| What is the most important information I should know about EVEKEO ODT? |
EVEKEO ODT may cause serious side effects, including:
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Abuse, misuse, and addiction.EVEKEO ODT has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of EVEKEO 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 EVEKEO ODT or when it is used in ways that are not approved, such as snorting or injection.
- Your healthcare provider should check you or your child's risk for abuse, misuse, and addiction before starting treatment with EVEKEO ODT and will monitor you or your child during treatment.
- EVEKEO ODT may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
- Do not give EVEKEO ODT to anyone else. See "
What is EVEKEO ODT?" for more information.
- Keep EVEKEO ODT in a safe place and properly dispose of any unused medicine. See "
How should I store EVEKEO ODT?" for more information.
- Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
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 treatment with EVEKEO ODT. Tell your healthcare provider if you or your child have 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 have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with EVEKEO ODT.
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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 EVEKEO ODT.
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Mental (psychiatric) problems, including:
- new or worse behavior and thought problems
- new or worse bipolar illness
- new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms
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 during treatment with EVEKEO ODT, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
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| What is EVEKEO ODT? |
| EVEKEO ODT is a central nervous system (CNS) stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age. EVEKEO ODT may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. |
| It is not known if EVEKEO ODT is safe and effective in children under 6 years of age. |
| EVEKEO 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 EVEKEO ODT in a safe place to protect it from theft. Never give your EVEKEO ODT to anyone else, because it may cause death or harm them. Selling or giving away EVEKEO ODT may harm others and is against the law.
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Do not take EVEKEO ODT if you or your child are:
- allergic to amphetamine or any of the ingredients in EVEKEO ODT. See the end of this Medication Guide for a complete list of ingredients in EVEKEO ODT.
- taking, or have stopped taking in the last 14 days, a medicine called a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid and the intravenous medicine methylene blue. Ask your healthcare provider or pharmacist if you are not sure if you or your child take one of these medicines.
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Before taking EVEKEO ODT, tell your healthcare provider about all medical conditions, including if you or your child:
- have heart problems, heart disease, heart defects, or high blood pressure
- have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression
- have or have had seizures (convulsions) or have had an abnormal brain wave test (EEG)
- have circulation problems in fingers and toes
- have or had repeated movements or sounds (tics) or Tourette's syndrome, or have a family history of tics or Tourette's syndrome
- are pregnant or plan to become pregnant. It is not known if EVEKEO ODT will harm the unborn baby.
- There is a pregnancy registry for females who are exposed to EVEKEO ODT during pregnancy. The purpose of the registry is to collect information about the health of females exposed to EVEKEO ODT and their baby. If you or your child becomes pregnant during treatment with EVEKEO ODT, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visit online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.
- are breastfeeding or plan to breastfeed. EVEKEO ODT passes into breast milk. You should not breastfeed during treatment with EVEKEO ODT. Talk to your healthcare provider about the best way to feed the baby during treatment with EVEKEO ODT.
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| Tell your healthcare provider about all the medicines that you or your child take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.
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| EVEKEO ODT and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed while taking EVEKEO ODT. |
| Especially tell your healthcare provider if you or your child takemedicines used to treat depression including MAOIs.
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| Know the medicines that you or your child takes. Keep a list of all medicines with you to show your healthcare provider and pharmacist when you get a new medicine. |
| Your healthcare provider will decide whether EVEKEO ODT can be taken with other medicines.
Do not start any new medicine during treatment with EVEKEO ODT without talking to your healthcare provider first. |
How should EVEKEO ODT be taken?
- Take EVEKEO ODT exactly as prescribed by your healthcare provider.
- Your healthcare provider may change the dose if needed.
- The first dose of EVEKEO ODT should be taken in the morning.
- EVEKEO ODT can be taken with or without food or liquid.
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Use the following instructions when taking EVEKEO ODT:
- The tablet should remain in the blister pack until you are ready to take or give it. Do not store the tablet for future use.
- Use dry hands to open the blister.
- Remove the tablet by pushing it through the back of the foil-lined blister pack.
- Place the whole tablet on the tongue and allow to dissolve in saliva without chewing or crushing. The tablet can be moved around between the tongue and roof of the mouth until it fully dissolves.
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| If you or your child take too much EVEKEO ODT, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. |
| What are possible side effects of EVEKEO ODT? |
EVEKEO ODT may cause serious side effects, including:
- See
"
What is the most important information I should know about EVEKEO ODT?"
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Slowing of growth (height and weight) in children.Children should have their height and weight checked often during treatment with EVEKEO ODT. EVEKEO ODT treatment may be stopped if your child is not growing or gaining weight.
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Seizures (convulsions).Your healthcare provider may stop treatment with EVEKEO ODT if you have a seizure.
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Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud's phenomenon).Signs and symptoms may include:
- fingers or toes may feel numb, cool, painful
- fingers or toes may change color from pale, to blue, to red
Tell your healthcare provider if you or your child has numbness, pain, skin color change, or sensitivity to temperature in the fingers or toes.
Call your healthcare provider right away if you or your child has any signs of unexplained wounds appearing on fingers or toes during treatment with EVEKEO ODT.
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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 EVEKEO ODT.
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Serotonin Syndrome.A potentially life-threatening problem called serotonin syndrome may happen when EVEKEO ODT is taken with certain other medicines. Stop taking EVEKEO ODT and call your healthcare provider or go to the nearest hospital emergency room right away if you or your child develop any of the following signs and symptoms of serotonin syndrome:
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- agitation
- fast heart beat
- flushing
- seizures
- coma
- sweating
- loss of coordination
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- confusion
- dizziness
- tremors, stiff muscles, or muscle twitching
- seeing or hearing things that are not real (hallucination)
- changes in blood pressure
- high body temperature (hyperthermia)
- nausea, vomiting, diarrhea
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| The most common side effects of EVEKEO ODT includedecreased appetite and trouble sleeping.
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| These are not all the possible side effects of EVEKEO ODT. |
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
- You may also report side effects to Arbor Pharmaceuticals, LLC at 1-800-461-7449.
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How should I store EVEKEO ODT?
- Store EVEKEO ODT at room temperature between 68°F to 77°F (20°C to 25°C).
- Store EVEKEO ODT blister packages in the provided plastic sleeve.
- Store EVEKEO ODT in a safe place, like a locked cabinet.
- Dispose of remaining, unused, or expired EVEKEO ODT by a medicine take-back program at a U.S. Drug Enforcement Administration (DEA) authorized collection site. If no take-back program or DEA authorized collector is available, mix EVEKEO ODT with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away EVEKEO ODT in the household trash. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.
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| Keep EVEKEO ODT and all medicines out of the reach of children. |
| General information about the safe and effective use of EVEKEO ODT. |
| Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use EVEKEO ODT for a condition for which it was not prescribed. Do not give EVEKEO ODT to other people, even if they have the same symptoms. It may harm them and it is against the law. You can ask your healthcare provider or pharmacist for information about EVEKEO ODT that is written for healthcare professionals. |
| What are the ingredients in EVEKEO ODT? |
| Active ingredient:amphetamine sulfate
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| Inactive ingredients:mannitol, silicified microcrystalline cellulose, crospovidone, ethylcellulose, amino methacrylate copolymer, anhydrous citric acid, magnesium stearate, dibutyl sebacate, malic acid and sucralose
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| Distributed by: Arbor
®Pharmaceuticals, LLC, Atlanta, GA 30328
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| All rights reserved. |
| For more information about EVEKEO ODT, please contact Arbor Pharmaceuticals, LLC at 1-800-461-7449 |