País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P)
Hikma Pharmaceutical
DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Donepezil hydrochloride tablets are an acetylcholinase 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 (1.0). Donepezil hydrochloride 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 16 mg/kg/day (approximately 16 times the maximum recommended human dose [MRHD] of 10 mg/day on a mg/m 2 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
Supplied as film-coated, round tablets containing either 5 mg or 10 mg of donepezil hydrochloride. The 5 mg tablets are white round film-coated tablets engraved with W20. Bottles of 30 Bottles of 90 Unit Dose Blister Package 100 (10x10) The 10 mg tablets are yellow round film coated tablets engraved with W21. Bottles of 30 Bottles of 90 Unit Dose Blister Package 100 (10x10) Storage : Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED HIKMA PHARMACEUTICAL ---------- 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 INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Donepezil hydrochloride tablets are an acetylcholinase 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 (1.0). (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) (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). 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 most common adverse re Llegiu el document complet