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After a minimum of 2 weeks and if well toleratedincrease the dose to 3 mg twice a daySubsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 2 weeks at the previous dose and if well toleratedThe maximum dose is 6 mg twice a day12 mg per day
In a study of 26 weeks duration702 patients were randomized to doses of 3 mg6 mgor 9 mg per day of EXELON or to placeboeach given in divided dosesThe fixed-dose study designwhich included a 12-week forced-dose titration phase and a 14-week maintenance phaseled to a high dropout rate in the 9 mg per day group because of poor tolerabilityAt 26 weeks of treatmentsignificant differences were observed for the ADAS-cog mean change from baseline for the 9 mg per day and 6 mg per day groupscompared to placeboNo significant differences were observed between any of the EXELON-dose groups and placebo for the analysis of the CIBIC-Plus mean rating of changeAlthough no significant differences were observed between EXELON treatment groupsthere was a trend toward numerical superiority with higher doses.
The following adverse reactions are described below and elsewhere in the labeling:
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