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Adzenys XR-ODT is a stimulant medicine that is used to treat attention deficit hyperactivity disorder (ADHD).
The Evekeo brand of amphetamine is used to treat ADHD and also narcolepsy. Evekeo is sometimes used to treat obesity in people who have not lost weight with diets or other treatments. Evekeo ODT is used only for ADHD.
Adzenys XR-ODT may also be used for purposes not listed in this medication guide.
Adzenys XR-ODT may be habit-forming. Tell your doctor if you have ever had drug or alcohol addiction.
Stimulants have caused stroke, heart attack, and sudden death in people with high blood pressure, heart disease, or a heart defect.
Do not use Adzenys XR-ODT if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.
Adzenys XR-ODT may cause unusual thoughts or behavior, especially if you have a history of depression, mental illness, or bipolar disorder.
Call your doctor right away if you have: signs of heart problems--chest pain, feeling light-headed or short of breath; or signs of psychosis--paranoia, aggression, new behavior problems, seeing or hearing things that are not real;
You should not use Adzenys XR-ODT if you are allergic to any stimulant medicine, or if you have:
moderate to severe high blood pressure;
overactive thyroid;
severe anxiety, tension, or agitation (stimulant medicine can make these symptoms worse); or
a history of drug or alcohol addiction.
Do not use Adzenys XR-ODT if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.
Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with Adzenys XR-ODT and cause a serious condition called serotonin syndrome.
Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:
heart problems or a congenital heart defect;
high blood pressure; or
a family history of heart disease or sudden death.
Tell your doctor if you or anyone in your family has ever had:
depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;
problems with drug or alcohol abuse;
motor tics (muscle twitches) or Tourette's syndrome;
kidney disease;
a thyroid disorder;
seizures or epilepsy;
an abnormal brain wave test (EEG);
coronary artery disease (clogged arteries); or
blood circulation problems in the hands or feet.
Taking Adzenys XR-ODT during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.
Adzenys XR-ODT is not approved for use by anyone younger than 6 years old.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
Adzenys XR-ODT may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.
You may take Adzenys XR-ODT with or without food.
Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
Remove an orally disintegrating tablet (ODT) from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves.
Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using only the form and strength your doctor prescribes.
Your doctor will need to check your progress on a regular basis. Tell any doctor who treats you that you are using this medicine.
Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.
Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.
Do not keep leftover opioid medication. Ask your pharmacist where to locate a drug take-back disposal program.
Take the missed dose as soon as you remember, but not late in the day. Skip the missed dose if it is almost evening. Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Adzenys XR-ODT could be fatal.
Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, hostility, violence, panic, muscle pain or weakness, and dark colored urine. These symptoms may be followed by depression and tiredness. Overdose may also cause seizure or coma.
Avoid drinking alcohol while you are taking Adzenys XR-ODT.
Avoid drinking fruit juices or taking vitamin C at the same time you take Adzenys XR-ODT. These can make your body absorb less of the medicine.
Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;
signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;
a seizure (convulsions);
muscle twitches (tics); or
changes in your vision.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Adzenys XR-ODT can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.
Common side effects may include:
stomach pain, nausea, vomiting, diarrhea, constipation;
loss of appetite, weight loss;
mood changes, feeling restless or nervous, sleep problems (insomnia);
dry mouth, unusual or unpleasant taste in the mouth;
runny nose, nosebleeds;
increased heart rate;
headache, dizziness;
itching; or
impotence, sexual problems.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Ask your doctor before using a stomach acid medicine (including Alka-Seltzer or sodium bicarbonate). Some of these medicines can change the way your body absorbs Adzenys XR-ODT, and may increase side effects.
Many drugs can affect Adzenys XR-ODT. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Adzenys Xr-odt (www.drugs.com/mtm/adzenys-xr-odt.html).
Note: This document contains side effect information about amphetamine. Some of the dosage forms listed on this page may not apply to the brand name Adzenys XR-ODT.
Applies to amphetamine: oral suspension extended release, oral tablet, oral tablet extended release disintegrating
Oral route (Suspension, Extended Release; Tablet, Extended Release, Disintegrating)
CNS stimulants, including amphetamine extended-release oral formulations, other amphetamine-containing products, and methylphenidate, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
Oral route (Tablet)
Abuse potential is high with the use of amphetamines. Using amphetamines for a prolonged period of time may lead to drug dependence and must be avoided. Pay particular attention to the possibility of patients obtaining amphetamines for distribution to others or for nontherapeutic use. Prescribe and dispense amphetamines sparingly. Sudden death and serious cardiovascular adverse events may occur with misuse of amphetamines.
Along with its needed effects, amphetamine (the active ingredient contained in Adzenys XR-ODT) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking amphetamine:
More common
Less common
Rare
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking amphetamine:
Symptoms of overdose
Some side effects of amphetamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Incidence not known
Applies to amphetamine: oral suspension extended release, oral tablet, oral tablet disintegrating, oral tablet disintegrating extended release
The most commonly reported side effects with amphetamine (the active ingredient contained in Adzenys XR-ODT) products include dry mouth, anorexia, weight loss, abdominal pain, nausea, insomnia, restlessness, emotional lability, dizziness, and tachycardia.
Frequency not reported: Palpitations, tachycardia, elevated blood pressure, cardiomyopathy
Postmarketing reports: Peripheral vasculopathy, myocardial infarction, sudden death, Raynaud's phenomenon
There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.
Postmarketing reports: Hypersensitivity reactions including angioedema and anaphylaxis
Postmarketing reports: Urticaria, rash, serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis, alopecia
Rare (less than 0.1%): Psychotic episodes
Frequency not reported: Euphoria, dysphoria, insomnia, restlessness, irritability, depression, aggression, anger, logorrhea, dermatillomania
Frequency not reported: Overstimulation, dizziness, dyskinesia, tremor, headache, exacerbation of motor/phonic tics and Tourette's syndrome, paresthesia, formication
Postmarketing reports: Rhabdomyolysis
Common (1% to 10%): Upper abdominal pain
Frequency not reported: Dry mouth, unpleasant taste, diarrhea, constipation, other GI disturbances, bruxism
Frequency not reported: Impotence, libido changes, frequent or prolonged erections
Frequency not reported: Urticaria
Frequency not reported: Anorexia, weight loss
Common (1% to 10%): Epistaxis, allergic rhinitis
Postmarketing reports: Blurred vision, mydriasis
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Adzenys Xr-odt (www.drugs.com/mtm/adzenys-xr-odt.html).
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