DONEPEZIL HYDROCHLORIDE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Zydus Pharmaceuticals (USA) Inc.

INN (Algemene Internationale Benaming):

DONEPEZIL HYDROCHLORIDE

Samenstelling:

DONEPEZIL HYDROCHLORIDE 5 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 tablets are 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 16 times the maximum recommended human dose [MRHD] of 10 mg/day on a mg/m2 basis) and 10 mg/kg/day (approximately 20 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 lactati

Product samenvatting:

Donepezil Hydrochloride Tablets USP, 5 mg are white to off-white, round-shaped, biconvex film-coated tablets debossed with "ZF9" on one side and plain on other side and are supplied as follows: NDC 68382-302-06 in bottle of 30 tablets NDC 68382-302-16 in bottle of 90 tablets NDC 68382-302-01 in bottle of 100 tablets NDC 68382-302-05 in bottle of 500 tablets NDC 68382-302-10 in bottle of 1000 tablets NDC 68382-302-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Donepezil Hydrochloride Tablets USP, 10 mg are white to off-white, round-shaped, biconvex film-coated tablets debossed with "ZF10" on one side and plain on other side and are supplied as follows: NDC 68382-303-06 in bottle of 30 tablets NDC 68382-303-16 in bottle of 90 tablets NDC 68382-303-01 in bottle of 100 tablets NDC 68382-303-05 in bottle of 500 tablets NDC 68382-303-10 in bottle of 1000 tablets NDC 68382-303-77 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.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
ZYDUS PHARMACEUTICALS (USA) 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 USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Donepezil hydrochloride tablets, USP 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 to10 mg once daily (2.1)
MODERATE TO SEVERE ALZHEIMER'S DISEASE - 10 mg once daily (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 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 studies of donepezil
hydrochloride are nausea, diarrhea, insomnia, vomiting,
muscle cramps, fatigue, and anor