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Prescribing Information
ARICEPT® (donepezil hydrochloride) Tablets/ARICEPT® ODT (donepezil hydrochloride) Orally Disintegrating Tablets
Warnings
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Anesthesia: ARICEPT®, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia.

Cardiovascular Conditions: Because of their pharmacological action, cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes. This effect 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 ARICEPT®.

Gastrointestinal Conditions: Through their primary action, cholinesterase inhibitors may be expected to increase gastric acid secretion due to increased cholinergic activity. Therefore, patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those at increased risk for developing ulcers, e.g., those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDS). Clinical studies of ARICEPT® have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding.

ARICEPT®, as a predictable consequence of its pharmacological properties, has been shown to produce diarrhea, nausea and vomiting. These effects, when they occur, appear more frequently with the 10 mg/day dose than with the 5 mg/day dose. In most cases, these effects have been mild and transient, sometimes lasting one to three weeks, and have resolved during continued use of ARICEPT®.

Genitourinary: Although not observed in clinical trials of ARICEPT®, cholinomimetics may cause bladder outflow obstruction.

Neurological Conditions: Seizures: Cholinomimetics are believed to have some potential to cause generalized convulsions. However, seizure activity also may be a manifestation of Alzheimer's Disease.

Pulmonary Conditions: Because of their cholinomimetic actions, cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.


ARICEPT Safety Information
 

Important Safety Information

Cholinesterase inhibitors have the potential to increase gastric acid secretion. Patients at risk for developing ulcers, including those receiving concurrent NSAIDs, should be monitored closely for gastrointestinal bleeding.

In clinical trials, syncopal episodes have been reported (2% for ARICEPT versus 1% for placebo).

In clinical trials, the most common adverse events seen with ARICEPT were nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, anorexia, and ecchymosis. In studies, these were usually mild and transient.

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