Donepezil Hydrochloride is indicated for the symptomatic treatment of mild to moderate dementia of the Alzheimer's type.

Donepezil Hydrochloride is a centrally acting anticholinesterase agent. It binds reversibly with the enzyme acetylcholinesterase and inactivates it. This inhibits the hydrolysis (breakdown) of acetylcholine . As a result, the concentration of acetylcholine increases at cholinergic synapses in the brain , which helps improve cognitive function.

5 mg once daily orally at bed time. The 5 mg/day dose should be maintained for at least one month in order to allow the earliest clinical responses to treatment to be assessed and to allow steady-state concentrations of donepezil hydrochloride to be achieved. Following a one-month clinical assessment of treatment at 5 mg/day, the dose can be increased to 10 mg/day (once-a-day dosing). Since food does not affect the rate or extent of absorption of donepezil, it can be administered with or without food.

Anticholinergic drugs (e.g., atropine, benztropine): These drugs cross into the brain and produce the opposite effects of Donepezil. They should be avoided during therapy with donepezil. Drugs that may reduce the effect of donepezil: Carbamazepine, dexamethasone, phenobarbital, phenytoin. Drugs that may increase the effect of donepezil: Ketoconazole, quinidine, cimetidine.

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

Generally well tolerated, but some patients may experience: Nausea, vomiting, diarrhea. These adverse events are mild in intensity and transient, resolving during continued treatment without the need for dose modification. Less frequent side effects: Insomnia, Fatigue, Anorexia (loss of appetite), Muscle cramps, Generalized seizure.

Pregnancy: There are no adequate and well-controlled studies in pregnant women. Donepezil should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation: It is not known whether Donepezil Hydrochloride is secreted in human breast milk. Donepezil is not indicated in nursing mothers.

Caution should be taken in patients with: Sick sinus syndrome or other supraventricular conduction abnormalities.Risk of developing peptic ulcers, Asthma, Obstructive airway disease, During anesthetic procedures.

Renal & Hepatic Impairment: A similar dose schedule can be followed for patients with renal or mild to moderate hepatic impairment, as clearance of donepezil hydrochloride is not affected by these conditions.

Use in Children: There are no adequate and well-controlled trials to document the safety and efficacy of Donepezil hydrochloride in any illness occurring in children. Donepezil is not recommended for use in children.

Symptoms of overdose include: Nausea, vomiting, salivation, Overdosage with very high doses may result in cholinergic crisis, characterized by: Severe nausea, vomiting, salivation, Bradycardia (slow heart rate), Hypotension (low blood pressure), Increasing muscle weakness, Respiratory depression, Collapse, Convulsions (seizures), Management: As in any case of overdose, general supportive measures should be utilized. In case of cholinergic crisis, hospitalization of the patient is required.

Drugs for Dementia

Keep below 30°C. Protect from light and moisture. Keep out of the reach of children.