Evekeo ODT (amphetamine sulfate) orally disintegrating tablets | ADHD Medication

Time 2022-07-31 02:45:25

Web Name: Evekeo ODT (amphetamine sulfate) orally disintegrating tablets | ADHD Medication

WebSite: http://www.evekeoodt.com

ID:265704

Keywords:

amphetamine,sulfate,Evekeo,ODT

Description:


This site is intended for US residents only.Important Safety InformationPrescribing Information

Higher-strength racemic amphetamine available

to treat Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6-17

An IR* ADHD stimulant therapy with a balanced 1:1 racemic mixture of levoamphetamine and dextroamphetimine available in 15-mg and 20-mg strengths as an orally disintegrating tablet formulation.1,2

*Immediate-Release.

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Indication

Evekeo ODT (amphetamine sulfate) 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.

Important Safety Information

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.

Before taking EVEKEO ODT, tell your healthcare provider about all medical conditions, including if you or your child:

have heart problems, heart defects, or high blood pressurehave mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depressionhave or have had seizures (convulsions) or have had an abnormal brain wave test (EEG)have circulation problems in fingers and toesare pregnant or plan to become pregnant. It is not known if EVEKEO ODT will harm the unborn babyThere 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 womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedicationsare 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 ODTEVEKEO 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 ODTTell your healthcare provider about all the medicines that you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you or your child take medicines used to treat depression including MAOIsKnow 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 medicineYour 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

Do not take Evekeo ODT if you or your child:

allergic to amphetamine or any of the ingredients in EVEKEO ODT. See the end of the Medication Guide for a complete list of ingredients in EVEKEO ODTtaking, 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

EVEKEO ODT may cause serious side effects, including:

Abuse and dependence. EVEKEO ODT, other amphetamine -containing medicines, and methylphenidate have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with EVEKEO ODTTell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugsYour healthcare provider can tell you more about the differences between physical and psychological dependence and drug addictionHeart-related problems, including:sudden death in children and adolescents who have heart problems or heart defectsincreased blood pressure and heart rate

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 defects, high blood pressure, or a family history of these problems.

Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with EVEKEO ODT.

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.

Mental (psychiatric) problems, including:new or worse behavior and thought problemsnew or worse bipolar illnessnew 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.

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.Seizures (convulsions). Your healthcare provider may stop treatment with EVEKEO ODT if you have a seizure.Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include:fingers or toes may feel numb, cool, painfulfingers 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.

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:agitationconfusionfast heart beatdizzinessflushingtremors, stiff muscles, or muscle twitchingseizuresseeing or hearing things that are not real (hallucination)comachanges in blood pressuresweatinghigh body temperature (hyperthermia)loss of coordinationnausea, vomiting, diarrhea

The most common side effects of EVEKEO ODT include decreased appetite and trouble sleeping.

These are not all the possible side effects of EVEKEO ODT. Call your doctor for medical advice about side effects.

You are encouraged to report side effects of prescription drugs to Arbor Pharmaceuticals, LLC Medical Information at 1-866-516-4950 or to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional safety information, consult the Evekeo ODT full Prescribing Information and Medication Guide.

References: 1. EVEKEO ODT [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC; 2019. 2. Childress AC, Brams M, Cutler AJ, et al. The efficacy and safety of Evekeo, racemic amphetamine sulfate, for treatment of attention-deficit/hyperactivity disorder symptoms: a multicenter, dose-optimized, double-blind, randomized, placebo-controlled crossover laboratory classroom study. J Child Adolesc Psychopharmacol. 2015;25(5):402-414.

About Arbor Pharmaceuticals | Privacy Policy

EVEKEO ODT is a trademark of Arbor Pharmaceuticals, LLC.

© 2021 Arbor Pharmaceuticals, LLC. All rights reserved.

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