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:

Hikma Pharmaceutical

INN (International Name):

DONEPEZIL HYDROCHLORIDE

Composition:

DONEPEZIL HYDROCHLORIDE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Donepezil hydrochloride tablets are an acetylcholinase 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 (1.0). 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 16 times the maximum recommended human dose [MRHD] of 10 mg/day on a mg/m 2 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

Product summary:

Supplied as film-coated, round tablets containing either 5 mg or 10 mg of donepezil hydrochloride. The 5 mg tablets are white round film-coated tablets engraved with W20.     Bottles of 30     Bottles of 90     Unit Dose Blister Package 100 (10x10) The 10 mg tablets are yellow round film coated tablets engraved with W21.     Bottles of 30     Bottles of 90     Unit Dose Blister Package 100 (10x10) Storage : Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
HIKMA PHARMACEUTICAL
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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
INITIAL U.S. APPROVAL: 1996
INDICATIONS AND USAGE
Donepezil hydrochloride tablets are an acetylcholinase 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 (1.0). (1)
DOSAGE AND ADMINISTRATION
MILD TO MODERATE ALZHEIMER’S DISEASE - 5 mg or 10 mg administered
once daily (2.1)
SEVERE ALZHEIMER’S DISEASE - 10 mg administered once daily (2.2)
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. (2.3) (2)
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
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
The most common adverse re