Donepezil: Drug information

For additional information see "Donepezil: Patient drug information"

For abbreviations, symbols, and age group definitions show table

Brand Names: US

Adlarity;
Aricept

Brand Names: Canada

ACH-Donepezil;
ACT Donepezil ODT [DSC];
AG-Donepezil;
APO-Donepezil;
Aricept;
Aricept RDT [DSC];
Auro-Donepezil;
BIO-Donepezil;
JAMP-Donepezil;
M-Donepezil;
Mar-Donepezil;
MINT-Donepezil;
NAT-Donepezil;
NRA-Donepezil;
PMS-Donepezil;
PRIVA-Donepezil [DSC];
SANDOZ Donepezil;
SANDOZ Donepezil ODT [DSC];
Septa-Donepezil [DSC];
TARO-Donepezil;
TEVA-Donepezil

Pharmacologic Category

Acetylcholinesterase Inhibitor (Central)

Dosing: Adult

Alzheimer disease

Alzheimer disease:

Oral:

Mild to moderate: Initial: 5 mg once daily; may increase to 10 mg once daily after 4 to 6 weeks (Ref).

Moderate to severe: Initial: 5 mg once daily; may increase to 10 mg once daily after 4 to 6 weeks; may increase further to 23 mg once daily if stable on 10 mg daily for ≥3 months (Ref).

Note: Doses of 23 mg/day may be associated with a limited increase in efficacy compared to 10 mg/day and with increased adverse effects (Ref).

Transdermal: Initial: 5 mg per 24-hour patch applied once weekly; may increase to 10 mg per 24-hour patch applied once weekly after 4 to 6 weeks (maximum: 10 mg per 24 hours).

Missed dose: If a patch falls off or a dose is missed, apply a new patch immediately and then replace this patch 7 days later to start a new one-week cycle.

Dementia

Dementia (ie, Parkinson disease dementia, dementia with Lewy bodies, comorbid vascular dementia) (off-label use): Oral: Initial: 5 mg once daily; may increase to 10 mg once daily after 4 to 6 weeks (Ref).

Transitioning from oral to transdermal: Patients being treated with a total oral daily dose of 5 mg may be switched to 5 mg per 24-hour patch applied once weekly. Patients being treated with a total oral daily dose of 5 mg for at least 4 to 6 weeks may be increased to a 10 mg per 24-hour patch applied once weekly. Patients being treated with a total oral daily dose of 10 mg may be switched to the 10 mg per 24-hour patch applied once weekly.

Discontinuation of therapy: Discontinuation of therapy may result in worsening of cognitive function (Ref). Avoid abrupt discontinuation except in the case of severe adverse drug reaction to minimize withdrawal symptoms (eg, altered mental status, hallucinations, delusions, insomnia, increased anxiety and agitation). In general, cholinesterase inhibitors should be tapered using a 50% dose reduction or stepwise reduction via available dose formulations every 4 weeks to the lowest dose prior to discontinuation. Consider re-initiation if clear worsening of the condition occurs after withdrawal (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function: Oral, transdermal: Mild to severe impairment: No dosage adjustment necessary (Ref).

Hemodialysis, intermittent (thrice weekly): Oral, transdermal: Unlikely to be dialyzed (highly protein bound): No supplemental dose or dosage adjustment necessary (Ref). One small case series in hemodialysis patients reported efficacy and tolerability using an initial oral dose of 2.5 mg/day titrated to 5 mg/day after 1 month (Ref).

Peritoneal dialysis: Oral, transdermal: Unlikely to be dialyzed (highly protein bound): No supplemental dose or dosage adjustment necessary (Ref).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing. Note: The Canadian labeling recommends a maximum dose of 5 mg once daily in elderly women (≥85 years of age) of low body weight.

Adverse Reactions (Significant): Considerations

Cardiac effects

Acetylcholinesterase inhibitors, including donepezil, have been associated with cardiac effects, such as conduction abnormalities (eg, atrioventricular block, arrhythmias [including prolonged QT interval on ECG and torsades de pointes], bradycardia) and hypertension (Ref). Syncope has also been reported (Ref).

Mechanism: Related to the mechanism of action; increased cholinergic activity results in vagotonic effects (Ref).

Onset: Delayed; reported months to years after initiation (Ref).

Risk factors:

• Older adults (Ref)

• History of cardiovascular disease (eg, ischemic heart disease, heart failure) (Ref)

• History of cardiac conduction abnormalities or sick sinus syndrome (Ref)

• History of stroke or transient ischemic attack, diabetes, or syncope (Ref)

• Concurrent antihypertensives (especially beta-blockers), antiarrhythmics, antidepressants, and antipsychotics (Ref)

GI effects and weight loss

Dose-related GI effects are the most common adverse reactions associated with donepezil. Symptoms may include nausea, vomiting, and diarrhea (Ref). A systematic review of studies reported less GI effects with donepezil compared to rivastigmine (Ref). In another study, donepezil had the lowest rates of GI effects except for diarrhea compared to both galantamine and rivastigmine (Ref). Weight loss and/or anorexia may also occur. GI effects are typically transient and self-limiting with resolution within 1 to 3 weeks of initiation.

Mechanism: Dose-related; related to mechanism of action. Increased cholinergic activity increases smooth muscle contraction, peristalsis, and sphincter relaxation in the GI tract, leading to GI effects (Ref).

Onset: Varied; weight loss/anorexia may occur from the beginning of treatment to any time within the first year of therapy. More research is needed in this area, especially beyond 1 year (Ref).

Risk factors:

• Higher doses (≥10 mg/day)

• Dose initiation or titration

• Patients weighing <55 kg

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling for oral formulations unless otherwise specified.

>10%:

Gastrointestinal: Diarrhea (dose-related; 5% to 15%) (table 1)Diarrhea, nausea (dose-related; 3% to 19%) (table 2)Nausea

**Donepezil: Adverse Reaction: Diarrhea**
Drug (Donepezil)	Placebo	Dose	Indication	Number of Patients (Donepezil)	Number of Patients (Placebo)	Comments
15%	5%	10 mg/day	Mild to moderate Alzheimer disease	315	315	One-week titration
10%	5%	5 mg/day or 10 mg/day	Mild to moderate Alzheimer disease	747	355	N/A
8%	5%	5 mg/day	Mild to moderate Alzheimer disease	311	315	No titration
8%	N/A	23 mg/day	Moderate to severe Alzheimer disease	963	N/A	N/A
5%	N/A	10 mg/day	Moderate to severe Alzheimer disease	471	N/A	N/A
10%	4%	5 mg/day or 10 mg/day	Severe Alzheimer disease	501	392	N/A

**Donepezil: Adverse Reaction: Nausea**
Drug (Donepezil)	Placebo	Dose	Indication	Number of Patients (Donepezil)	Number of Patients (Placebo)	Comments
19%	6%	10 mg/day	Mild to moderate Alzheimer disease	315	315	One-week titration
11%	6%	5 mg/day or 10 mg/day	Mild to moderate Alzheimer disease	747	355	N/A
5%	6%	5 mg/day	Mild to moderate Alzheimer disease	311	315	No titration
12%	N/A	23 mg/day	Moderate to severe Alzheimer disease	963	N/A	N/A
3%	N/A	10 mg/day	Moderate to severe Alzheimer disease	471	N/A	N/A
6%	2%	5 mg/day or 10 mg/day	Severe Alzheimer disease	501	392	N/A

Local: Application-site reaction (transdermal: including application-site dermatitis, application-site edema [<1%], application-site erythema [65%], application-site pain, application-site pruritus, papule of skin [16%: application-site])

Nervous system: Insomnia (2% to 14%)

Miscellaneous: Accidental injury (7% to 13%)

1% to 10%:

Cardiovascular: Chest pain (2%), hypertension (3%) (table 3)Hypertension, syncope (2%) (table 4)Syncope

**Donepezil: Adverse Reaction: Hypertension**
Drug (Donepezil)	Placebo	Dose	Indication	Number of Patients (Donepezil)	Number of Patients (Placebo)
3%	2%	5 mg/day or 10 mg/day	Severe Alzheimer disease	501	392

**Donepezil: Adverse Reaction: Syncope**
Drug (Donepezil)	Placebo	Dose	Indication	Number of Patients (Donepezil)	Number of Patients (Placebo)
2%	1%	5 mg/day or 10 mg/day	Mild to moderate Alzheimer disease	747	355
2%	1%	5 mg/day or 10 mg/day	Severe Alzheimer disease	501	392

Dermatologic: Ecchymoses (4% to 5%), eczema (3%)

Endocrine & metabolic: Hyperlipidemia (2%), weight loss (dose-related; 3% to 5%) (table 5)Weight Loss

**Donepezil: Adverse Reaction: Weight Loss**
Drug (Donepezil)	Placebo	Dose	Indication	Number of Patients (Donepezil)	Number of Patients (Placebo)
3%	1%	5 mg/day or 10 mg/day	Mild to moderate Alzheimer disease	747	355
5%	N/A	23 mg/day	Moderate to severe Alzheimer disease	963	N/A
3%	N/A	10 mg/day	Moderate to severe Alzheimer disease	471	N/A

Gastrointestinal: Anorexia (dose-related; 2% to 8%) (table 6)Anorexia, gastrointestinal hemorrhage (1%), vomiting (dose-related; 3% to 9%) (table 7)Vomiting

**Donepezil: Adverse Reaction: Anorexia**
Drug (Donepezil)	Placebo	Dose	Indication	Number of Patients (Donepezil)	Number of Patients (Placebo)	Comments
7%	2%	10 mg/day	Mild to moderate Alzheimer disease	315	315	One-week titration
4%	2%	5 mg/day or 10 mg/day	Mild to moderate Alzheimer disease	747	355	N/A
3%	2%	5 mg/day	Mild to moderate Alzheimer disease	311	315	No titration
5%	N/A	23 mg/day	Moderate to severe Alzheimer disease	963	N/A	N/A
2%	N/A	10 mg/day	Moderate to severe Alzheimer disease	471	N/A	N/A
8%	4%	5 mg/day or 10 mg/day	Severe Alzheimer disease	501	392	N/A

**Donepezil: Adverse Reaction: Vomiting**
Drug (Donepezil)	Placebo	Dose	Indication	Number of Patients (Donepezil)	Number of Patients (Placebo)	Comments
8%	3%	10 mg/day	Mild to moderate Alzheimer disease	315	315	One-week titration
5%	3%	5 mg/day or 10 mg/day	Mild to moderate Alzheimer disease	747	355	N/A
3%	3%	5 mg/day	Mild to moderate Alzheimer disease	311	315	No titration
9%	N/A	23 mg/day	Moderate to severe Alzheimer disease	963	N/A	N/A
3%	N/A	10 mg/day	Moderate to severe Alzheimer disease	471	N/A	N/A
8%	4%	5 mg/day or 10 mg/day	Severe Alzheimer disease	501	392	N/A

Genitourinary: Urinary frequency (2%), urinary incontinence (1% to 3%)

Hematologic & oncologic: Bruise (2%), hemorrhage (2%)

Nervous system: Abnormal dreams (3%), asthenia (1% to 2%), confusion (2%), depression (2% to 3%), dizziness (2% to 8%), drowsiness (1% to 2%), emotional lability (2%), fatigue (1% to 8%), hallucination (3%), headache (3% to 10%), hostility (3%), nervousness (3%), pain (3% to 9%), personality disorder (2%)

Neuromuscular & skeletal: Arthritis (2%), back pain (3%), increased creatine phosphokinase in blood specimen (3%), muscle cramps (6% to 8%)

Miscellaneous: Fever (2%)

<1%: Gastrointestinal: Peptic ulcer

Postmarketing (any formulation):

Cardiovascular: Atrioventricular block (Hundae 2014; Suleyman 2006), bradycardia (Suleyman 2006), prolonged QT interval on ECG (Leitch 2007; Tanaka 2009), torsades de pointes (Tanaka 2009)

Dermatologic: Skin rash (Lim 2018)

Endocrine & metabolic: Hyponatremia (Shareef 2017)

Gastrointestinal: Cholecystitis, pancreatitis (Niinomi 2019)

Hematologic & oncologic: Hemolytic anemia

Hepatic: Hepatitis (Dierckx 2008; Verrico 2000)

Nervous system: Aggressive behavior, agitation (Leung 2014), neuroleptic malignant syndrome (Matsumoto 2004; Warwick 2008), seizure (Babic 1999; Kumlien 2010)

Neuromuscular & skeletal: Rhabdomyolysis (Fleet 2019; Sahin 2014)

Contraindications

Hypersensitivity to donepezil, piperidine derivatives, or any component of the formulation; patients with a history of contact dermatitis with the use of transdermal donepezil (transdermal).

Warnings/Precautions

Concerns related to adverse effects:

• Rhabdomyolysis: Rare cases of rhabdomyolysis (including acute renal failure) have been reported after a few months of therapy (Sahin 2014) or in the days following therapy initiation and dose increase (Aricept Canadian product monograph 2014). Use with caution in patients with risk factors for rhabdomyolysis (eg, concomitant medications associated with rhabdomyolysis, history of muscular disorders, uncontrolled hypothyroidism, renal/hepatic impairment). Discontinuation of therapy may be necessary for marked elevation of CPK levels and/or symptoms (eg, muscle pain, tenderness or weakness, malaise, fever, dark urine) suggesting rhabdomyolysis.

Disease-related concerns:

• Peptic ulcer disease: Use with caution in patients at risk of ulcer disease (eg, previous history or NSAID use); cholinesterase inhibitors may increase gastric acid secretion. Monitor for symptoms of bleeding.

• Respiratory disease: Use with caution in patients with chronic obstructive pulmonary disease and/or asthma.

• Seizure disorder: Use with caution in patients with a history of seizure disorder; cholinomimetics may potentially cause generalized seizures, although seizure activity may also result from Alzheimer disease.

• Urinary tract obstruction: Use with caution in patients with bladder outlet obstruction; cholinomimetics may cause or worsen outflow obstructions.

Dosage form specific issues:

• Aspartame: Some products may contain aspartame, which is metabolized to phenylalanine and must be avoided (or used with caution) in patients with phenylketonuria.

• Transdermal: Application-site reactions have been reported, which may lead to contact dermatitis; discontinue therapy if an intense local reaction occurs (eg, increasing erythema, edema, papules, vesicles) and if symptoms do not improve after 48 hours of patch removal.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Patch Weekly, Transdermal, as hydrochloride:

Adlarity: 5 mg/day (1 ea, 4 ea); 10 mg/day (1 ea, 4 ea)

Tablet, Oral, as hydrochloride:

Aricept: 5 mg, 10 mg, 23 mg

Generic: 5 mg, 10 mg, 23 mg

Tablet Disintegrating, Oral, as hydrochloride:

Generic: 5 mg, 10 mg

Generic Equivalent Available: US

May be product dependent

Pricing: US

Patch weekly (Adlarity Transdermal)

5 mg/day (per each): $135.00

10 mg/day (per each): $135.00

Tablet, orally-disintegrating (Donepezil HCl Oral)

5 mg (per each): $7.79

10 mg (per each): $7.79

Tablets (Aricept Oral)

5 mg (per each): $20.24

10 mg (per each): $20.24

23 mg (per each): $18.10

Tablets (Donepezil HCl Oral)

5 mg (per each): $0.18 - $8.67

10 mg (per each): $0.18 - $8.67

23 mg (per each): $10.41 - $11.36

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral, as hydrochloride:

Aricept: 5 mg, 10 mg

Generic: 5 mg, 10 mg

Tablet Disintegrating, Oral, as hydrochloride:

Aricept RDT: 5 mg [DSC], 10 mg [DSC]

Generic: 5 mg [DSC], 10 mg [DSC]

Administration: Adult

Oral: Administer at bedtime without regard to food.

Aricept 23 mg tablet: Swallow whole with water; do NOT crush or chew due to an increased rate of absorption. The 23 mg strength is provided in a unique film-coated formulation different from the 5 mg or 10 mg tablet strengths, which results in an altered pharmacokinetic profile.

Aricept ODT: Allow tablet to dissolve completely on tongue and follow with water.

Transdermal: Allow patch pouch to reach room temperature prior to removing from packaging for application; do not use external heat sources to warm. Use within 24 hours of removing from the refrigerator; do not apply a cold patch. Patches should be applied weekly to a clean, hairless area of the back avoiding the spine (preferred), upper buttocks, or upper outer thigh; avoid a location that may be rubbed by tight clothing. Press firmly for 30 seconds to ensure proper adherence. Do not apply to red, irritated, or cut skin or an area where medication, cream, lotion, or powder has been applied. Do not shave the site. Rotate patch sites weekly; do not use the same site for at least 14 days. May bathe while wearing patch. Avoid long exposure to external heat sources (eg, excessive sunlight, heating pads, saunas, solariums). Dispose of any used patches by folding adhesive ends together and discard properly in trash away from children and pets; do not flush down the toilet.

Use: Labeled Indications

Alzheimer disease: Treatment of mild, moderate, or severe dementia of the Alzheimer type.

Use: Off-Label: Adult

Dementia (ie, Parkinson disease dementia, dementia with Lewy bodies, comorbid vascular dementia)

Medication Safety Issues

Sound-alike/look-alike issues:

Aricept may be confused with AcipHex, Ascriptin, and Azilect

Older Adult: High-Risk Medication:

Donepezil is identified in the Screening Tool of Older Person's Prescriptions (STOPP) criteria as a potentially inappropriate medication in older adults (≥65 years of age) with a history of persistent bradycardia, heart block, or recurring syncope with an unknown cause (O’Mahony 2023).

Metabolism/Transport Effects

Substrate of CYP2D6 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Agents with Clinically Relevant Anticholinergic Effects: Acetylcholinesterase Inhibitors may diminish the therapeutic effect of Agents with Clinically Relevant Anticholinergic Effects. Agents with Clinically Relevant Anticholinergic Effects may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy

Amifampridine: Acetylcholinesterase Inhibitors may enhance the therapeutic effect of Amifampridine. Amifampridine side effects may also be increased. Amifampridine may enhance the therapeutic effect of Acetylcholinesterase Inhibitors. Acetylcholinesterase inhibitor side effects may also be increased. Risk C: Monitor therapy

Antipsychotic Agents: Donepezil may enhance the neurotoxic (central) effect of Antipsychotic Agents. Risk C: Monitor therapy

Benoxinate: Acetylcholinesterase Inhibitors may enhance the therapeutic effect of Benoxinate. Specifically, the effects of benoxinate may be prolonged. Risk C: Monitor therapy

Beta-Blockers: Acetylcholinesterase Inhibitors may enhance the bradycardic effect of Beta-Blockers. Risk C: Monitor therapy

Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Risk C: Monitor therapy

Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Risk D: Consider therapy modification

Chlorprothixene: Acetylcholinesterase Inhibitors may enhance the adverse/toxic effect of Chlorprothixene. Acetylcholinesterase Inhibitors may enhance the therapeutic effect of Chlorprothixene. Risk C: Monitor therapy

Cholinergic Agonists: Acetylcholinesterase Inhibitors may enhance the adverse/toxic effect of Cholinergic Agonists. Specifically, cholinergic effects may be enhanced or increased. Risk C: Monitor therapy

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Risk C: Monitor therapy

Dipyridamole: May diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy

Etrasimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Fexinidazole: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole. Risk X: Avoid combination

Fingolimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Fingolimod. Management: Consult with the prescriber of any bradycardia-causing agent to see if the agent could be switched to an agent that does not cause bradycardia prior to initiating fingolimod. If combined, perform continuous ECG monitoring after the first fingolimod dose. Risk D: Consider therapy modification

Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy

Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Risk C: Monitor therapy

Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Risk C: Monitor therapy

Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Neuromuscular-Blocking Agents (Nondepolarizing): Acetylcholinesterase Inhibitors may diminish the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Risk C: Monitor therapy

Ozanimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Ponesimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Ponesimod. Management: Avoid coadministration of ponesimod with drugs that may cause bradycardia when possible. If combined, monitor heart rate closely and consider obtaining a cardiology consult. Do not initiate ponesimod in patients on beta-blockers if HR is less than 55 bpm. Risk D: Consider therapy modification

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. If combined, consider obtaining a cardiology consult regarding patient monitoring. Risk D: Consider therapy modification

Succinylcholine: Acetylcholinesterase Inhibitors may enhance the neuromuscular-blocking effect of Succinylcholine. Risk C: Monitor therapy

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies.

Breastfeeding Considerations

It is not known if donepezil is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

Mental status, weight, symptoms of GI intolerance, symptoms of active or occult GI bleeding.

Mechanism of Action

Alzheimer's disease is characterized by cholinergic deficiency in the cortex and basal forebrain, which contributes to cognitive deficits. Donepezil reversibly and noncompetitively inhibits centrally active acetylcholinesterase, the enzyme responsible for hydrolysis of acetylcholine. This appears to result in increased concentrations of acetylcholine available for synaptic transmission in the CNS.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Oral: Well absorbed; Transdermal: Delayed.

Distribution: V_dss: 12 to 16 L/kg.

Protein binding: ~96%, primarily to albumin (75%) and alpha₁-acid glycoprotein (21%).

Metabolism: Extensive hepatic metabolism via CYP2D6 and 3A4 and glucuronidation to four major metabolites (two are active).

Half-life elimination: Oral: 70 hours; time to steady-state: 15 days; Transdermal: ~91 hours.

Time to peak, plasma: Tablet, 10 mg: 3 hours; Tablet, 23 mg: ~8 hours; Transdermal: ~7 days; Note: Peak plasma concentrations almost twofold higher for the 23 mg tablet compared to the 10 mg tablet.

Excretion: Urine (57%; 17% as unchanged drug); feces (15%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Hepatic function impairment: Clearance decreased 20% in patients with stable alcoholic cirrhosis.

Older adult: Clearance decreases with increasing age. When compared with patients 65 years of age, 90-year-old patients have a 17% decrease in clearance, while 40-year-old patients have a 33% increase in clearance; effect may not be clinically significant.

Body weight: For body weight from 50 to 110 kg, clearance increased from 7.77 to 14.04 L/hour, with a value of 10 L/hour for 70 kg individuals.

CYP2D6 genotype: When compared with CYP2D6 extensive metabolizers, poor metabolizers had a 31.5% slower clearance and ultra-rapid metabolizers had a 24% faster clearance.

Transdermal: AUC and C_max were 14% to 18% lower and 21% to 24% higher, respectively, when applied to the thigh and buttocks compared to the back. Exposure was increased temporarily by up to 60% when application site was exposed to heat.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Aricept | Donepex | Dopzil | Doxera | Tregona;
(AR) Argentina: Aflimet | Alzaimax | Cebrocal | Crialix | Cristaclar | DONENOVA | Donepecilo richet | Donepecilo vannier | Donepes | Donepes Dor | Donnox | Donpex | Endoclar | Eranz | Lupracil | Oldinot | Onefin | Valpex | Valpex flash;
(AT) Austria: Aricept | Demelan | Donepezil +pharma | Donepezil accord | Donepezil actavis | Donepezil bluefish | Donepezil genericon | Donepezil HCl 1A Pharma | Donepezil hcl arcana | Donepezil hcl sandoz | Donepezil krka | Donepezil Pfizer | Donepezil ratiopharm | Donepezil Stada;
(AU) Australia: Apo donepezil | Arazil | Aricept | Aricept d | Aridon | Cm Donepezil | Donepezil | Donepezil an | Donepezil Drla | Donepezil Ga | Donepezil Rbx | Donepezil Sandoz | Donepezil Synthon | Noumed donepezil | Pharmacor donepezil | Stada Donepezil | Twc donepezil;
(BD) Bangladesh: Ameloss | Elzer | Memorin;
(BE) Belgium: Aricept | Donepezil Apotex | Donepezil Eg | Donepezil krka | Donepezil mylan | Donepezil Sandoz | Donepezil teva;
(BG) Bulgaria: Alzancer | Aricept | Aripezil | Darizol | Donecept | Dopezal | Yasnal;
(BR) Brazil: Aricept | Arozep | Clorhydrate de Donepezila | Cloridrato de donepezila | Danpezil | Don | Donila | Epez | Eranz | Furp donepezila | Labrea | Nepezil | Reczil | Senes | Ziledon | Zymea;
(CH) Switzerland: Aricept | Aricept Evess | Donepezil actavis | Donepezil Helvepharm | Donepezil Mepha | Donepezil nobel | Donepezil Sandoz | Donepezil spirig hc | Donepezil zentiva;
(CI) Côte d'Ivoire: Aricept;
(CL) Chile: Dazolin | Donap | Dopaben | Eranz | Evimal | Evocaz cd | Fincip | Ideclar | Nepokare;
(CN) China: A rui si | Aricept | Fu si ke | Nuo chong | Si bo hai;
(CO) Colombia: Alzedon | Alzit | Arizil | Bradonex | Donecil | Donepecilo | Donepezilo Clorhidrato | Donepezilo de clorhidrato | Dopecilo | Eranz | Geriapexil | Glix | Lindezip | Nepecil | Pezicep;
(CZ) Czech Republic: Adonep | Alzil | Apo donepezil | Aricept | Calofra | Darezil | Donepezil +pharma | Donepezil accord | Donepezil actavis | Donepezil bluefish | Donepezil krka | Donepezil mylan | Donepezil Orion | Donepezil pmcs | Donepezil ratiopharm | Donepezil Sandoz | Donepezil teva | Donpethon | Dospelin | Kognezil | Landex | Promemore | Yasnal;
(DE) Germany: Aricept | Aricept Evess | Donepegamma | Donepezil Aaa | Donepezil Aluid | Donepezil elpen | Donepezil HCL | Donepezil HCl 1A Pharma | Donepezil hcl aurobindo | Donepezil hcl basics | Donepezil hcl betapharm | Donepezil hcl biomo | Donepezil hcl biomo pharma | Donepezil hcl CT | Donepezil hcl hexal | Donepezil hcl mylan | Donepezil hcl neuraxpharm | Donepezil hcl puren | Donepezil hcl ratiopharm | Donepezil hormosan | Donepezil hydrochloride actavis | Donepezil hydrochloride bluefish | Donepezil hydrochloride hennig | Donepezil hydrochloride heumann | Donepezil Stada | Donepezilhydrochlorid | Donepezilhydrochlorid q | Memac | Neuristor | Yasnal;
(DO) Dominican Republic: Alzil | Aricept | Donecil | Doneclar | Donepezilo Clorhidrato | Donezel | Dopezil | Dosteril | Evocaz cd | Medebral | Vio Geric | Zeuton;
(EC) Ecuador: Alzit | Aricept | Arizil | Claripezil | Donecil | Doneclar | Donevitae | Dozept | Eranz | Lirpan;
(EE) Estonia: Aricept | Divare | Donepezil accord | Donepezil actavis | Donepezil Orion | Yasnal;
(EG) Egypt: Alkapezil | Alzepizil | Alzimer | Aricept | Donecept | Donepezil | Donhimer | Lidemtzil | Zymadone;
(ES) Spain: Aricept | Aricept flas | Donepezilo actavis | Donepezilo almus | Donepezilo alter | Donepezilo Apotex | Donepezilo aurobindo | Donepezilo bluefish | Donepezilo cinfa | Donepezilo combix | Donepezilo Kern | Donepezilo kern pharma | Donepezilo krka | Donepezilo macleods | Donepezilo Mylan | Donepezilo Normon | Donepezilo Pensa | Donepezilo pensa pharma | Donepezilo pharmacia | Donepezilo Pharmagenus | Donepezilo qualigen | Donepezilo Ranbaxy | Donepezilo Ratiopharm | Donepezilo Sandoz | Donepezilo sanovel | Donepezilo stada | Donepezilo tarbis | Donepezilo Tecnigen | Donepezilo teva | Donepezilo Tevagen | Donepezilo ur | Donepezilo viatris | Lixben | Uxazen | Yasnal;
(FI) Finland: Aricept | Donepezil | Donepezil accord | Donepezil actavis | Donepezil bluefish | Donepezil krka | Donepezil mylan | Donepezil Orifarm | Donepezil Orion | Donepezil Sandoz | Donepezil teva | Doneratio | Dopezon | Mikzil | Yasnal | Zauton;
(FR) France: Aricept | Donepezil actavis | Donepezil Alter | Donepezil Arrow | Donepezil biogaran | Donepezil bluefish | Donepezil cristers | Donepezil Eg | Donepezil Evolugen | Donepezil intas | Donepezil krka | Donepezil mylan | Donepezil Pfizer | Donepezil ranbaxy | Donepezil Sandoz | Donepezil teva | Donepezil zentiva | Donepezil Zydus;
(GB) United Kingdom: Aricept | Aricept Evess | Donepezil;
(GR) Greece: Adtreat | Aricept | Aripezil | Caricia | Cenipil | Cerebrol | Covolos | Dementis | Dezial | Donacept | Donegal | Donelet | Donepezil actavis | Donepezil genepharma | Donepezil generics | Donepezil/Generics | Donepezil/mylan | Donept | Donester | Dospelin | Dozilax | Filosept | Hania | Miltus | Nepanizil | Nepezil | Niritos | Penezil | Pezale | Peziled | Rafazil | Sulbenin | Tactrol | Venaxen | Zakalmer | Zinocept | Zopitel;
(HK) Hong Kong: Alzedon | Alzhemept | Aricept | Aricept Evess | Donecept | Donepezil | Donepezil hcl genepharm | Vastia;
(HR) Croatia: Aricept | Donepezil Pliva;
(HU) Hungary: Alzepil | Aricept | Cognezil | Donecept | Donectil | Donefien | Donenorm | Donepezil accord | Donepezil bluefish | Donepezil mylan | Donepezil Orion | Donepezil Stada | Donepezil teva | Donestad | Donesyn | Palixid;
(ID) Indonesia: Aldomer | Aloxtra | Alzim | Aricept | Donacept | Donepezil | Dozil | Fordesia;
(IE) Ireland: Aricept | Aripez | Aripil | Arizime | Donecept | Donelinn | Donepezil | Donepezil HCL Bluefish | Donepezil hydrochloride bluefish | Donepezil krka | Donesyn | Dozept;
(IL) Israel: Aricept | Asenta | Memorit;
(IN) India: Almerzil | Alzepil | Alzidoc | Alzil | Alzymer | Aricep | Arizex | Cognidep | Demenza | Donasure | Donaz | Donecept | Donep | Donetaz | Donibiz | Dope | Dopezil | Dorent | Lapezil | Nozil | Remenda;
(IT) Italy: Aricept | Destezil | Donepezil | Donepezil accord | Donepezil actavis | Donepezil almus | Donepezil aurobindo | Donepezil bluefish | Donepezil doc | Donepezil Eg | Donepezil germed | Donepezil mylan | Donepezil pensa | Donepezil ranbaxy | Donepezil Sandoz | Donepezil tecnigen | Donepezil teva italia | Donepezil zentiva | Lizidra | Memac | Yasnal | Yasnoro;
(JO) Jordan: Alzancer | Aricept | Dementile | Demenza | Donagen | Donazet | Donex | Doxera;
(JP) Japan: Allydone | Aricept | Donepezil Hcl Amel | Donepezil hydrochloride kunihiro | Donepezil hydrochloride od kunihiro | Donepezil hydrochloride Towa;
(KE) Kenya: Alzer | Aricept | Donecept | Torpezil;
(KR) Korea, Republic of: A Pezil fd | A-Pezil | Adone | Adope | Adozil | Ahngook donepezil | Alcept | Alchphil | Aldigm | Aldigm od | Aldocept | Alicete | Alicezil | Alite | Allopezil | Alpezil | Altsupezil | Altsupezil od | Alzcare | Alzcept | Alzmer | Anepezil | Aricept | Aricept Evess | Aridone | Arigen | Aripe | Aripezil | Arison | Arist | Arite | Arizet | Arocet | Artpezil | Aukocept | Bearcept | Bearcept odt | Brencept | Ceptpezil | Citpezil | Ctpezil | Demendone | Demenpezil | Demenpezil odt | Dimancare | Dimendone | Dimenpezil | Dimensept | Dimensol | Domentac | Donacept | Done cool | Doneable | Donecept | Donecept odt | Donecet | Donecia | Donecigi | Donedid | Donef | Doneforce | Donefujil | Donegreen | Doneil | Donel | Donemax | Donemin | Doneone | Donepa | Donepect | Donepem | Donepen | Donepet | Donepez | Donepezil | Donepezil hcl daewon | Donepezil hcl odt | Donepezil Jw | Donepezil one | Donepil | Donepin | Doneptin | Doneran | Donerin | Donet | Donete | Donetin | Donezen | Donezil | Donezin | Donpezil | Dope | Doperin | Dopezil | Dopinel | Doricept | Easypezil | Enpicept | Gcp donepezil | Genupharma donepezil hcl | Hanlim Donepezil | Hanwha donepezil | Hicept | Highsilverdone | Hipezil | Hipezil od | Hydone | Icept | Inist donepezil | J cept | J done | J pezil | Jw donepezil | Keicept | Mahapezil | Miracet | Nelson donepezil | Neocept | Neopezil | Neurocare | Neurocept | Neurodone | Neuropezil | Neutoin | Neutoin odf | Newcept | Newdonpizil | Onept | Penedo | Pharmdone | Remecept | S pezil | Samoh donepezil | Samsung donepezil | Silvercept | Silvercept od | Tdcept | Teva donepezil odt | Union donepezil | Unipezil | Varopezil | Vastia | Vastia od | WI Donepezil | Withupezil | Y cept;
(KW) Kuwait: Aricept;
(LB) Lebanon: Alzepil | Aricept | Aripezil | Donazet | Donecept | Donepezil Arrow | Donepezil biogaran | Dopezil;
(LT) Lithuania: Alertan | Alzepil | Aricept | Divare | Donepezil | Donepezil accord | Donepezil Orion | Dopomnil | Yasnal;
(LU) Luxembourg: Aricept | Donepezil Eg | Donepezil hcl ratiopharm | Donepezil Sandoz;
(LV) Latvia: Alzepil | Aricept | Donepezil accord | Donepezil actavis | Donepezil bluefish | Donepezil elpen | Donepezil puren | Donesyn | Yasnal;
(MA) Morocco: Actacept | Alkapezil | Aricept | Desenil | Donepezil zenith | Donzep | Dozicept | Dozyl;
(MX) Mexico: Braix | Demalz | Donepezilo | Dozimev | Dubliet | Eranz | Jafizadane | Pegden | Pezzil | Sundonnez | Zydone;
(MY) Malaysia: Alzer | Aricept | Demealran | Donepezil/genepharm | Donezil | Tonizep | Torpezil;
(NL) Netherlands: Navazil;
(NO) Norway: Aricept | Donepezil | Donepezil accord | Donepezil aspen | Donepezil krka | Donepezil Orifarm | Donepezil Sandoz;
(NZ) New Zealand: Aricept | Donepezil | Donezil;
(PE) Peru: Alisep | Carencil | Carencil odt | Diovol | Donecil | Donnez | Dozil | Eranz | Evocaz cd | Nicorvas;
(PH) Philippines: Alnepezil | Alzancer | Aricept | Aricept Evess | Arizil | Done | Donezel | Dopezil | Servonex | Torpezil | Zypezil;
(PK) Pakistan: Azenil | Donecept | Donep | Donzil | Dopez | Dopzil | Dozido | Dozido d | Nepezil | Nepzil | Nimcept | Vastia | Vorizol | Zildon;
(PL) Poland: Alzdone | Alzepezil | Apo doperil | Aricept | Cogiton | Cognezil | Donecept | Donectil | Donemed | Donepesan | Donepex | Donepezil bluefish | Donepezil generics | Donepezil hydrochloride accord | Donepezil polfarmex | Doneprion | Donestad | Donesyn | Memocept | Memorion | Mensapex | Pamigen | Pezilgen | Ricordo | Symepezil | Yasnal;
(PR) Puerto Rico: Adlarity | Aricept | Donepezil | Donepezil HCL;
(PT) Portugal: Alizil | Alkimus | Aricept | Dizil | Dizil odis | Donepezilo Accord | Donepezilo actavis | Donepezilo alter | Donepezilo aurobindo | Donepezilo azevedos | Donepezilo bluefish | Donepezilo bluepharma | Donepezilo ciclum | Donepezilo cinfa | Donepezilo Farmoz | Donepezilo Fixime | Donepezilo genedec | Donepezilo goldfarma | Donepezilo krka | Donepezilo medirex | Donepezilo mepha | Donepezilo Mylan | Donepezilo pharmakern | Donepezilo Ranbaxy | Donepezilo Ratiopharm | Donepezilo Sandoz | Donepezilo stada | Donepezilo teva | Donepezilo tolife | Donepezilo wynn | Donepezilo zentiva | Sofatin;
(PY) Paraguay: Butiral | Donecep | Doneclar | Donepecilo bauel top | Donepecilo libra | Donepecilo richmond | Donepezil hidrocloruro imedic | Donepezilo heisecke | Dopec | Dopecil | Evocaz cd | Vencel | Vencel odt;
(QA) Qatar: Aricept;
(RO) Romania: Alzepil | Aricept | Aricept Evess | Cogiton | Cognezil | Darizol | Davia | Donecept | Donectil | Donepezil bluefish | Donepezil stada hemofarm | Donepezil teva | Donepezil torrent | Dospelin | Tuadin | Xalinat | Yasnal | Zildon;
(RU) Russian Federation: Alzepil | Aricept | Dementis | Donepezil kanon | Yasnal;
(SA) Saudi Arabia: Dement | Dementile | Donecept | Pms donepezil;
(SE) Sweden: Aricept | Azepezil | Donepezil accord | Donepezil actavis | Donepezil aspen | Donepezil aurobindo | Donepezil bluefish | Donepezil Ebb | Donepezil jubilant | Donepezil krka | Donepezil mylan | Donepezil Orifarm | Donepezil Orion | Donepezil Sandoz | Donepezil Stada | Donepezil teva;
(SG) Singapore: Aricept;
(SI) Slovenia: Aricept | Donepezil actavis | Donepezil mylan | Donepezil Pliva | Donepezilijev klorid | Donezepil accord | Yasnal;
(SK) Slovakia: Adonep | Altzer | Aricept | Calofra | Cognezil | Donepezil +pharma | Donepezil accord | Donepezil bluefish | Donepezil mylan | Donepezil Orion | Donepezil teva | Donesyn | Landex | Medozil | Napezacta | Promemore | Yasnal | Yasnal Q;
(TH) Thailand: Alzime | Aricept | Aricept Evess | Ceptia | Donept | Dopezil | Dozemo | Tonizep | Tonizep fdt;
(TN) Tunisia: Alzhecept | Arizil | Dopezil | Norocept;
(TR) Turkey: Alzamed | Alzancer | Alzil | Aricept | Aricept Evess | Arypez | Dement | Dezira | Doenza | Dozyl | Dozyl easy | Memkar | Memoboost | Neurem | Zhedon;
(TW) Taiwan: Apo donepezil | Arcdone | Arezil | Aricept | Donepezil | Epalon | Nepes | Nomi Nox | Remecin | Rewise;
(UA) Ukraine: Almer | Alzepil | Aripezil | Donerum | Donex | Servonex;
(UG) Uganda: Alzer;
(UY) Uruguay: Darial | Donep | Endoclar | Eranz | Maoxel | Oldinot | Piridon | Renacilo | Valpex;
(VE) Venezuela, Bolivarian Republic of: Dazolin | Donaspen | Dozher | Eranz | Greit;
(VN) Viet Nam: Anepzil | Rizax;
(ZA) South Africa: Aricept | Ariknow | Arimentia | Arimer | Curlovon | Donecept | Donepezil unicorn | Jubezil | Macleods donepezil | Nepizel | Zepanalz;
(ZW) Zimbabwe: Torpezil

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Donepezil: Drug information