DONEPEZIL HYDROCHLORIDE tablet, orally disintegrating

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

DONEPEZIL HYDROCHLORIDE (UNII: 3O2T2PJ89D) (DONEPEZIL - UNII:8SSC91326P)

Prieinama:

Sandoz Inc

INN (Tarptautinis Pavadinimas):

DONEPEZIL HYDROCHLORIDE

Sudėtis:

DONEPEZIL HYDROCHLORIDE 5 mg

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 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 bac

Produkto santrauka:

Donepezil hydrochloride orally disintegrating tablets 5 mg, are white, round tablets imprinted with SZ on one side and 265 on the other side. They are available as follows: NDC 0781-5276-64, unit dose blister package of 30 tablets (3x10) NDC 0781-5276-31, bottles of 30 tablets NDC 0781-5276-01, bottles of 100 tablets NDC 0781-5276-10, bottles of 1000 tablets Donepezil hydrochloride orally disintegrating tablets 10 mg, are yellow, round tablets imprinted with SZ on one side and 266 on the other side. They are available as follows: NDC 0781-5277-64, unit dose blister package of 30 tablets (3x10) NDC 0781-5277-31, bottles of 30 tablets NDC 0781-5277-01, bottles of 100 tablets NDC 0781-5277-10, bottles of 1000 tablets Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET, ORALLY
DISINTEGRATING
SANDOZ 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 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 ORWWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
•
•
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 1/2019
Orally Disintegrating Tablets (ODT): 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