Generic Name

Memantine

Brand Names
Donepezil, Namzaric, Aricept
FDA approval date: November 25, 1996
Classification: Cholinesterase Inhibitor
Form: Tablet, Kit, Capsule, Solution

What is Donepezil (Memantine)?

Donepezil hydrochloride 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 hydrochloride is an acetylcholinesterase inhibitor 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 .
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Brand Information

    DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE)
    1OVERDOSAGE
    Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose of any drug.
    As in any case of overdose, general supportive measures should be utilized. Overdosage with cholinesterase inhibitors can result in cholinergic crisis characterized by severe nausea, vomiting, salivation, sweating, bradycardia, hypotension, respiratory depression, collapse, and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved. Tertiary anticholinergics such as atropine may be used as an antidote for donepezil hydrochloride overdosage. Intravenous atropine sulfate titrated to effect is recommended: an initial dose of 1.0 to 2.0 mg IV with subsequent doses based upon clinical response. Atypical responses in blood pressure and heart rate have been reported with other cholinomimetics when co-administered with quaternary anticholinergics such as glycopyrrolate. It is not known whether donepezil hydrochloride and/or its metabolites can be removed by dialysis (hemodialysis, peritoneal dialysis, or hemofiltration).
    Dose-related signs of toxicity in animals included reduced spontaneous movement, prone position, staggering gait, lacrimation, clonic convulsions, depressed respiration, salivation, miosis, tremors, fasciculation, and lower body surface temperature.
    2DESCRIPTION
    Donepezil hydrochloride is a reversible inhibitor of the enzyme acetylcholinesterase, known chemically as (±)-2, 3-dihydro-5, 6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1
    Donepezil Hydrochloride
    Donepezil Hydrochloride Tablets USP are available for oral administration in film-coated tablets containing 23 mg of donepezil hydrochloride.
    Inactive ingredients in 23 mg tablets include colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, sodium starch glycolate. The film coating includes hypromellose, iron oxide red, polyethylene glycol, talc and titanium dioxide.
    Meets USP Dissolution Test 3.
    3PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information).
    Instruct patients and caregivers to take donepezil hydrochloride only once per day, as prescribed.
    Instruct patients and caregivers that donepezil hydrochloride can be taken with or without food. Donepezil hydrochloride 23 mg tablets should be swallowed whole without the tablets being split, crushed or chewed.
    Advise patients and caregivers that donepezil hydrochloride may cause nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and decreased appetite.
    Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant.
    LUPIN and the
    Manufactured for:
    Lupin Pharmaceuticals, Inc.
    Naples, FL 34108
    United States.
    Manufactured by:
    Lupin Limited
    Goa 403 722
    INDIA.
    Revised: November 2024                                                                                                                   ID#: 279137
    4PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    DONEPEZIL HYDROCHLORIDE TABLETS
    Rx Only
    23 mg
    NDC 68180-527-06
    30 TABLETS
    DONEPEZIL HYDROCHLORIDE TABLETS
Rx Only
23 mg
NDC 68180-527-06
30 TABLETS
    Donepezil has been selected.