DONEPEZIL HYDROCHLORIDE tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Contract Pharmacy Services-PA

INN（国际名称）:

DONEPEZIL HYDROCHLORIDE

组成:

DONEPEZIL HYDROCHLORIDE 5 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 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 weaning

產品總結:

Supplied as film-coated, round tablets containing either 5 mg or 10 mg of donepezil HCl. The 5 mg tablets are white. The strength, in mg (5), is debossed on one side and a stylized G is debossed on the other side. Blisters of 30     (NDC# 67046-128-30) The 10 mg tablets are yellow. The strength, in mg (10), is debossed on one side and a stylized G is debossed on the other side. Blisters of 30     (NDC# 67046-129-30) Storage : Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature].

授权状态:

New Drug Application

产品特点

DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
CONTRACT PHARMACY SERVICES-PA
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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
RECENT MAJOR CHANGES
None
INDICATIONS AND USAGE
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 (1). (1)
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) (2)
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 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 rea