for Parkinson’s disease (5.2), oral use o Myasthenia gravis (5.3), and Initial U.S. Approval: 1975 o o Decreased gastrointestinal motility in patients with autonomic ----------------------------INDICATIONS AND USAGE---------------------------­ neuropathy. (5.4). • DITROPAN XL® (oxybutynin chloride) is a muscarinic antagonist • Urinary Retention: Use with caution in patients with clinically significant indicated for the treatment of overactive bladder with symptoms of urge bladder outflow obstruction because of the risk of urinary retention (5.5) urinary incontinence, urgency, and frequency. (1) • Gastrointestinal Adverse Reactions: Use with caution in patients with • DITROPAN XL® is also indicated for the treatment of pediatric patients gastrointestinal obstructive disorders or decreased intestinal motility due to aged 6 years and older with symptoms of detrusor overactivity associated risk of gastric retention. Use with caution in patients with gastroesophageal with a neurological condition (e.g., spina bifida). (1) reflux or in patients concurrently taking drugs that can exacerbate esophagitis. (5.6) -----------------------DOSAGE AND ADMINISTRATION----------------------­ DITROPAN XL® must be swallowed whole with the aid of liquids, and must ------------------------------ADVERSE REACTIONS------------------------------­ not be chewed, divided, or crushed. DITROPAN XL® may be administered The most common (incidence ≥5%) adverse reactions were dry mouth, with or without food. (2) constipation, diarrhea, headache, somnolence, and dizziness. (6) • Adults: Start with 5 mg or 10 mg, once daily at approximately the same To report SUSPECTED ADVERSE REACTIONS, contact Janssen at time every day. Dose should not exceed 30 mg per day. (2.1) 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or • Pediatric patients (6 years of age or older): Start with 5 mg, once daily at www.fda.gov/medwatch. approximately the same time every day. Dose should not exceed 20 mg per day. (2.2) -------------------------------DRUG INTERACTIONS------------------------------­ • Co-administration with other anticholinergic drugs may increase the ----------------------DOSAGE FORMS AND STRENGTHS--------------------­ frequency and/or severity of anticholinergic-like effects. (7) Extended release tablets 5 mg, 10 mg and 15 mg (3) • Co-administration with strong cytochrome P450 (CYP) 3A4 inhibitors -------------------------------CONTRAINDICATIONS------------------------------­ (e.g., ketoconazole) increases the systemic exposure of oxybutynin. (7) • Urinary retention (4) -----------------------USE IN SPECIFIC POPULATIONS-----------------------­ • Gastric Retention (4) ® • Pediatric Use: DITROPAN XL is not recommended in pediatric patients • Uncontrolled narrow angle glaucoma (4) ® who cannot swallow the tablet whole without chewing, dividing or • Known hypersensitivity to DITROPAN XL , oxybutynin or any ® crushing, or in children under the age of 6 years. (8.4) component of DITROPAN XL (4) • Renal or Hepatic Impairment: There have been no studies conducted in ------------------------WARNINGS AND PRECAUTIONS----------------------­ patients with renal or hepatic impairment. (8.6, 8.7) • Angioedema: Angioedema has been reported with oxybutynin. If ® See 17 for PATIENT COUNSELING INFORMATION. symptoms of angioedema occur, discontinue DITROPAN XL Revised: 09/2016 immediately and initiate appropriate therapy. (5.1) FULL PRESCRIBING INFORMATION: CONTENTS* 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 1 INDICATIONS AND USAGE 8.3 Nursing Mothers 2 DOSAGE AND ADMINISTRATION 8.4 Pediatric Use 2.1 Adults 8.5 Geriatric Use 2.2 Pediatric Patients Aged 6 Years of Age and Older 8.6 Renal Impairment 3 DOSAGE FORMS AND STRENGTHS 8.7 Hepatic Impairment 4 CONTRAINDICATIONS 10 OVERDOSAGE 5 WARNINGS AND PRECAUTIONS 11 DESCRIPTION 5.1 Angioedema 12 CLINICAL PHARMACOLOGY 5.2 Central Nervous System Effects 12.1 Mechanism of Action 5.3 Worsening of Symptoms of Myasthenia Gravis 12.2 Pharmacodynamics 5.4 Worsening of Symptoms of Decreased 12.3 Pharmacokinetics Gastrointestinal Motility in Patients with 13 NONCLINICAL TOXICOLOGY Autonomic Neuropathy 13.1 Carcinogenesis, Mutagenesis, Impairment of 5.5 Urinary Retention Fertility 5.6 Gastrointestinal Adverse Reactions 14 CLINICAL STUDIES 6 ADVERSE REACTIONS 16 HOW SUPPLIED/STORAGE AND HANDLING 6.1 Clinical Trials Experience 16.1 Storage 6.2 Postmarketing Experience 17 PATIENT COUNSELING INFORMATION 7 DRUG INTERACTIONS *Sections or subsections omitted from the full prescribing information are not listed. 1 Reference ID: 3985332 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE ® DITROPAN XL (oxybutynin chloride) is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. DITROPAN XL® is 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). 2 DOSAGE AND ADMINISTRATION ® DITROPAN XL must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed. DITROPAN XL® may be administered with or without food. 2.1 Adults The recommended starting dose of DITROPAN XL® is 5 or 10 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 30 mg/day). In general, dosage adjustment may proceed at approximately weekly intervals. 2.2 Pediatric Patients Aged 6 Years of Age and Older The recommended starting dose of DITROPAN XL® is 5 mg once daily at approximately the same time each day. Dosage may be adjusted in 5-mg increments to achieve a balance of efficacy and tolerability (up to a maximum of 20 mg/day). 3 DOSAGE FORMS AND STRENGTHS ® DITROPAN XL extended-release tablets are available as 5, 10 and 15 mg tablets for oral use: 5 mg: Pale yellow, round, tablet with “5 XL” printed on one side with black ink. 10 mg: Pink, round, tablet with “10 XL” printed on one side with black ink. 15 mg: Gray, round, tablet with “15 XL” printed on one side with black ink. 4 CONTRAINDICATIONS ® DITROPAN XL is contraindicated in patients with urinary retention, gastric retention and other severe decreased gastrointestinal motility conditions, uncontrolled narrow-angle glaucoma. ® DITROPAN XL is 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. 2 Reference ID: 3985332 5 WARNINGS AND PRECAUTIONS 5.1 Angioedema Angioedema of the face, lips, tongue and/or larynx has been reported with oxybutynin. In some cases, angioedema occurred after the first dose. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, oxybutynin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided. 5.2 Central Nervous System Effects Oxybutynin is associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions (6)]. A variety of CNS anticholinergic effects have been reported, including hallucinations, agitation, confusion and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly in the first few months after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how DITROPAN XL® affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered. DITROPAN XL® should be used with caution in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms. DITROPAN XL® should be used with caution in patients with Parkinson’s disease due to the risk of aggravation of symptoms. 5.3 Worsening of Symptoms of Myasthenia Gravis ® DITROPAN XL should be used with caution in patients with myasthenia gravis due to the risk of aggravation of symptoms. 5.4 Worsening of Symptoms of Decreased Gastrointestinal Motility in Patients with Autonomic Neuropathy ® DITROPAN XL should be used with caution in patients with autonomic neuropathy due to the risk of aggravation of symptoms of decreased gastrointestinal motility. 5.5 Urinary Retention ® DITROPAN XL should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [see Contraindications (4)]. 5.6 Gastrointestinal Adverse Reactions ® DITROPAN XL should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [see Contraindications (4)]. 3 Reference ID: 3985332 DITROPAN XL®, like other anticholinergic drugs, may decrease gastrointestinal
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