Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P)
Sandoz Inc
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 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
Donepezil hydrochloride tablets are supplied as round, film-coated tablets containing either 5 mg or 10 mg of donepezil hydrochloride. The 5 mg tablets are white and debossed with SZ 135 on one side. NDC 0781-5274-31, in bottles of 30 tablets NDC 0781-5274-92, in bottles of 90 tablets NDC 0781-5274-01, in bottles of 100 tablets NDC 0781-5274-10, in bottles of 1000 tablets NDC 0781-5274-13, unit dose blister package of 100 (10x10) The 10 mg tablets are yellow and debossed with SZ 136 on one side. NDC 0781-5275-31, in bottles of 30 tablets NDC 0781-5275-92, in bottles of 90 tablets NDC 0781-5275-01, in bottles of 100 tablets NDC 0781-5275-10, in bottles of 1000 tablets NDC 0781-5275-13, unit dose blister package of 100 (10x10) Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET SANDOZ INC ---------- 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 INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Donepezil hydrochloride tablet 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) • SEVERE ALZHEIMER'S DISEASE - 10 mg once daily (2.2) DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • • • ADVERSE REACTIONS Most common adverse reactions in clinical studies of donepezil hydrochloride are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia (6.1). TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC. AT 1-800-525-8747 OR FDA AT 1-800-FDA- 1088 OR_WWW.FDA.GOV/MEDWATCH_. DRUG INTERACTIONS • • USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm (8.1). SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 1/2019 FULL PRESCRIBING INFORMATION: CONTENTS* Tablets: 5 mg and 10 mg (3) Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives (4) 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 th Les hele dokumentet