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Ditropan XL USPI 20210329 S-038 Clean HIGHLIGHTS OF PRESCRIBING INFORMATION • Central Nervous System (CNS) effects: CNS effects have been reported These highlights do not include all the information needed to use with oxybutynin. If patient experiences anticholinergic CNS effects, ® DITROPAN XL® safely and effectively. See full prescribing information consider dose adjustment or discontinuation of DITROPAN XL . (5.2) for DITROPAN XL®. • Use with caution due to aggravation of symptoms: o Pre-existing dementia in patients treated with cholinesterase DITROPAN XL® (oxybutynin chloride) Extended Release Tablets for inhibitors (5.2), oral use o Parkinson’s disease (5.2), Initial U.S. Approval: 1975 o Myasthenia gravis (5.3), and 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 time every day. Dose should not exceed 30 mg per day. (2.1) To report SUSPECTED ADVERSE REACTIONS, contact Janssen • Pediatric patients (6 years of age or older): Start with 5 mg, once daily at Pharmaceuticals, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at approximately the same time every day. Dose should not exceed 20 mg per 1-800-FDA-1088 or www.fda.gov/medwatch. day. (2.2) -------------------------------DRUG INTERACTIONS------------------------------- ----------------------DOSAGE FORMS AND STRENGTHS--------------------- • Co-administration with other anticholinergic drugs may increase the Extended release tablets 5 mg and 10 mg (3) frequency and/or severity of anticholinergic-like effects. (7) • Co-administration with strong cytochrome P450 (CYP) 3A4 inhibitors -------------------------------CONTRAINDICATIONS------------------------------- (e.g., ketoconazole) increases the systemic exposure of oxybutynin. (7) • Urinary retention (4) • Gastric Retention (4) -----------------------USE IN SPECIFIC POPULATIONS------------------------ ® • Uncontrolled narrow angle glaucoma (4) • Pediatric Use: DITROPAN XL is not recommended in pediatric patients • Known hypersensitivity to DITROPAN XL®, oxybutynin or any who cannot swallow the tablet whole without chewing, dividing or component of DITROPAN XL® (4) crushing, or in children under the age of 6 years. (8.4) • 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 symptoms of angioedema occur, discontinue DITROPAN XL® See 17 for PATIENT COUNSELING INFORMATION. immediately and initiate appropriate therapy. (5.1) Revised: 03/2021 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 8.1 Pregnancy 2 DOSAGE AND ADMINISTRATION 8.2 Lactation 2.1 Adults 8.4 Pediatric Use 2.2 Pediatric Patients Aged 6 Years of Age and Older 8.5 Geriatric Use 3 DOSAGE FORMS AND STRENGTHS 8.6 Renal Impairment 4 CONTRAINDICATIONS 8.7 Hepatic Impairment 5 WARNINGS AND PRECAUTIONS 10 OVERDOSAGE 5.1 Angioedema 11 DESCRIPTION 5.2 Central Nervous System Effects 12 CLINICAL PHARMACOLOGY 5.3 Worsening of Symptoms of Myasthenia Gravis 12.1 Mechanism of Action 5.4 Worsening of Symptoms of Decreased 12.2 Pharmacodynamics Gastrointestinal Motility in Patients with 12.3 Pharmacokinetics Autonomic Neuropathy 13 NONCLINICAL TOXICOLOGY 5.5 Urinary Retention 13.1 Carcinogenesis, Mutagenesis, Impairment of 5.6 Gastrointestinal Adverse Reactions Fertility 6 ADVERSE REACTIONS 14 CLINICAL STUDIES 6.1 Clinical Trials Experience 16 HOW SUPPLIED/STORAGE AND HANDLING 6.2 Postmarketing Experience 17 PATIENT COUNSELING INFORMATION 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS *Sections or subsections omitted from the full prescribing information are not listed. 1 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 and 10 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. 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 angioedema. 2 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 DITROPAN XL®, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis and intestinal atony. DITROPAN XL® should be used with caution
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