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Exelon is a brand name for Rivastigmine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE EXELON PATCH is an acetylcholinesterase inhibitor indicated for treatment of: • Mild, moderate, and severe dementia of the Alzheimer’s type (AD). ( 1.1 ) • Mild-to-moderate dementia associated with Parkinson’s disease (PD). ( 1.2 ) 1.1 Alzheimer’s Disease EXELON PATCH is indicated for the…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION • Apply patch on intact skin for a 24-hour period; replace with a new patch every 24 hours. 6 mg/24 hours EXELON PATCH. 5 mg/24 hours, which is the minimum effective dose. 3 mg/24 hours. 3 mg/24 hours once daily.
3 mg/24 hours once daily. 6 mg per 24 hours. 4)] . Dose Titration Increase the dose only after a minimum of 4 weeks at the previous dose, and only if the previous dose has been tolerated. 5 mg/24 hours for as long as therapeutic benefit persists.
3 mg/24 hours dose. 3 mg/24 hours is the effective dose. 1)] . 3 mg/24 hours administered once per day; replace with a new patch every 24 hours. 3 mg/24 hours administered once per day; replace with a new patch every 24 hours. Interruption of Treatment If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower strength EXELON PATCH.
6 mg/24 hours EXELON PATCH and titrate as described above. 3)] . 6 mg/24 hours EXELON PATCH if such toxicities develop. 6 mg/24 hours EXELON PATCH. 5 mg/24 hours EXELON PATCH. Instruct patients or caregivers to apply the first patch on the day following the last oral dose.
4 Important Administration Instructions EXELON PATCH is for transdermal use on intact skin. (a) Do not use the patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way. (b) Apply the EXELON PATCH once a day.
• Press down firmly for 30 seconds until the edges stick well when applying to clean, dry, hairless, intact healthy skin in a place that will not be rubbed against by tight clothing. • Use the upper or lower back as the site of application because the patch is less likely to be removed by the patient.
If sites on the back are not accessible, apply the patch to the upper arm or chest. • Do not apply to a skin area where cream, lotion, or powder has recently been applied. (c) Do not apply to skin that is red, irritated, or cut. (d) Replace the EXELON PATCH with a new patch every 24 hours.
1), Overdosage (10)] . If a patch falls off or if a dose is missed, apply a new patch immediately, and then replace this patch the following day at the usual application time. , another spot on the upper back) on consecutive days. Do not apply a new patch to the same location for at least 14 days.
(f) May wear the patch during bathing and in hot weather. Avoid long exposure to external heat sources (excessive sunlight, saunas, solariums). (g) Place used patches in the previously saved pouch and discard in the trash, away from pets or children.
4)] Most common adverse reactions (less than 5% and higher than with placebo): Nausea, vomiting, and diarrhea. gov/medwatch. 1 Clinical Trials Experience 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.
EXELON PATCH has been administered to 4516 patients with Alzheimer’s disease during clinical trials worldwide. Of these, 3005 patients have been treated for at least 26 weeks, 1771 patients have been treated for at least 52 weeks, 974 patients have been treated for at least 78 weeks, and 24 patients have been treated for at least 104 weeks.
5 mg/24 hours EXELON PATCH arm and at a frequency at higher than in the placebo group, were nausea, vomiting, and diarrhea. 5 mg/24 hours EXELON PATCH. 5 mg/24 hours, EXELON Capsules 6 mg twice daily, and placebo groups who discontinued treatment due to adverse events were 10%, 8%, and 5%, respectively.
The most common adverse reactions in the EXELON PATCH-treated groups that led to treatment discontinuation in this study were nausea and vomiting. 5 mg/24 hours, EXELON Capsules 6 mg twice daily, and placebo groups, respectively. 5 mg/24 hours, EXELON Capsules 6 mg twice daily, and placebo groups, respectively.
Adverse Reactions Observed at an Incidence of Greater than or Equal to 2% Table 1 lists adverse reactions seen at an incidence of greater than or equal to 2% in either EXELON PATCH-treated group in Study 1, and for which the rate of occurrence was greater for patients treated with that dose of EXELON PATCH than for those treated with placebo.
5 mg/24 hours EXELON PATCH.
Table 1:
5 WARNINGS AND PRECAUTIONS • Hospitalization and, rarely, death have been reported due to application of multiple patches at same time. Ensure patients or caregivers receive instruction on proper dosing and administration. 1 ) • Gastrointestinal Adverse Reactions: May include significant nausea, vomiting, diarrhea, anorexia/decreased appetite, and weight loss, and may necessitate treatment interruption.
Dehydration may result from prolonged vomiting or diarrhea and can be associated with serious outcomes. 2 ) • Application-site reactions may occur with the patch form of rivastigmine. , increasing erythema, edema, papules, vesicles), and if symptoms do not significantly improve within 48 hours after patch removal.
1 Medication Errors Resulting in Overdose Medication errors with EXELON PATCH have resulted in serious adverse reactions; some cases have required hospitalization, and rarely, led to death. The majority of medication errors have involved not removing the old patch when putting on a new one and the use of multiple patches at one time.
4)] . 2 Gastrointestinal Adverse Reactions EXELON PATCH can cause gastrointestinal adverse reactions, including significant nausea, vomiting, diarrhea, anorexia/decreased appetite, and weight loss. Dehydration may result from prolonged vomiting or diarrhea and can be associated with serious outcomes.
1)] . 1)] . 6 mg/24 hours dose to reduce the possibility of severe vomiting and its potentially serious sequelae. A postmarketing report described a case of severe vomiting with esophageal rupture following inappropriate reinitiation of treatment of an oral formulation of rivastigmine without retitration after 8 weeks of treatment interruption.
Inform caregivers to monitor for gastrointestinal adverse reactions and to inform the physician if they occur. 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.
3)] . 2)] . • Known hypersensitivity to rivastigmine, other carbamate derivatives, or other components of the formulation. ( 4 ) • History of application-site reactions with rivastigmine transdermal patch suggestive of allergic contact dermatitis.
2 )
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(h) Wash hands with soap and water after removing the patch. In case of contact with eyes or if the eyes become red after handling the patch, rinse immediately with plenty of water, and seek medical advice if symptoms do not resolve.
Proportion of Adverse Reactions Observed With a Frequency of Greater Than or Equal to 2% and Occurring at a Rate Greater Than Placebo in Study 1 Abbreviation: ARs, adverse reactions. 4 mg/24 hours, 1% of patients who received the EXELON Capsule at doses up to 6 mg twice daily, and 0% of those who received placebo.
**Weight Decreased as presented in Table 1 is based upon clinical observations and/or adverse events reported by patients or caregivers. Body weight was also monitored at prespecified time points throughout the course of the clinical study.
4 mg/24 hours, 11% of patients who received the EXELON Capsule at doses up to 6 mg twice daily and 6% of those who received placebo. It is not clear how much of the weight loss was associated with anorexia, nausea, vomiting, and the diarrhea associated with the drug.
3 mg/24 hours group was nausea, followed by vomiting, fall, weight decreased, application-site erythema, decreased appetite, diarrhea and urinary tract infection (Table 3). 5 mg/24 hours group. Patients with nausea, vomiting, diarrhea and decreased appetite experienced these reactions more often during the first 4 weeks of the double-blind treatment phase.
These reactions decreased over time in each treatment group. Weight decreased was reported to have increased over time in each treatment group. Discontinuation Rates Table 2 displays the most common adverse reactions leading to discontinuation during the 48-week, double-blind treatment phase in Study 2.
Table 2:
Proportion of Most Common Adverse Reactions (Greater Than 1% at any Dose) Leading to Discontinuation During 48-week Double-Blind Treatment Phase in Study 2 Abbreviation: ARs, adverse reactions. 5 mg/24 hours group in Study 2, included dizziness and upper abdominal pain.
The percentage of patients with these reactions decreased over time in each treatment group (Table 3). 5 mg/24 hours groups.
Table 3:
Proportion of Adverse Reactions Over Time in the 48-week Double-Blind Treatment Phase (at least 3% in any Treatment Group) in Study 2 Abbreviations: DB, double blind; ARs, adverse reactions. *Decreased Weight as presented in Table 3 is based upon clinical observations and/or adverse events reported by patients or caregivers.
Body weight was monitored as a vital sign at pre-specified time points throughout the course of the clinical study. 3 mg/24 hours during the 48-week double-blind treatment period. 6 mg/24 hours EXELON PATCH were application-site erythema, fall, insomnia, vomiting, diarrhea, weight decreased, and nausea (Table 4).
Patients in the lower-dose group reported more events of agitation, urinary tract infection, and hallucinations than patients in the higher-dose group. 6 mg/24 hours (n = 359), who discontinued treatment due to adverse reactions were 21% and 14%, respectively.
3%). Otherwise, all AEs leading to discontinuation were reported in less than 1% of patients. 6 mg/24 hours group, included application-site erythema, fall, insomnia, vomiting, diarrhea, weight decreased, and nausea (Table 4). 1%) in severity.
3 mg/24 hours patch group, while the numbers of patients reporting moderate events were comparable between groups. 4%) than at the lower-dose (10%) treatment groups. 1%), all adverse reactions reported as severe occurred in less than 1% of patients in either treatment group.
Table 4:
Proportion of Adverse Reactions in the 24-week Double-BlindTreatment Phase (at least 5% in any Treatment Group) in Study 3 Abbreviation: ARs, adverse reactions. *Weight Decreased as presented in Table 4 is based upon clinical observations and/or adverse events reported by patients or caregivers.
Body weight was monitored as a vital sign at prespecified time points throughout the course of the clinical study. 3 mg/24 hours during the 24-week double-blind treatment. 3% of EXELON PATCH patients. 4% in the Chinese population and Japanese population, respectively.
Cases of skin irritation were captured separately on an investigator-rated skin irritation scale. 7% of EXELON PATCH patients in a double-blind controlled study in Japanese patients. Parkinson’s Disease Dementia 76-week International Open-Label Trial (Study 4) EXELON PATCH has been administered to 288 patients with mild-to-moderate Parkinson’s Disease Dementia in a single, 76-week, open-label, active-comparator safety study.
Of these, 256 have been treated for at least 12 weeks, 232 for at least 24 weeks, and 196 for at least 52 weeks. 5 mg/24 hours. EXELON Capsule (target maintenance dose of 12 mg/day) served as the active comparator and was administered to 294 patients.
Adverse reactions are presented in Table 5.
Table 5:
Proportion of Adverse Reactions Reported at a Rate Greater Than or Equal to 2% During the Initial 24-Week Period in Study 4 Adverse reaction EXELON PATCH Total patients studied 288 Percentage (%) Psychiatric disorders Insomnia 6 Depression 6 Anxiety 5 Agitation 3 Nervous system disorders Tremor 7 Dizziness 6 Somnolence 4 Hypokinesia 4 Bradykinesia 4 Cogwheel rigidity 3 Dyskinesia 3 Gastrointestinal disorders Abdominal pain 2 Vascular disorders Hypertension 3 General disorders and administration-site conditions Fall 12 Application-site erythema 11 Application-site irritation, pruritus, rash 3; 5; 2 Fatigue 4 Asthenia 2 Gait disturbance 4 Additional adverse reactions observed during the 76-week prospective, open-label study in patients with dementia associated with Parkinson’s disease treated with EXELON PATCH: Frequent (those occurring in at least 1/100 patients): dehydration, weight decreased, aggression, hallucination visual.
In patients with dementia associated with Parkinson’s disease, the following adverse drug reactions have only been observed in clinical trials with EXELON Capsules: Frequent: nausea, vomiting, decreased appetite, restlessness, worsening of Parkinson’s disease, bradycardia, diarrhea, dyspepsia, salivary hypersecretion, sweating increased; Infrequent (those occurring between 1/100 to 1/1000 patients): dystonia, atrial fibrillation, atrioventricular block.
2 Postmarketing Experience The following adverse reactions have been identified during post approval use of EXELON Capsules, EXELON Oral Solution, or EXELON PATCH. 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.
Cardiac Disorders :
Tachycardia, QTc prolongation, torsades de pointes Hepatobiliary Disorders : Abnormal liver function tests, hepatitis Nervous System Disorders : Parkinson’s disease (worsening), seizure, tremor Psychiatric Disorders : nightmares Skin and Subcutaneous Tissue Disorders : Allergic dermatitis, application-site hypersensitivity, blister, disseminated allergic dermatitis, Stevens-Johnson syndrome, urticaria Vascular Disorders : Hypertension
3 Skin Reactions Skin application-site reactions may occur with EXELON PATCH. These reactions are not in themselves an indication of sensitization. However, use of rivastigmine patch may lead to allergic contact dermatitis. , increasing erythema, edema, papules, vesicles), and if symptoms do not significantly improve within 48 hours after patch removal.
In these cases, treatment should be discontinued [see Contraindications (4)] . In patients who develop application-site reactions to EXELON PATCH, suggestive of allergic contact dermatitis and who still require rivastigmine, treatment should be switched to oral rivastigmine only after negative allergy testing and under close medical supervision.
It is possible that some patients sensitized to rivastigmine by exposure to rivastigmine patch may not be able to take rivastigmine in any form. There have been isolated postmarketing reports of patients experiencing disseminated allergic dermatitis when administered rivastigmine irrespective of the route of administration (oral or transdermal).
In these cases, treatment should be discontinued [see Contraindications (4)] . Patients and caregivers should be instructed accordingly. 4 Other Adverse Reactions From Increased Cholinergic Activity Neurologic Effects Extrapyramidal Symptoms : Cholinomimetics, including rivastigmine, may exacerbate or induce extrapyramidal symptoms.
Worsening of parkinsonian symptoms, particularly tremor, has been observed in patients with dementia associated with Parkinson’s disease who were treated with EXELON Capsules.
Seizures :
Drugs that increase cholinergic activity are believed to have some potential for causing seizures. However, seizure activity also may be a manifestation of Alzheimer's disease. Peptic Ulcers/Gastrointestinal Bleeding Cholinesterase inhibitors, including rivastigmine, may increase gastric acid secretion due to increased cholinergic activity.
, those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of rivastigmine have shown no significant increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding.
Use with Anesthesia Rivastigmine, as a cholinesterase inhibitor, is likely to exaggerate succinylcholine-type muscle relaxation during anesthesia. , bradycardia). The potential for this action may be particularly important in patients with sick sinus syndrome or other supraventricular cardiac conduction conditions.
Genitourinary Effects Although not observed in clinical trials of rivastigmine, drugs that increase cholinergic activity may cause urinary obstruction. Pulmonary Effects Drugs that increase cholinergic activity, including EXELON PATCH, should be used with care in patients with a history of asthma or obstructive pulmonary disease.
5 Impairment in Driving or Use of Machinery Dementia may cause gradual impairment of driving performance or compromise the ability to use machinery. The administration of rivastigmine may also result in adverse reactions that are detrimental to these functions.
During treatment with EXELON PATCH, routinely evaluate the patient's ability to continue driving or operating machinery.