DONEPEZIL HYDROCHLORIDE tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

NuCare Pharmaceuticals, Inc.

DCI (Dénomination commune internationale):

DONEPEZIL HYDROCHLORIDE

Composition:

DONEPEZIL HYDROCHLORIDE 5 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 hydrochloride 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 16 mg/kg/day (approximately 16 times the maximum recommended human dose [MRHD] of 10  mg/day on a mg/m 2 basis)  and 10 mg/kg/day (approximately 20 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

Descriptif du produit:

Supplied as film-coated, round tablets containing 5 mg, or 10 mg of donepezil hydrochloride, USP. The 5 mg tablets are blue, round, film-coated tablets, debossed with ‘HH205' on one side. NDC 68071-3396-3 Bottles of 30 Storage: Store at controlled room temperature, 15°C to 30°C (59°F to 86°F).

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
NUCARE PHARMACEUTICALS, INC.
----------
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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Donepezil hydrochloride 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 administered once
daily ( 2.1)
MODERATE TO SEVERE ALZHEIMER’S DISEASE: 10 mg administered once
daily ( 2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg, 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, fati