দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P)
Macleods 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 hydrochloride is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. Risk Summary There are no adequate data on the developmental risks associated with the use of donepezil hydrochloride in pregnant women. In animal studies, developmental toxicity was not observed when donepezil was administered to pregnant rats and rabbits during organogenesis, but administration to rats during the latter part of pregnancy and throughout lactation resulted in increased stillbirths and decreased offspring survival at clinically relevant doses [see Data ]. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. The background risks of major birth de
Supplied as film-coated, round tablets containing either 5 mg, 10 mg or 23 mg donepezil hydrochloride USP. Donepezil Hydrochloride 5 mg and 10 mg Tablets, USP The 5 mg tablets are white to off white, round, biconvex, film-coated tablets debossed with 'ML 89' on one side and plain on the other side. The 10 mg tablets are yellow, round, biconvex, film-coated tablets debossed with 'ML 88' on one side and plain on the other side. Donepezil Hydrochloride 23 mg Tablets The 23 mg tablets are red, round, biconvex, film-coated tablets debossed with "C 26" on one side and plain on the other side. Supplied as round tablets containing either 5 mg or 10 mg of donepezil hydrochloride USP. The 5 mg orally disintegrating tablets are yellow coloured, circular, flat face beveled edge uncoated tablets debossed with "CL 31" on one side and plain on the other side. The 10 mg orally disintegrating tablets are yellow, circular, flat face beveled edge uncoated tablets debossed with "CL 32" on one side and plain on the other side. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING MACLEODS PHARMACEUTICALS LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DONEPEZIL HYDROCHLORIDE TABLETS AND DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DONEPEZIL HYDROCHLORIDE TABLETS AND DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS. DONEPEZIL HYDROCHLORIDE TABLETS,FOR ORAL USE DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Donepezil hydrochloride 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 to 10 mg once daily (2.1) Moderate to Severe Alzheimer’s Disease: 10 mg to 23 mg once daily (2.2) DOSAGE FORMS AND STRENGTHS Tablets: 5 mg,10 mg, and 23 mg (3) Orally Disintegrating Tablets (ODT) : 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) The use of donepezil hydrochloride tablets in a dose of 23 mg once daily is associated with weight loss (5.5) Cholinomimetics may cause bladder outflow সম্পূর্ণ নথি পড়ুন