The efficacy and safety of donepezil in patients with Alzheimer’s disease: results of a US multicentre, randomized, double-blind, placebo-controlled trial. Diagnosis and treatment of Alzheimer disease and related disorders: consensus statement of the American Association for Geriatric Psychiatry, the Alzheimer’s Association, and the American Geriatrics Society. Ce site respecte les Collecte et traitement d’informations relatives à votre utilisation de ce service afin de vous adresser ultérieurement des publicités et/ou du contenu personnalisés dans d’autres contextes, par exemple sur nos autres sites ou applications. En désactivant ces cookies, vous ne pourrez plus partager les articles depuis le site Vidal sur les réseaux sociaux. Actualités. • The diagnosis of Alzheimer’s disease has been adequately confirmed according to current clinical guidelines or locally agreed pathways. 19 3. 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Contraception : gratuité … Centrally active, reversible acetylcholinesterase inhibitor.Palliative treatment of mild to moderate dementia of the Alzheimer’s type (Alzheimer’s disease, presenile or senile dementia).Comparative studies have not been performed to date, but donepezil does not share the hepatotoxic potential of tacrine and may be preferable to tacrine as a first-line treatment because it can be administered once daily and does not require regular monitoring of liver function.Administer conventional or orally disintegrating tablets orally once daily, usually at bedtime.Orally disintegrating tablets: Place on tongue and allow to dissolve; follow with water.Donepezil hydrochloride orally disintegrating and conventional film-coated tablets are bioequivalent.Available as donepezil hydrochloride; dosage expressed in terms of the salt.Some data suggest the possibility of additional benefit with higher (10 mg daily) dosage in some patients;Daily administration of 10 mg should not be considered until patient has received 5 mg daily for 4–6 weeks, since occurrence of adverse effects may be influenced by the rate of increase in dosage.Known hypersensitivity to donepezil or piperidine derivatives or any ingredient in the formulation.Potential for exaggerated succinylcholine-type muscle relaxation during anesthesia.Cholinesterase inhibitors may produce bradycardia or heart block via vagotonic effects on the sinoatrial or AV nodes.Possible diarrhea, nausea, and vomiting, particularly at dosage of 10 mg daily.Carefully monitor patients, especially those at increased risk for developing ulcers (e.g., those with history of peptic ulcer disease, those receiving concomitant NSAIA therapy), for symptoms of active or occult GI bleeding.Although not reported in clinical studies with donepezil, cholinomimetic agents may cause bladder outflow obstruction.Use with caution in patients with a history of asthma or obstructive pulmonary disease.Cholinomimetic agents may have the potential to cause generalized seizures; however, seizures also may be a manifestation of Alzheimer’s disease.Not known whether donepezil is distributed into milk.Dementia of the Alzheimer’s type occurs principally in patients >55 years of age.Nausea, diarrhea, insomnia, vomiting, muscle cramp, fatigue, anorexia.Pharmacokinetic interactions unlikely with drugs highly bound to plasma proteins.Unlikely to alter clearance of drugs metabolized by CYP3A4 or CYP2D6.Possible pharmacokinetic interaction (altered plasma donepezil concentrations) with CYP2D6 or CYP3A4 inducers or inhibitors.Possible interference with activity of anticholinergic agentsNo clinically important effects observed on pharmacokinetics of either drug with concomitant useNo clinically important effects observed on pharmacokinetics of either drug with concomitant usePharmacokinetic interactions (including protein binding interactions) unlikelyPlasma donepezil concentrations increased by 36% with concomitant use; no change in ketoconazole pharmacokineticsInhibition of donepezil metabolism observed in vitroNeuromuscular blocking agents (e.g., succinylcholine)Pharmacokinetic interactions (including protein binding interactions) unlikelyOrally disintegrating and conventional film-coated tablets are bioequivalent.Food does not affect rate or extent of absorption when administered as conventional film-coated tablets.Extensively metabolized to 4 major metabolites (2 known to be active) and a number of minor metabolites.Eliminated in urine and feces (57 and 15%, respectively, over 10 days, with 28% still unrecovered; about 17% of the dose recovered in urine as unchanged drug).In patients with stable alcoholic cirrhosis, clearance appears to be reduced by about 20%.In patients with moderate to severe renal impairment (ClPrecise mechanism(s) of action in patients with dementia of the Alzheimer’s type not fully elucidated.Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.Importance of informing patients of other important precautionary information.6. 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