DONEPEZIL HYDROCHLORIDE- donepezil hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

DONEPEZIL HYDROCHLORIDE

Composition:

DONEPEZIL HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET
SANDOZ INC
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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