Exelon Patch Dosage/Direction for Use

Posology: (See Table 6).

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Mild to moderately severe dementia of the Alzheimer's type or associated with Parkinson's disease: Initial dose and dose titration to the effective dose: Treatment is started with Exelon Patch 5 once a day. After a minimum of four weeks of treatment and if well tolerated, this dose should be increased to Exelon Patch 10, the recommended effective dose which can be continued for as long as a therapeutic benefit for the patient exists.
Individual responses to rivastigmine may vary and some patients may derive additional benefit from higher doses. Subsequent increases to Exelon Patch 15 should always be based on good tolerability of the current dose and may be considered only after a minimum of four weeks of treatment at each dose level.
Severe dementia of the Alzheimer's type: Initial dose and dose titration to the effective dose: Treatment is started with Exelon Patch 5 once a day. Subsequently the dose should be increased to Exelon Patch 10 and then to Exelon Patch 15 which is the demonstrated effective dose. These dose increases should always be based on good tolerability of the current dose and may be considered only after a minimum of four weeks of treatment at each dose level.
Interruption of treatment: Treatment should be temporarily interrupted if gastrointestinal adverse effects and/or worsening of existing extrapyramidal symptoms (e.g., tremor) are observed until these adverse effects resolve. Patch treatment can be resumed at the same dose if treatment is not interrupted for more than three days. Otherwise, treatment should be re-initiated with Exelon Patch 5.
If adverse effects persist on re-initiation of therapy, the dose should be temporarily reduced to the previous well-tolerated dose.
Switching from capsules or oral solution: Patients treated with Exelon capsules may be switched to Exelon patches as follows: A patient who is on a dose of <6 mg per day oral rivastigmine can be switched to Exelon Patch 5.
A patient who is on a stable and well tolerated dose of 9 mg per day oral rivastigmine can be switched to Exelon Patch 10. If the oral dose of 9 mg per day has not been stable and well tolerated, a switch to Exelon Patch 5 is recommended.
It is recommended to apply the first patch on the day following the last oral dose.
Special populations: Renal impairment: No dose adjustment is necessary for patients with renal impairment (see PHARMACOLOGY: Pharmacokinetics under Actions).
Hepatic impairment: Due to increased exposure in mild to moderate hepatic impairment, as observed with the oral formulation, dosing recommendations to titrate according to individual tolerability should be closely followed. Patients with clinically significant hepatic impairment may experience more dose dependent adverse reactions. Patients with severe hepatic impairment have not been studied. Particular caution should be exercised in titrating these patients (see PRECAUTIONS and PHARMACOLOGY: Pharmacokinetics under Actions).
Patients with body weight below 50 kg: Particular caution should be exercised in titrating patients with body weight below 50 kg above the recommended effective dose of Exelon Patch 10. They may experience more adverse reactions and may be more likely to discontinue due to adverse reactions (see PRECAUTIONS).
Pediatric patients (below 18 years): The use of Exelon in pediatric patients has not been studied and is therefore not recommended.
Method of administration: Exelon transdermal patches should be applied once a day to clean, dry, hairless, intact healthy skin on the upper or lower back, upper arm or chest, in a place which will not be rubbed by tight clothing. The patch should be replaced by a new one after 24 hours.
Important administration instructions (patients and caregivers should be instructed): The previous day's patch must be removed before applying a new one.
The patch should be replaced by a new one after 24 hours. Only one patch should be worn at a time (see PRECAUTIONS and OVERDOSAGE).
The patch should not be applied to skin that is red, irritated or cut. It is recommended to change the application site daily to avoid potential irritation, although consecutive patches can be applied to the same general anatomic site (e.g., another spot on the upper back).
The patch should be pressed down firmly for at least 30 seconds using the palm of the hand until the edges stick well.
If the patch falls off, a new one should be applied for the rest of the day, then it should be replaced at the same time as usual the next day.
The patch can be used in everyday situations, including bathing and during hot weather.
The patch should not be exposed to any external heat sources (e.g., excessive sunlight, saunas, solarium) for long periods of time.
The patch should not be cut into pieces.
Wash hands with soap and water after applying/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.