DONEPEZIL HYDROCHLORIDE tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Rebel Distributors Corp

DCI (Denominação Comum Internacional):

DONEPEZIL HYDROCHLORIDE

Composição:

DONEPEZIL HYDROCHLORIDE 10 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Donepezil hydrochloride tablets are 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 tablets are 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/m 2 basis), respectively. Oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout lactation to

Resumo do produto:

Donepezil hydrochloride is supplied as film-coated tablets containing 5 mg or 10 mg of donepezil hydrochloride. The 10 mg tablets are yellow, round, biconvex, film coated tablets, debossed with ‘W’ on one side and ‘312’ on another side. Bottles of 90                                                      NDC#    42254-305-90 Storage: Store at 20°-25 °C (68°-77°F) [see USP Controlled Room Temperature].

Status de autorização:

Abbreviated New Drug Application

Características técnicas

DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
REBEL DISTRIBUTORS CORP
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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
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 (1.0).
DOSAGE AND ADMINISTRATION
MILD TO MODERATE ALZHEIMER'S DISEASE - 5 mg or 10 mg administered once
daily (2.1)
SEVERE ALZHEIMER'S DISEASE - 10 mg administered once daily (2.2)
A dose of 10 mg once daily can be administered once patients have been
on a daily dose of 5 mg for 4 to 6 weeks. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 mg (3)
CONTRAINDICATIONS
Patients with 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
The most common adverse reactions in clinic