País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P)
KAISER FOUNDATION HOSPITALS
Donepezil Hydrochloride
Donepezil Hydrochloride 10 mg
ORAL
PRESCRIPTION DRUG
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. 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/m 2 basis) and 10 mg/kg/day (approximately 7 times the MRHD on a mg/m 2 basis), respectively. Oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout lac
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. 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 2160 NDC 0179-0208-88 Storage: Store at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature].
Abbreviated New Drug Application
DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED KAISER FOUNDATION HOSPITALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DONEPEZIL HYDROCHLORIDE TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DONEPEZIL HYDROCHLORIDE TABLETS, USP. DONEPEZIL HYDROCHLORIDE TABLETS, USP FOR ORAL USE INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Donepezil is a acetycholinesterase 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) (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 Llegiu el document complet