GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Donepezil tablets (mild to moderate Alzheimer disease)

Local official-label summaryBase record retrieved 2026-09-05See the evidence for this drug2 sources available - open source summaries, references and comparisons

Aricept

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Official source

Donepezil tablets (mild to moderate Alzheimer disease) - selected U.S. labeling

Product / population
Adults with mild to moderate Alzheimer disease; oral 5 mg and 10 mg tablets. This summary excludes the 23 mg regimen and transdermal formulations.
Renal measure
Indexed clearance in the label pharmacokinetic study; not an automatic renal dose-selection equation.
Labeled basic dosing

Start 5 mg orally each evening. A 10 mg daily dose may be used only after 4-6 weeks at 5 mg; 10 mg/day is the labeled maximum for this disease-severity scope.

Renal information and dialysis

A study of 11 subjects with renal clearance below 18 mL/min/1.73 m2 found no difference in donepezil clearance versus matched controls. No separate numeric renal or dialysis regimen is given in the selected label.

Selected warnings and limits

Monitor for bradycardia/heart block, syncope, gastrointestinal adverse effects and weight loss. Do not transfer this titration to another dosage form or disease-severity regimen.

Source revision: Label revision date not separately recorded; retrieval date is not the revision date. | Retrieved: 2026-09-05. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975

Scope: Selected dosing/renal sections read; concise local summary, not full prescribing information. GlobalRPh v6.6.

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Evidence sources and renal implications

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Official product label

Donepezil tablets (mild to moderate Alzheimer disease) - selected U.S. labeling

Adults with mild to moderate Alzheimer disease; oral 5 mg and 10 mg tablets. This summary excludes the 23 mg regimen and transdermal formulations.

Renal method: Indexed clearance in the label pharmacokinetic study; not an automatic renal dose-selection equation.
Retrieved: 2026-09-05

Read local renal resultOpen original reference
Handbook

Renal Drug Handbook, fifth edition - Donepezil tablets (mild to moderate Alzheimer disease)

Historical renal/RRT cross-check for the named ingredient; not a current U.S. prescribing instruction.

Renal method: Book table headings say GFR (mL/min); the preface states adjustment information is based on Cockcroft-Gault CrCl, not indexed eGFR. Do not substitute methods.
Retrieved: 2026-09-05

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Renal dosing and precautions

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Official source

Donepezil tablets (mild to moderate Alzheimer disease) - selected U.S. labeling

Adults with mild to moderate Alzheimer disease; oral 5 mg and 10 mg tablets. This summary excludes the 23 mg regimen and transdermal formulations.

Method: Indexed clearance in the label pharmacokinetic study; not an automatic renal dose-selection equation.

Renal information and dialysisRead this complete source summary
Handbook source

Renal Drug Handbook, fifth edition - Donepezil tablets (mild to moderate Alzheimer disease)

Historical renal/RRT cross-check for the named ingredient; not a current U.S. prescribing instruction.

Method: Book table headings say GFR (mL/min); the preface states adjustment information is based on Cockcroft-Gault CrCl, not indexed eGFR. Do not substitute methods.

Historical renal and dialysis observationsRead this complete source summary

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Original content / product scopeDonepezil tablets (mild to moderate Alzheimer disease) - selected U.S. labelingRenal Drug Handbook, fifth edition - Donepezil tablets (mild to moderate Alzheimer disease)
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Exact product and population matter. This added page contains locally stored, source-specific clinical summaries. Historical handbook information, when present, is identified separately and may conflict with U.S. labeling. Confirm indication, population, kidney-function method, monitoring and the full prescribing information before applying a regimen.
Locally stored source content

Exact product and population

Product identity selected for the separately displayed source protocols below. Reference: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975

Product and population scope

Adults with mild to moderate Alzheimer disease; oral 5 mg and 10 mg tablets. This summary excludes the 23 mg regimen and transdermal formulations.

RDM31-donepezil-tablets-scope · Source section: Editorial scope tied to selected U.S. labelRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

Donepezil tablets (mild to moderate Alzheimer disease) - selected U.S. labeling

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U.S. product labeling / DailyMed · Adults with mild to moderate Alzheimer disease; oral 5 mg and 10 mg tablets. This summary excludes the 23 mg regimen and transdermal formulations.

Renal method: Indexed clearance in the label pharmacokinetic study; not an automatic renal dose-selection equation.
Source date: Label revision date not separately recorded; retrieval date is not the revision date.
Retrieved: 2026-09-05

Selected dosing/renal sections read; concise local summary, not full prescribing information.

Labeled basic dosing

Start 5 mg orally each evening. A 10 mg daily dose may be used only after 4-6 weeks at 5 mg; 10 mg/day is the labeled maximum for this disease-severity scope.

RDM31-donepezil-tablets-label-dose · Source locator: 2.1

Renal information and dialysis

A study of 11 subjects with renal clearance below 18 mL/min/1.73 m2 found no difference in donepezil clearance versus matched controls. No separate numeric renal or dialysis regimen is given in the selected label.

RDM31-donepezil-tablets-label-renal · Source locator: 12.3 Renal Disease

Selected warnings and limits

Monitor for bradycardia/heart block, syncope, gastrointestinal adverse effects and weight loss. Do not transfer this titration to another dosage form or disease-severity regimen.

RDM31-donepezil-tablets-label-limits · Source locator: 5.2, 5.3, 5.5

Source identity and provenance
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975
Retrieved
2026-09-05
DailyMed Set ID
98e451e1-e4d7-4439-a675-c5457ba20975
Renal-function method
Indexed clearance in the label pharmacokinetic study; not an automatic renal dose-selection equation.
Source date/version
Label revision date not separately recorded; retrieval date is not the revision date.
Hash meaning
SHA-256 identifies this local summary, not original SPL XML or label PDF.
Local summary SHA-256
5c3421a838893909288af1120a4ad6e41faa59a2c3facdb35b286c663a97aa26
Separate handbook layer

Renal Drug Handbook cross-check

Handbook

Renal Drug Handbook, fifth edition - Donepezil tablets (mild to moderate Alzheimer disease)

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UK Renal Pharmacy Group / CRC Press · Historical renal/RRT cross-check for the named ingredient; not a current U.S. prescribing instruction.

Renal method: Book table headings say GFR (mL/min); the preface states adjustment information is based on Cockcroft-Gault CrCl, not indexed eGFR. Do not substitute methods.
Source date: Fifth edition, 2019
Retrieved: 2026-09-05

Historical source, separately displayed. Renal tables were read with page-image inspection.

Historical renal and dialysis observations

The historical 20-50, 10-20 and below-10 mL/min bands all retain usual dosing. Peritoneal, conventional HD and continuous removal are described as unlikely; high-flux/HDF removal is unknown. No reduction is proposed for those modalities.

RDM31-donepezil-tablets-book · Source locator: Dose in renal impairment; renal replacement therapies; Other information

Source-specific limits

The dialysis statements are the book's historical assessment; the label study is not a dialysis efficacy study.

Source identity and provenance
Retrieved
2026-09-05
Handbook page
Printed page(s) 335; PDF page(s) 354
Renal-function method
Book table headings say GFR (mL/min); the preface states adjustment information is based on Cockcroft-Gault CrCl, not indexed eGFR. Do not substitute methods.
Source date/version
Fifth edition, 2019
U.S. product identity basis
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975
Hash meaning
SHA-256 identifies the local paraphrase; the source PDF is not redistributed.
Local summary SHA-256
630336aab5d16e5570c808a6008e79ff44ec6e13fbf9242931378c6e40e0bc8d

Provenance and preservation

Additional summaries stored on this page: 1 official-label, 0 RX List, 0 professional, 1 handbook. Empty additional-source groups are not shown. A missing layer is not a no-adjustment recommendation.

Original source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=98e451e1-e4d7-4439-a675-c5457ba20975
Source retrieval
2026-09-05. This is not the source publication or label revision date.
Original source type
multisource addition
Local text SHA-256
2e6975039a369625bbaa8ea8d9bc515bf0756b7107db5a94d369c153b58ec23f
Import versus clinical validation
Source-section locators identify where retained content came from. A source-section identifier does not assert that every numeric statement has been independently corroborated. The local text hash is not a hash of original HTML, an FDA PDF or SPL XML.

This page is an additional exact-product entry, not a recovered GlobalRPh monograph. Its primary scope text and separately attributed clinical summaries are locally included.

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