Donepezil

Donepezil is 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.

Donepezil is available under the following different brand names: Aricept, and Aricept ODT.

Dosage Forms and Strengths

Tablet

• 5 mg
• 10 mg
• 23 mg

Tablet, oral disintegrating

• 5 mg
• 10 mg

Dosage Considerations – Should be Given as Follows:

Alzheimer's Disease

Dementia of the Alzheimer's type

Mild to moderate

• 5 mg orally at bedtime initially, may increase to 10 mg/day after 4-6 weeks if warranted

Moderate to severe

• 5 mg orally at bedtime initially, may increase to 10 mg/day after 4-6 weeks; may further increase to 23 mg/day after 3 months if warranted

Administration

Take at bedtime before retiring

Take with or without food

ODT (orally disintegrating tablet): Dissolve on tongue and follow with water

• Treat for a minimum of 3 weeks and for at least 2 weeks following resolution of symptoms

Dose Modification

Renal Impairment

• not studied

Hepatic Impairment

• not studied

Not recommended for pediatric use.

Side effects associated with use of Donepezil, include the following:

• Nausea
• Diarrhea
• Insomnia
• Accident
• Infection
• Headache
• Vomiting
• Cramping
• Fatigue
• Loss of appetite
• High blood pressure (hypertension)
• Abnormal dreams
• Hallucinations
• Confusion
• Lightheadedness or fainting

Postmarketing side effects of donepezil reported include:

• Abdominal pain
• Agitation
• Aggression
• Cholecystitis
• Convulsions
• Heart block (all types)
• Hemolytic anemia
• Hepatitis
• Low blood sodium
• Muscle wasting (rhabdomyolysis)
• Neuroleptic malignant syndrome
• Pancreatitis
• Rash
• QTc prolongation
• Stevens Johnson syndrome
• Toxic epidermal necrolysis
• Torsade de pointes

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Severe interactions of donepezil include:
  • none
• Serious interactions of donepezil include:
  • ambenonium
• Donepezil has moderate interactions with at least 97 different drugs.
• Donepezil has mild interactions with at least 156 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

• This medication contains donepezil. Do not take Aricept or Aricept ODT if you are allergic to donepezil or any ingredients contained in this drug
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• This medication contains donepezil
• Do not take Diflucan if you are allergic to donepezil or any ingredients contained in this drug

Effects of Drug Abuse

• No information provided

Short-Term Effects

• See "What Are Side Effects Associated with Using Donepezil ?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Donepezil ?”

Cautions

• Risk of GI bleed, especially in patients with history of gastric ulcer or those on nonsteroidal anti-inflammatory drugs (NSAIDs)
• Cholinesterase inhibitors are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia
• Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block
• Can cause vomiting (higher risk with dose of 23 mg/day)
• May cause anorexia and/or weight loss (dose dependent)
• Cholinomimetics may cause bladder outflow obstructions
• Cholinomimetics are believed to have some potential to cause generalized convulsions
• Cholinesterase inhibitors should be prescribed with care with history of asthma or obstructive pulmonary disease
• Use with caution in patients with history of seizure disorders, urinary tract obstruction, peptic ulcer disease, cardiac conduction abnormalities, or respiratory disease including COPD or asthma
• May be associated with QT prolongation and torsades de pointes; use caution in patients at risk of cardiac repolarization
• Rare cases of neuroleptic malignant syndrome reported; may consider discontinuing therapy if symptoms occur
• Rare cases of rhabdomyolysis reported following few months of therapy or following therapy initiation; use caution in patients with risk factors rhabdomyolysis, including medications associated with rhabdomyolysis; consider discontinuing therapy if marked elevation of CPK levels or symptoms suggesting rhabdomyolysis occur
• Low weight patients under 55 kg may experience more weight loss, nausea, and vomiting than patients greater than 55 kg

Pregnancy and Lactation

• Use donepezil with caution during pregancy if benefits outweigh risks. Animal studies show risk and human studies are not available, or neither animal nor human studies were done
• It is unknown if Donepezil is excreted in breast milk; use caution if breastfeeding