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Medication misuse and dosing errors resulting in overdose: Medication misuse and dosing errors with Exelon transdermal patch have resulted in serious adverse reactions; some cases have required hospitalization, and rarely led to death (see OVERDOSAGE). The majority of medication misuse and dosing errors have involved not removing the old patch when putting on a new one and the use of multiple patches at one time. Patients and their caregivers must be instructed on important administration instructions for Exelon transdermal patch (see DOSAGE & ADMINISTRATION).
Gastrointestinal disorders: The incidence and severity of adverse reactions generally increase with increasing doses, particularly at dose changes. If treatment is interrupted for more than three days, it should be re-initiated with Exelon Patch 5.
Gastrointestinal disorders such as nausea, vomiting and diarrhoea may occur when initiating treatment and/or increasing the dose. They may respond to a dose reduction. In other cases, use of Exelon patches has been discontinued. Patients who show signs or symptoms of dehydration resulting from prolonged vomiting or diarrhoea can be managed with iv fluids and dose reduction or discontinuation if recognized and treated promptly. Dehydration can be associated with serious outcomes (see ADVERSE REACTIONS).
Weight loss: Patients with Alzheimer's disease may lose weight while taking cholinesterase inhibitors, including rivastigmine. The patient's weight should be monitored during therapy with Exelon patches.
Other adverse reactions from increased cholinergic activity: As with other cholinergic substances care must be taken when prescribing Exelon patches: to patients with sick sinus syndrome or conduction defects (sino-atrial block, atrioventricular block) (see ADVERSE REACTIONS); to patients with active gastric or duodenal ulcers or patients predisposed to these conditions because gastric acid secretions may be increased; to patients predisposed to urinary obstruction and seizures because cholinomimetics may induce or exacerbate these diseases; to patients with a history of asthma or obstructive pulmonary disease.
Like other cholinomimetics, rivastigmine may induce or exacerbate extrapyramidal symptoms. In patients with dementia associated with Parkinson's disease who were treated with Exelon capsules, worsening of Parkinsonian symptoms, particularly tremor, has been observed. Such adverse events may also occur with Exelon patches, particularly with Exelon Patch 15 which provide higher exposure (AUC) than that achieved with twice-daily administration of Exelon 6 mg capsules.
QT prolongation and torsade de pointes: Electrocardiogram QT prolongation may occur in patients treated with certain cholinesterase inhibitor products including rivastigmine. Rivastigmine may cause bradycardia which constitutes a risk factor in the occurrence of torsade de pointes, predominantly in patients with risk factors. Caution is advised in patients at higher risk of developing torsade de pointes; for example, those with uncompensated heart failure, recent myocardial infarction, bradyarrhythmias, hypokalemia or hypomagnesemia, personal or family history of QT prolongation, or concomitant use with medicinal products known to induce QT prolongation and/or torsade de pointes. Clinical monitoring may also be required (see INTERACTIONS).
Application site reactions and skin reactions: Skin application site reactions may occur with Exelon Patch and are usually mild or moderate in intensity (see Application site reactions under ADVERSE REACTIONS). These reactions are not in themselves an indication of sensitization. However, use of rivastigmine patch may lead to allergic contact dermatitis.
Allergic contact dermatitis should be suspected if application site reactions spread beyond the patch size, if there is evidence of a more intense local reaction (e.g., 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).
In patients who develop application site reactions suggestive of allergic contact dermatitis to Exelon Patch 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 post-marketing reports of patients experiencing allergic dermatitis (disseminated) when administered rivastigmine irrespective of the route of administration (oral, transdermal). In these cases, treatment should be discontinued (see CONTRAINDICATIONS). Patients and caregivers should be instructed accordingly.
Special populations: Patients with body weight below 50 kg may experience more adverse reactions and may be more likely to discontinue due to adverse reactions. Carefully titrate and monitor these patients for adverse reactions (e.g., excessive nausea or vomiting) and consider reducing the maintenance dose to 4.6 mg/24 h transdermal patch if such adverse reactions develop (see DOSAGE & ADMINISTRATION).
Hepatic impairment: Patients with clinically significant hepatic impairment may experience more adverse reactions. Dosing recommendations to titrate according to individual tolerability should be closely followed. Patients with severe hepatic impairment have not been studied. Particular caution should be exercised in titrating these patients (see DOSAGE & ADMINISTRATION and PHARMACOLOGY: Pharmacokinetics under Actions).
Driving and using machines: Alzheimer's and Parkinson's disease dementia may cause gradual impairment of driving performance or compromise the ability to use machinery. Rivastigmine may induce dizziness and somnolence, mainly when initiating treatment or increasing the dose. Therefore, in patients with dementia treated with rivastigmine, the ability to continue driving or operating complex machines should be routinely evaluated by the treating physician.
