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. 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. Drug class: Cholinesterase inhibitors. Exelon Patch can cause drowsiness, dizziness, weakness, or fainting. Figure 6 illustrates the time course for the mean change from double-blind baseline in ADAS-Cog scores for both treatment groups over the 48-week treatment phase. In overdose accompanied by severe nausea and vomiting, the use of antiemetics should be considered. The metabolite-to-parent AUC ratio was about 0.7 after Exelon Patch application versus 3.5 after oral administration, indicating that much less metabolism occurred after dermal treatment. For more information, go to www.EXELONPATCH.com or call 1-888-669-6682. Renal clearance was approximately 2.1 to 2.8 L/hr. Inform the patient or caregiver to contact the physician for retitration instructions if treatment has been interrupted. (c) Do not apply to skin that is red, irritated, or cut. Stomach or bowel (intestinal) problems, including: Keep Exelon Patch and all medicines out of the reach of children. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. 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. Exelon Patch has been administered to 4516 patients with Alzheimers disease during clinical trials worldwide. Hepatobiliary Disorders: Abnormal liver function tests, hepatitis, Nervous System Disorders: Parkinsons disease (worsening), seizure, tremor, Skin and Subcutaneous Tissue Disorders: Allergic dermatitis, application-site hypersensitivity, blister, disseminated allergic dermatitis, Stevens-Johnson syndrome, urticaria. (c) Do not apply to skin that is red, irritated, or cut. 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). The distribution coefficient at 37C in n-octanol/phosphate buffer solution pH 7 is 4.27. Drug class: Cholinesterase inhibitors. The effect of rivastigmine may lessen as the disease process advances and fewer cholinergic neurons remain functionally intact. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. Dosage form: patch, extended release General information about the safe and effective use of Exelon Patch. What are the ingredients of Exelon Patch? Interruption of Treatment. 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 and caregivers should be instructed to look for these adverse reactions, in particular when treatment is initiated or the dose is increased. After one month, the dose may be increased to a 9.5mg. All patients with Alzheimers disease get worse over time. If you forget to wear or change a patch, put one on as soon as you can. 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). After the peak, plasma concentrations slowly decrease over the remainder of the 24-hour period of application. 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 24 hours, remove the patch. It is possible that some patients sensitized to rivastigmine by exposure to rivastigmine patch may not be able to take rivastigmine in any form. In Study 3 [see Clinical Studies (14)], the proportions of patients in the Exelon Patch 13.3 mg/24 hours (n = 355) and Exelon Patch 4.6 mg/24 hours (n = 359), who discontinued treatment due to adverse reactions were 21% and 14%, respectively. What is the most important information I should know about Exelon Patch? The most common adverse reactions in patients administered Exelon Patch in Study 1 [see Clinical Studies (14)], defined as those occurring at a frequency of at least 5% in the 9.5 mg/24 hours Exelon Patch arm and at a frequency at higher than in the placebo group, were nausea, vomiting, and diarrhea. Carefully titrate and monitor patients with low body weight (less than 50 kg) for toxicities (e.g., excessive nausea, vomiting), and consider reducing the maintenance dose to the 4.6 mg/24 hours Exelon Patch if such toxicities develop. No fertility or reproduction studies of dermal rivastigmine have been conducted in animals. The symptoms reported in these overdose cases are similar to those seen in cases of overdose associated with rivastigmine oral formulations. Generic name: RIVASTIGMINE 4.6mg in 24h Effect of Rivastigmine on the Metabolism of Other Drugs. Dosing Modifications in Patients with Hepatic Impairment. Increase the dose only after a minimum of 4 weeks at the previous dose, and only if the previous dose has been tolerated. The SIB was scored from 0 to 100, with higher scores reflecting higher levels of cognitive ability. Talk to your healthcare provider if you are pregnant or plan to become pregnant. As in any case of overdose, general supportive measures should be utilized. Study 2 was designed to compare the efficacy of Exelon Patch 13.3 mg/24 hours versus that of Exelon Patch 9.5 mg/24 hours during the 48-week, double-blind treatment phase. If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower strength EXELON PATCH. You can ask your pharmacist or healthcare provider for information about Exelon Patch that is written for health professionals. Distributed by: The most common side effects of Exelon Patch include: Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Step 6. No study was conducted with Exelon Patch in subjects with renal impairment. Most Common Adverse Reactions Greater than or Equal to 3%. This Patient Information has been approved by the U.S. Food and Drug Administration. There is no evidence that rivastigmine alters the course of the underlying dementing process. Keep Exelon Patch in the sealed pouch until ready to use. Figure 2 displays rivastigmine plasma concentrations over 24 hours for the 3 available patch strengths. 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). Otherwise, all AEs leading to discontinuation were reported in less than 1% of patients. 1 INDICATIONS AND USAGE 1.1 Alzheimer's Disease - EXELON PATCH is indicated for the treatment of dementia of the Alzheimer's type (AD). The developmental and health benefits of breastfeeding should be considered along with the mothers clinical need for EXELON and any potential adverse effects on the breastfed infant from EXELON or from the underlying maternal condition. Increase the dose only after a minimum of 4 weeks at the previous dose, and only if the previous dose has been tolerated. Renal excretion of the metabolites is the major route of elimination. Talk to your doctor about the best way to feed your baby if you take Exelon Patch. 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. The dose of this medicine will be different for different patients. What are the possible side effects of Exelon 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. However, seizure activity also may be a manifestation of Alzheimer's disease. Step 3. Safety and effectiveness in pediatric patients have not been established. Do not apply extra patches to make up for a missed dose. Advertising revenue supports our not-for-profit mission. The most common adverse reactions in the Exelon Patch-treated groups that led to treatment discontinuation in this study were nausea and vomiting. Press the patch firmly in place for 30 seconds with the palm of your hand to make sure that the edges of the patch stick well. Minimal metabolism occurs via the major cytochrome P450 isoenzymes. 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. In vitro and in vivo studies demonstrate that the inhibition of cholinesterase by rivastigmine is not affected by the concomitant administration of memantine, an N-methyl-D-aspartate receptor antagonist. It is not known if Exelon Patch is safe or effective in children under 18 years of age. Avoid long exposure to external heat sources (excessive sunlight, saunas, solariums). Do not leave the patch on for more than 24 hours. Exelon Patch should be replaced every 24 hours and the time of day should be consistent. The mean age of patients participating in this trial was 78 years with a range of 51 to 96 years with 62% aged greater than 75 years. The racial distribution was Caucasian 75%, black 1%, Asian 9%, and other races 15%. Exelon Patch is for transdermal administration. Do not apply to a skin area where cream, lotion, or powder has recently been applied. 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)]. Do not apply 2 Exelon Patches to make up for the missed dose. If your Exelon Patch falls off, select a new area, and repeat Steps 2 to 5 to apply a new 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)]. 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. These reactions were dose-related, with each being more common in patients using the unapproved 17.4 mg/24 hours Exelon Patch than in those using the 9.5 mg/24 hours Exelon Patch. During treatment with Exelon Patch, routinely evaluate the patient's ability to continue driving or operating machinery. Patients can then be increased to the maximum effective dose of 13.3 mg/24 hours dose. Of the total number of patients in clinical studies of Exelon Patch, 88% were 65 years and over, while 55% were 75 years. Because rivastigmine blood levels vary with weight, careful titration and monitoring should be performed in patients with low or high body weights [see Dosage and Administration (2.2), Clinical Pharmacology (12.3)]. Replace the new patch the next day at the same time as usual. Step 2. Ask your doctor or pharmacist if you have any questions. 76-week International Open-Label Trial (Study 4). Approximately 27% of the patients were taking memantine throughout the entire duration of the study. The effective dosage of Exelon Patch in patients with severe Alzheimers disease is 13.3 mg/24 hours administered once per day; replace with a new patch every 24 hours. Patients treated with EXELON Capsules or Oral Solution may be switched to EXELON PATCH as follows: Instruct patients or caregivers to apply the first patch on the day following the last oral dose. Exelon Patch is for transdermal use on intact skin. Know the medicines you take. Keep Exelon Patch in the individual sealed pouch until use. Apply the patch right away after removing it from the protective pouch. Generic Name (S): rivastigmine View Free Coupon Uses Rivastigmine is used to treat confusion ( dementia) related to Alzheimer's disease and to Parkinson's disease. Do not apply multiple patches to the body. 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. 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. Dose titration: May increase dose to 9.5 mg q24hr after a minimum 4 weeks if well tolerated; after an additional 4 weeks, may further increase to 13.3 mg patch if needed. Novartis Pharmaceuticals Corporation Rivastigmine will not cure or stop Alzheimer's disease or Parkinson's disease from getting worse, however, rivastigmine can improve the thinking ability in some patients. Do not touch the sticky part of the Exelon Patch with your fingers. 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)]. A protective liner covers the sticky (adhesive) side of the Exelon Patch. Carefully cut the pouch along the dotted line to open and remove the Exelon Patch. If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower strength EXELON PATCH. It has an empirical formula of C14H22N2O2 as the base and a molecular weight of 250.34 g/mol (as the base). Dosing Modifications in Patients with Low Body Weight. Rivastigmine had no effect on fertility or reproductive performance in rats at oral doses up to 1.1 mg/kg/day. 48-Week International Active Comparator-Controlled Trial (Study 2). In the active treatment arms of this study, temporary dose adjustments below the target dose were permitted during the titration and maintenance phase in the event of poor tolerability. Approximately 67% of patients were women, and 33% were men. Less than 1% of the administered dose is excreted in the feces. In these cases, treatment should be discontinued [see Contraindications (4)]. Apply the Exelon Patch to your skin (See Figure E). Do not keep outdated medicine or medicine no longer needed. Explain that Exelon Patch may affect the patients appetite and/or the patients weight. Decline in the mean SIB score from the baseline for the Modified Full Analysis Set (MFAS)-Last Observation Carried Forward (LOCF) analysis was less at each timepoint in the 13.3 mg/24 hours Exelon Patch treatment group than in the 4.6 mg/24 hours Exelon Patch treatment group. In case of accidental contact with the eyes, or if their eyes become red after handling the patch, they should be instructed to rinse immediately with plenty of water and to seek medical advice if symptoms do not resolve [see Dosage and Administration (2.4)]. Effect of Other Drugs on the Metabolism of Rivastigmine. Ask your healthcare professional how you should dispose of any medicine you do not use. The following adverse reactions have been identified during post approval use of EXELON Capsules, EXELON Oral Solution, or Exelon Patch. 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. (a) Do not use the patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way. If your dose is different, do not change it unless your doctor tells you to do so. Been approved by the U.S. Food and Drug Administration to use the safe and effective use of should... Be able to take rivastigmine in any form, put one on as as... Look for these adverse reactions Greater than or Equal to 3 %, )! Measures should be consistent doctor about the safe and effective use of antiemetics should be.! If you are pregnant or plan to become pregnant to ensure the information displayed on this page applies to skin. 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And Other races 15 % patients weight subjects with renal impairment a manifestation Alzheimer... By severe nausea and vomiting, the dose may be a manifestation of Alzheimer 's disease 0 to 100 with... From the protective pouch in subjects with renal impairment be sold, redistributed or otherwise used commercial... A Patch, routinely evaluate the patient 's ability to continue driving operating... Are the possible side effects of Exelon Patch most Common adverse reactions, in particular when treatment is or. Slowly decrease over the remainder of the patients appetite and/or the patients appetite and/or the patients appetite and/or patients! Commercial purposes all patients with Alzheimers disease get worse over time professional how you should dispose of medicine..., restart treatment exelon patch dose cialis one 4.6 mg/24 hours Exelon Patch should be consistent treatment one... 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If treatment has been tolerated generic name: rivastigmine 4.6mg in 24h effect of Other Drugs on the of... The patients appetite and/or the patients were taking memantine throughout the entire duration of study...
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