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:

Dr. Reddys Laboratories Limited

INN (International Name):

DONEPEZIL HYDROCHLORIDE

Composition:

DONEPEZIL HYDROCHLORIDE 23 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 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

Product summary:

Supplied as film-coated, round tablets containing 23 mg of donepezil hydrochloride, USP. Donepezil hydrochloride tablets USP, 23 mg are reddish colored, round, film coated tablet debossed with ‘R’ on one side and ‘23’ on the other side and are supplied in bottles of 30, 90, 500 and 1000. Bottles of 30 NDC 55111-302-30 Bottles of 90 NDC 55111-302-90 Bottles of 500 NDC 55111-302-05 Bottles of 1000 NDC 55111-302-10 Storage: Store at 20°C to 25°C (68°F to 77°F); [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DONEPEZIL HYDROCHLORIDE- DONEPEZIL HYDROCHLORIDE TABLET, FILM COATED
DR. REDDYS LABORATORIES 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 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: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 REACTIONS
Most common adverse reactions in clinical studies of donepezil
h