Aricept Evess Special Precautions

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimer's dementia. Diagnosis should be made according to accepted guidelines (eg, DSM IV, ICD 10). Therapy with donepezil should only be started if a caregiver who will regularly monitor drug intake for the patient is available. Maintenance treatment can be continued for as long as a therapeutic benefit for the patient exists. Therefore, the clinical benefit of donepezil should be reassessed on a regular basis. Discontinuation should be considered when evidence of a therapeutic effect is no longer present. Individual response to donepezil cannot be predicted. The use of Aricept Evess in patients with severe Alzheimer's dementia, other types of dementia or other types of memory impairment (eg, age-related cognitive decline), has not been investigated.
Anesthesia: Aricept Evess, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anaesthesia.
Cardiovascular Conditions: Because of their pharmacological action, cholinesterase inhibitors may have vagotonic effects on heart rate (eg, bradycardia). The potential for this action may be particularly important to patients with "sick-sinus syndrome" or other supraventricular cardiac conduction conditions eg, sinoatrial or atrioventricular block.
There have been reports of syncope and seizures. In investigating such patients, the possibility of heart block or long sinusal pauses should be considered.
Gastrointestinal Conditions: Patients at increased risk for developing ulcers eg, those with a history of ulcer disease or those receiving concurrent NSAIDs, should be monitored for symptoms. However, the clinical studies with Aricept Evess showed no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding.
Genitourinary: Although not observed in clinical trials of Aricept Evess, cholinomimetics may cause bladder outflow obstruction.
Neurological Conditions: Seizures: Cholinomimetics are believed to have some potential to cause generalized convulsions. However, seizures may also be a manifestation of Alzheimer's disease.
Cholinomimetics may have the potential to exacerbate or induce extrapyramidal symptoms.
Pulmonary Conditions: Because of their cholinomimetic actions, cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.
The administration of Aricept Evess concomitantly with other inhibitors of AChE, agonists or antagonists of the cholinergic system should be avoided.
Severe Hepatic Impairment: There are no data for patients with severe hepatic impairment.
Mortality in Vascular Dementia Clinical Trials: Three clinical trials of 6-months duration were conducted studying individuals meeting the NINDS-AIREN criteria for probable or possible vascular dementia. The NINDS-AIREN criteria is designed to identify patients whose dementia appears to be due solely to vascular causes and to exclude patients with Alzheimer's disease. In the 1st study, the mortality rates were 2/198 (1%) on donepezil HCl 5 mg, 5/206 (2.4%) on donepezil HCl 10 mg and 7/199 (3.5%) on placebo. In the 2nd study, the mortality rates were 4/208 (1.9%) on donepezil HCl 5 mg, 3/215 (1.4%) on donepezil HCl 10 mg and 1/193 (0.5%) on placebo. In the 3rd study, the mortality rates were 11/648 (1.7%) on donepezil HCl 5 mg and 0/326 (0%) on placebo. The mortality rate for the 3 VaD studies combined in the donepezil HCl group (1.7%) was numerically higher than in the placebo group (1.1%), however, this difference was not statistically significant. The majority of deaths in patients taking either donepezil HCl or placebo appear to result from various vascular related causes, which could be expected in this elderly population with underlying vascular disease. An analysis of all serious nonfatal and fatal events showed no difference in the rate of occurrence in the donepezil HCl group relative to placebo.
In pooled Alzheimer's disease studies (n=4146) and when these Alzheimer's disease studies were pooled with other dementia studies including the vascular dementia studies (total n= 6888), the mortality rate in the placebo groups numerically exceeded that in the donepezil HCl groups.
Effects on the Ability to Drive or Operate Machinery: Donepezil has minor or moderate influence on the ability to drive and use machines. Dementia may cause impairment of driving performance or compromise the ability to use machinery. Furthermore, donepezil can induce fatigue, dizziness and muscle cramps, mainly when initiating or increasing the dose. The ability of Alzheimer patients on donepezil to continue driving or operating complex machines should be routinely evaluated by the treating physician.
Use in pregnancy: There are no adequate data from the use of donepezil in pregnant women. Studies in animals have not shown teratogenic effect, but have shown peri- and postnatal toxicity (see Toxicology under Actions). The potential risk for humans is unknown. Aricept Evess should not be used during pregnancy unless clearly necessary.
Use in lactation: donepezil is excreted in the milk of rats. It is not known whether donepezil HCl is excreted in human breast milk and there are no studies in lactating women. Therefore, women on donepezil should not breastfeed.
Use in children: Aricept Evess is not recommended for use in children.