Oxybutynin - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Angioedema: Angioedema has been reported with oxybutynin.

If symptoms of angioedema occur, discontinue Oxybutynin chloride extended-release tablets immediately and initiate appropriate therapy.

Central Nervous System (CNS) effects: CNS effects have been reported with oxybutynin.

If patient experiences anticholinergic CNS effects, consider dose adjustment or discontinuation of Oxybutynin chloride extended-release tablets.

Use with caution due to aggravation of symptoms: Pre-existing dementia in patients treated with cholinesterase inhibitors Parkinson's disease Myasthenia gravis Decreased gastrointestinal motility in patients with autonomic neuropathy.

Urinary Retention: Use with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention Gastrointestinal Adverse Reactions: Use with caution in patients with gastrointestinal obstructive disorders or decreased intestinal motility due to risk of gastric retention.

Use with caution in patients with gastroesophageal reflux or in patients concurrently taking drugs that can exacerbate esophagitis.

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 ] .

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 Oxybutynin chloride extended-release tablets affect them.

If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

Oxybutynin chloride extended-release tablets should be used with caution in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.

Oxybutynin chloride extended-release tablets 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 Oxybutynin chloride extended-release tablets should be used with caution in patients with myasthenia gravis due to the risk of symptom aggravation.

5.4 Worsening of Symptoms of Decreased Gastrointestinal Motility in Patients with Autonomic Neuropathy Oxybutynin chloride extended-release tablets 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 Oxybutynin chloride extended-release tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [see Contraindications ].

5.6 Gastrointestinal Adverse Reactions Oxybutynin chloride extended-release tablets should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [see Contraindications ].

Oxybutynin chloride extended-release tablets, 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.

Oxybutynin chloride extended-release tablets 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.

As with any other nondeformable material, caution should be used when administering Oxybutynin chloride extended-release tablets to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic).