University of Washington

AIDS Clinical Trials Group

Drug Information Sheet

 

Selegiline Transdermal System (STS)

 

Other Names: Carbex®

Manufacturer: Somerset Pharmaceuticals, Inc.

What is it?

Selegiline is a medication that is used in combination with other medications to treat people with Parkinson’s Disease, a disease characterized by difficulty with movement and muscle control.  It is thought that selegiline might be beneficial in treating other conditions, including depression, Attention Deficit Hyperactivity Disorder, and HIV-associated cognitive impairment.  The purpose of this study is to determine if selegiline is useful for HIV-associated cognitive impairment and to show that it is safe to use.

 

How does it work?

The exact mechanism of how selegiline works is not known.  It is possible that selegiline decreases the formation of oxygen-free radicals which can damage neurons.  It may also directly increase the formation of protective antioxidant enzymes.  Also, it has been suggested that selegiline may have a “rescue effect” on dying or injured neurons.  These are all possible ways in which selegiline may work to improve cognitive function in people with HIV-associated cognitive impairment.

 

How do I use the patch?

·         Selegiline Transdermal System (STS) or matching placebo will be supplied in individual foil pouches

·         Apply a new Selegiline Transdermal System every day at approximately the same time each day (i.e. every morning, or every afternoon, or every evening) to a different site on the body

·         Select the site for the new patch and wash the area gently with soap and lukewarm water.  Rinse with clean water until all soap is removed and gently dry the area with a clean dry towel.

·         Remove the patch from the packet just before you are ready to apply it.  Remove the protective backing and throw it away.  Try not to touch the exposed side of the patch as the medication could come off on your fingers.

·         Press the sticky side of the patch firmly against the skin site that was just washed and dried.  Make sure the patch is flat against the skin (there are no bumps or folds in the patch) and is sticking securely.  Be sure the edges are stuck to the skin surface.

·         After the patch has been applied, wash your hands thoroughly to remove any medicine that may have gotten on them – do not touch your eyes until after your hands are washed.

·         Following the 24-hour application period, the patch should be removed from the skin and folded in half so that the adhesive side of the patch adheres to itself.  After the patch is removed, wash the patch site gently and rinse.

·         If the patch falls off during the day, reapply it to the same area and use adhesive tape.  If the patch can not be reapplied, use a new patch in the same area.

 

Special Considerations

·         Selegiline Transdermal System should be stored at controlled room temperature in a dry place, out of the reach of children.

·         Bring all unused patches to the clinic during each scheduled visit.


 

Interactions

Some drugs taken together may have interactions that cause illness or impair the effectiveness of the drugs. It is a good idea to always check with your study clinician before taking any other medications, prescription or otherwise, to be sure it will not interact with Selegiline Transdermal System.

 

The following is a list of prohibited medications.  Use of these medications during the study may result in severe side effects and study medications may be stopped temporarily.

 

 

Other medications should only be used with extreme caution.  These include tricyclic antidepressants and antidepressants such as Prozac, Luvox, Paxil, Wellbutrin, Celexa, and Effexor.  Also, various herbal or natural remedies should be used with caution.  Lastly, certain foods, such as aged cheese, red wine, beef or chicken liver, yeast extracts, and sauerkraut may interact with selegiline as they contain a substance called tyramine.   Excessive tyramine can lead to increases in blood pressure (hypertension) that can be fatal.

 

Side Effects

Not everyone experiences side effects.  When they do occur, they may be mild, moderate or severe.  Some side effects cannot be felt by the patient but can be found through laboratory tests, so it is important to see your study clinician regularly for checkups so that side effects can be detected early and treated.

 

The reported side effects associated with Selegiline include: hypotension (low blood pressure), hypertension (high blood pressure), dry mouth, gas, diarrhea, constipation, abnormal dreams, dizziness, sleepiness, and skin irritation where patch has been placed.

 

If you experience any of the following symptoms, you should contact your study clinician immediately:

 

Hypotension:  lightheadedness, faintness, blurred vision, weakness, unsteadiness, nausea

 

Hypertension:  headache at the base of the of the neck (occipital headache), neck stiffness or soreness, nausea, vomiting, sweating, light sensitivity, tight throat or chest pain, changes in heart rhythm (heart is beating fast or slow)

 

Original Date: 5/2001