ARICEPT donepezil hydrochloride tablet film coated

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Bryant Ranch Prepack

INN (আন্তর্জাতিক নাম):

DONEPEZIL HYDROCHLORIDE

রচনা:

DONEPEZIL HYDROCHLORIDE 10 mg

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

ARICEPT- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ARICEPT SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ARICEPT TABLETS AND ARICEPT ORALLY
DISINTEGRATING TABLETS (ODT).
ARICEPT (DONEPEZIL HYDROCHLORIDE) TABLETS
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Addition of new dosage strength: ARICEPT 23 mg
INDICATIONS AND USAGE
ARICEPT 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)
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: 5 mg, 10 mg and 23 mg (3)
Orally Disintegrating Tablets (ODT): 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).
ARICEPT 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 ARICEPT in a dose of 23 mg once daily is associated with
weight loss (5.5).
Cholinomimetics may