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Exelon (Rivastigmine Tartrate) - Summary

 
 



EXELON SUMMARY

Exelon® (rivastigmine tartrate) is a reversible cholinesterase inhibitor and is known chemically as (S)-N-Ethyl-N-methyl-3-[1-(dimethylamino)ethyl]-phenyl carbamate hydrogen-(2R,3R)-tartrate. Rivastigmine tartrate is commonly referred to in the pharmacological literature as SDZ ENA 713 or ENA 713. It has an empirical formula of C14H22N2O2 • C4H6O6 (hydrogen tartrate salt – hta salt) and a molecular weight of 400.43 (hta salt). Rivastigmine tartrate is a white to off-white, fine crystalline powder that is very soluble in water, soluble in ethanol and acetonitrile, slightly soluble in n-octanol and very slightly soluble in ethyl acetate. The distribution coefficient at 37°C in n-octanol/phosphate buffer solution pH 7 is 3.0.

Exelon® (rivastigmine tartrate) is indicated for the treatment of mild to moderate dementia of the Alzheimer's type.

      Exelon® (rivastigmine tartrate) is indicated for the treatment of mild to moderate dementia associated with Parkinson’s disease.

      The dementia of Parkinson’s disease is purportedly characterized by impairments in executive function, memory retrieval, and attention in patients with an established diagnosis of Parkinson’s disease. The diagnosis of the dementia of Parkinson’s disease, however, can reliably be made in patients in whom a progressive dementia syndrome occurs (without the necessity to document the specific deficits described above) at least 2 years after a diagnosis of Parkinson’s disease has been made, and in whom other causes of dementia have been ruled out (see CLINICAL PHARMACOLOGY, Clinical Trial Data).


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NEWS HIGHLIGHTS

Media Articles Related to Exelon (Rivastigmine)

Medical News Today: Fat deposits in brain may hasten Alzheimer's disease
Source: Featured Health News from Medical News Today [2015.08.28]
New research suggests that abnormal fat deposits found in the brains of people who died from Alzheimer's disease could trigger or accelerate the condition.

Fat deposits in brain may hasten Alzheimer's disease
Source: Biology / Biochemistry News From Medical News Today [2015.08.28]
New research suggests that abnormal fat deposits found in the brains of people who died from Alzheimer's disease could trigger or accelerate the condition.

Waterford research on Alzheimer's disease suggests that measuring macular pigment offers potential as a biomarker of cognitive health
Source: Eye Health / Blindness News From Medical News Today [2015.08.25]
Results to be showcased internationally in the Journal of Alzheimer's DiseaseOngoing European Research Council-funded research at Waterford Institute of Technology's (WIT) Macular Pigment...

UNMC statewide study to test new model for caregivers of those with Alzheimer's disease, dementia
Source: Caregivers / Homecare News From Medical News Today [2015.08.20]
The responsibility of caring for loved ones with Alzheimer's disease or dementia can be overwhelming - physically, mentally and financially.

Alzheimer's Disease
Source: MedicineNet Advance Medical Directives Specialty [2015.08.13]
Title: Alzheimer's Disease
Category: Diseases and Conditions
Created: 8/26/2008 12:00:00 AM
Last Editorial Review: 8/13/2015 12:00:00 AM

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Published Studies Related to Exelon (Rivastigmine)

Rivastigmine transdermal patch 13.3 mg/24 h: a review of its use in the management of mild to moderate Alzheimer's dementia. [2014]
Rivastigmine is unique among cholinesterase inhibitors commonly used in the treatment of mild to moderate Alzheimer's disease (AD) in that it is available as a transdermal patch formulation (Exelon(®) patch, Rivastach(®) patch, Prometax(®) patch)... By further slowing functional deterioration without markedly compromising tolerability, increasing the transdermal rivastigmine dose to the 15 cm(2) patch has a favourable benefit-risk profile-and therefore represents a valid option-in the treatment of patients with mild to moderate AD who have previously experienced functional and cognitive decline while receiving the 10 cm(2) patch.

Efficacy and safety of donepezil, galantamine, rivastigmine, and memantine for the treatment of Alzheimer's disease: a systematic review and meta-analysis. [2014]
rivastigmine, and memantine for the treatment of AD... CONCLUSIONS: Cholinesterase inhibitors and memantine are able to stabilize or

The ReSPonD trial--rivastigmine to stabilise gait in Parkinson's disease a phase II, randomised, double blind, placebo controlled trial to evaluate the effect of rivastigmine on gait in patients with Parkinson's disease who have fallen. [2013]
BACKGROUND: Gait impairment is common in people with Parkinson's disease. There is a lack of effective interventions to target this debilitating complication and therefore a need to identify new therapeutic options... If effective, it would offer a new therapeutic option to ameliorating gait and cognitive deficits in a population at high risk of falls.

Rivastigmine as alternative treatment for refractory REM behavior disorder in Parkinson's disease. [2012]
disease in whom conventional therapy failed... CONCLUSIONS: The results of this pilot trial need to be confirmed by further

Rivastigmine transdermal patch and capsule in Alzheimer's disease: influence of disease stage on response to therapy. [2011.12]
OBJECTIVES: The cholinesterase inhibitor rivastigmine is approved for the symptomatic treatment of mild to moderate Alzheimer's disease (AD). This exploratory, hypothesis-forming analysis assessed response to rivastigmine according to severity of dementia at baseline... CONCLUSIONS: Rivastigmine benefits AD patients across dementia stages. Similar to previous cholinesterase inhibitor studies, greatest treatment effects with rivastigmine patch and capsule were seen in patients with more advanced dementia, most likely driven by greater placebo decline in this population. Copyright (c) 2010 John Wiley & Sons, Ltd. Copyright (c) 2010 John Wiley & Sons, Ltd.

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Clinical Trials Related to Exelon (Rivastigmine)

Rivastigmine and Huperzine A as Treatments for Cocaine Dependence [Completed]
The purpose of this study is to determine the safety and effects of rivastigmine and huperzine A (HupA), potential treatments for cocaine abuse, when used before experimental administration of cocaine, on a number of physical and psychological measures.

Rivastigmine as a Treatment for Methamphetamine Dependence [Completed]
To study the effects of treatment with rivastigmine on craving produced by experimental administration of methamphetamine.

A Double-Blind, Placebo-controlled Crossover Study of Repeat Rivastigmine Administration in Healthy Male Volunteers [Completed]
Rivastigmine is a carbamate, approved by the FDA for the treatment of mild to moderate dementia associated with Alzheimer's and Parkinson's diseases. Studies conducted in the Israel Institute of Biological Research (IIBR) have yielded encouraging results in utilizing rivastigmine pre-treatment as an alternative to pyridostigmine in partially protecting against organophosphate poisoning, particularly protecting the central nervous system. The target population for this indication may consist of otherwise healthy people (e. g. soldiers). Although the treatment regimen has not been established yet it is assumed, based on animal experiments, that rivastigmine is likely to be administered in repeated doses. In this setting, further evaluation of the drug's effects and pharmacokinetics in young healthy subjects is warranted. The objectives of this study are: 1) To assess the safety and tolerability of repeated rivastigmine administration (1. 5 mg and 3 mg) in young healthy male volunteers; 2) To determine the pharmacokinetic profile of rivastigmine (1. 5 mg and 3 mg) following a single and multiple dose administrations; 3) To assess the extent of blood ChE inhibition following a single and multiple administrations of rivastigmine and 4) To correlate physiological and behavioral effects with blood rivastigmine concentrations and blood ChE inhibition in these subjects. This double-blind, placebo-controlled study will be divided in 3 identical periods, preceded with a two-day initial training in performing cognitive performance tests. Each period will consist of in-house confinement for 5 days in which rivastigmine will be administered 5 times at an interval of 12 hours. During each period, each subject will receive either rivastigmine 1. 5 mg X 5, or either rivastigmine 3. 0 mg X 5 or placebo X 5. The treatment in each period will be randomly assigned in a crossover manner. Rivastigmine pharmacokinetics will and acetylcholinesterase inhibition will be assessed after the first and the last dose of each period and will be correlated with physiological and cognitive parameters: performance tests, visual functions, peak airway flow, saliva production (sialometry) and vital signs. The emergence of adverse events will be monitored throughout the study

Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44 [Completed]
The core study assessed the efficacy of a higher dose of rivastigmine 13. 3 mg/24 h transdermally (15 cm^2 patch) compared to a lower dose of the rivastigmine 4. 6 mg/24 h transdermally (5 cm^2 patch) in patients with Severe Dementia of the Alzheimer's Type in a 24-week study. The extension study obtained additional safety and efficacy data, as well as provided the higher dose rivastigmine patch to all patients who completed the core study for an additional 24 weeks.

Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline [Completed]
The purpose of this study was to support the optimal use of rivastigmine patch in long-term treatment of Alzheimer's Disease in patients demonstrating functional and cognitive decline at the target maintenance dose of rivastigmine patch 10 cm^2.

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Reports of Suspected Exelon (Rivastigmine) Side Effects

Death (309)Fall (124)Vomiting (86)Pneumonia (78)Cerebrovascular Accident (69)Malaise (63)Dementia Alzheimer's Type (63)Nausea (61)Somnolence (60)Confusional State (57)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Exelon has an overall score of 10. The effectiveness score is 10 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
 

Exelon review by 58 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   memory
Dosage & duration:   4.5 mg taken twice daily for the period of last 4 years or so
Other conditions:   depression
Other drugs taken:   lexapro namenda trileptal ambien
  
Reported Results
Benefits:   overall benefits were great. memory has not gotten worse and there is less frustration on my part. Makes my day much better. Although, I have peaks and lows...my lows have been better.
Side effects:   i did not find any side effects.
Comments:   the treatment was for slowing down the progression of memory loss. And it has!

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Page last updated: 2015-08-28

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