At 24 weeks, the mean differences in the ADAS-Cog change scores for the rivastigmine-treated patients compared to the patients on placebo, were 1.8, 2.9, and 1.8 units for the Rivastigmine Transdermal System 9.5 mg/24 hours, Rivastigmine Transdermal System 17.4 mg/24 hours, and Rivastigmine Capsule 6 mg twice daily groups, respectively. Doubling the dose from 3 mg to 6 mg twice a day results in a 3-fold increase in area under the curve (AUC). 0000013132 00000 n Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved. The between-treatment group difference for Rivastigmine Transdermal System 13.3 mg/24 hours versus Rivastigmine Transdermal System 9.5 mg/24 hours was nominally statistically significant at week 24 (p=0.027), but not at week 48 (p=0.227), which was the primary endpoint.This was a 24-week randomized double-blind, clinical investigation in patients with severe Alzheimer's disease [diagnosed by NINCDS-ADRDA and DSM-IV criteria, Mini-Mental State Examination (MMSE) score greater than or equal to 3 and less than or equal to 12]. You may need to read it again. Below is a text only representation of the Patient Information Leaflet. Instruct patients and their caregivers on important administration instructions for Rivastigmine Transdermal System Rivastigmine transdermal system can cause gastrointestinal adverse reactions, including significant nausea, vomiting, diarrhea, anorexia/decreased appetite, and weight loss.

1.5 mg* 100 Capsules. Slow heartbeat and fainting may also occur.If you forget to take Rivastigmine Rosemont Oral SolutionIf you find you have forgotten to take your dose of Rivastigmine Rosemont, wait and take the next dose at the usual time. It is critical to inform caregivers that if therapy has been interrupted for more than 3 days because of intolerance, the next dose should not be administered without contacting the physician regarding proper retitration.Skin application site reactions may occur with Rivastigmine Transdermal System. It may be helpful for this to be part of a daily routine, such as the daily bath or shower. (d) Replace the Rivastigmine Transdermal System with a new patch every 24 hours. 0000010035 00000 n Functional decline was assessed by the investigator and cognitive decline was defined as a decrease in the MMSE score of greater than or equal to 2 points from the previous visit or a decrease of greater than or equal to 3 points from baseline.Study 2 was designed to compare the efficacy of Rivastigmine Transdermal System 13.3 mg/ 24 hours versus that of Rivastigmine Transdermal System 9.5 mg/24 hours during the 48-week, double-blind treatment phase.The ability of the Rivastigmine Transdermal System 13.3 mg/24 hours to improve cognitive performance over that provided by the Rivastigmine Transdermal System 9.5 mg/24 hours was assessed by the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog) The ability of the Rivastigmine Transdermal System 13.3 mg/24 hours to improve overall function versus that provided by Rivastigmine Transdermal System 9.5 mg/24 hours was assessed by the instrumental subscale of the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-IADL).The ADCS-IADL subscale is composed of items 7 to 23 of the caregiver-based ADCS-ADL scale. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.Due to the risk of additive extrapyramidal adverse reactions, the concomitant use of metoclopramide and Rivastigmine is not recommended.Rivastigmine may increase the cholinergic effects of other cholinomimetic medications and  may also interfere with the activity of anticholinergic medications (e.g., oxybutynin, tolterodine). The ADAS-Cog scoring range is from 0 to 70, with higher scores indicating greater cognitive impairment. Based on No pharmacokinetic interaction was observed between rivastigmine taken orally and digoxin, warfarin, diazepam or fluoxetine in studies in healthy volunteers. The difference between the 1 mg to 4 mg per day group and placebo was not statistically significant.Figure 4: Time-course of the Change from Baseline in ADAS-cog Score for Patients Completing 26 Weeks of TreatmentFigure 5 illustrates the cumulative percentages of patients from each of the 3 treatment groups who had attained at least the measure of improvement in ADAS-cog score shown on the x-axis. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.Oral administration of rivastigmine to pregnant rats and rabbits throughout organogenesis produced no adverse effects on embryo-fetal development up to the highest dose tested (2.3 mg/kg/day), which is 2 and 4 times, respectively, the MRHD of 12 mg per day on a body surface area (mg/m There are no data on the presence of rivastigmine in human milk, the effects on the breastfed infant, or the effects of rivastigmine on milk production. In these cases, treatment should be discontinued Cholinesterase inhibitors, including rivastigmine, may increase gastric acid secretion due to increased cholinergic activity.