"Today, the U.S. Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer's disease, before the onset of noticeable (overt) dementia.
- Patient Information:
Details with Side Effects
Parkinson's Disease Dementia
Exelon Patch is indicated for the treatment of mild to moderate dementia associated with Parkinson's disease (PDD).
DOSAGE AND ADMINISTRATION
Initiate treatment with one 4.6 mg/24 hours Exelon Patch applied to the skin once daily.
Increase the dose only after a minimum of 4 weeks at the previous dose, and only if the previous dose has been well tolerated. For mild to moderate AD and PDD patients continue the recommended effective dose of 9.5 mg/24 hours for as long as therapeutic benefit persists. Patients can then be increased to the maximum effective dose of 13.3 mg/24 hours dose. For patients with severe AD, 13.3 mg/24hours is the recommended effective dose. 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, ADVERSE REACTIONS].
Mild to Moderate Alzheimer's Disease and Mild to Moderate Parkinson's Disease Dementia
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.
Severe Alzheimer's Disease
The effective dosage of Exelon Patch in patients with severe Alzheimer's disease is 13.3 mg/24 hours administered once per day; replace with a new patch every 24 hours.
Interruption of Treatment
If dosing is interrupted for three days or fewer, restart treatment with the same or lower strength Exelon Patch. If dosing is interrupted for more than three days, restart treatment with the 4.6 mg/24 hours Exelon Patch and titrate as described above.
Dosing in Specific Populations
Dosing Modifications in Patients with Hepatic Impairment
Consider using the 4.6 mg/24 hours Exelon Patch as both the initial and maintenance dose in patients with mild (Child-Pugh score 5 to 6) to moderate (Child-Pugh score 7 to 9) hepatic impairment [see Use In Specific Populations, CLINICAL PHARMACOLOGY].
Dosing Modifications in Patients with Low Body Weight
Because rivastigmine blood levels vary with weight [see Use In Specific Populations, CLINICAL PHARMACOLOGY], carefully titrate and monitor patients with low body weight ( < 50kg) 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.
Switching to Exelon Patch from Exelon Capsules or Exelon Oral Solution
Patients treated with Exelon capsules or oral solution may be switched to Exelon Patch as follows:
- A patient who is on a total daily dose of < 6 mg of oral rivastigmine can be switched to the 4.6 mg/24 hours Exelon Patch.
- A patient who is on a total daily dose of 6 mg to 12 mg of oral rivastigmine can be switched to the 9.5 mg/24 hours Exelon Patch.
Instruct patients or caregivers to apply the first patch on the day following the last oral dose.
Important Administration Instructions
Exelon Patch is for transdermal use on intact skin.
- Do not use the patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way.
- 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.
- Do not apply to skin that is red, irritated, or cut.
- Replace the Exelon Patch with a new patch every 24 hours. Instruct patients to only wear one patch at a time (remove the previous day's patch before applying a new patch) [see WARNINGS AND PRECAUTIONS and OVERDOSAGE]. 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.
- Change the site of patch application daily to minimize potential irritation, although a new patch can be applied to the same general anatomic site (e.g., another spot on the upper back) on consecutive days. Do not apply a new patch to the same location for at least 14 days.
- May wear the patch during bathing and in hot weather. But avoid long exposure to external heat sources (excessive sunlight, saunas, solariums).
- Place used patches in the previously saved pouch and discard in the trash, away from pets or children.
Dosage Forms And Strengths
Exelon Patch is available in three strengths. Each patch has a beige backing layer labeled as either:
- EXELON® PATCH 4.6 mg/24 hours, AMCX
- EXELON® PATCH 9.5 mg/24 hours, BHDI
- EXELON® PATCH 13.3 mg/24 hours, CNFU
Storage And Handling
Exelon Patch: 4.6 mg/24 hours
Each patch of 5 cm² contains 9 mg rivastigmine base with in vivo release rate of 4.6 mg/24 hours.
Carton of 30………………………NDC 0078-0501-15
Exelon Patch: 9.5 mg/24 hours
Each patch of 10 cm² contains 18 mg rivastigmine base with in vivo release rate of 9.5 mg/24 hours.
Carton of 30………………………..NDC 0078-0502-15
Exelon Patch: 13.3 mg/24 hours
Each patch of 15 cm² contains 27 mg rivastigmine base with in vivo release rate of 13.3 mg/24 hours.
Carton of 30………………………..NDC 0078-0503-15
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep Exelon Patch in the individual sealed pouch until use. Each pouch contains one patch. Used systems should be folded, with the adhesive surfaces pressed together, and discarded safely.
Manufactured by: LTS Lohmann Therapy Systems Corporation West Caldwell, New Jersey 07006. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. Revised: June 2013·
Last reviewed on RxList: 7/30/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Exelon Patch Information
Exelon Patch - User Reviews
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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