Rivastigmine Patch

Rivastigmine Patch Manufacturers

• Sandoz Inc
  

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  Rivastigmine Patch | Sandoz Inc

  

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  2.1 Recommended Dosing

  Initial Dose

  Initiate treatment with one 4.6 mg/24 hours rivastigmine transdermal system 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 rivastigmine transdermal system 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 rivastigmine transdermal system 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 rivastigmine transdermal system. If dosing is interrupted for more than 3 days, restart treatment with the 4.6 mg/24 hours rivastigmine transdermal system 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 rivastigmine transdermal system 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 SpecificPopulations (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 rivastigmine transdermal system if such toxicities develop.

  2.3 Switching to Rivastigmine Transdermal System from Rivastigmine Tartrate Capsules or Rivastigmine Tartrate Oral Solution

  Patients treated with rivastigmine tartrate capsules or oral solution may be switched to rivastigmine transdermal system 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  rivastigmine transdermal system. • 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  rivastigmine transdermal system.

  Instruct patients or caregivers to apply the first patch on the day following the last oral dose.

  2.4 Important Administration Instructions

  Rivastigmine transdermal system 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 rivastigmine transdermal system 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 rivastigmine transdermal system 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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