DONEPEZIL HYDROCHLORIDE tablet, extended release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

AvKARE

INN (שם בינלאומי):

DONEPEZIL HYDROCHLORIDE

הרכב:

DONEPEZIL HYDROCHLORIDE 23 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 tablets 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 6 times the maximum recommended human dose [MRHD] of 23 mg/day on a mg/m 2 basis) and 10 mg/kg/day (approximately 7 times the MRHD on a mg/m 2 basis), respectively. Oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late g

leaflet_short:

Supplied as film-coated tablets containing 23 mg of donepezil hydrochloride. The 23 mg film-coated tablets are white, printed with “T004” in black ink on one side and plain on the other side. Bottles of 90   NDC  42291-246-90 Storage: Store at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET, EXTENDED
RELEASE
AVKARE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
DONEPEZIL HYDROCHLORIDE TABLETS
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DONEPEZIL HYDROCHLORIDE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DONEPEZIL
HYDROCHLORIDE.
DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE) TABLET, EXTENDED
RELEASE FOR ORAL
USE.
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Addition of new dosage strength: Donepezil hydrochloride tablets 23 mg
INDICATIONS AND USAGE
Donepezil hydrochloride tablets are 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).
MODERATE TO SEVERE ALZHEIMER’S DISEASE - 10 mg or 23 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. A dose of 23 mg once daily can be administered once
patients have been on a dose of 10
mg once daily for at least 3 months ( 2.3).
DOSAGE FORMS AND STRENGTHS
Tablets: 23 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 tablets 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).
The use of donepezil hyd