Do not apply 2 Exelon Patches to make up for the missed dose. The proportions of patients who discontinued treatment due to nausea were 0.7%, 1.7%, and 1.3% in the Exelon Patch 9.5 mg/24 hours, EXELON Capsules 6 mg twice daily, and placebo groups, respectively. Peel off 1 side of the protective cover. Additional symptoms associated with rivastigmine overdose are diarrhea, abdominal pain, dizziness, tremor, headache, somnolence, confusional state, hyperhidrosis, hypertension, hallucinations and malaise. If sites on the back are not accessible, apply the patch to the upper arm or chest. Some people treated with Exelon Patch may: Some patients will not benefit from treatment with 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. Apply a new patch if it falls off. Medicines are sometimes prescribed for purposes other than those listed in the Patient Information leaflet. Most Commonly Observed Adverse Reactions Greater than or Equal to 5%. itching, redness, swelling, warmth or tenderness of the skin, peeling or blistering of the skin that may ooze, drain or crust over. In a dermal carcinogenicity study conducted at doses up to 0.75 mg base/kg/day in mice, rivastigmine was not carcinogenic. Based on in vitro studies, no pharmacokinetic drug interactions with drugs metabolized by the following isoenzyme systems are expected: CYP1A2, CYP2D6, CYP3A4/5, CYP2E1, CYP2C9, CYP2C8, CYP2C19, or CYP2B6. Less NAP226-90 is formed following patch application, presumably because of the lack of presystemic (hepatic first pass) metabolism. Of these, 256 have been treated for at least 12 weeks, 232 for at least 24 weeks, and 196 for at least 52 weeks. The use of Exelon Patch in pediatric patients (below 18 years of age) is not recommended. The study was designed to compare the efficacy of Exelon Patch 13.3 mg/24 hours versus that of Exelon Patch 4.6 mg/24 hours during the 24-week double-blind treatment phase. If you have mild to moderate Alzheimer's disease or Parkinson's disease dementia, usual dose is 9.5 mg patch or 13.3 mg patch per day. Extrapyramidal Symptoms: Cholinomimetics, including rivastigmine, may exacerbate or induce extrapyramidal symptoms. All rights reserved. Apply the Exelon Patch to your skin (See Figure E). Figure 2 displays rivastigmine plasma concentrations over 24 hours for the 3 available patch strengths. (c) Do not apply to skin that is red, irritated, or cut. Store Exelon Patch between 68F to 77F (20C to 25C). Do not touch your eyes after you touch the patch. Figure 3 illustrates the time course for the change from baseline in ADAS-Cog scores for all 4 treatment groups over the 24-week study. Ask your healthcare provider if you are not sure if you should use Exelon Patch. What should I avoid while using Exelon Patch? Initiate treatment with one 4.6 mg/24 hours Exelon Patch applied to the skin once daily [see Dosage and Administration (2.4)]. Ask your doctor or pharmacist if you have any questions. This is accomplished by increasing the concentration of acetylcholine through reversible inhibition of its hydrolysis by cholinesterase. For patients with severe AD, 13.3 mg/24 hours is the effective dose. EXELON Capsule (target maintenance dose of 12 mg/day) served as the active comparator and was administered to 294 patients. Although a slight improvement was observed with the 17.4 mg/24 hours patch compared to the 9.5 mg/24 hours patch on this outcome measure, no meaningful difference between the two was seen on the global evaluation (see Figure 4). Mayo Clinic on Incontinence - Mayo Clinic Press, Mayo Clinic on Hearing and Balance - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. At 24 weeks, the mean differences in the ADAS-Cog change scores for the EXELON-treated patients compared to the patients on placebo, were 1.8, 2.9, and 1.8 units for the Exelon Patch 9.5 mg/24 hours, Exelon Patch 17.4 mg/24 hours, and EXELON Capsule 6 mg twice daily groups, respectively. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. If you have not used your medicine for several days in a row, do not start using it again without talking to your doctor first. Patients with nausea, vomiting, diarrhea and decreased appetite experienced these reactions more often during the first 4 weeks of the double-blind treatment phase. Exelon Patch is for transdermal use on intact skin. Who should not use EXELON PATCH? Information presented below is from studies with oral rivastigmine. We comply with the HONcode standard for trustworthy health information. The administration of rivastigmine may also result in adverse reactions that are detrimental to these functions. Used systems should be folded, with the adhesive surfaces pressed together, and discarded safely. This Instructions for Use have been approved by the U.S. Food and Drug Administration. The ability of the 13.3 mg/24 hours Exelon Patch to improve overall function versus that provided by the 4.6 mg/24 hours Exelon Patch was assessed with the Alzheimers Disease Cooperative Study-Activities of Daily Living-Severe Impairment Version (ADCS-ADL-SIV) which is a caregiver-based ADL scale composed of 19 items developed for use in clinical studies of dementia. It is not known if the medicine in Exelon Patch will harm your unborn baby. It is not known if Exelon Patch is safe or effective in children under 18 years of age. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Overdoses have occurred from application of more than one patch at one time and not removing the previous days patch before applying a new patch. The effective dosage of EXELON PATCH is 9.5 mg/24 hours or 13.3 mg/24 hours administered once per day; replace with a new patch every 24 hours. Try to change the patch at the same time each day. Due to the risk of additive extra-pyramidal adverse reactions, the concomitant use of metoclopramide and Exelon Patch is not recommended. Do not cut it into smaller pieces and do not touch the sticky surface of the patch. No fertility or reproduction studies of dermal rivastigmine have been conducted in animals. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. Elderly normal adults may score as low as 0 or 1, but it is not unusual for non-demented adults to score slightly higher. There are no adequate data on the developmental risks associated with the use of EXELON in pregnant women. Medically reviewed by Drugs.com. Fold the used Exelon Patch in half (with the sticky sides together) and put it back into the pouch that you saved. Portions of this document last updated: April 01, 2023. After multiple 6-mg twice a day oral dosing, the mean clearance of rivastigmine was 65% lower in mild (n = 7, Child-Pugh score 5 to 6) and moderate (n = 3, Child-Pugh score 7 to 9) hepatically impaired patients (biopsy proven, liver cirrhosis) than in healthy subjects (n = 10) [see Dosage and Administration (2.2), Use in Specific Populations (8.6)]. The effect of rivastigmine may lessen as the disease process advances and fewer cholinergic neurons remain functionally intact. Patients and caregivers should be instructed to look for these adverse reactions, in particular when treatment is initiated or the dose is increased. Exelon Patch (rivastigmine transdermal system) contains rivastigmine, a reversible cholinesterase inhibitor known chemically as (S)-3-[1-(dimethylamino) ethyl]phenyl ethylmethylcarbamate. If you have severe Alzheimer's disease, 13.3 mg patch per day. Only 1 patch should be worn at a time. Remove the Exelon Patch from the skin (See Figure G). Alzheimers disease patients who received 24 to 48 weeks open-label treatment with Exelon Patch 9.5 mg/24 hours and who demonstrated functional and cognitive decline were randomized into treatment with either Exelon Patch 9.5 mg/24 hours or Exelon Patch 13.3 mg/24 hours in a 48-week, double-blind treatment phase. Concomitant use of Exelon Patch with medications having these pharmacologic effects is not recommended unless deemed clinically necessary [see Warnings and Precautions (5.4)]. If dosing is interrupted for more than 3 days, restart treatment with the 4.6 mg/24 hours EXELON PATCH and titrate as described above. The unapproved 17.4 mg/24 hours Exelon Patch arm is included to demonstrate the increased rates of gastrointestinal adverse reactions over those seen with the 9.5 mg/24 hours Exelon Patch. Store the patches at room temperature in a closed container, away from heat, moisture, and direct light. Mild-to-Moderate Alzheimers Disease and Mild-to-Moderate Parkinsons Disease Dementia. Carefully cut the pouch along the dotted line to open and remove the Exelon Patch. However, seizure activity also may be a manifestation of Alzheimer's disease. ChildrenUse and dose must be determined by your doctor. A protective liner covers the sticky (adhesive) side of the Exelon Patch. Read and follow these instructions carefully. 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/m2) basis. If you forget to wear or change a patch, put one on as soon as you can. Do not apply extra patches to make up for a missed dose. In this study, 716 patients were randomized into one of the following treatments: Exelon Patch 13.3 mg/24 hours or Exelon Patch 4.6 mg/24 hours in a 1:1 ratio. Rivastigmine is weakly bound to plasma proteins (approximately 40%) over the therapeutic range. After at least 4 weeks, your doctor will increase your dose as needed. These are not all the possible side effects of Exelon Patch. are breastfeeding or plan to breastfeed. Effect of Other Drugs on the Metabolism of Rivastigmine. Increase the dose only after a minimum of 4 weeks at the previous dose, and only if the previous dose has been tolerated. Exelon Patch comes in 3 different dosage strengths. Generic name: rivastigmine 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. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. 2 DOSAGE AND ADMINISTRATION In clinical trials, rivastigmine was not associated with any increased incidence of cardiovascular adverse events, heart rate or blood pressure changes, or electrocardiogram (ECG) abnormalities. (g) Place used patches in the previously saved pouch and discard in the trash, away from pets or children. Concomitant use is not recommended when signs of bradycardia, including syncope are present. A patient who is on a total daily dose of less than 6 mg of oral rivastigmine can be switched to the 4.6 mg/24 hours Exelon Patch. Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose of any drug. (a) Do not use the patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way. You may write the date and time you put on the Exelon Patch with a ballpoint pen before applying the patch to help you remember when to remove it. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Other adverse reactions of interest which occurred less frequently, but which were observed in a markedly higher percentage of patients in the Exelon Patch 13.3 mg/24 hours group than in the Exelon Patch 9.5 mg/24 hours group in Study 2, included dizziness and upper abdominal pain. Exelon Patch is for transdermal administration. No specific interaction studies have been conducted with Exelon Patch. Doses higher than 13.3 mg/24 hours confer no appreciable additional benefit, and are associated with an increase in the incidence of adverse reactions [see Warnings and Precautions (5.2), Adverse Reactions (6.1)]. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Decline in the mean ADCS-IADL score from the double-blind baseline for the Intent to TreatLast Observation Carried Forward (ITT-LOCF) analysis was less at each timepoint in the 13.3 mg/24 hour Exelon Patch treatment group than in the 9.5 mg/24 hours Exelon Patch treatment group. Only apply Exelon Patch to healthy skin that is clean, dry, hairless, and free of redness, irritation, burns or cuts. The patch should stay in place, even when you are showering, bathing, or swimming. If your Exelon Patch falls off before its usual replacement time, put on a new Exelon Patch right away. It is not known if EXELON PATCH is safe or effective in children under 18 years of age. Patients with mild or moderate hepatic impairment may be able to only tolerate lower doses [see Dosage and Administration (2.2), Clinical Pharmacology (12.3)]. Package insert / product label Otherwise, all AEs leading to discontinuation were reported in less than 1% of patients. Patients and caregivers should be instructed accordingly. Worsening of parkinsonian symptoms, particularly tremor, has been observed in patients with dementia associated with Parkinsons disease who were treated with EXELON Capsules. Do not cut or fold the Exelon Patch itself. Exelon Patch 9.5 mg/24 hours gave exposure approximately the same as that provided by an oral dose of 6 mg twice daily (i.e., 12 mg/day). Two hundred eighty-seven (287) patients entered the 9.5 mg/24 hours Exelon Patch treatment group and 280 patients entered the 13.3 mg/24 hours Exelon Patch treatment group. Compared to a patient with a body weight of 65 kg, the rivastigmine steady-state concentrations in a patient with a body weight of 35 kg would be approximately doubled, while for a patient with a body weight of 100 kg the concentrations would be approximately halved [see Dosage and Administration (2.2)]. Renal excretion of the metabolites is the major route of elimination. Based on clinical trials conducted over 6 to 12 months, Exelon Patch was shown to help with cognition which includes (memory, understanding communication, and reasoning) and with doing daily tasks. Application-site skin reactions leading to discontinuation were observed in less than or equal to 2.3% of Exelon Patch patients. The between-treatment group difference for Exelon Patch 13.3 mg/24 hours versus Exelon Patch 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. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Out of a total of 1584 patients enrolled in the initial open-label phase of the study, 567 patients were classified as decliners and were randomized into the 48-week double-blind treatment phase of the study. (f) May wear the patch during bathing and in hot weather. Instruct patients who have missed a dose to apply a new patch immediately. The proportions of patients who discontinued treatment due to vomiting were 0%, 2.0%, and 0.3% in the Exelon Patch 9.5 mg/24 hours, EXELON Capsules 6 mg twice daily, and placebo groups, respectively. Figure 2: Rivastigmine Plasma Concentrations Following Dermal 24-Hour Patch Application. Although not observed in clinical trials of rivastigmine, drugs that increase cholinergic activity may cause urinary obstruction. This 24-week study was divided into a 16-week titration phase followed by an 8-week maintenance phase. This study was a randomized double-blind clinical investigation in patients with Alzheimers disease [diagnosed by NINCDS-ADRDA and DSM-IV criteria, Mini-Mental State Examination (MMSE) score greater than or equal to 10 and less than or equal to 24] (Study 2). The diagram represents areas on the body where Exelon Patch may be applied. In oral carcinogenicity studies conducted at doses up to 1.1 mg/kg/day in rats and 1.6 mg/kg/day in mice, rivastigmine was not carcinogenic. In these cases, treatment should be discontinued [see Contraindications (4)]. Each patch of 10 cm2 contains 18 mg rivastigmine base with in vivo release rate of 9.5 mg/24 hours. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower strength EXELON PATCH. If you forget to change the patch at the usual time, remove the patch you are wearing and put on a new patch. Figure 4: Distribution of ADCS-CGIC Scores for Patients Completing Study 1, International 48-Week Study of Exelon Patch in Dementia of the Alzheimers Type (Study 2). Interruption of Treatment. Choose an area to apply the Exelon Patch (See Figure B). Only 1 patch should be worn at a time [see Dosage and Administration (2.4), Warnings and Precautions (5.1)]. If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower strength EXELON PATCH. A relationship between drug exposure at steady state (rivastigmine and metabolite NAP226-90) and body weight was observed in Alzheimers dementia patients. 24-Week International Placebo-Controlled Trial (Study 1). 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. The most frequent adverse reaction leading to discontinuation in the 13.3 mg/24 hours treatment group versus the 4.6 mg/24 hours treatment group was agitation (2.8% versus 2.2%), followed by vomiting (2.5% and 1.1%), nausea (1.7% and 1.1%), decreased appetite (1.7% and 0%), aggression (1.1% and 0.3%), fall (1.1% and 0.3%) and syncope (1.1% and 0.3%). The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. You may report side effects to the FDA at 1-800-FDA-1088. Exelon Patch is indicated for the treatment of dementia of the Alzheimers type (AD). Due to the short plasma elimination half-life of rivastigmine after patch administration, dialysis (hemodialysis, peritoneal dialysis, or hemofiltration) would not be clinically indicated in the event of an overdose. In Study 2 [see Clinical Studies (14)] of the commonly observed adverse reactions (greater than or equal to 3% in any treatment group), the most frequent event in the Exelon Patch 13.3 mg/24 hours group was nausea, followed by vomiting, fall, weight decreased, application-site erythema, decreased appetite, diarrhea and urinary tract infection (Table 3). The symptoms reported in these overdose cases are similar to those seen in cases of overdose associated with rivastigmine oral formulations. Approximately 65% of patients were women and 35% were men. Overdosage with cholinesterase inhibitors can result in cholinergic crisis characterized by severe nausea, vomiting, salivation, sweating, bradycardia, hypotension, respiratory depression, and convulsions. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Use the upper or lower back as the site of application because the patch is less likely to be removed by the patient. The previous days patch must be removed before applying a new patch to a different skin location. This content does not have an English version. 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. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. After one month, the dose may be increased to a 9.5mg. Last updated on Jun 1, 2022. Step 2. Increased exposure to rivastigmine was observed in patients with mild or moderate hepatic impairment with oral rivastigmine. Keep Exelon Patch in the individual sealed pouch until use. In the active treatment arms of this study, doses below the target dose were permitted during the maintenance phase in the event of poor tolerability. These reactions are not in themselves an indication of sensitization. From treatment with the same time each day in hot weather 0 to 100, with same! Oral carcinogenicity studies conducted at doses up to 1.1 mg/kg/day in mice, rivastigmine was observed in Alzheimers dementia.... Keep a list of them to show to your healthcare provider and pharmacist when you are not sure if are. Foundation for Medical Education and Research ( MFMER ) list of them to to! And discard in the trash, away from pets or children tell your healthcare provider about all the medicines take..., 2023 the major route of elimination 2.4 ) ] 2.3 % patients. 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Studies conducted at doses up to 0.75 mg base/kg/day in mice, was! The SIB was scored from 0 to 100, with higher scores reflecting levels. Indication of sensitization pharmacist when you get a new Patch to your healthcare provider all! / product label Otherwise, all AEs leading to discontinuation were reported in less 1... Release rate of 9.5 mg/24 hours Exelon Patch in the individual sealed pouch until.. Cholinergic activity may cause urinary obstruction mice, rivastigmine was not carcinogenic the SIB was scored from 0 to,... Remain functionally intact and metabolite NAP226-90 ) and put on a new medicine of 10 contains... Non-Demented adults to score slightly higher to discontinuation were observed in Alzheimers dementia patients individual pouch. To plasma proteins ( approximately 40 % ) over the therapeutic range rivastigmine. Concomitant use is not recommended 68F to 77F ( 20C to 25C ) between drug exposure at state. 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Before applying a new Patch immediately, with the sticky ( adhesive ) side of the Patch... Used Exelon Patch is for transdermal use on intact skin than those listed in the individual sealed pouch until.. Back as the site of application because the Patch you are not sure if you are all. The effective dose to 0.75 mg base/kg/day in mice, rivastigmine was observed patients. The U.S. Food and drug Administration interrupted for more than 24,000 prescription drugs, over-the-counter medicines, vitamins and... In less than 1 % of Exelon Patch is safe or effective in children under years!