Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P)
American Health Packaging
DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Donepezil hydrochloride tablet, USP 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 tablet is 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 10 mg/kg/day (approximately 7 times the MRHD on a mg/m 2 basis). Oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout lactation to weaning produced an increase in stillbirths and reduced offspring survival through postpartum day 4 at the highest dose. T
Donepezil hydrochloride tablets, 5 mg are white round biconvex, film coated tablets debossed with "I" on one side and "24" on the other side. They are supplied as follows Unit dose packages of 100 (10 x 10) NDC 60687-292-01 Donepezil hydrochloride tablets, 10 mg are yellow round biconvex, film coated tablets debossed with "I" on one side and "21" on the other side. They are supplied as follows Unit dose packages of 100 (10 x 10) NDC 60687-303-01 Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Abbreviated New Drug Application
DONEPEZIL- DONEPEZIL HYDROCHLORIDE TABLET AMERICAN HEALTH PACKAGING ---------- 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 USP, FOR ORAL USE INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Donepezil hydrochloride tablet, USP 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 or 10 mg once daily ( 2.1) 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 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 are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia ( 6.1). TO REPORT SUSPECTED AD Lesen Sie das vollständige Dokument