Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P)
Torrent Pharmaceuticals Limited
DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Donepezil hydrochloride tablets, USP 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. Risk Summary There are no adequate data on the developmental risks associated with the use of donepezil 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 od pregnancy and throughout lactation resulted in increased stillbirths and decreased offspring survival at clinciallky relevant doses [see Data]. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clincially recognized pregnancies are 2% to 4% and 15% to 20%, respectively. The background risks of ma
Donepezil hydrochloride tablets, USP 5 mg are white to off white, circular, biconvex, film coated tablets debossed with ‘5’ on one side and plain on other side. Bottles of 30 NDC 13668-102-30 Bottles of 90 NDC 13668-102-90 Bottles of 500 NDC 13668-102-05 Bottles of 1000 NDC 13668-102-10 Bottles of 4000 NDC 13668-102-40 Donepezil hydrochloride tablets, USP 10 mg are peach colored, circular, biconvex, film coated tablets debossed with ‘10’ on one side and plain on other side. Bottles of 30 NDC 13668-103-30 Bottles of 90 NDC 13668-103-90 Bottles of 500 NDC 13668-103-05 Bottles of 1000 NDC 13668-103-10 Bottles of 2650 NDC 13668-103-26 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature].
Abbreviated New Drug Application
DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED TORRENT PHARMACEUTICALS LIMITED ---------- 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, FOR ORAL USE RX ONLY INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Donepezil hydrochloride tablets, USP 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) 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 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 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 Most common adverse reactions in clinical studies of donepezil hydrochloride tablets are nausea, diarrhea, insomnia, vomiting, muscle cramps Baca dokumen lengkap