DONEPEZIL HYDROCHLORIDE 5 MG- donepezil hydrochloride tablet, film coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Купи Сада

Активни састојак:

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

Доступно од:

Alembic Pharmaceuticals Limited

INN (Међународно име):

DONEPEZIL HYDROCHLORIDE

Састав:

DONEPEZIL HYDROCHLORIDE 5 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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 hydrochlorideis 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 and 10 mg/kg/day (approximately 7 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 produced an increase in stillbirths and reduced offspring survival through postpartum day 4 at the highes

Резиме производа:

Supplied as film-coated, round tablets containing either 5 mg, or 10 mg of donepezil hydrochloride USP. The 5 mg tablets are white to off white. The tablet is debossedwith ‘L160’ on one side and plain on other side. NDC 46708-092-30                bottle of 30 tablets NDC 46708-092-91                bottle of 1000 tablets NDC 46708-092-10                100 (10 x 10) tablets Unit dose blisters The 10 mg tablets are yellow. The tablet is debossedwith ‘L161’ on one side and plain on other side. NDC 46708-093-30                bottle of 30 tablets NDC 46708-093-91                bottle of 1000 tablets NDC 46708-093-10                100 (10 x 10) tablets Unit dose blisters Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

                                DONEPEZIL HYDROCHLORIDE 5 MG- DONEPEZIL HYDROCHLORIDE TABLET, FILM
COATED
ALEMBIC PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DONEPEZIL HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DONEPEZIL
HYDROCHLORIDE TABLETS.
DONEPEZIL HYDROCHLORIDE TABLETS USP, FILM COATED FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Donepezil hydrochlorideis 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). (1)
DOSAGE AND ADMINISTRATION
MILD TO MODERATE ALZHEIMER’S DISEASE - 5 mg or 10 mg administered
once daily (2.1)
MODERATE TO 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). (5)
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 (GI), 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)
                                
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