DONEPEZIL HYDROCHLORIDE tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

Donepezil Hydrochloride (UNII: 3O2T2PJ89D) (Donepezil - UNII:8SSC91326P)

Verfügbar ab:

Jubilant Cadista Pharmaceuticals Inc.

INN (Internationale Bezeichnung):

Donepezil Hydrochloride

Zusammensetzung:

Donepezil Hydrochloride 5 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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. 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

Produktbesonderheiten:

Supplied as white to off-white, round, film-coated tablets containing either 5 mg or 10 mg of donepezil hydrochloride, USP. The 5 mg tablets are white to off-white, round, film-coated tablets, debossed with ‘J’ on one side and ‘5’ on the other side.   Bottles of 30 (child-resistant)                          NDC 59746-329-30                         Bottles of 90 (child-resistant)                          NDC 59746-329-90 Bottles of 100 (child-resistant)                        NDC 59746-329-01         Bottles of 500                                                 NDC 59746-329-05 Bottles of 1000                                               NDC 59746-329-10 10 x 10 Unit-dose Tablets                              NDC 59746-329-03   The 10 mg tablets are white to off-white, round, film-coated tablets, debossed with ‘J’ on one side and ‘10’ on the other side.                 Bottles of 30 (child-resistant)                          NDC 59746-330-30                           Bottles of 90 (child-resistant)                          NDC 59746-330-90               Bottles of 100 (child-resistant)                        NDC 59746-330-01                                   Bottles of 500                                                 NDC 59746-330-05                           Bottles of 1000                                               NDC 59746-330-10                         10 x 10 Unit-dose Tablets                              NDC 59746-330-03 Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
JUBILANT CADISTA PHARMACEUTICALS INC.
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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 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 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 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)
ADVERSE REACTIONS
Most common adverse reactions in clinical studie