Donepezil

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 ( 1 ). 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.

• 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
• Dosing in Moderate to Severe 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 moderate to severe Alzheimer's disease is 23 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
• A dose of 23 mg per day should not be administered until patients have been on a daily dose of 10 mg for at least 3 months
• Administration Information Donepezil hydrochloride tablets should be taken in the evening, just prior to retiring
• Donepezil hydrochloride tablets can be taken with or without food
• The donepezil hydrochloride 23 mg tablet should not be split, crushed, or chewed

Tablets: 23 mg ( 3 ) Donepezil Hydrochloride Tablets USP are supplied as film-coated, round tablets containing 23 mg of donepezil hydrochloride. Donepezil Hydrochloride Tablets USP, 23 mg are reddish brown, round, film coated tablets debossed with 'G52' on one side and 'LU' on the other side.

• 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. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Instruct patients and caregivers to take donepezil hydrochloride only once per day, as prescribed
• Instruct patients and caregivers that donepezil hydrochloride can be taken with or without food
• Donepezil hydrochloride 23 mg tablets should be swallowed whole without the tablets being split, crushed or chewed
• Advise patients and caregivers that donepezil hydrochloride may cause nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and decreased appetite
• Advise patients to notify their healthcare provider if they are pregnant or plan to become pregnant. …

Known hypersensitivity to donepezil hydrochloride or to piperidine derivatives ( 4 ) Donepezil hydrochloride is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives.

Cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications ( 7.1 ). A synergistic effect may be expected with concomitant administration of succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists ( 7.2 ). 7.1 Use with Anticholinergics Because of their mechanism of action, cholinesterase inhibitors have the potential to interfere with the activity of anticholinergic medications. …

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 …

Most common adverse reactions in clinical studies of donepezil hydrochloride are nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, and anorexia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch . The following serious adverse reactions are described below and elsewhere in the labeling: Cardiovascular Conditions [ see Warnings and Precautions ( 5.2 ) ]. Nausea and Vomiting [ see Warnings and Precautions ( 5.3 ) ]. Peptic Ulcer Disease and GI Bleeding [ see Warnings and Precautions ( 5.4 ) ]. Weight Loss [ see Warnings and Precautions ( 5.5 ) ]. …

8.1 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 pregnancy and throughout lactation resulted in increased stillbirths and decreased offspring survival at …

Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose of any drug. As in any case of overdose, general supportive measures should be utilized. Overdosage with cholinesterase inhibitors can result in cholinergic crisis characterized by severe nausea, vomiting, salivation, sweating, bradycardia, hypotension, respiratory depression, collapse, and convulsions. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.