Amphetamine and Dextroamphetamine

Amphetamine/dextroamphetamine is a prescription medication used to treat ADHD (Attention Deficit Hyperactivity Disorder) and narcolepsy. Amphetamine/dextroamphetamine belongs to a group of drugs called centrally acting sympathomimetics.  These work by changing the amounts of certain natural substances in the brain.  

This medication comes in tablet form and an extended-release (long-acting) capsule to take by mouth. The tablet is usually taken 2 to 3 times daily, 4 to 6 hours apart, with or without food. The extended-release capsule is usually taken once daily in the morning with or without food.  

Swallow the extended-release amphetamine/dextroamphetamine capsules whole; do not chew or crush them.

Common side effects of amphetamine/dextroamphetamine include loss of appetite, headache, and trouble sleeping. Amphetamine/dextroamphetamine can also cause dizziness. Do not drive or operate machinery until you know how amphetamine/dextroamphetamine affects you.

Amphetamine/dextroamphetamine is a prescription medication used to treat 

• ADHD (Attention Deficit Hyperactivity Disorder) for children and adults.
  • Certain brands are approved for certain age groups. 
• Narcolepsy in children ages 6 and older and adults. Narcolepsy is a sleep disorder characterized by excessive daytime sleepiness

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended dose of amphetamine/dextroamphetamine depends on individual patient response. It is usually started at a low dose and gradually increased until an optimal response is seen. 

ADHD:

Adderall (amphetamine/dextroamphetamine) immediate-release tablets:

The first dose should be taken on awakening. Additional doses should be taken at 4-6 hour intervals if appropriate.

• In children ages 3 to 5 years, the starting dose of Adderall is usually 2.5 mg by mouth once daily in the morning. The dose may be increased gradually depending on individual response. The recommended dose range is 2.5 mg to 40 mg per day, given in 1 to 3 divided doses. 
• In children older than 6 years of age and in adolescents, the starting dose of Adderall is 5 mg by mouth once or twice daily. The dose may be increased gradually depending on individual response. The recommended dose range is 5 mg to 40 mg per day, given in 1 to 3 divided doses. 
• In adults, the starting dose of Adderall is 5 mg by mouth once or twice daily. The dose may be increased gradually depending on individual response. the recommended dose range is 5 mg to 40 mg per day, given in 1 to 3 divided doses. 

Mydayis (amphetamine/dextroamphetamine) extended-release capsules:

Because the effects of Mydayis may last up to 16 hours and it might cause insomnia, Mydayis should be taken on awakening. Mydayis may be taken with or without food, however, it should always be taken the same way (always with food or always without food). 

• In adolescents older than 12 years of age, the recommended starting dose is 12.5 mg once daily in the morning upon awakening. Dosage may be adjusted by 12.5 mg no sooner than weekly, up to a recommended maximum dose of 25 mg once daily. 
• In adults, the recommended starting dose is 12.5 mg to 25 mg once daily in the morning upon awakening. Dosage may be adjusted by 12.5 mg no sooner than weekly, up to a maximum dose of 50 mg once daily.

Adderall XR (amphetamine/dextroamphetamine) extended-release capsules:

• In children older than 6 years of age, the starting dose range is usually 5 mg to 10 mg once daily in the morning. Dosage may be gradually increased up to a maximum dose of 30 mg per day depending on individual response.
• In adolescents, the starting dose is usually 10 mg once daily in the morning. Dosage may be gradually increased depending on individual response. Higher doses up to 60 mg per day have been evaluated. 
• In adults, the usual starting dose is 20 mg once daily in the morning. Dosage may be gradually increased depending on individual response. Higher doses up to 60 mg per day have been evaluated. 

Narcolepsy:

Adderall (amphetamine/dextroamphetamine) immediate-release tablets:

The first dose should be taken on awakening. Additional doses should be taken at 4-6 hour intervals if appropriate.

The recommended dose range is between 5 mg to 60 mg per day in divided doses. 

Amphetamines have a high potential for abuse. Administration of amphetamines for prolonged periods of time may lead to drug dependence and must be avoided. Particular attention should be paid to the possibility of subjects obtaining amphetamines for non-therapeutic use or distribution to others, and the drugs should be prescribed or dispensed sparingly.

Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events.

Serious side effects have been reported with amphetamine/dextroamphetamine including the following:

• Abuse and dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment. 
• Serious Cardiovascular Events. Inform your doctor if you have any heart problems. Stroke, heart attack, and sudden death have been reported in patients with serious structural heart and rhythm problems. 
• Hypertension (increased blood pressure) and increased heart rate.
• Psychosis. Tell your healthcare provider right away if you have some or all of the following symptoms of psychosis:
  • Thoughts and speech are unorganized
  • Experience beliefs that are not based in reality 
  • Hear, see, or feel things that are not there
• Aggressive Behavior
• Vision Disturbances. Tell your doctor if you experience the following symptoms:
  • Difficulty focusing eyes
  • Blurred vision
• Seizures. Your healthcare provider will stop treatment with this medication if you or child has a seizure.
• Serotonin syndrome. This can may happen when this medication is taken with certain other medicines and may be life-threatening. Medications that may increase risk may include medications that increase serotonin (e.g., monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs). Call your healthcare provider or go to the nearest hospital emergency room if you notice any of the following symptoms:
  • Agitation or restlessness
  • Confusion
  • Rapid heart rate and high blood pressure
  • Loss of muscle coordination or twitching muscles
  • Heavy sweating
• Slowing of growth (height and weight) in children. Your healthcare provider will monitor your child's height and weight when on this medication.
• Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include:
  • fingers or toes may feel numb, cool, painful
  • fingers or toes may change color from pale, to blue, to red

Tell your healthcare provider if you have or your child has any pain, numbness, skin color change, or sensitivity to temperature in the fingers or toes.

Do not take amphetamine/dextroamphetamine if you

• are allergic to amphetamine/dextroamphetamine or to any of its ingredients.
• are allergic to other stimulant medications such as benzphetamine (Didrex), lisdexamfetamine (Vyvanse), or methamphetamine (Desoxyn).
• have advanced heart disease.
• have been told that you have moderate to severe high blood pressure. 
• have glaucoma. Glaucoma is a disease that damages a major nerve in your eye. Notify your doctor if you have vision problems.
• are taking, or have taken within the past 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI)
• have a history of drug abuse.
• have problems with aggressive behavior.

Serious side effects have been reported with amphetamine/dextroamphetamine.  See the "Amphetamine/dextroamphetamine Precautions" section.

Common side effects of amphetamine/dextroamphetamine include the following:

• Headache
• Insomnia (trouble sleeping)
• Loss of appetite
• Abdominal pain
• Weight loss
• Anxiety
• Diarrhea
• Dizziness
• Dry mouth
• Irritability

This is not a complete list of amphetamine/dextroamphetamine side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Acidifying agents such guanethidine, reserpine, glutamic acid HCl, ascorbic acid, and fruit juices 
• Urinary acidifying agents such as ammonium chloride and sodium acid phosphate 
• Adrenergic blockers
• Gastrointestinal alkalizing agents such as sodium carbonate and urinary alkalizing agents such as acetazolamide
• Tricyclic antidepressants such as trimipramine (Surmontil), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil)

• Monoamine oxidase inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• Antihistamines
• Antihypertensives
• Chlorpromazine
• Haloperidol
• Ethosuximide
• Lithium
• Meperidine
• Methenamine
• Norepinephrine
• Phenobarbital
• Phenytoin
• Propoxyphene
• medications that reduce the acid level in your stomach such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), rabeprazole (Aciphex), cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), ranitidine (Zantac)
• medications that could lead to serotonin syndrome such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), desvenlafaxine (Pristiq), nefazodone (Serzone), paroxetine (Paxil, Pexeva), sertraline (Zoloft), venlafaxine (Effexor), trimipramine (Surmontil), isocarboxazid (Marplan), amitriptyline (Elavil), nortriptyline (Pamelor, Aventyl), protriptyline (Vivactil), and clomipramine (Anafranil), and linezolid (Zyvox)
• medications that block a protein in the body (CYP2D6) such as quinidine (Qualaquin), fluoxetine (Prozac, Sarafem), amitriptyline (Elavil, Amitril, Amitid), and paroxetine (Paxil)
• Veratrum alkaloids

This is not a complete list of amphetamine/dextroamphetamine drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Amphetamine/dextroamphetamine falls into category C. There are no well-controlled studies that have been done in pregnant women. Amphetamine/dextroamphetamine should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Amphetamine/dextroamphetamine has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from amphetamine/dextroamphetamine, a choice should be made whether to stop nursing or to stop the use of this medication. The importance of the drug to the mother should be considered.