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:

Macleods Pharmaceuticals Limited

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 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/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

পণ্য সারাংশ:

Supplied as film-coated, round, biconvex tablets containing 23 mg of donepezil hydrochloride USP. The 23 mg tablets are red in color, debossed with “C 26” on one side and plain on the other side. Bottles of 30                                                       (NDC# 33342-061-07) Bottles of 90                                                       (NDC# 33342-061-10) Unit Dose Blister Package 100(10 x 10) (NDC# 33342-061-12) Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
MACLEODS PHARMACEUTICALS LIMITED
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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 23 MG FOR ORAL USE.
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
None .
INDICATIONS AND USAGE
Donepezil hydrochloride USP 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)
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 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 hydrochloride tablets 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 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)
ADVE