MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
Memantine hydrochloride and donepezil hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the Alzheimer's type. This combination therapy is specifically for patients who have already been stabilized on a 10 mg daily dose of donepezil hydrochloride. The medication combines two different classes of drugs, an NMDA receptor antagonist and an acetylcholinesterase inhibitor, to address the cognitive symptoms of the disease.
How MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE Works
This combination product utilizes two distinct mechanisms to address the symptoms of Alzheimer's disease. Memantine acts as an uncompetitive NMDA receptor antagonist that binds to receptor-operated cation channels to manage the persistent activation of these receptors by glutamate. Donepezil enhances cholinergic function by reversibly inhibiting acetylcholinesterase, the enzyme responsible for the hydrolysis of acetylcholine. This inhibition increases the concentration of acetylcholine in the central nervous system to improve neurotransmission.
Details
- Status
- Prescription
- First Approved
- 2017-01-27
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
Companies
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE Approval History
What MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE Treats
1 indicationsMEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE is approved for 1 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Alzheimer's Disease
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Active Pipeline
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE FDA Label Details
ProIndications & Usage
FDA Label (PDF)Memantine and donepezil hydrochlorides extended-release capsules is indicated for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on 10 mg of donepezil hydrochloride once daily. Memantine and donepezil hydrochlorides extended-release capsules is a combination of memantine hydrochloride, an NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor, indicated for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on 10 mg of donepezil hydrochloride once daily.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.