Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P)
Alembic Pharmaceuticals Limited
DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Donepezil hydrochloride 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 hydrochlorideis 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 and 10 mg/kg/day (approximately 7 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 lactation to weaning produced an increase in stillbirths and reduced offspring survival through postpartum day 4 at the highes
Supplied as film-coated, round tablets containing either 5 mg, or 10 mg of donepezil hydrochloride USP. The 5 mg tablets are white to off white. The tablet is debossedwith ‘L160’ on one side and plain on other side. NDC 46708-092-30 bottle of 30 tablets NDC 46708-092-91 bottle of 1000 tablets NDC 46708-092-10 100 (10 x 10) tablets Unit dose blisters The 10 mg tablets are yellow. The tablet is debossedwith ‘L161’ on one side and plain on other side. NDC 46708-093-30 bottle of 30 tablets NDC 46708-093-91 bottle of 1000 tablets NDC 46708-093-10 100 (10 x 10) tablets Unit dose blisters Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]
Abbreviated New Drug Application
DONEPEZIL HYDROCHLORIDE 5 MG- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED ALEMBIC PHARMACEUTICALS LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DONEPEZIL HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DONEPEZIL HYDROCHLORIDE TABLETS. DONEPEZIL HYDROCHLORIDE TABLETS USP, FILM COATED FOR ORAL USE INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Donepezil hydrochlorideis 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). (1) DOSAGE AND ADMINISTRATION MILD TO MODERATE ALZHEIMER’S DISEASE - 5 mg or 10 mg administered once daily (2.1) MODERATE TO 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) (2) 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). (5) 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 bleeding (GI), 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) Aqra d-dokument sħiħ