MedPath

Donepezil

Generic Name
Donepezil
Brand Names
Adlarity, Aricept, Namzaric
Drug Type
Small Molecule
Chemical Formula
C24H29NO3
CAS Number
120014-06-4
Unique Ingredient Identifier
8SSC91326P

Overview

In 2016, the global burden of dementia was estimated to be 43.8 million, demonstrating a significant increase from a global prevalence of 20.2 million in 1990. Donepezil, also known as Aricept, is a piperidine derivative acetylcholinesterase inhibitor used in the management of the dementia of Alzheimer's Disease, and in some cases, is used to manage other types of dementia. Donepezil was first approved by the FDA in 1996, and its extended-release form was approved in combination with Memantine in 2014 to manage moderate and severe forms of Alzheimer's dementia. A donepezil transdermal delivery system, Adlarity, was approved by the FDA in March 2022 for the treatment of Alzheimer's dementia. Though it does not alter the progression of Alzheimer's disease, donepezil is effective in managing the symptoms of its associated dementia.

Background

In 2016, the global burden of dementia was estimated to be 43.8 million, demonstrating a significant increase from a global prevalence of 20.2 million in 1990. Donepezil, also known as Aricept, is a piperidine derivative acetylcholinesterase inhibitor used in the management of the dementia of Alzheimer's Disease, and in some cases, is used to manage other types of dementia. Donepezil was first approved by the FDA in 1996, and its extended-release form was approved in combination with Memantine in 2014 to manage moderate and severe forms of Alzheimer's dementia. A donepezil transdermal delivery system, Adlarity, was approved by the FDA in March 2022 for the treatment of Alzheimer's dementia. Though it does not alter the progression of Alzheimer's disease, donepezil is effective in managing the symptoms of its associated dementia.

Indication

Donepezil, administered orally or via transdermal delivery system, is indicated for the treatment of dementia of the Alzheimer's type. It is also available as an extended-release capsule in combination with memantine for the treatment of moderate-to-severe dementia of the Alzheimer's type in patients previously stabilized on 10mg of donepezil hydrochloride once daily. Off-label uses include the management of vascular dementia, Parkinson's Disease-associated dementia, and Lewy body dementia, amongst others.

Associated Conditions

  • Alzheimer's Disease (AD)
  • Dementia With Lewy Body Disease
  • Dementia due to Parkinson's disease
  • Dementia of the Alzheimer's Type
  • Vascular Dementia (VaD)
  • Moderate Alzheimer's Type Dementia
  • Severe Alzheimer's Type Dementia

FDA Approved Products

donepezil hydrochloride
Manufacturer:Solco Healthcare US, LLC
Route:ORAL
Strength:10 mg in 1 1
Approved: 2023/08/30
NDC:43547-276
Aricept
Manufacturer:Eisai Inc.
Route:ORAL
Strength:5 mg in 1 1
Approved: 2023/11/17
NDC:62856-245
Donepezil Hydrochloride
Manufacturer:Aurobindo Pharma Limited
Route:ORAL
Strength:5 mg in 1 1
Approved: 2024/01/08
NDC:65862-325
DONEPEZIL HYDROCHLORIDE
Manufacturer:Jubilant Cadista Pharmaceuticals Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2019/01/26
NDC:59746-330
DONEPEZIL HYDROCHLORIDE
Manufacturer:Jubilant Cadista Pharmaceuticals Inc.
Route:ORAL
Strength:5 mg in 1 1
Approved: 2019/01/26
NDC:59746-329

Singapore Approved Products

No Singapore products found for this drug

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