Donepezil | Aricept

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).

  • Mild to Moderate Alzheimer’s Disease – 5 mg or 10 mg administered once daily (2.1)
  • Moderate to Severe Alzheim er’s Disease – 10 mg or 23 mg administered once daily (2.2)

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

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

Donepezil | Aricept Prescribing Information Highlights

The following points are shortened, highlighted information from prescribing information for this drug. For the full prescribing information PDF, click the button below to be directed to the FDA PDF label for this drug.

DONEPEZIL | ARICEPT FULL PRESCRIBING INFO PDF

—–INDICATIONS AND USAGE—–

  • See description above.

—–DOSAGE AND ADMINISTRATION—–

  • See description above.

—–CONTRAINDICATIONS—–

  • Patients with known hypersen sitivity to donepezil hydrochloride or to piperidine derivatives

—–WARNINGS—–

  • 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 ob served 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 ARICE PT in a dose of 23 mg once daily is associated with weight loss (5.5).
  • Cholinomimetics may cause bladder outflow obstructions (5.6).
  • Cholinomimetics are believed t o 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).

—–DRUG INTERACTIONS—–

  • Cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications (7.3).
  • A synergistic effect may be expected with concomitant administration of succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists (7.4).

—–USE IN SPECIFIC POPULATIONS—–

  • Based on animal data, ARICEPT may cause fetal harm (8.1).

More Information on Donepezil | Aricept

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