RECENT MAJOR CHANGES

Addition of new dosage strength: ARICEPT 23mg

INDICATIONS AND USAGE

ARICEPT is an acetylcholinesterase inhibitor indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and severe Alzheimer's Disease (1.0).

DOSAGE AND ADMINISTRATION

• Mild to Moderate Alzheimer's Disease - 5mg or 10mg administered once daily (2.1)
• Moderate to Severe Alzheimer's Disease - 10mg or 23mg administered once daily (2.2)

A dose of 10mg once daily can be administered once patients have been on a daily dose of 5mg for 4 to 6weeks. A dose of 23mg once daily can be administered once patients have been on a dose of 10mg once daily for at least 3months (2.3).

DOSAGE FORMS AND STRENGTHS

• Tablets: 5mg, 10mg and 23mg (3)
• Orally Disintegrating Tablets (ODT): 5mg and 10mg (3)

CONTRAINDICATIONS

• Patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives (4)

WARNINGS AND PRECAUTIONS

• Cholinesterase inhibitors are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia (5.1).
• Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block (5.2).
• ARICEPT can cause vomiting. Patients should be observed closely at initiation of treatment and after dose increases (5.3).
• Patients should be monitored closely for symptoms of active or occult gastrointestinal (GI) bleeding, especially those at increased risk for developing ulcers (5.4).
• The use of ARICEPT in a dose of 23mg once daily is associated with weight loss (5.5).
• Cholinomimetics may cause bladder outflow obstructions (5.6).
• Cholinomimetics are believed to have some potential to cause generalized convulsions (5.7).
• Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease (5.8).

ADVERSE REACTIONS

The most common adverse reactions in clinical studies of ARICEPT are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. at 1-888-274-2378 (fax 1-201-746-3207) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

• Cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications (7.3).
• A synerg

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