Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P)
INDICUS PHARMA LLC
DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Donepezil hydrochloride tablets 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 tablets 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 lact
Supplied as film-coated, round, biconvex tablets containing 5 mg, or 10 mg of donepezil hydrochloride. The 5 mg tablets are white to off white colored and debossed with ‘I42’ on one side and plain on other side. Bottles of 30 (NDC# 24724-028-03) Bottles of 1000 (NDC# 24724-028-10) Unit Dose Blister Package 100 (10x10) (NDC# 24724-028-01) The 10 mg tablets are pink colored and debossed with ‘I41’ on one side and plain on other side. Bottles of 30 (NDC# 24724-029-03) Bottles of 1000 (NDC# 24724-029-10) Unit Dose Blister Package 100 (10x10) (NDC# 24724-029-01) Storage: Store at 20°-25°C (68°-77°F); [See USP Controlled Room Temperature]
Abbreviated New Drug Application
DONEPEZIL HYDROCHLORIDE - DONEPEZIL TABLET, FILM COATED INDICUS PHARMA LLC ---------- 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,5 MG AND 10 MG INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Donepezil hydrochloride tablets are 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 (1.0). 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 tablets 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 adver Przeczytaj cały dokument