ARICEPT (donepezil hydrochloride) – Treatment for Alzheimer’s Dementia

ARICEPT is a medication containing donepezil hydrochloride, used to treat dementia associated with Alzheimer's disease. It is approved for use in mild, moderate, and severe stages of this condition, helping manage symptoms by affecting brain chemistry.

ARICEPT is prescribed for the treatment of dementia of the Alzheimer’s type, effective in patients with:

• Mild Alzheimer's Disease
• Moderate Alzheimer's Disease
• Severe Alzheimer's Disease

donepezil hydrochloride

ARICEPT works as an acetylcholinesterase inhibitor. It increases the levels of acetylcholine, a chemical messenger in the brain that is reduced in Alzheimer’s disease, by preventing its breakdown. This helps improve communication between brain cells and may alleviate symptoms of dementia.

Mild to Moderate Alzheimer's Disease

• Start at 5 mg once daily in the evening before bedtime.
• After 4 to 6 weeks on 5 mg, dosage may be increased to 10 mg once daily.
• Maximum dose is 10 mg daily.

Moderate to Severe Alzheimer's Disease

• Start at 5 mg once daily in the evening before bedtime.
• Increase to 10 mg daily after 4 to 6 weeks on 5 mg.
• Further increase to 23 mg once daily only after at least 3 months on 10 mg daily.
• Maximum dose is 23 mg daily.

Administration Instructions

• Take ARICEPT in the evening, just before going to sleep.
• Can be taken with or without food.
• 23 mg tablets should not be split, crushed, or chewed.
• Orally disintegrating tablets (5 mg and 10 mg) should be allowed to dissolve on the tongue and then followed by water.

ARICEPT is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or other piperidine derivatives.

Important Safety Information

• Anesthesia: ARICEPT may enhance muscle relaxation effects of succinylcholine-type anesthetics.
• Heart Effects: Can cause slow heart rate (bradycardia) or heart block, even in patients without prior heart problems; syncopal episodes have been reported.
• Gastrointestinal Effects: Commonly causes nausea, vomiting, diarrhea, especially when increasing doses; close monitoring advised during initiation and dose escalation.
• Gastrointestinal Bleeding: May increase gastric acid secretion; patients at risk for ulcers or taking NSAIDs should be closely observed for GI bleeding symptoms.
• Weight Loss: Use of the 23 mg dose is associated with significant weight loss in some patients.
• Urinary Effects: May cause bladder outflow obstruction, though not seen in clinical trials.
• Seizures: Potential risk of convulsions; however, seizures can also be symptoms of Alzheimer’s disease itself.
• Respiratory Issues: Use with caution in patients with asthma or obstructive pulmonary disease.

Common Adverse Reactions

Most side effects relate to ARICEPT’s cholinomimetic action and tend to be transient. They include:

• Nausea
• Diarrhea
• Vomiting
• Insomnia
• Muscle cramps
• Fatigue
• Anorexia

Adverse Reactions Leading to Discontinuation

Higher doses and rapid dose increases tend to increase these effects and rates of discontinuation:

• Mild to Moderate Alzheimer’s: nausea, vomiting, diarrhea
• Severe Alzheimer’s: anorexia, nausea, diarrhea, urinary tract infections
• Moderate to Severe (23 mg dose): nausea, vomiting, diarrhea, dizziness

Other Reported Reactions

Rare post-marketing reports include agitation, aggression, confusion, heart block, hemolytic anemia, hepatitis, hyponatremia, neuroleptic malignant syndrome, pancreatitis, rash, rhabdomyolysis, QTc prolongation, and torsade de pointes.

Cholinesterase inhibitors like ARICEPT may intensify muscle relaxation from succinylcholine-type anesthetics during surgery. Use caution with other medications affecting heart rhythm, as ARICEPT can cause bradycardia and heart block. Concurrent use of NSAIDs may increase risk of gastrointestinal bleeding.

Store ARICEPT tablets and orally disintegrating tablets under recommended conditions as provided by the manufacturer. Specific temperature and handling instructions are not detailed in the source text.