DONEPEZIL- donepezil hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

American Health Packaging

INN (International Name):

DONEPEZIL HYDROCHLORIDE

Composition:

DONEPEZIL HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Donepezil hydrochloride tablet, USP 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 tablet is 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 10 mg/kg/day (approximately 7 times the MRHD on a mg/m 2 basis). 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 highest dose. T

Product summary:

Donepezil hydrochloride tablets, 5 mg are white round biconvex, film coated tablets debossed with "I" on one side and "24" on the other side. They are supplied as follows Unit dose packages of 100 (10 x 10) NDC 60687-292-01 Donepezil hydrochloride tablets, 10 mg are yellow round biconvex, film coated tablets debossed with "I" on one side and "21" on the other side. They are supplied as follows Unit dose packages of 100 (10 x 10) NDC 60687-303-01 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DONEPEZIL- DONEPEZIL HYDROCHLORIDE TABLET
AMERICAN HEALTH PACKAGING
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DONEPEZIL HYDROCHLORIDE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DONEPEZIL HYDROCHLORIDE
TABLETS.
DONEPEZIL HYDROCHLORIDE TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Donepezil hydrochloride tablet, USP 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 AND ADMINISTRATION
Mild to Moderate Alzheimer's Disease: 5 mg or 10 mg once daily ( 2.1)
Severe Alzheimer's Disease: 10 mg once daily ( 2.2)
DOSAGE FORMS AND STRENGTHS
•Tablets: 5 mg and 10 mg ( 3)
CONTRAINDICATIONS
Known hypersensitivity to donepezil hydrochloride or to piperidine
derivatives ( 4)
WARNINGS AND PRECAUTIONS
Cholinesterase inhibitors are likely to exaggerate
succinylcholine-type muscle relaxation during
anesthesia ( 5.1).
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 closely for symptoms of active or occult
gastrointestinal (GI) bleeding,
especially those at increased risk for developing ulcers ( 5.4).
Cholinomimetics may cause bladder outflow obstructions ( 5.6).
Cholinomimetics are believed to have some potential to cause
generalized convulsions ( 5.7).
Cholinesterase inhibitors should be prescribed with care to patients
with a history of asthma or
obstructive pulmonary disease ( 5.8).
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 AD