DONEPEZIL HYDROCHLORIDE tablet, film coated DONEPEZIL HYDROCHLORIDE tablet, orally disintegrating

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Macleods Pharmaceuticals Limited

INN (Tarptautinis Pavadinimas):

DONEPEZIL HYDROCHLORIDE

Sudėtis:

DONEPEZIL HYDROCHLORIDE 5 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 hydrochloride is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. Risk Summary There are no adequate data on the developmental risks associated with the use of donepezil hydrochloride in pregnant women. In animal studies, developmental toxicity was not observed when donepezil was administered to pregnant rats and rabbits during organogenesis, but administration to rats during the latter part of pregnancy and throughout lactation resulted in increased stillbirths and decreased offspring survival at clinically relevant doses [see Data ]. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. The background risks of major birth de

Produkto santrauka:

Supplied as film-coated, round tablets containing either 5 mg, 10 mg or 23 mg donepezil hydrochloride USP. Donepezil Hydrochloride 5 mg and 10 mg Tablets, USP The 5 mg tablets are white to off white, round, biconvex, film-coated tablets debossed with 'ML 89' on one side and plain on the other side. The 10 mg tablets are yellow, round, biconvex, film-coated tablets debossed with 'ML 88' on one side and plain on the other side. Donepezil Hydrochloride 23 mg Tablets The 23 mg tablets are red, round, biconvex, film-coated tablets debossed with "C 26" on one side and plain on the other side. Supplied as round tablets containing either 5 mg or 10 mg of donepezil hydrochloride USP. The 5 mg orally disintegrating tablets are yellow coloured, circular, flat face beveled edge uncoated tablets debossed with "CL 31" on one side and plain on the other side. The 10 mg orally disintegrating tablets are yellow, circular, flat face beveled edge uncoated tablets debossed with "CL 32" on one side and plain on the other side. 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].

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE TABLET, ORALLY
DISINTEGRATING
MACLEODS PHARMACEUTICALS LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DONEPEZIL
HYDROCHLORIDE TABLETS AND DONEPEZIL HYDROCHLORIDE ORALLY
DISINTEGRATING
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DONEPEZIL
HYDROCHLORIDE TABLETS AND DONEPEZIL HYDROCHLORIDE ORALLY
DISINTEGRATING
TABLETS.
DONEPEZIL HYDROCHLORIDE TABLETS,FOR ORAL USE
DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS
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)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg,10 mg, and 23 mg (3)
Orally Disintegrating Tablets (ODT) : 5 mg and 10 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 tablets in a dose of 23 mg once
daily is associated with weight loss
(5.5)
Cholinomimetics may cause bladder outflow