Adzenys XR-ODT

What is Adzenys XR-ODT?

Adzenys XR-ODT (Generic Name: amphetamine) is an extended-release, orally disintegrating stimulant medication primarily used to treat attention deficit hyperactivity disorder (ADHD) in children ages 6-12, adolescents, and adults. It is popular among patients who can’t or don’t like to swallow pills. According to the FDA, Adzenys XR-ODT is a federally controlled substance (CII) because it can be abused or lead to dependence. It is an amphetamine.

Adzenys XR-ODT may improve focus and decrease impulsivity and hyperactive behavior, two hallmark symptoms in patients with ADHD. It has not been studied in children under the age of 6.

How Do You to Use Adzenys XR-ODT to Treat ADHD?

Before starting or refilling an Adzenys XR-ODT prescription, read the medication guide included with your pills, as it may be updated with new information.

This guide should not replace a conversation with your doctor, who has a holistic view of your or your child’s medical history, other diagnoses, and other prescriptions. If you have questions, ask your doctor or pharmacist before you begin taking the medication.

What is the Typical Dosage for Adzenys XR-ODT?

As with all medications, follow your Adzenys XR-ODT prescription instructions exactly. Adzenys XR-ODT is taken orally, once daily in the morning with or without food, and with or without water.

Do not drink alcohol while taking this medication.

Adzenys XR-ODT is an orange-flavored quick-dissolving tablet. To keep it from dissolving before you place the tablet in your mouth, leave it contained in its blister package until you are ready to take it. When opening the medication, make sure your hands are clean and dry so as not to accidentally trigger dissolution. Peel back the blister package backing to take out the tablet, instead of pushing it through the foil. Place the tablet on your tongue to dissolve. Do not crush or chew the tablet.

The time-release formulation is designed to maintain a steady level of medication in your body throughout the day. Neos Therapeutics, the drug’s manufacturer, says the drug is formulated using two different kinds of “micro-particles” that dissolve at different rates. Fifty percent dissolve immediately upon the medication’s administration, while the other 50 percent dissolve slowly to release the medication steadily throughout the day.

The optimal dosage varies by patient; it is not determined by age, weight, or height, but rather by how a person metabolizes the medication. If you or your child has kidney problems, your doctor may recommend a lower dose.

For updated information about dosages, interactions, and precautions, see the Adzenys XR-ODT drug monograph on WebMD.

While the active ingredient in Adzenys XR-ODT is the same as that in Adderall XR, the technique used to produce the Orally Dissolving Tablet (ODT) results in different compositions which may have different effects. As a result, patients who are being treated with Adderall XR who then switch to Adzenys XR-ODT cannot use the same dose of Adzenys to replace their current dose of Adderall. To determine the correct dosage, patients who are already being treated with Adderall XR can use a comparison chart, available on the Adzenys XR-ODT website. All medication changes and adjustments should be made only after consultation with a medical professional.

Your doctor may adjust your prescribed dose of Adzenys XR-ODT until you or your child experiences the best response – that is, the lowest dosage at which you experience the greatest improvement in symptoms without side effects. If you or your child exceeds the prescribed daily dosage, call your doctor or poison control, or seek emergency medical care.

During treatment, your doctor may periodically ask you to stop taking your Adzenys XR-ODT so that they can monitor ADHD symptoms; check vital statistics including blood, heart, and blood pressure; or evaluate height and weight. If any problems are found, your doctor may recommend discontinuing treatment.

After long-term usage, some patients develop a tolerance to Adzenys XR-ODT. If you notice that your current dosage is no longer controlling symptoms, talk to your doctor to plan a course of action.

What Side Effects Are Associated with Adzenys XR-ODT?

The most common side effects of Adzenys XR-ODT are similar to those associated with Adderall XR and other stimulant medications, and are as follows:

Children (ages 6 to 12): insomnia, decreased appetite, stomach pain, sudden mood shifts (often as medication is wearing off), nervousness, and rarely, nausea and vomiting.

There has been some concern that stimulants may cause a slowing of growth in children and adolescents, however, research findings are mixed. Some studies show no impact on growth at all,¹ while others find what is considered “negligible” slowing of growth.² If you find evidence of suppressed growth in your child, talk to your doctor about what steps might help.

Adolescents (ages 13 to 17): difficulty sleeping, decreased appetite, stomach pain, and weight loss.

Taking Adzenys XR-ODT may impair your or your teenager’s ability to drive, operate machinery, or perform other potentially dangerous tasks. This side effect usually wears off with time. If side effects are bothersome, or do not go away, talk to your doctor.

Adults: insomnia, decreased appetite, dry mouth, nausea, dizziness, weakness, headache, anxiety, increased heartbeat, weight loss, and restlessness.

Most people taking this medication do not experience any of these side effects.

Adzenys XR-ODT and Cardiac Side Effects

While there has long been concern that stimulant medication, Adzenys XR-ODT included, could potentially cause cardiac side effects. no evidence of this has been found. In fact, a recent meta-analysis of 19 observational studies including 3.9 million participants, found that stimulants do not place patients of any age at greater risk for cardiovascular events such as heart failure and hypertension.³

Patients with any heart-related problems or a family history of heart and blood pressure issues should discuss these conditions with their doctor before starting Adzenys XR-ODT. Call your doctor immediately if you or your child experiences warning signs such as chest pain, shortness of breath, or fainting.

Adzenys XR-ODT and Substance Abuse

Research has clearly shown that substance abuse is rarely caused by stimulant medication.⁴  In fact, studies show that adolescents who use stimulants on a regular basis are far less likely to abuse other substances than teens with ADHD who are not treated.⁵

Adzenys XR-ODT is a “Schedule II Stimulant,” a designation that the Drug Enforcement Agency uses for drugs with a high potential for abuse, especially among people who do not have ADHD. Other Schedule II drugs include Dexedrine, Adderall, and cocaine. People with a history of drug abuse should use caution when trying this medication. Taking the medication exactly as prescribed can reduce potential for abuse.

Also, disclose to your physician all mental health issues including any family history of suicide, bipolar illness, or depression. For individuals with a personal or family history of psychosis, bipolar disorder or other serious mental health conditions, Adzenys XR-ODT may create new or exacerbate symptoms.

Discuss circulation problems with your doctor before taking Adzenys XR-ODT, which has been known to cause numbness, coolness, or pain in fingers or toes, including Raynaud’s phenomenon. Report to your doctor any new blood-flow problems, pain, skin color changes, or sensitivities to temperature while taking Adzenys XR-ODT.

The above is not a complete list of potential side effects. If you notice any health changes not listed above, discuss them with your doctor or pharmacist.

What Precautions Are Associated with Adzenys XR-ODT?

Store Adzenys XR-ODT in a secure place out of reach of children, and at room temperature. Keep the tablets in the blister packaging and hard plastic travel case or carton until you are ready to take it or administer it to your child. Dispose of unused or expired Adzenys XR-ODT at an authorized collection site. If none is available, mix it with a non-toxic, but undesirable substance like coffee grounds to make it less appealing to children or pets, then place in a sealed container and discard in household trash.

You should not take Adzenys XR-ODT if you are allergic to amphetamines, or have taken an antidepressant monoamine oxidase inhibitor (MAOI) in the past 14 days. This can cause a serious drug interaction.

If you are thinking of becoming pregnant, discuss the use of Adzenys XR-ODT with your doctor. Animal studies indicate a potential risk of fetal harm. Adzenys XR-ODT is passed through breastmilk, so it is recommended that mothers do not nurse while taking it.

The effects of Adzenys XR-ODT on the elderly have not been studied.

What Interactions Are Associated with Adzenys XR-ODT?

Before taking Adzenys XR-ODT, discuss all other active prescription medications with your doctor. Adderall XR can have a dangerous, possibly fatal, interaction with antidepressants including MAOIs.

Exercise caution with medicines that are known to interact with amphetamines including anti-psychotics, lithium, narcotic pain medicines, seizure medications, blood thinners, blood pressure medications, stomach acid medications — like antacids — and cold or allergy medicines that contain decongestants. Even over-the-counter medications may contain ingredients that raise or lower the level of the medication in your blood to a dangerous level. Speak with your doctor about all other prescription and over-the-counter medications you take.

Share a list of all vitamin or herbal supplements, and prescription and non-prescription medications you take with the pharmacist when you fill your prescription, and let all doctors and physicians know you are taking Adzenys XR-ODT before having any surgery or laboratory tests. The above is not a complete list of all possible drug interactions.

Adzenys XR-ODT and Other ADHD Medications: Next Steps

• Free Download:A Parent’s Guide to ADHD Medications
• Free Download: Medication Monitoring Log
• Read: Five Rules for Treating ADHD in Children with Stimulant Medications
• Read: A Patient’s Primer on the Stimulant Medications Used to Treat ADHD

Sources:

1 Harstad E, Weaver A, Katusic S, Robert C. Colligan, Kumar S, Chan E, Voigt R, Barbaresi W. (2014.) ADHD, Stimulant Treatment, and Growth: A Longitudinal Study. Pediatrics. https://publications.aap.org/pediatrics/article-abstract/134/4/e935/77034/ADHD-Stimulant-Treatment-and-Growth-A-Longitudinal

² Greenhill L, Swanson J, Hechtman L, Waxmonsky J, Arnold L, Molina B, Hinshaw S, Jensen P, Abikoff H, Wigal T, Stehli A, Howard A, Hermanussen M, Hanć T (2020),Trajectories of Growth Associated With Long-Term Stimulant Medication in the Multimodal Treatment Study of Attention-Deficit/Hyperactivity Disorder,
Journal of the American Academy of Child & Adolescent Psychiatry, v 59, Issue 8. 978-989,https://www.jaacap.org/article/S0890-8567(19)31443-1/fulltext

³Zhang L, Yao H, Li L, et al. (2022). Risk of Cardiovascular Diseases Associated with Medications Used in Attention-Deficit/Hyperactivity Disorder: A Systematic Review and Meta-Analysis. JAMA Netw Open. https://doi.org/10.1001/jamanetworkopen.2022.43597

⁴McCabe, S.E., Schulenberg, J.E., Wilens, T.E., Schepis, T.S., McCabe, V.V., Veliz, P.T. (2023). Cocaine or Methamphetamine Use During Young Adulthood Following Stimulant Use for Attention-Deficit/Hyperactivity Disorder During Adolescence. JAMA Netw Open. 6(7):e2322650. https://doi.org/10.1007/s11920-013-0436-6

⁵Wilens, T. E., Biederman, J., Mick, E., Faraone, S. V., & Spencer, T. (1997). Attention deficit hyperactivity disorder (ADHD) is associated with early onset substance use disorders. The Journal of nervous and mental disease.185(8), 475–482. https://doi.org/10.1007/s11920-013-0436-6

http://www.neostxcontent.com/Labeling/Adzenys/Adzenys_MG.pdf
http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s000lbl.pdf