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:

Solco Healthcare US, LLC

INN (আন্তর্জাতিক নাম):

DONEPEZIL HYDROCHLORIDE

রচনা:

DONEPEZIL HYDROCHLORIDE 23 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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. 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/m2 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 prod

পণ্য সারাংশ:

Supplied as film-coated, round tablets containing 23 mg of donepezil hydrochloride. The 23 mg tablets are reddish in color. The strength, in mg (23), is debossed on one side. Bottles of 30 (NDC# 43547-382-03) Bottles of 90 (NDC# 43547-382-09) Bottles of 100 (NDC# 43547-382-10) Bottles of 500 (NDC# 43547-382-50) Storage Store at 20º-25ºC (68º-77ºF), excursions permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
SOLCO HEALTHCARE US, LLC
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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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Donepezil hydrochloride tablets are 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
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 23 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to donepezil hydrochloride or to piperidine
derivatives (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions in clinical studies of donepezil
hydrochloride are nausea, diarrhea, insomnia, vomiting,
muscle cramps,
fatigue, and anorexia (6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SOLCO HEALTHCARE US,
LLC AT 1-866-257-2597
OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
•
•
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, donepezil hydrochloride may cause
fetal
harm (8.1).
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2019
FULL PRESCRIBING INFORMATION: CONTENTS*
Mild to Moderate Alzheimer's Disease: 5 mg to 10 mg administered once
daily (2.1)
Moderate to Severe Alzheimer's Disease: 10 mg to 23 mg administered
once daily (2.2)
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