DONEPEZIL HYDROCHLORIDE - donepezil hydrochloride 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:

ACETRIS HEALTH, LLC

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 tablets are contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. Teratogenic Effects 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 through

Product summary:

Supplied as film-coated, round tablets containing 5 mg, and 10 mg of donepezil hydrochloride. Donepezil Hydrochloride Tablets USP, 5 mg are white to off-white, circular, biconvex, film-coated tablets debossed with ‘X’ on one side and ‘11’ on the other side.                             Bottles of 30                               NDC 52343-089-30                             Bottles of 90                               NDC 52343-089-90                             Bottles of 1,000                          NDC 52343-089-99 Donepezil Hydrochloride Tablets USP, 10 mg are yellow colored, circular, biconvex, film-coated tablets debossed with ‘X’ on one side and ‘12’ on the other side.                            Bottles of 30                                NDC 52343-090-30                            Bottles of 90                                NDC 52343-090-90                            Bottles of 1,000                           NDC 52343-090-99 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 HYDROCHLORIDE TABLET, FILM COATED
ACETRIS HEALTH, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DONEPEZIL HYDROCHLORIDE TABLETS USP SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DONEPEZIL
HYDROCHLORIDE TABLETS USP.
DONEPEZIL HYDROCHLORIDE TABLETS USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Donepezil 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 in a dose of 23 mg once daily is
associated with weight loss (5.5)
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
hydrochlori