Consumer Important Safety Information
Most Important Information About ADZENYS XR-ODT:
Abuse, misuse, and addiction. ADZENYS XR-ODT has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of ADZENYS XR-ODT, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of ADZENYS XR-ODT or when it is used in ways that are not approved, such as snorting or injection.
- ADZENYS XR-ODT may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
- Do not give ADZENYS XR-ODT to anyone else.
- Keep ADZENYS XR-ODT in a safe place and properly dispose of any unused medicine.
- Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting ADZENYS XR-ODT. Tell your healthcare provider if you or your child has any heart problems, heart disease, or heart defects. Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking ADZENYS XR-ODT.
- Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with ADZENYS XR-ODT.
- Mental (Psychiatric) problems: Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems while taking ADZENYS XR-ODT, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
What is ADZENYS XR-ODT: ADZENYS XR-ODT is a central nervous system (CNS) stimulant prescription medicine. It is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). ADZENYS XR-ODT may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD. It is not known if ADZENYS XR-ODT is safe and effective in children under 6 years of age. ADZENYS XR-ODT is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep ADZENYS XR-ODT in a safe place to prevent it from theft. Never give your ADZENYS XR-ODT to anyone else because it may harm them. Selling or giving away ADZENYS XR-ODT may harm others and is against the law.
Who Should Not Take ADZENYS XR-ODT: ADZENYS XR-ODT should not be taken if you or your child:
- Are allergic to amphetamine, or any of the ingredients in ADZENYS XR-ODT
- Are taking or have taken within the past 14 days an anti-depression medicine called monoamine oxidase inhibitor or MAOI
What Should I Tell My Healthcare Provider Before Taking ADZENYS XR-ODT?
- All health conditions (or family history) of heart problems or high blood pressure; mental problems; circulation problems; kidney problems; if you, your child, or family member have or had repeated movements or sounds (tics) or Tourette’s syndrome; if you or your child are pregnant or plan to become pregnant; or if you or your child is breastfeeding or plan to breastfeed.
- All medications that you or your child takes.
- Any anti-depression medicines including MAOIs
- Do not start any new medicine while taking ADZENYS XR-ODT without talking to your healthcare provider first.
Avoid drinking alcohol while taking ADZENYS XR-ODT.
The most common side effects of ADZENYS XR-ODT include decreased appetite and problems sleeping. ADZENYS XR-ODT can cause serious side effects, including:
- Slowing growth (height and weight) in children. Children should have their height and weight checked often during treatment with ADZENYS XR-ODT.
- Circulation problems in fingers and toes. [Peripheral vasculopathy, including Raynaud’s phenomenon]: fingers and toes may feel numb, cool, painful and/or change from pale to blue or red. Call your healthcare provider right away if you or your child have any unexplained wounds appearing on fingers or toes while taking ADZENYS XR-ODT.
- New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment with ADZENYS XR-ODT.
- Common side effects of ADZENYS XR-ODT in children 6 to 12 years of age also include: stomach pain, extreme mood change, vomiting, nervousness, nausea, and fever.
- Common side effects of ADZENYS XR-ODT in children 13 to 17 years of age also include: stomach pain and weight loss.
- Common side effects of ADZENYS XR-ODT in adults also include: dry mouth, headache, weight loss, nausea, anxiety, restlessness, dizziness, fast heartbeat, diarrhea, weakness, and urinary tract infections
These are not all the possible side effects of ADZENYS XR-ODT.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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