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 Parkinsons
disease.
The dementia of Parkinsons disease is purportedly characterized by
impairments in executive function, memory retrieval, and attention in patients
with an established diagnosis of Parkinsons disease. The diagnosis of the
dementia of Parkinsons 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
Parkinsons 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 HIGHLIGHTSMedia Articles Related to Exelon (Rivastigmine)
Alzheimer's Disease Source: MedicineNet Immunizations Specialty [2017.06.01] Title: Alzheimer's Disease Category: Symptoms and Signs Created: 8/5/2014 12:00:00 AM Last Editorial Review: 6/1/2017 12:00:00 AM
Dementia, Alzheimer's Disease, and Aging Brains Source: MedicineNet Hydrocephalus Specialty [2016.08.01] Title: Dementia, Alzheimer's Disease, and Aging Brains Category: Slideshows Created: 12/3/2009 10:07:00 AM Last Editorial Review: 8/1/2016 12:00:00 AM
Alzheimer's Disease Symptoms & Early Diagnosis Source: MedicineNet memantine Specialty [2016.07.27] Title: Alzheimer's Disease Symptoms & Early Diagnosis Category: Slideshows Created: 9/21/2015 12:00:00 AM Last Editorial Review: 7/27/2016 12:00:00 AM
Caring for Someone With Alzheimer's Disease Source: MedicineNet memantine Specialty [2016.05.16] Title: Caring for Someone With Alzheimer's Disease Category: Slideshows Created: 2/16/2010 2:51:00 PM Last Editorial Review: 5/16/2016 12:00:00 AM
7 Alzheimer's Disease Stages and Symptoms Source: MedicineNet Advance Medical Directives Specialty [2016.05.12] Title: 7 Alzheimer's Disease Stages and Symptoms Category: Diseases and Conditions Created: 7/30/2014 12:00:00 AM Last Editorial Review: 5/12/2016 12:00:00 AM
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.
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.
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 >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased 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: 2017-06-01
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