DONEPEZIL HYDROCHLORIDE tablet

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Par Pharmaceutical, Inc.

INN (আন্তর্জাতিক নাম):

DONEPEZIL HYDROCHLORIDE

রচনা:

DONEPEZIL HYDROCHLORIDE 23 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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 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 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/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 sti

পণ্য সারাংশ:

Supplied as round shaped, biconvex tablets containing 23 mg of donepezil hydrochloride The 23 mg tablets are white to off-white round shaped, biconvex tablet debossed “232” on one side and “p” on the other side. NDC 49884-232-11 Bottles of 30 tablets NDC 49884-232-09 Bottles of 90 tablets NDC 49884-232-05 Bottles of 500 tablets Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET
PAR PHARMACEUTICAL, INC.
----------
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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Donepezil hydrochloride 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)
DOSAGE AND ADMINISTRATION
•Mild to Moderate Alzheimer’s Disease - 5 mg to 10 mg once daily
(2.1)
•Moderate to Severe Alzheimer’s Disease – 10 mg to 23 mg 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
•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 (GI) bleeding, especially those
at increased risk for developing ulcers (5.4).
•The use of donepezil hydrochloride in a dose of 23 mg once daily is
associated with weight loss (5.5).
•Cholinomimetics may cause bladder outflow obstructions (5.6).
•Cholinomimetics are believed to have some potential to