DONEPEZIL HYDROCHLORIDE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Torrent Pharmaceuticals Limited

INN (Algemene Internationale Benaming):

DONEPEZIL HYDROCHLORIDE

Samenstelling:

DONEPEZIL HYDROCHLORIDE 5 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Donepezil hydrochloride tablets, USP 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. Risk Summary There are no adequate data on the developmental risks associated with the use of donepezil 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 od pregnancy and throughout lactation resulted in increased stillbirths and decreased offspring survival at clinciallky relevant doses [see Data].  In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clincially recognized pregnancies are 2% to 4% and 15% to 20%, respectively.  The background risks of ma

Product samenvatting:

Donepezil hydrochloride tablets, USP 5 mg are white to off white, circular, biconvex, film coated tablets debossed with ‘5’ on one side and plain on other side.     Bottles of 30                                           NDC 13668-102-30      Bottles of 90                                           NDC 13668-102-90      Bottles of 500                                         NDC 13668-102-05     Bottles of 1000                                       NDC 13668-102-10     Bottles of 4000                                       NDC 13668-102-40 Donepezil hydrochloride tablets, USP 10 mg are peach colored, circular, biconvex, film coated tablets debossed with ‘10’ on one side and plain on other side.     Bottles of 30                                           NDC 13668-103-30      Bottles of 90                                           NDC 13668-103-90      Bottles of 500                                         NDC 13668-103-05     Bottles of 1000                                       NDC 13668-103-10     Bottles of 2650                                       NDC 13668-103-26 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature].

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
TORRENT PHARMACEUTICALS LIMITED
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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
RX ONLY
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Donepezil hydrochloride tablets, USP 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
Mild to Moderate Alzheimer's Disease: 5 mg to 10 mg once daily ( 2.1)
Moderate to Severe Alzheimer's Disease: 10 mg once daily ( 2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 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 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)
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)
ADVERSE REACTIONS
Most common adverse reactions in clinical studies of donepezil
hydrochloride tablets are nausea, diarrhea,
insomnia, vomiting, muscle cramps