Evekeo ODT

Evekeo ODT is a stimulant medicine that treats attention deficit hyperactivity disorder (ADHD) in children. Some brands of amphetamine are for children aged 6 years and older. Evekeo can be used in children as young as 3 years old.

Evekeo is also used to treat narcolepsy in adults and children who are at least 6 years old, or obesity in adults and children who are at least 12 years old and have not lost weight with diets or other treatments.

Evekeo ODT is specifically used to treat ADHD in children who are at least 6 years old.

Evekeo ODT may also be used for other purposes not listed in this medication guide.

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.

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

Do not use this medicine more often than prescribed.

You may take Evekeo ODT with or without food.

Dyanavel XR tablets may be chewed if you are unable to swallow.

Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).

Remove an orally disintegrating tablet from the package with dry hands only when you are ready to use the medicine. Allow the orally disintegrating tablet to dissolve in your mouth without chewing.

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 medicine your doctor prescribes.

Your doctor will need to check your progress regularly and may need medical tests to check your heart function. Tell any doctor who treats you that you are using this medicine.

Store this medicine in the original container at room temperature away from moisture and heat.

Do not keep leftover medicine. Ask your pharmacist about a drug take-back program. You may also mix the leftover medicine with cat litter or coffee grounds in a sealed plastic bag and throw the bag in the trash.

Stimulants can lead to stroke, heart attack, and sudden death in individuals with high blood pressure, heart disease, or a heart defect.

Do not use Evekeo ODT if you have taken an MAO inhibitor in the last 14 days. A dangerous drug interaction could happen. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine.

Evekeo ODT may be habit-forming. Misuse can lead to addiction, overdose, or death. Keep this medicine in a place where others cannot access it. Selling or sharing this medicine is illegal.

Contact your doctor immediately if you experience: signs of heart problems such as chest pain, feeling light-headed, or shortness of breath; signs of psychosis like paranoia, aggression, new behavior issues, or seeing/hearing things that are not real; or signs of circulation problems including numbness, pain, cold feeling, unexplained wounds, or changes in skin color (pale, red, or blue appearance) in your fingers or toes.

This medicine can impact the results of certain medical tests. Inform any doctor treating you that you are using Evekeo ODT.

You should not use Evekeo ODT if you are allergic to any stimulant medicine, or if you have taken an MAO inhibitor in the last 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

You may not be able to use Evekeo ODT if you have:

• chest pain or breathing problems caused by heart disease;
• hardening of the arteries;
• moderate to severe high blood pressure;
• overactive thyroid;
• a history of drug abuse; or
• if you are agitated.

Stimulants have caused stroke, heart attack, and sudden death in some 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 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;
• a thyroid disorder;
• seizures or epilepsy;
• an abnormal brain wave test (electroencephalogram; EEG);
• coronary artery disease (clogged arteries);
• blood circulation problems in the hands or feet; or
• kidney disease.

Tell your doctor if you are pregnant or plan to become pregnant. Taking Evekeo ODT during pregnancy may increase the risk of premature birth or low birth weight. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of amphetamine on the baby.

Do not breastfeed.

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

Evekeo ODT may cause serious side effects. Call your doctor immediately if you have:

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

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

Common side effects of Evekeo ODT may include:

• increased heart rate;
• mood changes, anxiety, feeling restless or nervous;
• trouble sleeping;
• dry mouth, stomach pain, nausea, vomiting, diarrhea, constipation;
• loss of appetite, weight loss;
• sexual problems (impotence in males);
• headache, dizziness; or
• itching.

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.

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

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. An overdose can be fatal.

Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, confusion, hostility, hallucinations, heart problems, blood pressure changes, panic, muscle pain or weakness, stomach cramps, vomiting, or diarrhea. These symptoms may be followed by depression and tiredness. Overdose may also lead to seizure or coma.

Avoid drinking fruit juices such as cranberry juice or taking vitamin C at the same time you take Evekeo ODT. These can make your body absorb less of Evekeo ODT.

Avoid drinking alcohol.

Avoid driving or doing dangerous activities until you know how this medicine will affect you. Your reactions could be impaired.

Sometimes, it is not safe to use certain medicines together. Some drugs can change the blood levels of other drugs you take, which may increase side effects or make the medicines less effective.

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

Tell your doctor about all your current medicines. Many drugs can affect Evekeo ODT, especially:

• antidepressants including desipramine, protriptyline, paroxetine, fluoxetine;
• lithium or other medicines for depression or mental illness;
• blood pressure medicines;
• blood thinners (warfarin, Coumadin, Jantoven);
• cold or allergy medicines containing a decongestant;
• opioid (narcotic) medicines; or
• seizure medicines.

This list is not complete, and many other drugs may affect Evekeo ODT. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.