DONEPEZIL HYDROCHLORIDE- donepezil hydrochloride tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P)

Available from:

Major Pharmaceuticals

INN (International Name):

DONEPEZIL HYDROCHLORIDE

Composition:

DONEPEZIL HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 hydrochlorideis contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.  Pregnancy Category C There are no adequate or well-controlled studies in pregnant women. Donepezil hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral administration of donepezil to pregnant rats and rabbits during the period of organogenesis did not produce any teratogenic effects at doses up to 16 mg/kg/day and 10 mg/kg/day (approximately 7 times the MRHD on a mg/m2 basis), respectively. Oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout lactation to weaning produced an increase in stillbirths and reduced offspring survival through postpartum day 4 at the hig

Product summary:

Supplied as film-coated, round tablets containing either 5 mg or 10 mg of donepezil hydrochloride USP. The 5 mg tablets are white to off white. The tablet is debossed with 'L160' on one side and plain on other side. NDC 0904-6408-80         bottle of 1000 tablets NDC 0904-6408-61         100 (10 x 10) tablets Unit dose blisters The 10 mg tablets are yellow. The tablet is debossed with 'L161' on one side and plain on other side. NDC 0904-6409-80         bottle of 1000 tablets NDC 0904-6409-61        100 (10 x 10) tablets Unit dose blisters Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
MAJOR PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DONEPEZIL HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DONEPEZIL
HYDROCHLORIDE TABLETS.
DONEPEZIL HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Donepezil hydrochlorideis 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). (1)
DOSAGE AND ADMINISTRATION
•Mild to Moderate Alzheimer’s Disease - 5 mg or 10 mg once daily
(2.1)
•Moderate to Severe Alzheimer’s Disease - 10 mg once daily (2.2)
(2)
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
. Cholinesterase inhibitors are likely to exaggerate
succinylcholine-type muscle relaxation during anesthesia (5.1). (5)
•
•
•
•
•
•
ADVERSE REACTIONS
MOST COMMON ADVERSE REACTIONS IN CLINICAL STUDIES OF DONEPEZIL
HYDROCHLORIDE ARE NAUSEA, DIARRHEA, INSOMNIA,
VOMITING, MUSCLE CRAMPS, FATIGUE, AND ANOREXIA (6.1). TO REPORT
SUSPECTED ADVERSE REACTIONS,
CONTACT ALEMBIC PHARMACEUTICALS LIMITED AT 1-866 210 9797 OR FDA AT
1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH (6)
DRUG INTERACTIONS
•
•
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, donepezil hydrochloride may cause
fetal harm (8.1). (8)
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
Tablets: 5 mg and 10 mg (3)
Known hypersensitivity to donepezil hydrochloride or to piperidine
derivatives (4)
Cholinesterase inhibitors may have vagotonic effects on the sinoatrial
and atrioventricular nodes manifesting as
bradycardia or heart block (5.2)
Donepezil hydrochloride can cause vomiting. Patients should be
observed closely at initiation of treatment and after
dose increases (5.3).
Patients should be monitored