Darifenacin - Warnings and Precautions

5 WARNINGS AND PRECAUTIONS Darifenacin extended-release tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention Darifenacin extended-release tablets should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention Darifenacin extended-release tablets should be used with caution in patients being treated for narrow-angle glaucoma and only where the potential benefits outweigh the risks Central Nervous System Effects: Somnolence has been reported with darifenacin extended-release tablets.

Advise patients not to drive or operate heavy machinery until they know how darifenacin extended-release tablets affect them 5.1 Risk of Urinary Retention Darifenacin extended-release tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.

5.2 Decreased Gastrointestinal Motility Darifenacin extended-release tablets should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention.

Darifenacin extended-release tablets, like other anticholinergic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as severe constipation, ulcerative colitis, and myasthenia gravis.

5.3 Controlled Narrow-Angle Glaucoma Darifenacin extended-release tablets should be used with caution in patients being treated for narrow-angle glaucoma and only where the potential benefits outweigh the risks.

5.4 Angioedema Angioedema of the face, lips, tongue, and/or larynx have been reported with darifenacin.

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, darifenacin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

5.5 Central Nervous System Effects Darifenacin extended-release tablets are associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions ] .

A variety of CNS anticholinergic effects have been reported, including headache, confusion, hallucinations and somnolence.

Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose.

Advise patients not to drive or operate heavy machinery until they know how darifenacin extended-release tablets affect them.

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

5.6 Patients with Hepatic Impairment The daily dose of darifenacin extended-release tablets should not exceed 7.5 mg for patients with moderate hepatic impairment (Child-Pugh B).

Darifenacin extended-release tablets have not been studied in patients with severe hepatic impairment (Child-Pugh C) and therefore are not recommended for use in this patient population [see Dosage and Administration Use in Specific Populations and Clinical Pharmacology ] .