Amphetamine/Dextroamphetamine, Oral

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KEY POINTS

• This medicine is taken by mouth to treat narcolepsy or attention deficit/hyperactivity disorder. Take it exactly as directed.
• If you use this medicine for a long time, you may become dependent on it. Prescriptions for this medicine cannot be refilled.
• This medicine may cause sudden death in people who have heart problems. Your healthcare provider should check blood pressure and heart rate regularly while you are taking this medicine. Keep all appointments for checkups.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: amphetamine; stimulant

Generic and brand names: amphetamine/dextroamphetamine, oral; Adderall; Adderall XR

What is this medicine used for?

This medicine is taken by mouth to treat narcolepsy or attention deficit/hyperactivity disorder (ADHD).

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you (or a family member) have ever had:

• An allergic reaction to any medicine or to tartrazine (a yellow dye used in some medicines)
• Blood vessel disease or circulation problems such as Raynaud's disease
• Glaucoma
• Heart disease or heart rhythm problems
• High blood pressure
• High cholesterol
• Liver or kidney problems
• Mental health problems such as anxiety, bipolar disorder, depression, schizophrenia, or thoughts of suicide
• Problems with alcohol or drug abuse
• Thyroid problems
• Tourette's syndrome, tics, epilepsy, or other seizure disorder

Do not take an MAO inhibitor antidepressant such as phenelzine (Nardil), tranylcypromine (Parnate), or isocarboxazid (Marplan) and this medicine within 14 days of each other. You may have serious side effects. Talk with your healthcare provider about this.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more of it than prescribed. When you take this medicine for a long time or in large dosages, you may become dependent on it. Do not stop taking this medicine without your healthcare provider's approval. You may need to reduce your dosage gradually to avoid withdrawal symptoms.

Check with your healthcare provider before using this medicine in children under age 6. When this medicine is prescribed for a child, all doses should be given by an adult.

This medicine comes in regular tablets and extended-release capsules.

If you have extended-release capsules, swallow them whole with water. Do not chew or crush the capsule or the medicine inside the capsule. Ask your pharmacist if you have the extended-release form of this medicine.

You may take this medicine with or without food. Do not take this medicine with fruit juices. Juices may make this medicine less effective. When possible, take this medicine early in the day (usually no later than 2 PM or 6 hours before your bedtime) to avoid trouble sleeping at night. If you have a long-acting form of the medicine, take it at least 10 hours before bedtime.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: restlessness, tremors, muscle twitches, fast breathing, confusion, hallucinations, panic, aggressiveness, unexplained muscle pain, muscle weakness, fever, dark colored urine, depression, tiredness, nausea, vomiting, diarrhea, stomach pain, irregular heartbeat, lightheadedness, fainting, seizures, coma.

What should I watch out for?

Your healthcare provider should check blood pressure and heart rate regularly while you are taking this medicine. Call your healthcare provider right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking this medicine. This medicine may cause sudden death in people who have heart problems.

Call your healthcare provider right away if you notice any new or worsening mental symptoms or problems while taking this medicine, especially:

• More outgoing or aggressive behavior than normal
• Hallucinations (seeing or hearing things that are not real)
• Psychosis (believing things that are not real)
• Paranoia (unusually suspicious)

Amphetamines have a high potential for abuse. If you use this medicine for a long time, you may become dependent on it. Prescriptions for this medicine cannot be refilled. You must see your healthcare provider again so that he or she can determine if you should take more of this medicine.

This medicine is a controlled substance. It is illegal for you to give it to anyone else.

Rarely, this medicine may cause problems with the blood vessels in your fingers or toes. Contact your healthcare provider right away if your fingers or toes feel numb, cool, painful, or change color from pale, to blue, to red, or if you have unexplained wounds or sores on your hands or feet while taking this medicine.

Rarely, this medicine may cause a painful erection of the penis that will not return to normal. If this happens, contact your healthcare provider or get medical care right away. It can lead to permanent erectile dysfunction if not treated.

This medicine may make you dizzy or cause blurred vision. Do not drive or operate machinery unless you are fully alert and can see clearly. Take care to avoid falling.

This medicine may slow growth in children. Children should have their height and weight checked regularly while taking this medicine. Talk to your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Irregular or fast heartbeat; chest pain; seizures; trouble breathing; hallucinations; changes in mood, behavior, or thoughts; thoughts of suicide; severe nervousness or anxiety; severe dizziness or fainting; severe skin ulcers; numbness, pain, or skin color changes in fingers or toes; blurred vision.

Other: Restlessness, nervousness, dizziness, headache, dry mouth, change in taste sensation, diarrhea, trouble sleeping, constipation, change in sexual ability or desire, loss of appetite, tremors, weight loss.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), quinapril (Accupril), and ramipril (Altace)
• Alpha blockers such as doxazosin (Cardura), prazosin (Minipress), tamsulosin (Flomax), and terazosin
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antacids that contain aluminum or magnesium, such as Gaviscon, Maalox, and Mylanta
• Antidepressants such as amitriptyline, citalopram (Celexa), desipramine (Norpramin), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), mirtazapine (Remeron), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antihistamines such as chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and meclizine (Dramamine)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), brexpiprazole (Rexulti), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), perphenazine, pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as ethosuximide (Zarontin), phenobarbital, and phenytoin (Dilantin, Phenytek)
• Atomoxetine (Strattera)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Buspirone
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), and verapamil (Calan, Covera, Verelan)
• Decongestants such as oxymetazoline (Afrin, Dristan), phenylephrine (Neo-Synephrine, Sudafed PE), and pseudoephedrine (Sudafed)
• Dextromethorphan, an ingredient in many cough, cold, or allergy medicines such as Robitussin-DM
• Diet pills such as benzphetamine (Regimex), diethylpropion (Tenuate), phendimetrazine, and phentermine (Adipex-P, Suprenza)
• Diuretics (water pills) such as acetazolamide (Diamox), chlorothiazide (Diuril), hydrochlorothiazide (Microzide), hydroflumethiazide (Saluron), and methyclothiazide (Enduron)
• Doxepin (Silenor)
• Linezolid (Zyvox)
• Lithium (Lithobid)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to block or prevent stomach acid such as dexlansoprazole (Dexilant), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (AcipHex)
• Medicines to treat breathing or lung problems such as albuterol (ProAir, Proventil, Ventolin), aminophylline, arformoterol (Brovana), formoterol (Perforomist), levalbuterol (Xopenex), metaproterenol, salmeterol (Serevent), and theophylline
• Medicines to treat urinary and kidney problems such as ammonium chloride, methenamine (Hiprex, Urex), potassium citrate (Urocit-K), sodium bicarbonate, and sodium citrate (Bicitra)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), ergotamine (Ergomar), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Alsuma, Imitrex, Sumavel), and zolmitriptan (Zomig)
• Natural remedies such as ephedra, SAMe, St. John's wort, Syrian rue, and tryptophan
• Nausea medicines such as prochlorperazine (Compro) and promethazine
• Other stimulants such as armodafinil (Nuvigil), dexmethylphenidate (Focalin), dextroamphetamine (Dexedrine), lisdexamfetamine (Vyvanse), methamphetamine (Desoxyn), methylphenidate (Concerta, Daytrana, Metadate, Ritalin), and modafinil (Provigil)
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Reserpine
• Vitamin C (ascorbic acid) or products that contain vitamin C

Do not drink caffeinated coffee, cola, and tea while taking this medicine to prevent jitteriness or trouble sleeping. Caffeine may increase side effects of this medicine. Talk with your healthcare provider about this.

Do not drink alcohol while taking this medicine. Alcohol may limit the effectiveness of this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.