INFORMATION TO HELP YOU GET STARTED
The following brief instructions will guide you on:
- Opening the blister pack
- Taking the medication
- Routine monitoring
- Proper storage
Before you start
Take Adzenys XR-ODT once daily in the morning. Your doctor may adjust the dose until it is right for you or your child.
- Leave the tablet in the blister pack until you are ready to take or give it.
- Use dry hands to open the blister pack.
- Tear along the perforation, bend the blister where indicated, and peel back the blister's labeled backing to take out the tablet. Do not push the tablet through the foil.
Opening the Adzenys XR-ODT blister pack
This video can help you understand the proper method
for opening the Adzenys XR-ODT blister pack.
Taking the medication
- Place the tablet on the tongue.
Take Adzenys XR-ODT as soon as you open
the blister pack. The tablet will dissolve in your mouth so that it can be swallowed.
- Do not crush or chew.
Routine monitoring when taking Adzenys XR-ODT
- Your doctor may sometimes stop Adzenys XR-ODT treatment for a while to check ADHD symptoms.
- Your doctor may do regular checks of your or your child's blood, heart, and blood pressure while taking Adzenys XR-ODT.
- Children should have their height and weight checked often while taking Adzenys XR-ODT. Adzenys XR-ODT treatment may be stopped if a problem is found during these check-ups.
If you or your child take(s) too much Adzenys XR-ODT, call your doctor or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.
Storing your medication
- Store Adzenys XR-ODT at room temperature between 68°F to 77°F (20°C to 25°C).
- Store Adzenys XR-ODT in a safe place, like a locked cabinet.
- Store Adzenys XR-ODT in the blister packaging until you are ready to take or give it.
- Store Adzenys XR-ODT blister packages in the hard plastic travel case provided after removal from the carton.
- Keep Adzenys XR-ODT and all medicines out of the reach of children
Do not take Adzenys XR-ODT or Adzenys ER if you or your child is:
- allergic to amphetamine or any ingredients in Adzenys XR-ODT or Adzenys ER.
- taking or has taken an anti-depression medicine called monoamine oxidase inhibitor (MAOI) within the past 14 days.
- you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in people with heart problems or defects, and sudden death, stroke and heart attack have happened in adults. Your doctor should check for heart problems prior to prescribing either Adzenys XR-ODT or Adzenys ER and will check you or your child’s blood pressure and heart rate during treatment. Call the doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking either Adzenys XR-ODT or Adzenys ER.
- you or your child has mental problems, or a family history of suicide, bipolar illness, or depression. This is important because the following could occur: new or worse behavior and thought problems, new or worse bipolar illness, new psychotic symptoms (hearing voices, believing things that are not true, are suspicious) or new manic symptoms. Call the doctor right away if there are any new or worsening mental symptoms during treatment.
- you or your child has circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Fingers or toes may feel numb, cool, painful, sensitive to temperature and/or change color from pale, to blue, to red. Call the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking either Adzenys XR-ODT or Adzenys ER.
- you or your child is having symptoms of serotonin syndrome which may happen when Adzenys XR-ODT or Adzenys ER is taken with certain other medicines and may be life threatening. Call your doctor or go to the nearest hospital emergency room if you have any of the following symptoms: agitation, hallucinations, coma or other changes in mental status, problems controlling your movements or muscle twitching, fast heartbeat, high or low blood pressure, sweating or fever, muscle stiffness or tightness, nausea, vomiting or diarrhea.
- your child is having slowing of growth (height and weight). Your child should have his or her height and weight checked often while taking either Adzenys XR-ODT or Adzenys ER. The doctor may stop treatment if a problem is found during these check-ups.
- you or your child has kidney problems. Your doctor may lower the dose.
- you or your child is, or plans to become pregnant. If you or your child becomes pregnant during treatment with either Adzenys XR-ODT or Adzenys ER, talk to your doctor about registering with the National Pregnancy Registry for Psychostimulants.
- you or your child is breastfeeding, or plans to breastfeed. You or your child should not breastfeed while taking either Adzenys XR-ODT or Adzenys ER.
- you or your child takes any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Adzenys XR-ODT and Adzenys ER and some medicines may interact with each other and cause serious side effects.
Do not start any new medicine while taking either Adzenys XR-ODT or Adzenys ER without talking to your doctor first.
- drinking alcohol.
- Children 6 – 12 Years: Decreased appetite, problems sleeping, stomach pain, extreme mood change, vomiting, nervousness, nausea, and fever.
- Children 13 – 17 Years: Decreased appetite, problems sleeping, stomach pain and weight loss, and nervousness.
- Adults: Dry mouth, decreased appetite, problems sleeping, headache, weight loss, nausea, anxiety, restlessness, dizziness, fast heart beat, diarrhea, weakness, and urinary tract infections.
These are not all the possible side effects of Adzenys XR-ODT and Adzenys ER. Call your doctor for medical advice about side effects.
What are Adzenys XR-ODT and Adzenys ER?
Adzenys XR-ODT and Adzenys ER are central nervous system (CNS) stimulant prescription medicines used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. Adzenys XR-ODT and Adzenys ER are federally controlled substances (CII) because they contain amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep both Adzenys XR-ODT or Adzenys ER in a safe place to protect it from theft. Selling or giving away your Adzenys XR-ODT or Adzenys ER may cause death or harm to others and is against the law.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.