Oxybutynin Chloride

WARNINGS 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.

ADVERSE REACTIONS The safety and efficacy of Oxybutynin Chloride Syrup was evaluated in a total of 199 patients in three clinical trials comparing oxybutynin chloride with oxybutynin chloride extended release tablets (see Table 3 ). These participants were treated with oxybutynin chloride 5-20 mg/day for up to 6 weeks. Table 3 shows the incidence of adverse events judged by investigators to be at least possibly related to treatment and reported by at least 5% of patients. Table 3 Incidence (%) of Adverse Events Reported by ≥ 5% of Patients Using Oxybutynin Chloride (5-20 mg/day) Body System Adverse Event Oxybutynin Chloride (5-20 MG/DAY) (N=199) Infections and Infestations Urinary tract infection 6.5% Psychiatric Disorders Insomnia Nervousness 5.5% 6.5% Nervous System Disorders Dizziness Somnolence Headache 16.6% 14.0% 7.5% Eye Disorders Blurred vision 9.6% Gastrointestinal Disorders Dry mouth Constipation Nausea Dyspepsia 71.4% 15.1% 11.6% 6.0% Renal and Urinary Disorders Urinary Hesitation Urinary Retention 8.5% 6.0% The most common adverse events reported by patients receiving oxybutynin chloride 5-20 mg/day were the expected side effects of anticholinergic agents. The incidence of dry mouth was dose-related. In addition, the following adverse events were reported by 1 to <5% of patients using oxybutynin chloride (5-20 mg/day) in all studies. Infections and Infestations: nasopharyngitis, upper respiratory tract infection, bronchitis, cystitis, fungal infection; Metabolism and Nutrition Disorders: fluid retention; Psychiatric Disorders: confusional state; Nervous System Disorders: dysgeusia, sinus headache; Eye Disorders: keratoconjunctivitis sicca, eye irritation; Cardiac Disorders: palpitations, sinus arrhythmia; Vascular Disorders: flushing; Respiratory, Thoracic and Mediastinal Disorders: nasal dryness, cough, pharyngolaryngeal pain, dry throat, sinus congestion, hoarseness, asthma, nasal congestion; Gastrointestinal Disorders: diarrhea, abdominal pain, loose stools, flatulence, vomiting, abdominal pain upper, dysphagia, aptyalism, eructation, tongue coated; Skin and Subcutaneous Tissue Disorders: dry skin, pruritis; Musculoskeletal and Connective Tissue Disorders: back pain, arthralgia, pain in extremity, flank pain; Renal and Urinary Disorders: dysuria, pollakiuria; General Disorders and Administration Site Conditions: fatigue, edema peripheral, asthenia, pain, thirst, edema; Investigations: blood pressure increased, blood glucose increased, blood pressure decreased; Injury, Poisoning, and Procedural Complications: fall. Postmarketing Surveillance Because postmarketing adverse events 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. The following additional adverse events have been reported from worldwide postmarketing experience with oxybutynin chloride: Psychiatric Disorders: psychotic disorder, agitation, hallucinations; memory impairment; Nervous System Disorders: convulsions; Eye disorders: cycloplegia, mydriasis; Cardiac Disorders: tachycardia; QT interval prolongation; Gastrointestinal Disorders: decreased gastrointestinal motility; Skin and Subcutaneous Tissue Disorders: rash, decreased sweating; Renal and Urinary Disorders: impotence; Reproductive system and breast disorders: Suppression of lactation. General Disorders and Administration Site Conditions: hypersensitivity reactions, including angioedema with airway obstruction, urticaria, and face edema; rare anaphylactic reactions requiring hospitalization for emergency treatment.

<table><caption>Table 3 Incidence (%) of Adverse Events Reported by &#x2265; 5% of Patients Using Oxybutynin Chloride (5-20 mg/day)</caption><col/><col/><col/><tbody><tr><td> Body System</td><td> Adverse Event</td><td> Oxybutynin Chloride (5-20 MG/DAY) (N=199) </td></tr><tr><td> Infections and Infestations</td><td> Urinary tract infection</td><td> 6.5%</td></tr><tr><td> Psychiatric Disorders</td><td> Insomnia Nervousness </td><td> 5.5% 6.5% </td></tr><tr><td> Nervous System Disorders</td><td> Dizziness Somnolence Headache </td><td> 16.6% 14.0% 7.5% </td></tr><tr><td> Eye Disorders</td><td> Blurred vision</td><td> 9.6%</td></tr><tr><td> Gastrointestinal Disorders</td><td> Dry mouth Constipation Nausea Dyspepsia </td><td> 71.4% 15.1% 11.6% 6.0% </td></tr><tr><td> Renal and Urinary Disorders</td><td> Urinary Hesitation Urinary Retention </td><td> 8.5% 6.0% </td></tr></tbody></table>