国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P)
Aidarex Pharmaceuticals LLC
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 is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. Teratogenic Effects 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 16 times the maximum recommended human dose [MRHD] of 10 mg/day on a mg/m2 basis) and 10 mg/kg/day (approximately 20 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
Donepezil Hydrochloride Tablets USP are supplied as tablets containing 10 mg of donepezil hydrochloride, USP. 10 mg: Yellow, round, biconvex film-coated, unscored tablets, with beveled edges and debossed "TEVA" on one side and 739 on the other side. Available in bottles of 30 and 90. Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Abbreviated New Drug Application
DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED AIDAREX PHARMACEUTICALS LLC ---------- 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 Hydrochloride Tablets USP are acetylcholinesterase inhibitors 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 or 10 mg administered once daily (2.1) SEVERE ALZHEIMER'S DISEASE - 10 mg administered once daily (2.2) A dose of 10 mg once daily can be administered once patients have been on a daily dose of 5 mg for 4 to 6 weeks (2.3). DOSAGE FORMS AND STRENGTHS Tablets: 5 mg and 10 mg (3) CONTRAINDICATIONS Patients with 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). 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 The m 阅读完整的文件