Adzenys ER; Adzenys XR-ODT; Dyanavel XR; Evekeo
- This drug may be habit-forming; avoid long-term use. Give this drug to your child as you were told by the doctor. Tell the doctor if your child has ever abused drugs or alcohol. Misuse of this drug may cause unsafe heart-related side effects or even sudden death. Tell the doctor if your child has any heart disease.
- It is used to treat attention deficit problems with hyperactivity.
- It is used to treat narcolepsy.
- It is used to treat obesity.
- It may be given to your child for other reasons. Talk with the doctor.
- If your child has an allergy to this drug or any part of this drug.
- If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If your child or a family member has any of these health problems: Blood vessel disease, high blood pressure, heart structure problems or other heart problems, or Tourette’s syndrome or tics.
- If your child has any of these health problems: Glaucoma; nervous, anxious, or tense state; or overactive thyroid.
- If your child has ever had any of these health problems: Drug abuse or stroke.
- If your child is taking any of these drugs: Acetazolamide or sodium bicarbonate
- If your child has taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for certain other health problems in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.
- If your child is taking any of these drugs: Linezolid or methylene blue.
If your child is breast-feeding a baby:
- Be sure your child does not breast-feed a baby while taking this drug.
Liquid (suspension) (Adzenys ER):
- If your child is taking any of these drugs: Cimetidine, dexlansoprazole, esomeprazole, famotidine, lansoprazole, nizatidine, omeprazole, pantoprazole, rabeprazole, or ranitidine.
This is not a list of all drugs or health problems that interact with this drug.
Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
- Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
- Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
- If your child has been taking this drug for a long time or at high doses, it may not work as well and your child may need higher doses to get the same effect. This is known as tolerance. Call the doctor if this drug stops working well. Do not give more than ordered.
- If your child has been taking this drug for many weeks, talk with your child’s doctor before stopping. You may want to slowly stop this drug.
- Your child may have some heart tests before starting this drug. Talk with your child’s doctor.
- This drug may cause high blood pressure.
- Check blood pressure and heart rate as the doctor has told you. Talk with the doctor.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
- Talk with the doctor before giving OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
- Do not switch between different forms of this drug without first talking with the doctor.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- This drug may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
- Different brands of this drug may be for use in different ages of children. Talk with the doctor before giving this drug to a child.
If your child is pregnant:
- Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
Liquid (suspension) (Adzenys ER):
- This drug has both sodium polystyrene sulfonate and sorbitol in it. Very bad and sometimes deadly bowel problems have happened with the use of these drugs together. When this happened, the dose was much higher than what is in this drug. Talk with the doctor.
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
- Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
- A fast heartbeat.
- A heartbeat that does not feel normal.
- Change in eyesight.
- Trouble controlling body movements.
- Change in color of hands or feet from pale to blue or red.
- Numbness, pain, tingling, or cold feeling of the hands or feet.
- Any sores or wounds on the fingers or toes.
- Dark urine.
- Not able to pass urine or change in how much urine is passed.
- Muscle pain or weakness.
- For males, erections (hard penis) that happen often or that last a long time.
- Sudden deaths have happened with this drug in people with heart problems or heart defects. Stroke and heart attack have also happened in adults taking this drug. Call the doctor right away if your child has a change in strength on 1 side that is greater than the other, trouble speaking or thinking, change in balance, drooping on 1 side of the face, change in eyesight, chest pain or pressure, shortness of breath, or very bad dizziness or passing out.
- New or worse behavior and mood changes like change in thinking, anger, and hallucinations have happened with this drug. Tell the doctor if your child or a family member has any mental or mood problems like low mood (depression) or bipolar illness, or if a family member has killed themselves. Call the doctor right away if your child has hallucinations; change in the way your child acts; or signs of mood changes like low mood (depression), thoughts of killing him/herself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
- A very bad and sometimes deadly health problem called serotonin syndrome may happen if your child takes this drug with drugs for depression, migraines, or certain other drugs. Call the doctor right away if your child has agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
If your child is or may be sexually active:
- Not able to get or keep an erection.
- Change in sex interest.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
- Dry mouth.
- Not hungry.
- Not able to sleep.
- Hard stools (constipation).
- Loose stools (diarrhea).
- Weight loss.
- Upset stomach or throwing up.
- Bad taste in your mouth.
- Feeling nervous and excitable.
- Belly pain.
- Feeling tired or weak.
These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
You may report side effects to your national health agency.
Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
- Give early in the day to help prevent sleep problems.
- Give this drug with or without food.
- To gain the most benefit, do not miss giving your child doses.
- Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
- Shake well before use.
- Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
- Do not add to food.
- Do not mix with other liquids.
- Put the cap back on after your child is done using a dose.
- Do not take this drug out of the blister pack until you are ready to give this drug to your child. Give this drug right away after opening the blister pack. Do not store the removed drug for future use.
- Do not push the tablet out of the foil when opening. Use dry hands to take it from the foil. Place on your child’s tongue and let it melt. Water is not needed. Do not let your child swallow it whole. Do not let your child chew, break, or crush it.
- Give a missed dose as soon as you think about it.
- If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
- Do not give 2 doses at the same time or extra doses.
- Store at room temperature.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
- After taking blister packs out of the carton, store in the plastic travel case that comes with this drug.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
- Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
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