DONEPEZIL HYDROCHLORIDE tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Physicians Total Care, Inc.

INN (nume internaţional):

DONEPEZIL HYDROCHLORIDE

Compoziție:

DONEPEZIL HYDROCHLORIDE 10 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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. Enter section text here 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 gestatio

Rezumat produs:

Storage : Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature].

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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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).
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 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