Amphetamine Extended-Release Suspension

What is this medication?

AMPHETAMINE (am FET a meen) treats attention-deficit hyperactivity disorder (ADHD). It works by improving focus and reducing impulsive behavior. It belongs to a group of medications called stimulants.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Adzenys, Dyanavel XR

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Circulation problems in fingers and toes
• Heart disease or a heart defect
• High blood pressure
• History of stroke
• History of substance use disorder
• Kidney disease
• Mental health condition
• Suicidal thoughts, plans, or attempt by you or a family member
• Tourette's syndrome
• An unusual or allergic reaction to dextroamphetamine, other amphetamines, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Shake well before using. Use a specially marked oral syringe, spoon, or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be prescribed for children as young as 6 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• MAOIS, such as Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Other stimulant medications for attention disorders

This medication may also interact with the following:

• Acetazolamide
• Ammonium chloride
• Antacids
• Ascorbic acid
• Certain medications for depression, anxiety, or mental health conditions
• Certain medications for stomach problems, such as cimetidine, famotidine, omeprazole, lansoprazole
• Glutamic acid
• Guanethidine
• Methenamine, sodium acid phosphate
• Reserpine
• Sodium bicarbonate

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. This prescription requires that you follow special procedures with your care team and pharmacy. You will need to have a new written prescription from your care team every time you need a refill.

This medication may affect your concentration, or hide signs of tiredness. Until you know how this medication affects you, do not drive, ride a bicycle, use machinery, or do anything that needs mental alertness.

Tell your care team if this medication loses its effects, or if you feel you need to take more than the prescribed amount. Do not change the dosage without talking to your care team.

For males, contact your care team right away if you have an erection that lasts longer than 4 hours or if it becomes painful. This may be a sign of a serious problem and must be treated right away to prevent permanent damage.

Decreased appetite is a common side effect when starting this medication. Eating small, frequent meals or snacks can help. Talk to your care team if you continue to have poor eating habits. Height and weight growth of a child taking this medication will be monitored closely.

Do not take this medication close to bedtime. It may prevent you from sleeping.

Tell your care team right away if you notice unexplained wounds on your fingers and toes while taking this medication. You should also tell your care team if you experience numbness or pain, changes in the skin color, or sensitivity to temperature in your fingers or toes.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increase in blood pressure
• Irritability, confusion, fast or irregular heartbeat, muscle stiffness, twitching muscles, sweating, high fever, seizure, chills, vomiting, diarrhea, which may be signs of serotonin syndrome
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Raynaud's—cool, numb, or painful fingers or toes that may change color from pale, to blue, to red
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Dizziness
• Dry mouth
• Headache
• Loss of appetite with weight loss
• Nausea
• Stomach pain
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep your medication in a safe place to protect it from theft. Do not share this medication with anyone. Selling or giving away this medication is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep container tightly closed. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.