Drugplain

Aricept 5 mg/1

donepezil hydrochloride · TABLET, FILM COATED · Eisai Inc.

No Recall HistoryCurrently in Shortage
Plain English

Aricept is a tablet, film coated containing donepezil hydrochloride at 5 mg/1, taken oral. Manufactured by Eisai Inc..

Key Facts

Brand Name
Aricept
Generic Name
donepezil hydrochloride
NDC Code (Product)
62856-245
Manufacturer
Eisai Inc.
Strength
5 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
NDA020690
Marketing Start
11/25/1996

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fall1,571 reports
confusional state1,108 reports
dizziness986 reports
nausea931 reports
death926 reports
diarrhoea924 reports
fatigue897 reports
asthenia822 reports
drug ineffective768 reports
hallucination754 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ARICEPT 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. ARICEPT 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 ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Mild to Moderate Alzheimer’s Disease: 5 mg to 10 mg once daily ( 2.1 ) Moderate to Severe Alzheimer’s Disease: 10 mg to 23 mg once daily ( 2.2 ) 2.1 Dosing in Mild to Moderate Alzheimer’s Disease The recommended starting dosage of ARICEPT is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of ARICEPT in patients with mild to moderate Alzheimer’s disease is 10 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks. 2.2 Dosing in Moderate to Severe Alzheimer’s Disease The recommended starting dosage of ARICEPT is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of ARICEPT in patients with moderate to severe Alzheimer’s disease is 23 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks. A dose of 23 mg per day should not be administered until patients have been on a daily dose of 10 mg for at least 3 months. 2.3 Administration Information ARICEPT should be taken in the evening, just prior to retiring. ARICEPT can be taken…

Contraindications

4 CONTRAINDICATIONS ARICEPT is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications ( 7.1 ) A synergistic effect may be expected with concomitant administration of succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists ( 7.2 ) 7.1 Use with Anticholinergics Because of their mechanism of action, cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications. 7.2 Use with Cholinomimetics and Other Cholinesterase Inhibitors A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol.

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Cardiovascular Conditions [see Warnings and Precautions ( 5.2 )] Nausea and Vomiting [see Warnings and Precautions ( 5.3 )] Peptic Ulcer Disease and GI Bleeding [see Warnings and Precautions ( 5.4 )] Weight Loss [see Warnings and Precautions ( 5.5 )] Genitourinary Conditions [see Warnings and Precautions ( 5.6 )] Neurological Conditions: Seizures [see Warnings and Precautions ( 5.7 )] Pulmonary Conditions [see Warnings and Precautions ( 5.8 )] Most common adverse reactions in clinical studies of ARICEPT are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eisai Inc. at 1-888-274-2378 (fax 1-201-746-3207) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. ARICEPT has been administered to over 1,700 individ…

Frequently Asked Questions

What is Aricept used for?

Aricept contains donepezil hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Aricept a controlled substance?

Aricept is not classified as a controlled substance by the DEA.

What is the generic name for Aricept?

The generic name for Aricept is donepezil hydrochloride. There are 11 other brand versions of donepezil hydrochloride.

What is the NDC code for Aricept 5 mg/1?

The NDC (National Drug Code) for Aricept 5 mg/1 is 62856-245, listed by Eisai Inc..

Product NDC

62856-245

Package NDC

62856-245-30

Other Aricept Dosages

Other Donepezil Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)