Donepezil Hydrochloride

What it is and how it works

Mechanism of Action Current theories on the pathogenesis of the cognitive signs and symptoms of Alzheimer's disease attribute some of them to a deficiency of cholinergic neurotransmission. Donepezil hydrochloride is postulated to exert its therapeutic effect by enhancing cholinergic function. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by acetylcholinesterase. There is no evidence that donepezil alters the course of the underlying dementing process.

Indications

Donepezil hydrochloride tablet 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 . Donepezil hydrochloride tablet is 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.

Dosage and administration (summary)

Mild to Moderate Alzheimer's Disease: 5 mg to 10 mg once daily Moderate to Severe Alzheimer's Disease: 10 mg to 23 mg once daily Dosing in Mild to Moderate Alzheimer’s Disease The recommended starting dosage of donepezil hydrochloride tablet is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride tablets in patients with mild to moderate Alzheimer's disease is 10 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks.

Contraindications

Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives Donepezil hydrochloride is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.

Warnings and precautions

Cholinesterase inhibitors are likely to exaggerate succinylcholine-type muscle relaxation during anesthesia Cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes manifesting as bradycardia or heart block Donepezil hydrochloride can cause vomiting. Patients should be observed closely at initiation of treatment and after dose increases Patients should be monitored closely for symptoms of active or occult gastrointestinal (GI) bleeding, especially those at increased risk for developing ulcers The use of donepezil hydrochloride in a dose of 23 mg once da…

Pregnancy

Pregnancy 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 pregnanc…

Storage and supply

Donepezil Hydrochloride Tablets USP Donepezil Hydrochloride Tablets USP, 23 mg are reddish brown, round, film coated tablets, containing 23 mg of donepezil hydrochloride, debossed with 'G52' on one side and 'LU' on the other side, which are supplied as follows: NDC 68180-527-06 Bottle of 30s NDC 68180-527-09 Bottle of 90s Storage: Store at 25°C (77…

Source: Donepezil Hydrochloride (Donepezil Hydrochloride) — US FDA prescribing information, 2024-11-29, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.