Alzime Special Precautions

Anesthesia: Donepezil, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia.
Cadiovascular effects: Because of their pharmacological action, cholinesterase inhibitors may have vagotonic effects on the sinoatrial and atrioventricular nodes. This effect may manifest as bradycardia or heart block in patients with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil.
GI effects: Through their primary action, cholinesterase inhibitors may be expected to increase gastric acid secretion because of increased cholinergic activity. Therefore, monitor patients closely for symptoms of active or occult GI bleeding, especially those at increased risk for developing ulcers (e.g., those with a history of ulcer disease or those receiving concurrent non-steroidal anti-inflammatory drugs [NSAIDs]). Clinical studies of donepezil have shown no increase relative to placebo in the incidence of peptic ulcer disease or GI bleeding.
Donepezil, as a predictable consequence of its pharmacological properties, has been shown to produce diarrhea, nausea and vomiting. These effects, when they occur, appear more frequently with the 10 mg/day dose than with the 5 mg/day dose. In most cases, these effects have been mild and transient, sometimes lasting 1 to 3 weeks, and have resolved during continued use of donepezil.
Genitourinary effects: Although not observed in clinical trials, cholinomimetics may cause bladder outflow obstruction.
Pulmonary effects: Because of their cholinomimetic actions, prescribe cholinesterase inhibitors with care to patients with a history of asthma or obstructive pulmonary disease.
Seizures: Cholinomimetics are believed to have some potential to cause generalized convulsions. However, seizure activity also may be a manifestation of Alzheimer disease.
Hepatic function impairment: In a study of 10 patients with stable alcoholic cirrhosis, the clearance of donepezil was decrease 20% relative to 10 healthy age and sex-matched subjects.
Mutagenesis: In the chromosome aberration test in cultures of Chinese hamster lung cells, some clastogenic effects were observed.
Monitoring: Monitor patients closely for symptoms of active or occult (GI bleeding, especially those at increased risk for developing ulcers (e.g., those with a history of ulcer disease or those receiving NSAIDs).