Pooled safety profile of oral donepezil in Phase 3 placebo-controlled trials¹

IMPORTANT SAFETY INFORMATION

Contraindications

ADLARITY is contraindicated in patients with known hypersensitivity to donepezil or to piperidine derivatives or with a history of allergic dermatitis with use of ADLARITY.

INDICATION

ADLARITY is indicated for the treatment of mild, moderate, and severe dementia of the Alzheimer's type.

IMPORTANT SAFETY INFORMATION

Contraindications

ADLARITY is contraindicated in patients with known hypersensitivity to donepezil or to piperidine derivatives or with a history of allergic dermatitis with use of ADLARITY.

Warnings and Precautions

• Application site skin reactions: ADLARITY may cause skin application-site reactions. These reactions are not necessarily indicative of sensitization; however, allergic contact dermatitis may occur and should be suspected if application-site reactions spread beyond the size of the transdermal system, there is evidence of a more intense local reaction, and symptoms do not significantly improve within 48 hours of transdermal system removal.
• Anesthesia: ADLARITY, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia.
• Cardiovascular conditions: Cholinesterase inhibitors, including ADLARITY, may have vagotonic effects on the sinoatrial and atrioventricular nodes. These effects may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil.
• Nausea and vomiting: Donepezil, the active ingredient in ADLARITY, may cause diarrhea, nausea, and vomiting. In most cases these effects have been transient, although some cases lasted 1 to 3 weeks. Patients should be monitored closely during initiation of treatment and after dose increases.
• Peptic ulcer disease and gastrointestinal bleeding: Cholinesterase inhibitors, including ADLARITY, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs).
• Genitourinary conditions: Although not observed in clinical trials of ADLARITY, bladder outflow obstruction may occur.
• Seizures: Cholinomimetics, including ADLARITY, are believed to have some potential to cause generalized convulsions; however, seizure activity may also be a manifestation of Alzheimer's disease.
• Pulmonary conditions: Cholinesterase inhibitors, including ADLARITY, should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.

Adverse Reactions

The most common adverse reactions (greater than 5% with donepezil tablets and twice the placebo rate) are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia.

Drug Interactions

Cholinesterase inhibitors, including donepezil, have the potential to interfere with the activity of anticholinergic medications. A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol.

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