Amphetamine

IMPORTANT WARNING:

Amphetamine 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 amphetamine, 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; restlessness; irritability; 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 amphetamine may also cause serious heart problems or sudden death.

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 amphetamine for you.

Do not stop taking amphetamine 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 develop depression and extreme tiredness. if you suddenly stop taking amphetamine after overusing it.

Do not sell, give away, or let anyone else take your medication. Selling or giving away amphetamine may harm others and is against the law. Store amphetamine in a safe, preferably locked, place so that no one else can take it accidentally or on purpose.Keep track of how many tablets or how much suspension (liquid) 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 amphetamine and each time you refill your prescription. 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) 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?

Amphetamine (Adzenys^® ER, Adzenys^® XR, Dyanavel^® XR, Evekeo^®, Evekeo^® ODT, others) 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.Amphetamine (Evekeo^®, others) is also used to treat narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep). Amphetamine (Evekeo^®, others) is also used for a limited period of time (a few weeks) along with a reduced calorie diet and an exercise plan for weight loss in obese people unable to lose weight. Amphetamine 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?

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

HOW should this medicine be used?

Amphetamine comes as an immediate-release tablet (Evekeo^®), an orally disintegrating tablet (tablet that dissolves quickly in the mouth; Evekeo^® ODT), an extended-release (long-acting) orally disintegrating tablet (Adzenys^® XR), and as an extended-release (long-acting) suspension (Adzenys^® ER, Dyanavel^® XR) to take by mouth.The extended-release suspension is usually taken once daily in the morning with or without food.The orally disintegrating tablet is usually taken once daily in the morning with or without food or liquid. The extended-release orally disintegrating tablet is usually taken once daily in the morning with or without food. For treatment of ADHD or narcolepsy, the immediate-release tablet is usually taken with or without food 1 to 3 times daily, 4 to 6 hours apart, with the first dose in the morning. For weight loss, the immediate-release tablet is usually taken 30 to 60 minutes before meals.Amphetamine should not be taken in the late afternoon or 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 amphetamine exactly as directed.

Swallow the extended-release tablets whole, do not chew or crush them.

Do not try to push the orally disintegrating tablet (Evekeo^® ODT) or the extended-release orally disintegrating tablet (Adzenys^® XR) through the blister pack foil.Instead, use dry hands to peel back the foil packaging.Immediately take out the tablet and place it in your mouth.The tablet will quickly dissolve and can be swallowed with saliva.No water is needed to swallow the tablet.

Shake the extended-release suspension (Adzenys^® ER, Dyanavel^® XR) well before each use to mix the medication evenly.

Do not add the extended-release suspension (Adzenys^® ER) to food or mix it with other liquids.

It is important to use an oral syringe (measuring device) to accurately measure and take your dose of the extended-release suspension.Ask your pharmacist for a device if it was not provided.Wash the oral syringe thoroughly after each use.

If you or your child are taking amphetamine for ADHD, your doctor will probably start you on a low dose of amphetamine and increase your dose gradually, every 4 to 7 days, depending on the medication.Your doctor may tell you to stop taking amphetamine from time to time to see if the medication is still needed. Follow these directions carefully.

If you are taking amphetamine for narcolepsy, your doctor will probably start you on a low dose of amphetamine and increase your dose gradually, not more often than once every week. Follow these directions carefully.

The medication in each product is absorbed differently by the body, so one amphetamine product cannot be substituted for another product.If you are switching from one product to another, your doctor will prescribe a dose that is best for you.

What SPECIAL PRECAUTIONS should I follow?

Before taking amphetamine,

• tell your doctor and pharmacist if you are allergic to amphetamine, other stimulant medications such as benzphetamine, dextroamphetamine (Dexedrine^®, in Adderall^®), lisdexamfetamine (Vyvanse^®), and methamphetamine (Desoxyn^®); any other medications; or any of the other ingredients in amphetamine products.Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• Tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan^®), linezolid (Zyvox^®), methylene blue, phenelzine (Nardil^®), selegiline (Eldepryl^®, Emsam^®, Zelapar^®), and tranylcypromine (Parnate^®).

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

• The following nonprescription or herbal products may interact with amphetamine: St. John's wort; tryptophan or nutritional supplements you are taking including glutamic acid (L-glutamine); sodium acid phosphate; sodium bicarbonate (Arm and Hammer^™ Baking Soda, Soda Mint); medications for heartburn or ulcers such as cimetidine (Tagamet^®), esomeprazole (Nexium^®), omeprazole (Prilosec^®, in Zegerid^®); 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 amphetamine. Do not start any of these medications while taking amphetamine without discussing with your healthcare provider.

• tell your doctor if you have hyperthyroidism (condition in which there is too much thyroid hormone in the body), or strong feelings of anxiety, tension, or agitation. Your doctor will probably tell you not to take amphetamine.

• 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 or if you have or have ever had a heart defect, arteriosclerosis (hardening of the arteries), coronary artery disease (narrowing of the blood vessels that supply blood to the heart), high blood pressure, an irregular heartbeat, cardiomyopathy (thickening of the heart muscles),heart or blood vessel disease, 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 amphetamine 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), mania (frenzied, abnormally excited mood), psychosis, motor tics (repeated uncontrollable movements), verbal tics (repetition of sounds or words that is hard to control),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 seizures, an abnormal electroencephalogram (EEG; a test that measures electrical activity in the brain), or kidney disease.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking amphetamine, call your doctor.

• do not breastfeed while taking amphetamine.

• do not drive a car or operate machinery until you know how this medication affects you.

• do not drink alcohol while you are taking amphetamine.Alcohol can make the side effects from amphetamine worse.

• you should know that amphetamine 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 amphetamine 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 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?

Talk to your doctor about drinking fruit juice while taking this medicine.

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?

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

• dry mouth
• nausea
• diarrhea
• constipation
• unpleasant taste
• stomach cramps
• weight loss
• nose bleeding
• headache
• grinding or clenching teeth during sleep
• nervousness
• changes in sex drive or ability
• painful menstruation
• pain or burning when urinating

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking amphetamine and call your doctor immediately:

• dizziness
• weakness or numbness of an arm or leg
• motor or verbal tics
• believing things that are not true
• feeling unusually suspicious of others
• hallucinating (seeing things or hearing voices that do not exist)
• mania (frenzied or abnormally excited mood)
• 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
• seizures
• changes in vision or blurred vision
• blistering or peeling skin
• rash
• hives
• itching
• swelling of the face, throat, tongue, lips, or eyes
• difficulty breathing or swallowing
• numbness, pain, or sensitivity to temperature in the fingers or toes
• skin color change from pale to blue to red in the fingers or toes
• unexplained wounds appearing on fingers or toes

Amphetamine 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.

Amphetamine 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 amphetamine to your child.

Amphetamine 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 the orally disintegrating tablet blister packages in the provided plastic sleeves. Store the extended-release orally disintegrating tablet blister packages in the rigid, plastic travel case after removal from the carton. Store it at room temperature and away from light, 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
• confusion
• aggressive behavior
• shaking of a part of the body
• tiredness or weakness
• depression
• fast or irregular heartbeat
• nausea
• 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. Your doctor may order certain tests to check your body's response to amphetamine and your blood pressure.

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

This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that 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.