Label: DONEPEZIL HYDROCHLORIDE tablet, orally disintegrating
DONEPEZIL HYDROCHLORIDE tablet, orally disintegrating

  • NDC Code(s): 42658-119-01, 42658-119-04, 42658-119-08, 42658-119-51, view more
  • Packager: Hisun Pharmaceuticals USA, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 27, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for DONEPEZIL ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Donepezil hydrochloride orally disintegrating tablets, USP are indicated for the treatment of dementia of the Alzheimer's type. Efficacy has been demonstrated in patients with mild, moderate, and ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosing in Mild to Moderate Alzheimer's Disease - The recommended starting dosage of donepezil hydrochloride orally disintegrating tablets is 5 mg administered once per day in the evening ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Donepezil hydrochloride orally disintegrating tablets, USP 5 mg are white, round flat-faced bevel-edged tablets, debossed “HZ”on one side, and “5” on the other side. Donepezil hydrochloride orally ...
  • 4 CONTRAINDICATIONS
    Donepezil hydrochloride orally disintegrating tablet is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Anesthesia - Donepezil hydrochloride, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia. 5.2 Cardiovascular ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described below and elsewhere in the labeling: Cardiovascular Conditions [ see Warnings and Precautions (5.2) ...
  • 7 DRUG INTERACTIONS
    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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no adequate data on the developmental risks associated with the use of donepezil hydrochloride in pregnant women. In animal studies, developmental ...
  • 10 OVERDOSAGE
    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 ...
  • 11 DESCRIPTION
    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 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Current theories on the pathogenesis of the cognitive signs and symptoms of Alzheimer's disease attribute some of them to a deficiency of cholinergic ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - No evidence of carcinogenic potential was obtained in an 88-week carcinogenicity study of donepezil conducted in mice at oral doses up ...
  • 14 CLINICAL STUDIES
    14.1 Mild to Moderate Alzheimer's Disease - The effectiveness of donepezil hydrochloride as a treatment for mild to moderate Alzheimer's disease is demonstrated by the results of two randomized ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Donepezil hydrochloride orally disintegrating tablets, USP 5 mg are white, round flat-faced bevel-edged tablets, debossed “HZ” on one side, and “5” on the other side. Unit Dose Blister Package 30 ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Instruct patients and caregivers to take donepezil hydrochloride orally disintegrating tablets only once per ...
  • PATIENT PACKAGE INSERT
    PATIENT PACKAGE INSERT - Donepezil Hydrochloride Orally Disintegrating Tablets, USP - (doe-NEP-e-zil HYE-droe-KLOR-ide) Orally Disintegrating Tablets: 5 mg and 10 mg - Read this Patient Information ...
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - Donepezil Hydrochloride 5 MG TABLETS - NDC 42658-119-01 - Donepezil Hydrochloride 5 mg 30 Tablets
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - Donepezil Hydrochloride5 MG TABLETS - NDC 42658-119-04 - Donepezil Hydrochloride 5 mg 90 Tablets
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - Donepezil Hydrochloride5 MG TABLETS - NDC 42658-119-08 - Donepezil Hydrochloride 5 mg 1000 Tablets
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - Donepezil Hydrochloride5 MG TABLETS - NDC 42658-119-51 - Donepezil Hydrochloride 5 mg 3*10 Tablets
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - Donepezil Hydrochloride10 MG TABLETS - NDC 42658-120-01 - Donepezil Hydrochloride 10 mg 30 Tablets
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - Donepezil Hydrochloride10 MG TABLETS - NDC 42658-120-04 - Donepezil Hydrochloride 10 mg 90 Tablets
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - Donepezil Hydrochloride10 MG TABLETS - NDC 42658-120-08 - Donepezil Hydrochloride 10 mg 1000 Tablets
  • PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL - Donepezil Hydrochloride10 MG TABLETS - NDC 42658-120-51 - Donepezil Hydrochloride 10 mg 3*10 Tablets
  • INGREDIENTS AND APPEARANCE
    Product Information