Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P)
Zydus Pharmaceuticals USA Inc.
DONEPEZIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Donepezil hydrochloride orally disintegrating 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 orally disintegrating 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 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%
Donepezil Hydrochloride Orally disintegrating Tablets USP, 5 mg are white to off-white, round-shaped, biconvex, uncoated tablets engraved with 'ZF 14'on one side and plain on other side and are supplied as follows: NDC 68382-346-06 in bottle of 30 tablets NDC 68382-346-16 in bottle of 90 tablets NDC 68382-346-01 in bottle of 100 tablets NDC 68382-346-05 in bottle of 500 tablets NDC 68382-346-10 in bottle of 1000 tablets NDC 68382-346-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Donepezil Hydrochloride Orally Disintegrating Tablets USP, 10 mg are white to off-white, round-shaped, biconvex, uncoated tablets engraved with 'ZF 15'on one side and plain on other side and are supplied as follows: NDC 68382-347-06 in bottle of 30 tablets NDC 68382-347-16 in bottle of 90 tablets NDC 68382-347-01 in bottle of 100 tablets NDC 68382-347-05 in bottle of 500 tablets NDC 68382-347-10 in bottle of 1000 tablets NDC 68382-347-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.
Abbreviated New Drug Application
DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE TABLET, ORALLY DISINTEGRATING ZYDUS PHARMACEUTICALS USA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS. DONEPEZIL HYDROCHLORIDE ORALLY DISINTEGRATING TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1996 INDICATIONS AND USAGE Donepezil hydrochloride orally disintegrating 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) 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 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) 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 stu Կարդացեք ամբողջական փաստաթուղթը