Xelstrym

Store the individual protective pouches at room temperature away from light and moisture. Do not refrigerate or freeze. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed (see also How to Use section). For more details, read the Instructions for Use, or consult your pharmacist or local waste disposal company.

Do not share this medication with others. Sharing it is against the law.

Lab and/or medical tests (such as blood pressure, pulse, complete blood count, growth monitoring in children) may be done while you are using this medication. Keep all medical and lab appointments.

If switching from another form of dextroamphetamine to this patch, carefully follow your doctor's instructions.

If you miss a dose, use it as soon as you remember. If it is near bedtime or near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Misuse or abuse of dextroamphetamine can result in serious (possibly fatal) heart and blood pressure problems.

This medication can be habit-forming and should be used cautiously by people who have mental/mood disorders or a substance use disorder (such as overuse of or addiction to drugs/alcohol). Before using this medication, tell your doctor if you have a personal or family history of a substance use disorder. Do not increase your dose, use it more often, or use it for a longer time or in a different way than prescribed. Doing so may result in a decrease in the effect of this drug, drug dependence, or abnormal thoughts/behavior.

Your doctor may monitor you for a while after the medication is stopped, especially if you have used this drug for a long time or in high doses. (See also How to Use section.)

Read the Medication Guide provided by your pharmacist before you start using dextroamphetamine and each time you get a refill. Read and follow all directions in the Instructions for Use. Learn how to properly use, store, and discard the patches. If you have any questions, ask your doctor or pharmacist.

Apply this medication to the skin as directed by your doctor, usually once daily in the morning, 2 hours before you need the effects of this drug. Then remove the patch as directed by your doctor, usually 9 hours later. Applying this medication late in the day may cause trouble sleeping (insomnia). If you apply this patch in the early morning and still have trouble sleeping, your doctor may direct you to remove the patch within less than 9 hours. Carefully follow your doctor's instructions.

This medication should be applied to a clean, dry, hairless or nearly hairless area of skin on the upper chest, upper arm, upper back, hip, or sides of the waist (flanks). Before applying the patch, gently wash, rinse, and dry the application area. Do not apply to cut, scraped, burned, or irritated skin. Remove the patch from the pouch and apply right away as directed. Do not use a cut or damaged patch. When using a new patch the next day, apply to a different area of skin to avoid irritation. Do not apply a heating pad or other heat to the patch area since this may increase the risk of side effects. Bathing, swimming, or showering may affect how well the patch stays on the skin. If the patch does not stick properly or falls off, replace with a new patch at another site. Remove the new patch at your usual time, usually 9 hours after applying the first patch.

After removing the patch, fold it in half with the sticky sides together and throw it away as directed. Do not touch the sticky side with your fingers. Wash your hands after applying or removing the patch.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

The dosage is based on your medical condition and response to treatment. Your doctor may adjust your dose to find the dose that is best for you. During treatment, your doctor may sometimes recommend stopping the medication to see if it is still needed. Carefully follow your doctor's instructions.

If you suddenly stop using this medication, you may have withdrawal symptoms (such as severe tiredness, sleep problems, mental/mood changes such as depression). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used dextroamphetamine for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Use this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

Tell your doctor if your condition does not get better or if it gets worse.

Nervousness, trouble sleeping, loss of appetite, weight loss, dizziness, nausea, vomiting, or headache may occur. Mild irritation, pain, itching, or redness at the application site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including: signs of blood flow problems in the fingers or toes (such as coldness, numbness, pain, or skin color changes), unusual wounds on the fingers or toes, fast/pounding/irregular heartbeat, mental/mood/behavior changes (such as agitation, aggression, mood swings, depression, abnormal thoughts/behavior, thoughts of suicide), uncontrolled muscle movements (such as twitching, shaking), sudden outbursts of words/sounds, change in sexual ability/interest, frequent/prolonged erections (in males).

Get medical help right away if you have any very serious side effects, including: fainting, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), symptoms of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion).

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Warning section.

Before using dextroamphetamine, tell your doctor or pharmacist if you are allergic to it; or to other sympathomimetic drugs (such as amphetamine or lisdexamfetamine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, blood circulation problems (such as Raynaud's disease), glaucoma, heart problems (such as irregular heartbeat, heart failure, previous heart attack, problems with heart structure), family history of heart problems (such as sudden cardiac death, irregular heartbeat), mental/mood conditions (such as anxiety, agitation), personal/family history of mental/mood disorders (such as bipolar disorder, depression, psychosis, suicidal thoughts), personal/family history of uncontrolled muscle movements (motor tics, Tourette's syndrome), overactive thyroid (hyperthyroidism), stroke, seizures.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If used for a long time, this drug may affect a child's growth rate, weight, and final adult height. To reduce the risk, the doctor may recommend temporarily stopping the medication from time to time. Monitor the child's weight and height. Consult your doctor or pharmacist for more details.

Older adults may be more sensitive to the side effects of this drug, especially chest pain, trouble sleeping, or weight loss.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Infants born to mothers who are dependent on this medication may be born too soon (premature) and have low birth weight. They may also have withdrawal symptoms. Tell your doctor right away if you notice possible mood changes, agitation, or unusual tiredness in your newborn.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, metaxalone, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

Some products have ingredients that could raise your heart rate or blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products or diet aids).

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/ "ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

Dextroamphetamine is very similar to amphetamine or lisdexamfetamine. Do not use medications containing amphetamine or lisdexamfetamine while using dextroamphetamine.

This medication may interfere with certain lab/medical tests (such as blood and urine steroid levels, brain scan for Parkinson's disease), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.