DONEPEZIL HYDROCHLORIDE- donepezil tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Camber Pharmaceuticals, 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. 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 weaning pr

Product summary:

Donepezil hydrochloride tablets, USP 5 mg are white, round, biconvex, film coated tablets debossed on one side with SG and 139 on the other side. NDC 31722-139-10: Bottles of 1000 tablets Donepezil hydrochloride tablets, USP 10 mg are yellow, round, biconvex, film coated tablets debossed on one side with SG and 140 on the other side NDC 31722-140-10: Bottles of 1000 tablets Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DONEPEZIL HYDROCHLORIDE - DONEPEZIL TABLET, FILM COATED
CAMBER PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDEDTO USE
DONEPEZIL HYDROCHLORIDE TABLETS
SAFELY AND EFFECTIVELY. SEE FULLPRESCRIBING INFORMATION FOR DONEPEZIL
HYDROCHLORIDE TABLETS.
DONEPEZILHYDROCHLORIDE T
INDICATIONS AND USAGE
Donepezil hydrochloride 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)
• Moderate to Severe Alzheimer's Disease: 10 mg to 23 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).
• The use of donepezil hydrochloride tablets in a dose of 23 mg once
daily is associated with weight loss (5.5).
• Cholinomimetics may cause bladder outflow obstructions (5.6).
• Cholinomimetics ar