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In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 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/mThere 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.

The increase in prothrombin time induced by warfarin is not affected by administration of Rivastigmine.Population pharmacokinetic analysis with a database of 625 patients showed that the pharmacokinetics of Rivastigmine taken orally were not influenced by commonly prescribed medications such as antacids (n=77), antihypertensives (n=72),  beta-blockers (n=42), calcium channel blockers (n=75), antidiabetics (n=21), NSAIDs (n=79), estrogens (n=70), salicylate analgesics (n=177), antianginals (n=35) and antihistamines (n=15).In each study, the effectiveness of Rivastigmine tartrate capsules was evaluated using a dual outcome assessment strategy.The ability of Rivastigmine tartrate capsules to improve cognitive performance was assessed with the cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-cog), a multi-item instrument that has been extensively validated in longitudinal cohorts of Alzheimer's disease patients.

The CIBIC-Plus has not been systematically compared directly to assessments not using information from caregivers or other global methods.Figure 1 illustrates the time course for the change from baseline in ADAS-cog scores for all 3 dose groups over the 26 weeks of the study. Five percent of patients discontinued for vomiting, compared to less than 1% for patients on placebo.

Rivastigmine may cause some people to become dizzy, clumsy, or unsteady. The capsule shell contains gelatin, titanium dioxide, and yellow iron oxide. 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. Taking an overdose of rivastigmine may lead to convulsions (seizures) or shock. © 1998-2020 Mayo Foundation for Medical Education and Research (MFMER). Do not take other medicines unless they have been discussed with your doctor. The ADAS-cog scoring range is from 0 to 70, with higher scores indicating greater cognitive impairment. Contraindications. This difference was statistically significant in favor of Rivastigmine tartrate capsule treatment.Figure 8: Distribution of ADCS-CGIC Scores for Patients Completing 24 Weeks of Treatment in Study 4Patients’ age, gender, or race did not predict clinical outcome of Rivastigmine tartrate capsule treatment. During treatment with the Rivastigmine tartrate capsules, routinely evaluate the patient’s ability to continue driving or operating machinery.The following adverse reactions are described below and elsewhere in the labeling:Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.Rivastigmine tartrate capsules have been administered to over 5,297 individuals during clinical trials worldwide. If you are not able to do this, put on upper arm or chest. The 6 mg to 12 mg per day group was statistically significantly superior to placebo, as well as to the 1 mg to 4 mg per day group. The imprinting ink, common for all strengths, contains: black iron oxide, D&C yellow #10 aluminum lake, FD&C blue #1 brilliant blue FCF aluminum lake, FD&C blue #2 indigo carmine aluminum lake, FD&C red #40 allura red AC aluminum lake, shellac and may contain propylene glycol.Although the precise mechanism of action of Rivastigmine is unknown, it is thought to exert its therapeutic effect by enhancing cholinergic function. Manufacturer makes no recommendation. Atypical responses in blood pressure and heart rate have been reported with other drugs that increase cholinergic activity when coadministered with quaternary anticholinergics such as glycopyrrolate. All rights reserved. All rights reserved. The ADAS-cog examines selected aspects of cognitive performance including elements of memory, orientation, attention, reasoning, language, and praxis.

The administration of Rivastigmine may also result in adverse reactions that are detrimental to these functions. The drug can be administered orally or via a transdermal patch; the latter form reduces the prevalence of side effects, which typically include nausea and vomiting.

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