Adzenys XR-ODT

Amphetamine is a stimulant medicine that is used to treat attention deficit hyperactivity disorder (ADHD).

The Evekeo brand of amphetamine is used to treat ADHD and also narcolepsy. Evekeo is sometimes used to treat obesity in people who have not lost weight with diets or other treatments. Evekeo ODT is used only for ADHD.

Amphetamine may also be used for purposes not listed in this medication guide.

You should not use amphetamine if you are allergic to any stimulant medicine, or if you have:

• moderate to severe high blood pressure;
• overactive thyroid;
• severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse); or
• a history of drug or alcohol addiction.

Do not use amphetamine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with amphetamine and cause a serious condition called serotonin syndrome.

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;
• high blood pressure; or
• a family history of heart disease or sudden death.

Tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
• problems with drug or alcohol abuse;
• motor tics (muscle twitches) or Tourette's syndrome;
• kidney disease;
• a thyroid disorder;
• seizures or epilepsy;
• an abnormal brain wave test (EEG);
• coronary artery disease (clogged arteries); or
• blood circulation problems in the hands or feet.

Taking this medicine during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Amphetamine is not approved for use by anyone younger than 6 years old.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Amphetamine may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

You may take amphetamine with or without food.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Remove an orally disintegrating tablet (ODT) from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the form and strength your doctor prescribes.

Your doctor will need to check your progress on a regular basis. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Ask your pharmacist where to locate a drug take-back disposal program.

Take the missed dose as soon as you remember, but not late in the day. Skip the missed dose if it is almost evening. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amphetamine could be fatal.

Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, hostility, violence, panic, muscle pain or weakness, and dark colored urine. These symptoms may be followed by depression and tiredness. Overdose may also cause seizure or coma.

Avoid drinking alcohol while you are taking this medicine.

Avoid drinking fruit juices or taking vitamin C at the same time you take amphetamine. These can make your body absorb less of the medicine.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;
• signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
• signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;
• a seizure (convulsions);
• muscle twitches (tics); or
• changes in your vision.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Amphetamine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common side effects may include:

• stomach pain, nausea, vomiting, diarrhea, constipation;
• loss of appetite, weight loss;
• mood changes, feeling restless or nervous, sleep problems (insomnia);
• dry mouth, unusual or unpleasant taste in the mouth;
• runny nose, nosebleeds;
• increased heart rate;
• headache, dizziness;
• itching; or
• impotence, sexual problems.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask your doctor before using a stomach acid medicine (including Alka-Seltzer or sodium bicarbonate). Some of these medicines can change the way your body absorbs amphetamine, and may increase side effects.

Many drugs can affect amphetamine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about amphetamine.