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warnings and cautions
5 WARNINGS AND PRECAUTIONS Urinary Retention: Use caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. ( 5.1 ) Gastrointestinal Disorders: Use caution in patients with gastrointestinal obstructive disorders or decreased intestinal motility because of the risk of gastric retention. Use caution in patients with gastroesophageal reflux and/or those taking drugs that can cause or exacerbate esophagitis. ( 5.2 ) Central Nervous System Effects: Somnolence has been reported with products containing oxybutynin. Advise patients not to drive or operate heavy machinery until they know how OXYTROL affects them. ( 5.3 ) Angioedema: Angioedema has been reported with oral oxybutynin use. If symptoms of angioedema occur, discontinue OXYTROL and initiate appropriate therapy. ( 5.4 ) Skin Hypersensitivity: Discontinue OXYTROL in patients with skin hypersensitivity. ( 5.5 ) Myasthenia gravis: Use with caution in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction. ( 5.6 ) 5.1 Urinary Retention Administer OXYTROL with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. 5.2 Risks in Patients with Gastrointestinal Disorders Administer OXYTROL with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention. OXYTROL, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis or intestinal atony. OXYTROL should be used with caution in patients who have gastroesophageal reflux and/or who are concurrently taking drugs (such as bisphosphonates) that can cause or exacerbate esophagitis. 5.3 Central Nervous System Effects Products containing oxybutynin are associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported, including headache, dizziness, somnolence, confusion and hallucinations. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment. Advise patients not to drive or operate heavy machinery until they know how OXYTROL affects them. If a patient experiences anticholinergic CNS effects, drug discontinuation should be considered. 5.4 Angioedema Angioedema requiring hospitalization and emergency medical treatment has occurred with the first or subsequent doses of oral oxybutynin. In the event of angioedema, OXYTROL should be discontinued and appropriate therapy promptly provided. 5.5 Skin Hypersensitivity Patients who develop skin hypersensitivity to OXYTROL should discontinue drug treatment. 5.6 Exacerbation of Symptoms of Myasthenia Gravis Administer OXYTROL with caution to patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction.
6 ADVERSE REACTIONS The most common adverse reactions (incidence > 5% and > placebo) are application site reactions and dry mouth. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-800-272-5525 or contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of OXYTROL was evaluated in a total of 417 patients who participated in two clinical efficacy and safety studies and an open-label extension. Additional safety information was collected in earlier phase trials. In the two pivotal studies, a total of 246 patients received OXYTROL during the 12-week treatment periods. A total of 411 patients entered the open-label extension and of those, 65 patients and 52 patients received OXYTROL for at least 24 weeks and at least 36 weeks, respectively. No deaths were reported during treatment. No serious adverse events related to treatment were reported. Adverse reactions reported in the pivotal trials are summarized in Tables 1 and 2 below. Table 1: Number (%) of adverse reactions occurring in ≥ 2% of OXYTROL-treated patients and greater in the OXYTROL group than in the placebo group (Study 1). Adverse Reaction Placebo (N = 132) OXYTROL (3.9 mg/day) (N = 125) N % N % Application site pruritus 8 6.1% 21 16.8% Dry mouth 11 8.3% 12 9.6% Application site erythema 3 2.3% 7 5.6% Application site vesicles 0 0.0% 4 3.2% Diarrhea 3 2.3% 4 3.2% Dysuria 0 0.0% 3 2.4% Table 2: Number (%) of adverse reactions occurring in ≥ 2% of OXYTROL-treated patients and greater in the OXYTROL group than in the placebo group (Study 2). Adverse Reaction Placebo (N = 117) OXYTROL (3.9 mg/day) (N = 121) N % N % Application site pruritus 5 4.3% 17 14.0% Application site erythema 2 1.7% 10 8.3% Dry mouth 2 1.7% 5 4.1% Constipation 0 0.0% 4 3.3% Application site rash 1 0.9% 4 3.3% Application site macules 0 0.0% 3 2.5% Abnormal vision 0 0.0% 3 2.5% Most adverse reactions were described as mild or moderate in intensity. Severe application site reactions were reported by 6.4% of OXYTROL-treated patients in Study 1 and by 5.0% of OXYTROL-treated patients in Study 2. Adverse reactions that resulted in discontinuation were reported by 11.2% of OXYTROL-treated patients in Study 1 and 10.7% of OXYTROL-treated patients in Study 2. Most of these discontinuations were due to application site reaction. In the two pivotal studies, no patient discontinued OXYTROL treatment due to dry mouth. In the open-label extension, the most common treatment-related adverse reactions were: application site pruritus, application site erythema, and dry mouth. In a controlled clinical trial of skin sensitization, none of the 103 test subjects demonstrated skin hypersensitivity to OXYTROL. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of OXYTROL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Nervous System Disorders: dizziness, somnolence, confusion Psychiatric Disorders: hallucinations