Patient information: uses, side effects, how to take - Amphetamine Extended-Release

What is the most important information I should know about amphetamine extended-release orally disintegrating tablets?

Amphetamine extended-release orally disintegrating tablets may cause serious side effects, including:

Abuse, misuse, and addiction.Amphetamine extended-release orally disintegrating tablets has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of amphetamine extended-release orally disintegrating tablets, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of amphetamine extended-release orally disintegrating tablets or when it is used in ways that are not approved, such as snorting or injection.
- Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with amphetamine extended-release orally disintegrating tablets and will monitor you or your child during treatment.
- Amphetamine extended-release orally disintegrating tablets may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
- Do not give amphetamine extended-release orally disintegrating tablets to anyone else. See “ What is amphetamine extended-release orally disintegrating tablets?” for more information.
- Keep amphetamine extended-release orally disintegrating tablets in a safe place and properly dispose of any unused medicine. See “ How should I store amphetamine extended-release orally disintegrating tablets?” for more information.
- Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Risks for people with serious heart disease.Sudden death has happened in people who have heart defects or other serious heart disease.
Your healthcare provider should check you or your child carefully for heart problems before starting amphetamine extended-release orally disintegrating tablets. Tell your healthcare provider if you or your child has any heart problems, heart disease, or heart defects.
Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking amphetamine extended-release orally disintegrating tablets.
Increased blood pressure and heart rate.
Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with amphetamine extended-release orally disintegrating tablets.
Mental (Psychiatric) problems:

All Patients

new or worse behavior and thought problems
new or worse bipolar illness
new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms.

Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems while taking amphetamine extended-release orally disintegrating tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

What is amphetamine extended-release orally disintegrating tablets?

Amphetamine extended-release orally disintegrating tablets is a central nervous system (CNS) stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Amphetamine extended-release orally disintegrating tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Amphetamine extended-release orally disintegrating tablets is not recommended for use in children under 6 years of age with ADHD.

Amphetamine extended-release orally disintegrating tablets is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs.Keep amphetamine extended-release orally disintegrating tablets in a safe place to prevent it from theft. Never give your amphetamine extended-release orally disintegrating tablets to anyone else, because it may harm them. Selling or giving away amphetamine extended-release orally disintegrating tablets may harm others and is against the law.

Who should not take amphetamine extended-release orally disintegrating tablets?

Amphetamine extended-release orally disintegrating tablets should not be taken if you or your child:

are allergic to amphetamine, or any of the ingredients in amphetamine extended-release orally disintegrating tablets. See the end of this Medication Guide for a complete list of ingredients in amphetamine extended-release orally disintegrating tablets.
are taking or have taken within the past 14 days an anti-depression medicine called monoamine oxidase inhibitor or MAOI.

What should I tell my healthcare provider before taking amphetamine extended-release orally disintegrating tablets?

Amphetamine extended-release orally disintegrating tablets may not be right for you or your child. Before starting amphetamine extended-release orally disintegrating tablets, tell your or your child’s healthcare provider about all health conditions (or a family history of) including:

heart problems, heart disease, heart defects, or high blood pressure
mental problems including psychosis, mania, bipolar illness, or depression
circulation problems in fingers and toes

Tell your healthcare provider:

if you or your child have kidney problems. Your healthcare provider may lower the dose.
have or had repeated movements or sounds (tics) or Tourette’s syndrome, or have a family history of tics or Tourette’s syndrome.
if you or your child are pregnant, or plan to become pregnant. It is not known if amphetamine extended-release orally disintegrating tablets will harm your unborn baby.
- There is a pregnancy registry for women who are exposed to Amphetamine extended-release orally disintegrating tablets during pregnancy. The purpose of the registry is to collect information about the health of females exposed to amphetamine extended-release orally disintegrating tablets and their babies. If you or your child becomes pregnant during treatment with amphetamine extended-release orally disintegrating tablets, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants. You can register by calling 1-866-961-2388 or by visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.
if you or your child is breastfeeding or plan to breastfeed. Amphetamine extended-release orally disintegrating tablets passes into breast milk. You should not breastfeed while you are taking amphetamine extended-release orally disintegrating tablets. Talk to your healthcare provider about the best way to feed the baby during treatment with amphetamine extended-release orally disintegrating tablets.

Tell your healthcare provider about all of the medicines that you or your child takesincluding prescription and over-the-counter medicines, vitamins, and herbal supplements. Amphetamine extended-release orally disintegrating tablets and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking amphetamine extended-release orally disintegrating tablets.

Your healthcare provider will decide whether amphetamine extended-release orally disintegrating tablets can be taken with other medicines.

Especially tell your healthcare provider if you or your child takes:

anti-depression medicines including MAOIs

Know the medicines that you or your child take. Keep a list of your medicines with you to show your healthcare provider and pharmacist.

Do not start any new medicine while taking amphetamine extended-release orally disintegrating tablets without talking to your healthcare provider first.

How should amphetamine extended-release orally disintegrating tablets be taken?

Take amphetamine extended-release orally disintegrating tablets exactly as prescribed. Your healthcare provider may adjust the dose until it is right for you or your child.
Take amphetamine extended-release orally disintegrating tablets 1 time each day in the morning.

Amphetamine extended-release orally disintegrating tablets supplied in blister form:

Leave the tablet in the blister pack until you are ready to take or give it.
Use dry hands to open the blister pack.
Tear along the perforation, bend the blister where indicated and peel back the blister’s labeled backing to take out the tablet. Do not push the tablet through the foil.
Place the tablet on the tongue.
Take amphetamine extended-release orally disintegrating tablets as soon as you open the blister pack. The tablet will dissolve in your mouth (saliva) so that it can be swallowed.
Do not crush or chew.

Amphetamine extended-release orally disintegrating tablets supplied in bottle form:

Leave the tablet in the bottle until you are ready to take or give it.
Place the tablet on the tongue.
Take amphetamine extended-release oraly disintegrating tablets as soon as you open the bottle. The tablet will dissolve in your mouth (saliva) so that it can be swallowed.
Do not crush or chew.
Amphetamine extended-release orally disintegrating tablets can be taken with or without food.
Your healthcare provider may do regular checks of your or your child’s blood, heart, and blood pressure while taking amphetamine extended-release orally disintegrating tablets.
Children should have their height and weight checked often while taking amphetamine extended-release orally disintegrating tablets. Amphetamine extended-release orally disintegrating tablets treatment may be stopped if a problem is found during these check-ups.

If you or your child take too much amphetamine extended-release orally disintegrating tablets, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

What should I avoid while taking amphetamine extended-release orally disintegrating tablets?

drinking alcohol

What are possible side effects of amphetamine extended-release orally disintegrating tablets?

amphetamine extended-release orally disintegrating tablets can cause serious side effects, including:

See “What is the most important information I should know about amphetamine extended-release orally disintegrating tablets?”for information on reported heart and mental problems.
Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with amphetamine extended-release orally disintegrating tablets. Your healthcare provider may stop your child’s amphetamine extended-release orally disintegrating tablets treatment if they are not growing or gaining weight as expected.
Circulation problems in fingers and toes[Peripheral vasculopathy, including Raynaud’s phenomenon]:
- fingers or toes may feel numb, cool, painful
- fingers or toes may change from pale, to blue, to red

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

Call your healthcare provider right away if you have or your child has any unexplained wounds appearing on fingers or toes while taking amphetamine extended-release orally disintegrating tablets.

New or worsening tics or worsening Tourette’s syndrome.Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with amphetamine extended-release orally disintegrating tablets.

Common side effects of amphetamine extended-release orally disintegrating tablets includedecreased appetite and problems sleeping .

Common side effects of amphetamine extended-release orally disintegrating tablets in children 6 to 12 years of age also include:

stomach pain
nervousness

extreme mood change
nausea

vomiting
fever

Common side effects of amphetamine extended-release orally disintegrating tablets in children 13 to 17 years of age also include:

stomach pain

weight loss

Common side effects of amphetamine extended-release orally disintegrating tablets in adults also include:

dry mouth
nausea
dizziness
weakness

headache
anxiety
fast heart beat
urinary tract infections

weight loss
restlessness
diarrhea

Talk to your healthcare provider if you or your child have side effects that are bothersome or do not go away.

These are not all the possible side effects amphetamine extended-release orally disintegrating tablets.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.

How should I store amphetamine extended-release orally disintegrating tablets?

Store amphetamine extended-release orally disintegrating tablets blister or bottle packaing in a cool, dry place at room temperature between 68° F to 77° F (20° C to 25° C).
Store amphetamine extended-release orally disintegrating tablets in a safe place, like a locked cabinet.
Store amphetamine extended-release orally disintegrating tablets in the blister or bottle packaging until you are ready to take or give it.
Store amphetamine extended-release orally disintegrating tablets blister packages in the hard plastic travel case provided after removal from the carton.
Dispose of remaining, unused, or expired amphetamine extended-release orally disintegrating tablets by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix amphetamine extended-release orally disintegrating tablets with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away amphetamine extended-release orally disintegrating tablets in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

Keep amphetamine extended-release orally disintegrating tablets and all medicines out of the reach of children.

General information about the safe and effective use of amphetamine extended-release orally disintegrating tablets

Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not use amphetamine extended-release orally disintegrating tablets for a condition for which it has not been prescribed. Do not give amphetamine extended-release orally disintegrating tablets to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about amphetamine extended-release orally disintegrating tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about amphetamine extended-release orally disintegrating tablets that is written for healthcare professionals.

For more information about amphetamine extended-release orally disintegrating tablets or to get a plastic travel case contact Neos Therapeutics, Inc. at 1-888-236-6816.

What are the ingredients in amphetamine extended-release orally disintegrating tablets?

Active Ingredients:Amphetamine

Inactive Ingredients:Mannitol, Crospovidone, Microcrystalline Cellulose, Methacrylic Acid, Sodium Polystyrene Sulfonate, Citric Acid, Fructose, Orange Flavor, Colloidal Silicon Dioxide, Triethyl Citrate, Sucralose, Lake Blend Orange, Magnesium Stearate, and Polyethylene Glycol 3350.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 03/2026

Amphetamine Extended-Release: Uses, Side Effects and Dosage