Pronunciation:

dex-troe-am-FET-a-meen

Brand Names:

• Xelstrym

Dosage Forms:

• Patch, Extended Release

Warnings:

Abuse, Misuse, and AddictionDextroamphetamine has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including dextroamphetamine, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.Before prescribing dextroamphetamine, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout dextroamphetamine treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction .

Classifications:

Therapeutic—

CNS Stimulant

Chemical—

Amphetamine (class)

Uses of This Medicine:

Dextroamphetamine transdermal patch is used to treat attention-deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.

Dextroamphetamine works in the treatment of ADHD by increasing attention and decreasing restlessness in children and adults who are overactive, cannot concentrate for very long, or are easily distracted and impulsive. This medicine is used as part of a total treatment program that also includes social, educational, and psychological treatment.

This medicine is available only with a doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of dextroamphetamine transdermal patch in children younger than 6 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dextroamphetamine transdermal patch in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving dextroamphetamine.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Isocarboxazid
• Linezolid
• Methylene Blue
• Ozanimod
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Sibutramine
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone Acetate
• Acetazolamide
• Albuterol Sulfate
• Alfentanil
• Almotriptan
• Aluminum
• Amifampridine
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anileridine
• Apraclonidine Hydrochloride
• Arformoterol Tartrate
• Armodafinil
• Atomoxetine Hydrochloride
• Benzhydrocodone
• Benzthiazide
• Brimonidine Tartrate
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butorphanol
• Calcium Carbonate
• Carbamazepine
• Chlorothiazide
• Chlorpheniramine
• Cimetidine
• Cinacalcet
• Citalopram
• Clobazam
• Clomipramine
• Clonidine
• Cobicistat
• Cocaine
• Codeine
• Cyclobenzaprine
• Desipramine
• Desvenlafaxine
• Dexlansoprazole
• Dexmethylphenidate Hydrochloride
• Dextromethorphan
• Diazoxide
• Dibenzepin
• Difenoxin
• Dihydrocodeine
• Dihydroxyaluminum Aminoacetate
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Droxidopa
• Duloxetine
• Eletriptan
• Ephedrine Hydrochloride
• Ephedrine Sulfate
• Epinephrine
• Escitalopram
• Esomeprazole
• Ethylmorphine
• Fenfluramine
• Fentanyl
• Fluoxetine
• Fluticasone Propionate
• Fluvoxamine
• Formoterol Fumarate
• Frovatriptan
• Gepirone
• Granisetron
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Hydroxytryptophan
• Imipramine
• Iobenguane I 131
• Isoproterenol Hydrochloride
• Ketobemidone
• Lansoprazole
• Lasmiditan
• Levalbuterol Hydrochloride
• Levalbuterol Tartrate
• Levomilnacipran
• Levorphanol
• Lithium
• Lofepramine
• Lorcaserin
• Magaldrate
• Magnesium Carbonate
• Melitracen
• Meperidine
• Metaxalone
• Methadone
• Methamphetamine Hydrochloride
• Methylphenidate
• Midodrine Hydrochloride
• Milnacipran
• Mirabegron
• Mirtazapine
• Modafinil
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nicomorphine
• Norepinephrine Bitartrate
• Nortriptyline
• Oliceridine
• Omeprazole
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Oxycodone
• Oxymetazoline Hydrochloride
• Oxymorphone
• Palonosetron
• Pantoprazole
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Phenylephrine Hydrochloride
• Piritramide
• Polythiazide
• Protriptyline
• Pseudoephedrine Hydrochloride
• Quinidine
• Quinine
• Rabeprazole
• Remifentanil
• Ritonavir
• Rizatriptan
• Rolapitant
• Salmeterol Xinafoate
• Sertraline
• Sodium Bicarbonate
• St John's Wort
• Sufentanil
• Sumatriptan
• Tapentadol
• Terbinafine
• Terbutaline Sulfate
• Tetrahydrozoline Hydrochloride
• Tianeptine
• Tilidine
• Tramadol
• Trazodone
• Trichlormethiazide
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Xipamide
• Ziprasidone
• Zolmitriptan

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Agitation, severe or
• Alcohol or drug abuse, history of or
• Anxiety, severe or
• Heart attack, recent or
• Heart failure or
• Heart rhythm problems (eg, arrhythmia, ventricular arrhythmia), or family history of or
• Hypertension (high blood pressure), moderate to severe or
• Bipolar disorder (manic-depressive illness), or a family history of or
• Blood vessel problems (eg, Raynaud disease) or
• Depression, or a family history of or
• Hypertension (high blood pressure), mild or
• Mania, history of or
• Psychosis (mental illness), history of or
• Seizures, history of or
• Stroke, history of or
• Tourette syndrome, or family history of—Use with caution. May make these conditions worse.

• Heart or blood vessel disease (eg, cardiomyopathy, coronary artery disease) or
• Heart rhythm problems, severe—Should not be used in patients with these conditions.

• Kidney disease, severe (eg, end stage kidney disease)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

To use the skin patch:

• Make sure you wash your hands with soap and water after applying the patch. Do not use a hand sanitizer in place of soap and water.
• Do not use the patch if it is cut or damaged. When handling the skin patch, be careful not to touch the adhesive (sticky) surface with your hand. The adhesive part of the system contains some dextroamphetamine which can be absorbed into your body too fast through the skin of your hand. Wash your hands with soap and water if you accidentally touch the sticky side of the patch. Apply the patch right away after removing it from the protective pouch.
• 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. Choose a different place on your skin to apply the new patch. Do not put a new patch in the same place for at least one day (24 hours). Do not leave the patch on for more than 9 hours. It will not work as well after that time and it may irritate your skin.
• 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 (eg, waistbands or straps). Do not shave the skin where you will apply the patch. You may cut the hair with a pair of scissors.
• Remove the liner covering the sticky side of the skin patch. Place the sticky side against the skin. Slowly peel the clear liner while applying gentle pressure with fingers of your other hand to smooth the patch firmly in place, press the patch firmly with the palm of your hands to 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. If the patch falls off after applying it, throw it away and apply a new patch in a different area.
• You may apply oil-based product or water and soap to remove any glue on your skin.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For transdermal dosage form (skin patch):
  • For attention-deficit hyperactivity disorder (ADHD):
    • Adults—At first, 9 milligrams (mg) for 9 hours per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 18 mg for 9 hours per day.
    • Children 6 years of age and older—At first, 4.5 mg for 9 hours per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 18 mg for 9 hours per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

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.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for any unwanted effects.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI), including isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]), within the past 14 days.

This medicine may cause serious heart or blood vessel problems. This may be more likely in patients who have a family history of heart disease. Check with your doctor right away if you or your child have chest pain, trouble breathing, or fainting while taking this medicine.

You or your child will also need to have your blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

This medicine may cause some people to feel a false sense of well-being or to become dizzy, lightheaded, or less alert than they are normally. It may also cause blurred vision or other vision problems. Do not drive or do anything else that could be dangerous until you or your child know how this medicine affects you.

If you or your child have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor. Some signs that you may be dependent on dextroamphetamine are:

• A strong desire or need to continue taking the medicine.
• A need to increase the dose to receive the effects of the medicine.
• Withdrawal effects (for example, mental depression, nausea or vomiting, stomach cramps or pain, trembling, unusual tiredness or weakness) that occur after the medicine is stopped.

Tell your doctor right away if you or your family notices any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behaviors. Also tell your doctor if you or your child have hallucinations or any unusual thoughts, especially if they are new or getting worse quickly.

Symptoms of an overdose include: aggressive, agitation, angry, blurred vision, change in consciousness, chest pain or discomfort, confusion, dark urine, diarrhea, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fast, pounding, or irregular heartbeat or pulse, fever, headache, inability to speak, loss of consciousness, muscle cramps, spasms, pains, or stiffness, nausea, nervousness, overactive reflexes, pain or discomfort in the arms, jaw, back, or neck, pale, clammy skin, palpitations, panic state, pounding in the ears, restlessness, seeing, hearing, or feeling things that are not there, seizures, shakiness in the legs, arms, hands, or feet, shivering, slow or fast heartbeat, slurred speech, sweating, talking or acting with excitement you cannot control, temporary blindness, thirst, trembling or shaking of hands or feet, trouble breathing, unusual tiredness or weakness, vomiting, or weakness in the arm or leg on one side of the body, sudden and severe. Call your doctor right away if you notice these symptoms.

This medicine may cause slow growth in children. If your child is using this medicine, the doctor will need to keep track of your child's height and weight to make sure that your child is growing properly.

This medicine may cause Raynaud's phenomenon, which is a problem with blood circulation in the fingers or toes. Tell your doctor if you or your child have tingling or pain, a cold feeling, paleness, or skin color changes in the fingers or toes, especially when exposed to cold temperatures. Call your doctor right away if you have unexplained sores or ulcers on your fingers or toes.

Check with your doctor right away if you or your child have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

This medicine may cause skin site reactions, including allergic contact dermatitis. Check with your doctor right away if you have blistering, burning, crusting, dryness, or flaking of the skin or itching, scaling, severe redness, soreness, or swelling of the skin where the patch is applied.

Keep the patch away from heat, including hair dryer, heating pads, electric blankets, or water beds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, herbal (eg, St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Black, tarry stools

chills

cough

fever

lower back or side pain

painful or difficult urination

pale skin

sore throat

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Increased heart rate

increase in blood pressure

Incidence not known

Anger

bladder pain

blistering, burning, crusting, dryness, flaking, peeling, or loosening of the skin

bloody nose

bloody or cloudy urine

bloody vomit

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain, discomfort, or tightness

dark urine

delusions of persecution, mistrust, suspiciousness, or combativeness

diarrhea

difficulty in speaking

discouragement

dizziness

fast, slow, pounding, or irregular heartbeat or pulse

fear, nervousness

feeling sad or empty

frequent urge to urinate

hives, itching, skin rash

irritability

joint or muscle pain

lack of appetite

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

loss of interest or pleasure

mood swings

muscle cramps, spasms, pain, or stiffness

nausea

pain or discomfort in the arms, jaw, back, or neck

paleness or cold feeling in the fingertips and toes

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red irritated eyes

red skin lesions, often with a purple center

restlessness

scaling, severe redness, soreness, or swelling of the skin

seizures

severe stomach pain

shakiness in the legs, arms, hands, or feet

sleepiness or unusual drowsiness

sweating

swelling of the feet or lower legs

tingling or pain in the fingers or toes when exposed to cold

trembling or shaking of the hands or feet

trouble concentrating

trouble sleeping

twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

upper right abdominal or stomach pain

vomiting

weight decreased

yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Aggressive

agitation

angry

blurred vision

change in consciousness

chest pain or discomfort

confusion

diarrhea

dark urine

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

fast breathing

fast, slow, or irregular heartbeat

fever

headache

inability to speak

loss of consciousness

muscle cramps, spasms, pain, or stiffness

nausea

nervousness

overactive reflexes

pain or discomfort in the arms, jaw, back, or neck

pale, clammy skin

palpitations

pounding in the ears

restlessness

seeing, hearing, or feeling things that are not there

seizures

shivering

slow or fast heartbeat

slurred speech

stomach cramps

sweating

talking or acting with excitement you cannot control

temporary blindness

thirst

tremor

trouble breathing

unusual tiredness or weakness

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Decreased appetite

headache

Incidence not known

Bigger, dilated, or enlarged pupils (black part of eye)

change in taste

constipation

decreased interest in sexual intercourse

double vision

inability to have or keep an erection

increased sensitivity of the eyes to light

loss in sexual ability, desire, drive, or performance

loss of taste

loss or thinning of the hair

seeing double

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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