ARICEPT- donepezil hydrochloride tablet, film coated ARICEPT ODT- donepezil hydrochloride tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Eisai Inc.

INN (International Name):

DONEPEZIL HYDROCHLORIDE

Composition:

DONEPEZIL HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. Risk Summary There are no adequate data on the developmental risks associated with the use of ARICEPT  in pregnant women. In animal studies, developmental toxicity was not observed when donepezil was administered to pregnant rats and rabbits during organogenesis, but administration to rats during the latter part of pregnancy and throughout lactation resulted in increased stillbirths and decreased offspring survival at clinically relevant doses [see Data ]. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. The background risks of major birth defects and miscarriage for the indicated popula

Product summary:

Supplied as film-coated, round tablets containing 5 mg, 10 mg, or 23 mg of donepezil hydrochloride. The 5 mg tablets are white. The strength, in mg (5), is debossed on one side and ARICEPT is debossed on the other side. The 10 mg tablets are yellow. The strength, in mg (10), is debossed on one side and ARICEPT is debossed on the other side. The 23 mg tablets are reddish in color. The strength, in mg (23), is debossed on one side and ARICEPT is debossed on the other side. Supplied as round tablets containing either 5 mg or 10 mg of donepezil hydrochloride. The 5 mg orally disintegrating tablets are white. The strength, in mg (5), is debossed on one side and ARICEPT is debossed on the other side. The 10 mg orally disintegrating tablets are yellow. The strength, in mg (10), is debossed on one side and ARICEPT is debossed on the other side. Storage Store at controlled room temperature, 15ºC to 30ºC (59ºF to 86ºF).

Authorization status:

New Drug Application

Summary of Product characteristics

ARICEPT- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
ARICEPT ODT- DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING
EISAI INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARICEPT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ARICEPT.
ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLETS, FOR ORAL USE
ARICEPT ODT (DONEPEZIL HYDROCHLORIDE) ORALLY DISINTEGRATING TABLETS
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
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 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)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 10 mg, and 23 mg (3)
Orally Disintegrating Tablets (ODT): 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)
ARICEPT 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)
The use of ARICEPT in a dose of 23 mg once daily is associated with
weight loss (5.5)
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)
ADV