Adzenys-XR-ODT-amphetamineWhat is Adzenys XR-ODT?

Adzenys XR-ODT is a stimulant that can be used to treat the symptoms of attention deficit hyperactivity disorder (ADHD) for adults and children ages 6 and up.

How does Adzenys XR-ODT work?

Adzenys affects parts of the brain and central nervous system that control hyperactivity and impulses.

When did the U.S. Food and Drug Administration (FDA) approve Adzenys XR-ODT?

 Adzenys XR-ODT was approved by the FDA on January 27, 2016 for treating attention deficit hyperactivity disorder in patients 6 years and older. It was the first orally disintegrating amphetamine tablet approved by the FDA.

Is there a generic version of Adzenys XR-ODT?

Currently, there is no generic equivalent of the drug available in the US.

Are there any major differences between Adzenys XR-ODT and other stimulants used to treat ADHD?

There are a lot of similarities between Adzenys XR-ODT and other stimulants used to treat ADHD. They are all are habit-forming and classified as Schedule II controlled substances.  Therefore, if you have a history of substance use problems, you should talk to your doctor about this before taking either medication. As far as differences, Adzenys XR-ODT starts working within an hour, which takes longer than instant release forms of medication such as Ritalin. Adzenys XR-ODT also lasts up to 12 hours. Other medications such as Adderall are available in extended release versions as well, which also last up to 12 hours.

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Can children take Adzenys XR-ODT?

Children over the age of 6 may be prescribed the medication for ADHD. They should take the medication in the exact amount prescribed by their doctor. It’s also important to tell your child’s doctor about other medication complications or past substance use history and to report side effects. Also, be sure to monitor the growth of your child and report any slowing to their doctor.

Are there potential interaction issues for people taking Adzenys XR-ODT with other drugs? 

Do not take Adzenys XR-ODT if you have taken an MAO inhibitor in the past two weeks, as a dangerous interaction effect could occur. There are also hundreds of drugs which are known to interact with Adzenys XR-ODT in major, moderate, or mild ways, so let your doctor know what other medications you are taking before you begin the medication.

Are there any other medical conditions that would make someone ineligible for Adzenys XR-ODT therapy?

Adzenys XR-ODT might not be right for you if you or your child have heart problems, high blood pressure, kidney problems or circulation problem. The drug can also make symptoms of mental illness even worse, so talk to your doctor if you a history of mental illness such as depression or bipolar disorder, or a history of substance use problems.

What is the typical dose prescribed to someone taking Adzenys XR-ODT?

The starting dosage for children ages 6 to 17 is 6.3mg daily in the morning. Maximum dosage for children 6 to 12 is 18.8mg and for children 13 to 17 is 12.5mg. For adults, the maximum dosage is 12.5mg once daily. Tablets come in 6 different forms, including 3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, and 18.8 mg.

What are Adzenys XR-ODT’s most common side effects? 

  • stomach pain
  • mood changes
  • nausea
  • weight loss
  • dry mouth
  • dizziness
  • headache
  • fast heart beat
  • urinary tract infections.

Major side effects should be reported to your doctor immediately, and can include slowing of growth in children, heart related problems, increased blood pressure and heart rate, and sudden death, stroke, and heart attack in people with heart problems. You can also any side effects to the FDA at 1-800-FDA-1088 or online.

Are there any psychiatric side effects that come from taking Adzenys XR-ODT?

People who take Adzenys XR-ODT may experience nervousness, anxiety, and extreme mood changes. Aggressiveness, psychosis, suicidal and homicidal ideation have also been observed as side effects.

Is it safe for a woman who is pregnant, about to become pregnant, or nursing, to take Adzenys XR-ODT?

There are no controlled studies on human pregnancy and Adzenys XR-oDT, therefore researchers do not know whether the drug will harmful to the child. However, an amphetamine-dependent mother is at risk for premature delivery and low birth weight in the infant. The drug can also be transferred via breast milk in small amounts. Therefore, talk to your doctor if you are pregnant, planning to become pregnant, or are nursing before you take Adzenys XR-ODT.

Can symptoms occur if Adzenys XR-ODT is discontinued?

Some patients have reported withdrawal symptoms of low mood, fatigue, increased appetite, psychomotor retardation, nightmares, insomnia, or hypersomnia when they abruptly discontinue use of the drug.

If taken in overdose, is Adzenys XR-ODT toxic?

An overdose of Adzenys XR-ODT could be fatal, so seek immediately help or call the Poison Help Line at 1-800-222-1222 if you overdose. Overdose symptoms can include rapid breathing, restlessness, hypertension, nausea, vomiting, diarrhea, panic, confusion, hallucinations, abdominal cramps, hyperreflexia, hyperpryrexia, rhabdomyolysis. Poisoning that can result in death begins with convulsions and coma.

Is Adzenys XR-ODT habit-forming?

Like other CNS stimulants, Adzenys XR-ODT be habit-forming, as users may develop a tolerance to the drug over time. Make sure that you keep track of the medication, keep it locked in a safe place, and never take more than prescribed. It is illegal to give or sell the medication to others. Talk to your doctor if you have a past history of substance dependence before you begin taking the medication.

How much does Adzenys XR-ODT cost?

Thirty 3.1 mg Adzenys XR-ODT tablets costs approximately $293 if paying with cash.

Are there any disadvantages to Adzenys XR-ODT?

Disadvantages include potential side effects such as slowing of growth in children as well as stomach pain, extreme mood changes, weight loss, dizziness, headaches, and others. Also, because the drug is habit-forming, there is risk for abuse and overdose.

 

 

DISCLAIMER: The information contained herein should NOT be used as a substitute for the advice of an appropriately qualified and licensed physician or other health care provider.  This article mentions drugs that were FDA-approved and available at the time of publication and may not include all possible drug interactions or all FDA warnings or alerts. The author of this page explicitly does not endorse this drug or any specific treatment method. If you have health questions or concerns about interactions, please check with your physician or go to the FDA site for a comprehensive list of warnings.

 

 

 

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Last Updated: Jul 10, 2017