DONEPEZIL HYDROCHLORIDE tablet, film coated

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

Donepezil Hydrochloride (UNII: 3O2T2PJ89D) (Donepezil - UNII:8SSC91326P)

זמין מ:

Proficient Rx LP

INN (שם בינלאומי):

Donepezil Hydrochloride

הרכב:

Donepezil Hydrochloride 10 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. Pregnancy Category C:   There are no adequate or well-controlled studies in pregnant women. Donepezil hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral administration of donepezil to pregnant rats and rabbits during the period of organogenesis did not produce any teratogenic effects at doses up to 16 mg/kg/day (approximately 6 times the maximum recommended human dose [MRHD] of 23 mg/day on a mg/m2 basis) and 10 mg/kg/day (approximately 7 times the MRHD on a mg/m2 basis), respectively. Oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout lactation to wean

leaflet_short:

Supplied as white to off-white, round, film-coated tablets containing either 5 mg or 10 mg of donepezil hydrochloride, USP. The 10 mg tablets are white to off-white, round, film-coated tablets, debossed with “J” on one side and “10” on the other side. Bottles of 30                                       NDC 63187-401-30 Storage: Store at 20°C-25°C (68°F-77°F), excursions permitted to 15°C-30°C (59°F-86°F). [See USP Controlled Room Temperature].

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
PROFICIENT RX LP
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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 USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
RECENT MAJOR CHANGES
Addition of new dosage strength: Donepezil Hydrochloride Tablets 23 mg
INDICATIONS AND USAGE
Donepezil hydrochloride tablets, USP are an acetycholinesterase
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
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A dose of 10 mg once daily can be administered once patients have been
on a daily dose of 5 mg for 4 to 6 weeks. A dose
of 23 mg once daily can be administered once patients have been on a
dose of 10 mg once daily for at least 3 months (2.3).
DOSAGE FORMS AND STRENGTHS
● Tablets: 5 mg and 10 mg (3)
CONTRAINDICATIONS
● Patients with known hypersensitivity to donepezil hydrochloride or
to piperidine derivatives (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The 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 JUBILANT CADISTA
PHARMACEUTICALS INC. AT 1-800-313-
4623 OR FDA AT 1-800-FDA-1088 OR _WWW.FDA.GOV/MEDWATCH_.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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MILD TO MODERATE ALZHEIMER'S DISEASE - 5 mg or 10 mg administered once
daily (2.1)
MODERATE TO SEVERE ALZHEIMER'S DISEASE - 10 mg or 23 mg administered
once daily (2.2)
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 nod