Zenzedi tablets and oral solution (liquid) are used to treat attention deficit hyperactivity disorder (ADHD) in children who are 3 to 16 years old.

Zenzedi extended-release capsules are used to treat attention deficit hyperactivity disorder (ADHD) in children who are 6 to 16 years old.

Zenzedi skin patch is used to treat attention deficit hyperactivity disorder (ADHD) in adults and children at least 6 years old.

Zenzedi tablets, oral solution (liquid) and extended-release capsules are also used in the treatment of a sleep disorder called narcolepsy.

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

You should not use this medicine if you have glaucoma, overactive thyroid, severe agitation, moderate to severe high blood pressure, heart disease or coronary artery disease, or a history of drug or alcohol addiction.

Zenzedi may be habit-forming. Misuse can cause addiction, serious heart problems, or death.

Call your doctor right away if you have: chest pain, seeing or hearing things that are not real, decreased need for sleep, being agitated, unexplained wounds on your fingers or toes.

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.

Zenzedi may be habit-forming. Misuse can cause addiction, overdose, serious heart problems or death. Keep the medication where others cannot get to it. Selling or giving away this medicine is against the law.

Zenzedi is sometimes taken 2 or 3 times per day. Extended-release this medicine is taken only once per day.

Apply the patch to clean, dry, hairless skin. Press firmly into place for about 10 seconds. Leave the patch on while bathing, showering, or swimming. Apply the patch 2 hours before the effect is needed and remove the patch within 9 hours after application.

Choose a different place on your body each time you apply a new patch. Do not apply to the same skin twice in 7 days. Do not wear more than one patch at a time. Use only 1 patch per day. Never cut a skin patch.

Swallow the Zenzedi extended release capsule whole and do not crush, chew, break, or open it.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

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

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.

Store at room temperature away from moisture, heat, and light.

Read and carefully follow the instructions provided with this medicine about how to safely dispose of any unused portion. Do not flush Zenzedi skin patch down the toilet.

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

• moderate to severe high blood pressure, heart problems or coronary artery disease (clogged arteries);

• overactive thyroid, glaucoma;

• severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse); or

• a history of drug or alcohol addiction.

Do not use Zenzedi 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, tranylcypromine, and others.

Tell your doctor if you also use opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with Zenzedi could cause a serious condition called serotonin syndrome.

Tell your doctor if you or a family member has ever had:

• a heart defect, high blood pressure, a family history of heart disease or sudden death;

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;

• motor tics (muscle twitches) or Tourette's syndrome;

• seizures or epilepsy, an abnormal brain wave test (EEG);

• contact dermatitis;

• blood circulation problems or peripheral vascular disease such as Raynaud's syndrome; or

• kidney disease.

Tell your doctor if you are pregnant or plan to become pregnant. Using Zenzedi during pregnancy may increase the risk of premature birth, withdrawal symptoms or low birth weight.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of dextroamphetamine skin patch on the baby.

You should not breastfeed while using Zenzedi.

Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.

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

Overdose symptoms may include restlessness, rapid breathing, hallucinations, aggressiveness, vomiting, diarrhea, uneven heartbeats, fainting, seizures, or coma.

Zenzedi may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Avoid external heat sources like hair dryers, heat lamps or saunas while wearing Zenzedi skin patch.

Avoid drinking fruit juices or taking vitamin C while you take Zenzedi. These can make your body absorb less of the medicine.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stimulants have caused stroke, heart attack, and sudden death in certain people. Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, or feeling short of breath.

Zenzedi may cause serious side effects. Call your doctor at once if you have:

• signs of heart or blood circulation problems --chest pain, trouble breathing, numbness, cold feeling, or pale appearance of your fingers or toes;

• signs of mania or psychosis-- seeing or hearing things that are not real, aggression, paranoia, decreased need for sleep, risk-taking behavior, being agitated or talkative;

• a seizure, muscle twitches (tics), changes in your vision, blurry vision; or

• mild skin irritation where the patch is worn.

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.

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

Common side effects of Zenzedi may include:

• dry mouth, upset stomach, loss of appetite, weight loss;

• headache, dizziness, sleep problems (insomnia), irritability, muscle twitching (tics); or

• nausea, vomiting, increased blood pressure, tremors, fast heartbeats.

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.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

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

• an antacid, migraine headache medicine, seizure medicine;

• fentanyl, tramadol, lithium, buspirone;

• acetazolamide, tryptophan, methenamine, vitamin c products;

• an antidepressant, a diuretic or "water pill"; or

• blood pressure medication.

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