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Adderall (amphetamine)

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FDA ALERT [02/2006] Sudden Unexplained Death, Cardiac/Cardiovascular, and Psychiatric Adverse Events Associated with Stimulant Therapy for ADHD.

Rarely, sudden unexplained death has been associated with stimulant use.   Tell your prescriber about any history of heart disease in yourself or family member as it could increase the risk.  These drugs also increase blood pressure and heart rate.  Stimulants have a high potential for abuse and long term use may lead to dependence.  Use or misuse may cause sudden death and serious cardiovascular events or stroke.

Available as:

• Dexedrine^® (dextroamphetamine) – immediate release
  • Tablets:  5mg
• Dexedrine spansules^® (dextroamphetamine) – sustained release
  • Capsules:  5mg, 10mg, 15mg
• Adderall^® (mixed amphetamine salts) – immediate release
  • Tablets:  5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg, 30mg
• Adderall XR^® (mixed amphetamine salts) – extended release
  • Capsules:  5mg, 10mg, 15mg, 20mg, 25mg, 30mg
• Vyvanse® (lisdexamfetamine) - converted to dextroamphetamine in gut and liver
  • Capsuls: 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg

What are dextroamphetamine, mixed amphetamine salts and lisdexamfetamine and what do they treat?

Dextroamphetamine, mixed amphetamine salts, and lisdexamfetamine are prescription medications that have been proven effective in the treatment of attention-deficit hyperactivity disorder (ADHD) in children, adolescents and adults.  ADHD is associated with severe inattention, hyperactivity and impulsivity that interfere with an individual’s ability to function in school, at work or in social settings.  Examples of functionally impairing ADHD symptoms include making careless mistakes, losing things necessary for tasks, the inability to sit still and focus, and interrupting or intruding on others.   

Adults with ADHD have similar symptoms but typically have less hyperactivity;  are more prone to procrastination; become easily frustrated and take on many tasks at once while accomplishing none of them.  A person may have severe inattention without hyperactivity or impulsivity and still meet criteria for a diagnosis of ADHD.  A person with inattentive symptoms only can respond equally well to dextroamphetamine, mixed amphetamine salts or lisdexamphetamine as someone who has inattentive and/or hyperactive and impulsive symptoms.

Dextroamphetamine, mixed amphetamine salts and lisdexamfetamine increase effective use of dopamine and norepinephrine in parts of the brain that regulate attention and behavior in order to control symptoms associated with ADHD and improve functioning.  Scientific literature shows that stimulant medications including dextroamphetamine, mixed amphetamine salts and lisdexamfetamine are the most effective medication treatment options for ADHD.  However, behavioral interventions like positive rewards for good behavior and lifestyle modifications like breaking down homework into manageable 15-minute blocks are useful interventions to implement with or without medication . 

The American Academy of Pediatrics and the American Academy of Child and Adolescent Psychiatry consider these medicines to be the best treatment options.   Behavioral interventions and lifestyle modifications are also useful.  Scientific studies show adults with ADHD respond well to dextroamphetamine, mixed amphetamine salts and lisdexamfetamine.  However, lifestyle modifications in adults may be different than those in children.  For example, adults may use an electronic organizer or select a career that keeps them stimulated like traveling, sales or real estate.

Dextroamphetamine, mixed amphetamine salts and lisdexamfetamine are used as adjuncts to psychological, educational, social, and other remedial measures (i.e., appropriate educational placement, appropriate career selection) in the treatment of ADHD.

What is the most important information I should know about dextroamphetamine, mixed amphetamine salts and lisdexamfetamine?

Dextroamphetamine, mixed amphetamine salts and lisdexamfetamine should not be taken together with or within 14 days of taking a drug used to treat depression, called a Monoamine Oxidase Inhibitor (MAOI).  MAOIs include Nardil (phenelzine), Parnate (tranylcypromine), Emsam (selegiline), and other brands.  Some medications also have MAOI-like activity, such as linezolid (Zyvox® - an antibiotic) and should be avoided as well.  Coadministering dextroamphetamine, mixed amphetamine salts, or lisdexamfetamine within 2 weeks of taking a MAOI can result in serious, sometimes fatal, reactions, including high body temperature, high blood pressure, seizures (convulsions) and rarely coma.

Are there specific concerns about dextroamphetamine, mixed amphetamine salts and lisdexamfetamine use in pregnancy?

If you are planning on becoming pregnant, inform your healthcare provider immediately so that your healthcare provider can best manage your medications.

Amphetamine and dextroamphetamine have been shown to cause fetal malformation and death in mice when administered at a higher dose than that of human dose.  One report shows severe congenital deformity in a baby born to a woman who took dextroamphetamine (and other medication) during the first trimester of pregnancy. 

Infants born to mothers dependent on dextroamphetamine, mixed amphetamine salts or lisdexamfetamine have an increased risk of premature delivery and low birth weigh.  These infants may also experience symptoms of withdrawal such as agitation or lack of energy.

Several case reports show that amphetamine use during pregnancy significantly influences development of exposed children up to at least 10 years old with an increase in aggressive behavior.

Mothers taking dextroamphetamine, mixed amphetamine salts and lisdexamfetamine should be advised to refrain from breast-feeding as these drugs are excreted in breast milk.

What should I discuss with my healthcare provider before taking dextroamphetamine, mixed amphetamine salts and lisdexamfetamine?

• Symptoms that are most bothersome to you about your condition
• Any medical problems, including heart disease, high blood pressure or mental illness
• All other medications you are currently taking (including herbal products and dietary supplements)
• Any medication allergies you have.
• If you have or have had:  liver problems, high blood pressure, heart problems, irregular heartbeat, low blood pressure, depression, bipolar disorder or other psychiatric disorders
• Medications you have taken in the past to treat ADHD, mood or thought organization
• Any medication side effects that you may have experienced in the past, or are currently experiencing
• If you are pregnant, plan to become pregnant, or are breast-feeding
• If you drink alcohol or use illicit drugs

How should I take dextroamphetamine, mixed amphetamine salts or lesdexamfetamine?

These medications are taken by mouth, in the morning, with or without food, exactly as prescribed by your healthcare professional.

Although all forms of amphetamine and dextroamphetamine dissolve in the stomach to give the same active medication, there are some differences between each form. Different forms are available for this medication for several reasons: 1) for easier swallowing, 2) for fewer side effects, and 3) for taking this medicine fewer times each day.

• Tablets: Swallow the tablets whole. Chewing the tablets gives an unpleasant taste and can be irritating to the mouth and throat. Take it 1-3 times daily as instructed by your doctor.
• Sprinkle capsules (Dexedrine Spansule®): May be swallowed whole or opened and sprinkled onto food like applesauce or pudding. Sprinkle capsules should not be chewed. Take once daily as per your doctor’s instructions.
• Long acting capsules (Adderall XR®, and Dexedrine Spansule® and Vyvanse®) can be taken once daily.  Do not cut, crush, or chew.

What happens if I miss a dose of dextroamphetamine, mixed amphetamine salts or lisdexamfetamine?

If you miss a dose of these medications, take it as soon as you remember if it is not too close to when your next dose is due - discuss this with your healthcare provider. If it is close to your next dose, wait until then to take the medication and skip the missed dose.  Do not double your next dose or take more than what you have been told to take.

What should I avoid while taking, dextroamphetamine, mixed amphetamine salts or lisdexamfetamine?

You should not drink alcohol or use illegal drugs while taking amphetamine, dextroamphetamine, or mixed amphetamine salts.

The absorption of amphetamine medications can be reduced if strong organic acids are present in the stomach at the time of taking amphetamine medications.  The following foods should be avoided for 1 hour before and after taking an amphetamine medication:  citrus fruit, citrus juices, sodas/carbonated beverages, lemonade, Gatorade, vitamins/food and food supplements containing vitamin C.

What happens if I overdose with dextroamphetamine, mixed amphetamine salts or lisdexamfetamine?

If an overdose occurs, whether intentional or accidental, immediate medical attention is necessary. Call your doctor or emergency medical service (911).  You may also contact the poison control center (1-800-222-1222).

Overdosing with these medications may lead to high body temperature, abnormal heart rhythms, excessively high blood pressure, seizures, and in some cases, coma, and death.

What are the possible side effects of amphetamine?

Upset stomach, loss of appetite and insomnia are the most common side effects associated with the use of amphetamine medications. 

Common:

• Upset stomach can be managed by taking the medicine on a full stomach or lowering the dose.
• Loss of appetite and weight loss can be improved by serving the child his or her favorite foods when stimulant effects are low (for example in the morning before medication or at night when the medication effects are less), or use nutritional supplements.
• Insomnia can be improved by giving the medication as early in the day as possible, avoiding afternoon or evening dosing.  Some clinicians will prescribe sedating medications like clonidine, guanfacine, or trazodone at night.  Melatonin has also been found effective to manage insomnia associated with ADHD medication.
• Mild anxiety or restlessness can be managed with dosage reduction or changing medication.
• Rebound effects or symptoms of ADHD that come back late in the day when medication effects wear off can be managed by adjusting the timing of medication.  Discuss with prescriber.

Uncommon or rare:

• Abnormal involuntary movements or muscle twitches called tics (for example, excessive eye-blinking, nose scrunching, or shoulder shrugging) can be associated with methylphenidate and dexmethylphenidate.  If this occurs, the dose of medication should be lowered or the medication should be changed.
• Misuse of amphetamine medications may cause sudden death and serious cardiovascular adverse events.  Amphetamine medications should be avoided in individuals who have a heart defect (structural abnormalities), uncontrolled high blood pressure, or a disorder of the heart or blood vessels.
• Amphetamine medications are rarely associated with clinically significant increases in blood pressure or heart rate.  Blood pressure and heart rate should be monitored before starting medication, and then weekly while adjusting the dose and then every month to three months or when side effects like “racing heart”, shortness of breath or exercise fatigue becomes problematic.
• Severe anxiety, panic attacks, mania, hallucinations, paranoia and delusions are all possible.  If they occur, the medication should be discontinued, and the individual should be evaluated by their health care provider.

Talk with your healthcare provider if you experience side effects that are bothersome to you.

Go to an emergency room is you experience chest pain, shortness of breath, fainting or suicidal behavior.

Are there any risks for taking dextroamphetamine, mixed amphetamine salts or lisdexamfetamine for long periods of time: 

Growth Effects:

Although treatment with dextroamphetamine, mixed amphetamine salts and lisdexamfetamine can lead to mild growth suppression, many studies have shown that this deficit in growth is small, may attenuate with time, and should not be a clinical concern for most children treated with these medications.  Height, weight, and eating habits should be assessed before starting medication and regularly thereafter.  If a child’s growth is thought to be affected, the risk versus benefit of taking time off medication (drug holiday) to allow for growth acceleration should be considered.

What other drugs may interact with dextroamphetamine, mixed amphetamine salts or lisdexamfetamine?

• Medications used to treat depression such as Tricyclic antidepressants (TCA) and monoamine oxidase inhibitors (MAOI) can interact with these medications resulting in serious reactions including high body temperature, high blood pressure, and seizures (convulsions). Tell your healthcare provider if you are beginning or have recently discontinued any of these medications.
• Medications that may increase the effects and adverse effects of these medications include:
  • Atomoxetine (Strattera®), sibutramine (Meridia®), phenylephrine, guarana, and caffeine.
  • Fluoxetine(Prozac®), paroxetine (Paxil®), bupropion (Wellbutrin®), venlafaxine (Effexor®)
• Dextroamphetamine, mixed amphetamine salts or lisdexamfetamine may increase the blood level of some seizure medications such as phenobarbital or phenytoin.  If you are taking any of these medications, tell your healthcare provider immediately.

• These medications may inhibit antihypertensive response to some blood pressure medications such as clonidine, guanethidine and guanadrel.  Tell your healthcare provider immediately if you are taking any of these medications.

• Antacids may increase the effects of dextroamphetamine, mixed amphetamine salts and lisdexamfetamine.  Consult with your healthcare provider before consuming antacids while taking these medications.

• Urinary alkalinizers (bicarbonate) may increase the effects of these medications, while urinary acidifiers (citrus beverages) may decrease the effects..  Consult with your healthcare provider before starting any medications/food/food supplements that can alkalinize or acidify the urine.

How long does it take for dextroamphetamine, mixed amphetamine salts and lisdexamfetamine to work?

These medications start working within 1-3 hours of swallowing a dose.  The effect generally lasts about 4-5 hours for the immediate-release forms and 8-12 hours for the sustained release forms or lisdexamfetamine.  It may take several weeks to get the full benefit of the medication.  Your healthcare provider may also need to gradually adjust the dose over a period of several weeks to find the dose that works best for you.

 

Updated by Julie A. Dopheide, Pharm.D., BCPP
March 2008

NAMI wishes to thank the  College of Psychiatric and Neurologic Pharmacists  for producing this fact sheet.

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