Medication and Treatment Reviews

Adzenys XR-ODT

Generic Name: amphetamine

Uses

Adzenys XR-ODT 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 to Use Adzenys XR-ODT

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.

Dosage

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.

Tablets are available in 3.1mg, 6.3mg, 9.4mg, 12.5mg, 15.7mg and 18.8mg capsules. The time-release formulation is designed to maintain a steady level of medication in your body throughout the day. Neos Theraputics, 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.

Patients who are already being treated with Adderall XR can use a comparison chart, available on the Adzenys XR-ODT website, to convert their current dose of Adderall to a dose of Adzenys XR-ODT. However, to avoid overdosage, patients should not substitute Adzenys XR for other amphetamines milligram-per-milligram because different compositions may have different effects. 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 he or she 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.

Side Effects

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, nausea and vomiting, nervousness, and fever.

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

Adults: insomnia, decreased appetite, dry mouth, nausea, dizziness, weakness, headache, anxiety, increased heart beat, urinary tract infections, weight loss, restlessness, and diahrrea.

Other serious side effects include slowed growth in children, and new or exacerbated heart and mental problems. 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.

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

Report to your doctor any heart-related problems or a family history of heart and blood pressure problems. Patients with structural cardiac abnormalities and other serious heart problems have experienced sudden death, stroke, and heart attack while taking Adzenys XR-ODT. Stimulants can increase blood pressure and heart rate. Physicians should monitor these vital signs closely during treatment. Call your doctor immediately if you or your child experiences warning signs such as chest pain, shortness of breath, or fainting while taking Adzenys XR-ODT.

Also, disclose to your physician all mental health issues including any family history of suicide, bipolar illness, or depression. Adzenys XR-ODT may create new or exacerbate existing behavior or mental problems, bipolar illness, or psychotic symptoms including but not limited to hearing voices, believing things that aren’t true, or manic symptoms. Call your doctor immediately if you or your child experiences new or worsening mental health symptoms including hallucinations or sudden suspicions.

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.

Amphetamines like Adzenys XR-ODT have a high potential for abuse and addiction, especially among people who do not have ADHD. It is a “Schedule II Stimulant,” a designation that the Drug Enforcement Agency uses for drugs with a high potential for abuse. Other Schedule II drugs include Dexedrine, Ritalin, Adderall XR, 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.

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.

Precautions and Safety

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.

Interactions

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.

Sources:

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

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