Dextroamphetamine

IMPORTANT WARNING:

Dextroamphetamine can be habit-forming.Do not take a larger dose, take it more often, or take it for a longer time than prescribed by your doctor. If you take too much dextroamphetamine, you may continue to feel a need to take large amounts of the medication, and you may experience unusual changes in your behavior.You or your caregiver should tell your doctor immediately, if you experience any of the following symptoms: fast, pounding, or irregular heartbeat; sweating; dilated pupils; abnormally excited mood; irritability; restlessness; difficulty falling sleeping or staying asleep; hostility; aggression; anxiety; loss of appetite; loss of coordination; uncontrollable movement of a part of the body; flushed skin; vomiting; stomach pain; or thinking about harming or killing oneself or others or planning or trying to do so. Overusing dextroamphetamine may also cause serious heart problems or sudden death.

If you take too much dexmethylphenidate, you may continue to feel a need to take large amounts of the medication, and you may experience unusual changes in your behavior

Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications.Your doctor will probably not prescribe dextroamphetamine for you.

Do not stop taking dextroamphetamine without talking to your doctor, especially if you have overused the medication.Your doctor will probably decrease your dose gradually and monitor you carefully during this time.You may experience depression and extreme tiredness if you suddenly stop taking dextroamphetamine after overusing it.

Do not sell, give away, or let anyone else take your medication.Selling or giving away dextroamphetamine is against the law and may harm others. Store dextroamphetamine in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets or capsules are left so you will know if any are missing.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with dextroamphetamine and each time you get more medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

IMPORTANT NOTICE:

On June 30, 2025, FDA issued a drug safety communication about a risk of weight loss in patients younger than 6 years of age taking extended-release stimulants for ADHD and will be revising the labeling for all these products to reflect this new safety information. Although extended-release stimulants are not approved for children younger than 6 years, health care professionals can prescribe them “off label” to treat ADHD. For additional information, see https://www.fda.gov/media/187347/download.

WHY is this medicine prescribed?

Dextroamphetamine is used as part of a treatment program to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) in adults and children.Dextroamphetamine is also used to treat narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep). Dextroamphetamine is in a class of medications called central nervous system stimulants.It works by changing the amounts of certain natural substances in the brain.

Are there OTHER USES for this medicine?

Dextroamphetamine should not be used to treat excessive tiredness that is not caused by narcolepsy.

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

HOW should this medicine be used?

Dextroamphetamine comes as a liquid, tablet, and an extended-release (long-acting) capsule to take by mouth.The tablet is usually taken 2 to 3 times daily with or without food.The extended-release capsule is usually taken once a day with or without food. The liquid is usually taken once or twice daily with or without food. Take dextroamphetamine at around the same time(s) every day. If you are taking dextroamphetamine tablets, take your first dose as soon as you wake up in the morning, and space your doses by 4 to 6 hours.Do not take dextroamphetamine in the evening because it may cause difficulty falling asleep or staying asleep.Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dextroamphetamine exactly as directed.

Do not chew or crush the extended-release capsules.

Your doctor will probably start you on a low dose of dextroamphetamine and gradually increase your dose, not more often than once every week.

Your doctor may tell you to stop taking dextroamphetamine from time to time to see if the medication is still needed.Follow these directions carefully.

What SPECIAL PRECAUTIONS should I follow?

Before taking dextroamphetamine,

• tell your doctor and pharmacist if you are allergic to dextroamphetamine, any other medications, or any of the ingredients in dextroamphetamine preparations.Ask your pharmacist for a list of the ingredients.

• tell your doctor or pharmacist if you are taking or have stopped taking the following medications in the past two weeks: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan^®), linezolid (Zyvox^®), methylene blue, phenelzine (Nardil^®), selegiline (Eldepryl^®, Emsam^®, Zelapar^®), and tranylcypromine (Parnate^®).

• some medications should not be taken with dextroamphetamine. Other medications may cause dosing changes or extra monitoring when taken with dextroamphetamine. Make sure you have discussed any medications you are currently taking or plan to take before starting dextroamphetamine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking dextroamphetamine, please get the advice of your doctor or pharmacist.

• the following nonprescription or herbal products may interact with dextroamphetamine: St. John's wort; tryptophan; nutritional supplements including glutamic acid (L-glutamine); ascorbic acid; sodium acid phosphate; sodium bicarbonate (Arm and Hammer™ Baking Soda, Soda Mint); antacids; antacids or other medications for heartburn such as omeprazole (Prilosec^®); allergy medications (diphenhydramine, loratadine, fexofenadine, chlorpheniramine or cetirizine). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking dextroamphetamine. Do not start any of these medications while taking dextroamphetamine without discussing with your healthcare provider.

• tell your doctor if you have glaucoma (increased pressure in the eye that may cause vision loss), hyperthyroidism (a condition in which you have too much thyroid hormone in your body); feelings of anxiety, tension, or agitation.Your doctor will probably tell you not to take dextroamphetamine.

• tell your doctor if anyone in your family has or has ever had an irregular heartbeat or has died suddenly.Also tell your doctor if you have recently had a heart attack and if you have or have ever had a heart defect, high blood pressure, an irregular heartbeat, heart or blood vessel disease, hardening of the arteries, or other heart problems.Your doctor will examine you to see if your heart and blood vessels are healthy.Your doctor will probably tell you not to take dextroamphetamine if you have a heart condition or if there is a high risk that you may develop a heart condition.

• tell your doctor if you or anyone in your family has or has ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), or mania (frenzied, abnormally excited mood), facial or motor tics (repeated uncontrollable movements), verbal tics (repetition of sounds or words that is hard to control) or Tourette's syndrome (a condition characterized by the need to perform repeated motions or to repeat sounds or words), or has thought about or attempted suicide. Also tell your doctor if you have or have ever had mental illness,seizures, or an abnormal electroencephalogram (EEG; test that measures electrical activity in the brain). If your child is taking dextroamphetamine to treat ADHD, tell your child's doctor if your child has recently experienced unusual stress.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.If you become pregnant while taking dextroamphetamine, call your doctor.Do not breastfeed while taking dextroamphetamine.

• talk to your doctor about the risks and benefits of taking dextroamphetamine if you are 65 years of age or older. Older adults should not usually take dextroamphetamine because it is not as safe as other medications that can be used to treat the same condition.

• you should know that dextroamphetamine may make it difficult for you to perform activities that require alertness or physical coordination.Do not drive a car or operate machinery until you know how this medication affects you.

• you should know that dextroamphetamine should be used as part of a total treatment program for ADHD, which may include counseling and special education.Make sure to follow all of your doctor's and/or therapist's instructions.

• you should know that dextroamphetamine may cause sudden death in children and teenagers, especially children and teenagers with heart defects or serious heart problems.This medication also may cause sudden death, heart attack, or stroke in adults, especially adults with heart defects or serious heart problems. Call your or your child's doctor right away if you or your child has any signs of heart problems while taking this medication, including: chest pain, shortness of breath, or fainting.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it.However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule.Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Dextroamphetamine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• dry mouth
• unpleasant taste
• constipation
• weight loss
• changes in sex drive or ability

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• excessive tiredness
• slow or difficult speech
• dizziness
• weakness or numbness of an arm or leg
• seizures
• mood changes
• believing things that are not true
• feeling unusually suspicious of others
• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
• hallucinations (seeing things or hearing voices that do not exist)
• abnormal movements
• verbal tics
• changes in vision or blurred vision
• hives
• paleness or blue color of fingers or toes
• pain, burning, or tingling in the hands or feet
• unexplained wounds appearing on fingers or toes

Dextroamphetamine may cause sudden death in children and teenagers, especially children and teenagers who have heart defects or serious heart problems. This medication also may cause sudden death, heart attack or stroke in adults, especially adults who have heart defects or serious heart problems. Call your doctor right away if you or your child has any signs of heart problems while taking this medication including: chest pain, shortness of breath, or fainting. Talk to your doctor about the risks of taking this medication.

Dextroamphetamine may slow children's growth or weight gain. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight gain while he or she is taking this medication. Talk to your child's doctor about the risks of giving dextroamphetamine to your child.

Dextroamphetamine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children.Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• restlessness
• uncontrollable shaking of a part of your body
• dark red or cola colored urine
• muscle weakness or aching
• tirednessor weakness
• fast breathing
• fever
• confusion
• aggressive behavior
• hallucinations (seeing things or hearing voices that do not exist)
• panic
• depression
• irregular heartbeat
• dizziness
• fainting
• blurred vision
• upset stomach
• vomiting
• diarrhea
• stomach cramps
• seizures
• coma (loss of consciousness for a period of time)

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking dextroamphetamine.

This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so you do not run out of medication.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.