Dextroamphetamine (dex-troe-am-FET-a-meen)

Treats attention deficit hyperactivity disorder (ADHD).

Brand Name(s):

Xelstrym

When This Medicine Should Not Be Used:

How to Use This Medicine:

Patch

• Your doctor will tell you how many patches to use, where to apply them, and how often to apply them. Do not use more patches or apply them more often than your doctor tells you to. .
• Wash your hands with soap and water before and after applying a patch. Do not use a hand sanitizer in place of soap and water.
• Leave the patch in its sealed wrapper until you are ready to put it on. Tear the wrapper open carefully. NEVER CUT the wrapper or the patch with scissors. Do not use any patch that has been cut by accident. Do not use the patch if it is cut or damaged in any way.
• Do not touch the sticky side, because you will get medicine on your skin. Wash your hands with soap and water if you accidentally touch the sticky side of the patch.
• The patient instructions will show the body areas where you can wear the patch. When putting on each new patch, choose a different place within these areas. Do not put the new patch on the same place you wore the last one. Be sure to remove the old patch before applying a new one. Apply the patch 2 hours before the needed effect and remove it after 9 hours. Do not wear patches for longer than 9 hours a day total. Do not put a new patch in the same place for at least one day (24 hours).
• Apply the patch to a clean, dry, and healthy skin area on your chest, hip, flank (side of the waist), upper arm, or upper back. Choose an area that is free of scars, cuts, burns, rashes, that has very little to no hair, or any other skin irritation. Avoid putting the patch on areas where it could be rubbed by tight clothing, including waistbands or straps. Do not shave the skin where you will apply the patch. You may cut the hair with a pair of scissors.
• Press the patch firmly in place with the palm of your hand. Make sure there is good contact with your skin, especially around the edges of the patch.
• Do not put lotion, gel, oil, or powder on the skin area where the patch will be placed. Do not expose the application site to direct heat (including hair dryer, heating pad or electric blankets, heat lamps, saunas, hot tubs, and heated water beds).
• The patch might come off if you go swimming or take a bath or shower. If the edges lift, smooth down the patch and press firmly with the palm of your hand. Do not reapply with dressings, tape, or other adhesives.
• Put on a new patch if the old one has fallen off and cannot be reapplied.
• After you remove the patch, you may apply oil-based product or water and soap to remove any glue on your skin.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the patches in the original package.
• After removing a used patch, fold the patch in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) within the past 14 days.
• Some foods and medicines can affect how dextroamphetamine works. Tell your doctor if you are also using any of the following:
  • Ascorbic acid, buspirone, dextromethorphan, fentanyl, lithium, St John's wort, tramadol
  • Medicine to treat depression (including SNRIs, SSRIs, TCAs)
  • Triptan medicine to treat migraine headaches
  • Tryptophan supplement

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, heart or blood vessel disease, heart rhythm problems, high blood pressure, heart failure, Tourette syndrome, or a history of heart attack, stroke. Tell your doctor if you or anyone in your family has a history of depression, bipolar disorder, mental health problems, or drug or alcohol abuse.
• Do not breastfeed during treatment with this medicine.
• This medicine may cause the following problems:
  • Sudden death in people who have serious heart problems (including a heart defect)
  • Serious heart or blood vessel problems, including heart attack and stroke (especially in people who already have heart problems)
  • High blood pressure
  • Unusual changes in behavior or moods
  • Slow growth in children
  • Peripheral vasculopathy (a blood circulation problem), including Raynaud phenomenon
  • Serotonin syndrome (when used with certain medicines)
  • Skin site reactions
  • Onset or worsening of motor or verbal tics (including Tourette syndrome)
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may make you dizzy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Keep the patch away from heat, including hair dryer, heating pads, electric blankets, or water beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, fever, muscle spasms, seizures, twitching
• Blurred vision, lightheadedness or fainting, muscle cramps, seeing, hearing, or feeling things that are not there, sweating, trouble breathing
• Chest pain that may spread, fast, pounding, or uneven heartbeat, dizziness
• Constipation, diarrhea, nausea, vomiting, stomach pain
• Extreme energy or restlessness, confusion, agitation, unusual moods or behaviors
• Numbness or weakness in your arm or leg, or on one side of your body, pain in your lower leg
• Severe skin redness, swelling, itching, or blistering where the patch is worn
• Slow growth or weight loss in children
• Sores, coldness, numbness, color changes or unexplained wounds on your fingers or toes
• Sudden or severe headache, problems with vision, speech, or walking

If you notice these less serious side effects, talk with your doctor:

• Dry mouth
• Loss of appetite
• Trouble sleeping

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088