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:

Aurobindo Pharma Limited

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. Risk Summary There are no adequate data on the developmental risks associated with the use of donepezil hydrochloride in pregnant women. In animal studies, developmental toxicity was not observed when donepezil was administered to pregnant rats and rabbits during organogenesis, but administration to rats during the latter part of pregnancy and throughout lactation resulted in increased stillbirths and decreased offspring survival at clinically relevant doses [see Data] . In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. The background risks of major birth defects and miscarriage for the indicated population are unknown. Data Animal Data 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 produced an increase in stillbirths and reduced offspring survival through postpartum day 4 at the highest dose. The no-effect dose of 3 mg/kg/day is approximately equal to the MRHD on a mg/m2 basis. Risk Summary There are no data on the presence of donepezil or its metabolites in human milk, the effects on the breastfed infant, or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for donepezil hydrochloride and any potential adverse effects on the breastfed infant from donepezil hydrochloride or from the underlying maternal condition. The safety and effectiveness in pediatric patients have not been established. Alzheimer’s disease is a disorder occurring primarily in individuals over 55 years of age. The mean age of patients enrolled in the clinical studies with donepezil hydrochloride was 73 years; 80% of these patients were between 65 and 84 years old, and 49% of patients were at or above the age of 75. The efficacy and safety data presented in the clinical trials section were obtained from these patients. There were no clinically significant differences in most adverse reactions reported by patient groups ≥ 65 years old and < 65 years old. In the controlled clinical trial, among patients in the donepezil hydrochloride 23 mg treatment group, those patients weighing < 55 kg reported more nausea, vomiting, and decreased weight than patients weighing 55 kg or more. There were more withdrawals due to adverse reactions as well. This finding may be related to higher plasma exposure associated with lower weight.

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 65862-325-30                Bottles of 90                           NDC 65862-325-90                Bottles of 100                         NDC 65862-325-01                Bottles of 500                         NDC 65862-325-05                Bottles of 1,000                      NDC 65862-325-99                10 x 10 Unit-dose Tablets       NDC 65862-325-10 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 65862-326-30                Bottles of 90                           NDC 65862-326-90                Bottles of 100                         NDC 65862-326-01                Bottles of 500                         NDC 65862-326-05                Bottles of 1,000                      NDC 65862-326-99                10 x 14 Unit-dose Tablets       NDC 65862-326-14 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
AUROBINDO PHARMA LIMITED
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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, 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
hydrochloride are