Exelon

Exelon Manufacturers

• Physicians Total Care, Inc.
  

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  Exelon | Physicians Total Care, Inc.

  

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  2.1 Alzheimer’s Disease Table 1: Patch Size, Drug Content and Nominal Delivery Rate Rivastigmine Nominal Dose Rivastigmine Content per Exelon Patch Exelon Patch Size 4.6 mg/24 hours 9 mg   5 cm2 9.5 mg/24 hours 18 mg 10 cm2 2.1.1 Initial Dose

  Treatment is started with Exelon Patch 4.6 mg/24 hours.

  After a minimum of four weeks of treatment and if well tolerated, this dose should be increased to Exelon Patch 9.5 mg/24 hours, which is the recommended effective dose.

  2.1.2 Maintenance Dose

  Dose increases should occur only after a minimum of 4 weeks at the previous dose, and only if the previous dose has been well tolerated. The maximum recommended dose is 9.5 mg/24 hours. Higher doses confer no appreciable additional benefit, and are associated with significant increase in the incidence of adverse events [see Adverse Reactions (6)].

  If adverse effects (e.g., nausea, vomiting, diarrhea, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several days and then restart at the same or next lower dose level. If treatment is interrupted for longer than several days, treatment should be reinitiated with the lowest daily dose and titrated as described above [also see Warnings and Precautions (5)].

  2.1.3 Switching from Capsules or Oral S olution

  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 less than 6 mg of oral rivastigmine can be switched to Exelon Patch 4.6 mg/24 hours.

  A patient who is on a total daily dose of 6-12 mg of oral rivastigmine may be directly switched to Exelon Patch 9.5 mg/24 hours.

  It is recommended to apply the first patch on the day following the last oral dose.

  2.1.4 Method of Administration

  Exelon Patch should be applied once a day to clean, dry, hairless, intact healthy skin in a place that will not be rubbed against by tight clothing. The upper or lower back is recommended as the site of application because the patch is less likely to be removed by the patient; however, when sites on the back are not accessible the patch can be applied to the upper arm or chest. The patch should not be applied to skin that is red, irritated, or cut. It is recommended that the site of patch application be changed daily to avoid potential irritation, although consecutive patches can be applied to the same anatomic site (e.g., another spot on the upper back).

  The patch should be pressed down firmly until the edges stick well. The patch can be used in situations that include bathing and hot weather.

  The patch should be replaced with a new one every 24 hours. Do not apply a new patch to that same spot for at least 14 days. Patients and caregivers should be instructed accordingly [see Patient Counseling Information (17)].

  2.1.5 Incompatibilities

  To prevent interference with the adhesive properties of the patch, the patch should not be applied to a skin area where cream, lotion or powder has recently been applied.

  2.1.6 Special Populations

  2.1.6.1 Hepatic Impairment

  Dosage adjustment is not necessary in hepatically impaired patients, as the dose of drug is individually titrated to tolerability.

  2.1.6.2 Renal Impairment

  No dose adjustment is necessary for patients with renal impairment.

  2.1.6.3 Low Body Weight

  Patients with body weight below 50 kg may experience more adverse events and may be more likely to discontinue due to adverse events. Particular caution should be exercised in titrating these patients above the recommended maintenance dose of Exelon Patch 9.5 mg/24 hours.

  2.2 Parkinson’s Disease Dementia

        See Dosage and Administration (2.1).

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• Physicians Total Care, Inc.
  

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  Exelon | Physicians Total Care, Inc.

  

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  Dementia of the Alzheimer’s Type

  The dosage of Exelon® (rivastigmine tartrate) shown to be effective in controlled clinical trials in Alzheimer’s disease is 6-12 mg/day, given as twice-a-day dosing (daily doses of 3 to 6 mg BID). There is evidence from the clinical trials that doses at the higher end of this range may be more beneficial.

        The starting dose of Exelon is 1.5 mg twice a day (BID). If this dose is well tolerated, after a minimum of 2 weeks of treatment, the dose may be increased to 3 mg BID. Subsequent increases to 4.5 mg BID and 6 mg BID should be attempted after a minimum of 2 weeks at the previous dose. If adverse effects (e.g., nausea, vomiting, abdominal pain, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several doses and then restart at the same or next lower dose level. If treatment is interrupted for longer than several days, treatment should be reinitiated with the lowest daily dose and titrated as described above (see WARNINGS). The maximum dose is 6 mg BID (12 mg/day).

  Dementia Associated with Parkinson’s Disease

  The dosage of Exelon shown to be effective in the single controlled clinical trial conducted in dementia associated with Parkinson’s disease is 3-12 mg/day, given as twice-a-day dosing (daily doses of 1.5-6 mg BID). In that medical condition, the starting dose of Exelon is 1.5 mg BID; subsequently, the dose may be increased to 3 mg BID and further to 4.5 mg BID and 6 mg BID, based on tolerability, with a minimum of 4 weeks at each dose.

        Exelon should be taken with meals in divided doses in the morning and evening.

        Recommendations for Administration: Caregivers should be instructed in the correct procedure for administering Exelon Oral Solution. In addition, they should be directed to the Instruction Sheet (included with the product) describing how the solution is to be administered. Caregivers should direct questions about the administration of the solution to either their physician or pharmacist (see PRECAUTIONS: Information for Patients and Caregivers).

        Patients should be instructed to remove the oral dosing syringe provided in its protective case, and using the provided syringe, withdraw the prescribed amount of Exelon Oral Solution from the container. Each dose of Exelon Oral Solution may be swallowed directly from the syringe or first mixed with a small glass of water, cold fruit juice or soda. Patients should be instructed to stir and drink the mixture.

        Exelon Oral Solution and Exelon Capsules may be interchanged at equal doses.

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• Rebel Distributors Corp
  

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  Exelon | Rebel Distributors Corp

  

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  2.1 Alzheimer’s Disease

  Table 1: Patch Size, Drug Content and Nominal Delivery Rate Rivastigmine Nominal Dose Rivastigmine Content per Exelon Patch Exelon Patch Size 4.6 mg/24 hours 9 mg   5 cm2 9.5 mg/24 hours 18 mg 10 cm2

  2.1.1

  Initial Dose

  Treatment is started with Exelon Patch 4.6 mg/24 hours.

  After a minimum of four weeks of treatment and if well tolerated, this dose should be increased to Exelon Patch 9.5 mg/24 hours, which is the recommended effective dose.

  2.1.2

  Maintenance Dose

  Dose increases should occur only after a minimum of 4 weeks at the previous dose, and only if the previous dose has been well tolerated. The maximum recommended dose is 9.5 mg/24 hours. Higher doses confer no appreciable additional benefit, and are associated with significant increase in the incidence of adverse events [see Adverse Reactions (6)].

  If adverse effects (e.g., nausea, vomiting, diarrhea, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several days and then restart at the same or next lower dose level. If treatment is interrupted for longer than several days, treatment should be reinitiated with the lowest daily dose and titrated as described above [also see Warnings and Precautions (5)].

  2.1.3

  Switching from Capsules or Oral S

  olution

  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 less than 6 mg of oral rivastigmine can be switched to Exelon Patch 4.6 mg/24 hours.

  A patient who is on a total daily dose of 6-12 mg of oral rivastigmine may be directly switched to Exelon Patch 9.5 mg/24 hours.

  It is recommended to apply the first patch on the day following the last oral dose.

  2.1.4

  Method of Administration

  Exelon Patch should be applied once a day to clean, dry, hairless, intact healthy skin in a place that will not be rubbed against by tight clothing. The upper or lower back is recommended as the site of application because the patch is less likely to be removed by the patient; however, when sites on the back are not accessible the patch can be applied to the upper arm or chest. The patch should not be applied to skin that is red, irritated, or cut. It is recommended that the site of patch application be changed daily to avoid potential irritation, although consecutive patches can be applied to the same anatomic site (e.g., another spot on the upper back).

  The patch should be pressed down firmly until the edges stick well. The patch can be used in situations that include bathing and hot weather.

  The patch should be replaced with a new one every 24 hours. Do not apply a new patch to that same spot for at least 14 days. Patients and caregivers should be instructed accordingly [see Patient Counseling Information (17)].

  2.1.5

  Incompatibilities

  To prevent interference with the adhesive properties of the patch, the patch should not be applied to a skin area where cream, lotion or powder has recently been applied.

  2.1.6

  Special Populations

  2.1.6.1 Hepatic Impairment

  Dosage adjustment is not necessary in hepatically impaired patients, as the dose of drug is individually titrated to tolerability.

  2.1.6.2 Renal Impairment

  No dose adjustment is necessary for patients with renal impairment.

  2.1.6.3 Low Body Weight

  Patients with body weight below 50 kg may experience more adverse events and may be more likely to discontinue due to adverse events. Particular caution should be exercised in titrating these patients above the recommended maintenance dose of Exelon Patch 9.5 mg/24 hours.

  2.2 Parkinson’s Disease Dementia

        See Dosage and Administration (2.1).

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• Novartis Pharmaceuticals Corporation
  

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  Exelon | Novartis Pharmaceuticals Corporation

  

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  2.1     Recommended Dosing

  Initial Dose

  Initiate treatment with one 4.6 mg/24 hours EXELON PATCH applied to the skin once daily [see Dosage and Administration (2.4)].

  Dose Titration

  Increase the dose only after a minimum of 4 weeks at the previous dose, and only if the previous dose has been tolerated. For mild to moderate AD and PDD patients, continue the 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/24 hours is the 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 (5.2), Adverse Reactions (6.1)].

  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 3 days or fewer, restart treatment with the same or lower strength EXELON PATCH. 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.

  2.2     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 (8.6) and Clinical Pharmacology (12.3)].

  Dosing Modifications in Patients with Low Body Weight

  Carefully titrate and monitor patients with low body weight (<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.

  2.3     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.

  2.4     Important Administration Instructions

  EXELON PATCH is for transdermal use on intact skin.

  (a) Do not use the patch if the pouch seal is broken or the patch is cut, damaged, or changed in any way.

  (b) 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.

  (c) Do not apply to skin that is red, irritated, or cut.

  (d) Replace the EXELON PATCH with a new patch every 24 hours. Instruct patients to only wear 1 patch at a time (remove the previous day’s patch before applying a new patch) [see Warnings and Precautions (5.1) and Overdosage (10)]. 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.

  (e) 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.

  (f) May wear the patch during bathing and in hot weather. But avoid long exposure to external heat sources (excessive sunlight, saunas, solariums).

  (g) Place used patches in the previously saved pouch and discard in the trash, away from pets or children.

  (h) Wash hands with soap and water after 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.

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  2.1       Dosing in Alzheimer’s Disease

  EXELON should be taken with meals in divided doses in the morning and evening.

  The recommended dosage of EXELON Oral Solution and Capsules in Alzheimer’s disease is 6 mg to 12 mg per day, administered twice a day (daily doses of 3 mg to 6 mg twice a day). There is evidence from the clinical trials that doses at the higher end of this range may be more beneficial.

  Initial Dose

  Initiate treatment with the 1.5 mg twice a day with EXELON.

  Dose Titration

  After a minimum of 2 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 2 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).

  2.2       Dosing in Parkinson’s Disease Dementia

  EXELON should be taken with meals in divided doses in the morning and evening.

  The dosage of EXELON shown to be effective in the single controlled clinical trial conducted in dementia associated with Parkinson’s disease is 3 mg to 12 mg per day, administered twice a day (daily doses of 1.5 mg to 6 mg twice a day).

  Initial Dose

  Initiate treatment with the 1.5 mg twice a day with EXELON.

  Dose Titration

  After a minimum of 4 weeks and if well tolerated, increase the dose to 3 mg twice a day. Subsequent increases to 4.5 mg twice a day and 6 mg twice a day should be attempted after a minimum of 4 weeks at the previous dose and if well tolerated. The maximum dose is 6 mg twice a day (12 mg per day).

  2.3       Interruption of Treatment

  If adverse effects (e.g., nausea, vomiting, abdominal pain, loss of appetite) cause intolerance during treatment, the patient should be instructed to discontinue treatment for several doses and then restart at the same or next lower dose level.

  If dosing is interrupted for 3 days or fewer, restart treatment with the same or lower dose of EXELON. If dosing is interrupted for more than 3 days, treatment should be restarted with 1.5 mg twice a day and titrated as described above [see Warnings and Precautions (5.1)].

  2.4       Dosing in Specific Populations

  Dosing Modifications in Patients with Renal Impairment

  Patients with moderate and severe renal impairment may be able to only tolerate lower doses.

  Dosing Modifications in Patients with Hepatic Impairment

  Patients with mild (Child-Pugh score 5 to 6) and moderate (Child-Pugh score 7 to 9) hepatic impairment may be able to only tolerate lower doses. No data are available on the use of rivastigmine in patients with severe hepatic impairment.

  Dosing Modifications in Patients with Low Body Weight

  Carefully titrate and monitor patients with low body weight (less than 50 kg) for toxicities (e.g., excessive nausea, vomiting), and consider reducing the dose if such toxicities develop.

  2.5       Important Administration Instructions

  Caregivers should be instructed in the correct procedure for administering EXELON Oral Solution. In addition, they should be directed to the Instruction Sheet (included with the product) describing how the solution is to be administered. Caregivers should direct questions about the administration of the solution to either their physician or pharmacist [see Patient Counseling Information (17)].

  Patients should be instructed to remove the oral dosing syringe provided in its protective case, and using the provided syringe, withdraw the prescribed amount of EXELON Oral Solution from the container. Each dose of EXELON Oral Solution may be swallowed directly from the syringe or first mixed with a small glass of water, cold fruit juice, or soda. Patients should be instructed to stir and drink the mixture.

  EXELON Oral Solution and EXELON Capsules may be interchanged at equal doses.

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