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:

Sun Pharmaceutical Industries, 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 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 tablets 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 la

Product summary:

Donepezil hydrochloride tablets are supplied as film-coated, round tablets containing 5 mg, 10 mg, or 23 mg of donepezil hydrochloride, USP. The 5 mg tablets are white, biconvex, debossed with ‘440’ on one side and plain on other side.   Bottles of 30’s with Child Resistant Cap…..................NDC 62756-440-83 Bottles of 90’s with Child Resistant Cap…..................NDC 62756-440-81 Bottles of 100’s with Child Resistant Cap…................NDC 62756-440-88 Bottles of 100’s with Non Child Resistant Cap…........NDC 62756-440-08 Bottles of 1000’s with Non Child Resistant Cap…......NDC 62756-440-18 Unit-Dose blister pack of 30 (3 x 10) tablets………....NDC 62756-440-64 Unit-Dose blister pack of 100 (10 x 10) tablets………NDC 62756-440-65   The 10 mg tablets are yellow, biconvex, debossed with ‘445’ on one side and plain on other side.   Bottles of 30’s with Child Resistant Cap…..................NDC 62756-445-83 Bottles of 90’s with Child Resistant Cap…..................NDC 62756-445-81 Bottles of 100’s with Child Resistant Cap…................NDC 62756-445-88 Bottles of 100’s with Non Child Resistant Cap…........NDC 62756-445-08 Bottles of 1000’s with Non Child Resistant Cap…......NDC 62756-445-18 Unit-Dose blister pack of 30 (3 x 10) tablets………....NDC 62756-445-64 Unit-Dose blister pack of 100 (10 x 10) tablets………NDC 62756-445-65 The 23 mg tablets are peach, biconvex, debossed with ‘194’ on one side and plain on other side. Bottles of 30’s with Child Resistant Cap…..................NDC 62756-194-83 Bottles of 90’s with Child Resistant Cap…..................NDC 62756-194-81 Bottles of 1000’s with Non Child Resistant Cap…......NDC 62756-194-18 Storage: Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Dispense in tight containers (USP).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DONEPEZIL HYDROCHLORIDE - DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DONEPEZIL HYDROCHLORIDE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DONEPEZIL
HYDROCHLORIDE TABLETS.
DONEPEZIL HYDROCHLORIDE TABLETS, 5 MG AND 10 MG, FOR ORAL USE
DONEPEZIL HYDROCHLORIDE TABLETS, 23 MG, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
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, 10 mg and 23 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 RE