Dyanavel XR : Uses, Side Effects, Interactions & More

IMPORTANT WARNING:
Dyanavel XR (Amphetamine) can be habit-forming. Do not take a higher dose, take it more often, or take it for a longer time than prescribed by your doctor. If you take too much Dyanavel XR, you may still feel the need to take large amounts of the drug and you may experience unusual changes in your behavior. You or your doctor should inform your doctor immediately, if you experience any of the following symptoms: fast, pounding or irregular heartbeat; perspiration; dilated pupils; abnormally excited mood; restlessness; irratibility difficulty falling asleep or staying asleep; hostility; aggression; anxiety; loss of appetite; loss of coordination; uncontrollable movement of a part of the body; reddened skin; vomiting stomach pain; or thinking about harming or killing yourself or others, or planning or attempting to do so. Overuse of Dyanavel XRs can also cause serious heart problems or sudden death.

Tell your doctor if you or any member of your family drink or have ever drunk large amounts of alcohol, use or have ever used illegal drugs, or have overused prescription drugs. Your doctor probably won’t prescribe Dyanavel XRs for you.

Don’t stop taking Dyanavel XRs without checking with your doctor, especially if you’ve abused the drug. Your doctor will probably decrease your dose gradually and monitor you carefully during this time. You can develop depression and extreme tiredness. if you stop taking Dyanavel XR suddenly after abusing it.

Do not sell, give away, or let anyone else take your medicine. Selling or giving away Dyanavel XRs can harm others and is illegal. Store Dyanavel XR in a safe place, preferably closed, so that no one else can take it accidentally or on purpose. Keep track of how many tablets or suspension (liquid) are left to see if any are missing.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you start Dyanavel XR treatment and each time you get a refill. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) to obtain the Medication Guide.

Why is this medication prescribed?
Dyanavel XR (Amphetamine) is used as part of a treatment program to control the symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty concentrating, controlling actions and being still or silent as other people of the same age) in adults and children. Dyanavel XR (Evekeo, others) is also used to treat narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden bouts of sleep). Dyanavel XR (Evekeo and others) is also used for a limited period of time (a few weeks) in conjunction with a low-calorie diet and exercise plan to lose weight in obese people who are unable to lose weight. Dyanavel XR is in a class of medications called central nervous system stimulants. It works by changing the amounts of certain natural substances in the brain.

How should this medicine be used?
Dyanavel XR comes as an immediate-release tablet (Evekeo), an orally disintegrating tablet (tablet that dissolves quickly in the mouth; Evekeo ODT), an extended-release (long-acting) tablet that disintegrates by mouth (Adzenys XR), and as an extended-release suspension tablet (Adzenys ER, Dyanavel XR) to take by mouth. The extended-release suspension is usually taken once a day in the morning with or without food. The orally disintegrating tablet is usually taken once a day in the morning with or without food or liquid. The orally disintegrating extended-release tablet is usually taken once a day in the morning with or without food. For the treatment of ADHD or narcolepsy, the immediate-release tablet is usually taken with or without food one to three times a day, 4 to 6 hours apart, with the first dose in the morning. To lose weight, the immediate-release tablet is usually taken 30 to 60 minutes before meals. Dyanavel XR should not be taken in the late afternoon or evening because it can cause difficulty falling asleep or staying asleep. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any parts you do not understand. Take Dyanavel XR exactly as directed.

Swallow the extended-release tablets whole, do not chew or crush them.

Do not try to push the oral disintegrating tablet (Evekeo ODT) or the extended-release oral disintegrating tablet (Adzenys XR) through the blister. Instead, use dry hands to peel off the foil wrap. Immediately take the tablet out and put it in your mouth. The tablet will dissolve quickly and can be swallowed with saliva. No water is needed to swallow the tablet.

Shake the extended-release suspension (Adzenys ER, Dyanavel XR) well before each use to mix the medicine evenly.

Do not add the extended-release suspension (Adzenys ER) to food or mix it with other liquids.

It is important to use an oral syringe (measuring device) to accurately measure and take your dose of extended-release suspension. Ask your pharmacist for a device if they did not provide one. Wash the oral syringe well after each use.

If you or your child are taking Dyanavel XRs for ADHD, your doctor will likely prescribe a low dose of Dyanavel XR and increase it gradually, every 4 to 7 days, depending on the medication. Your doctor may tell you to stop taking Dyanavel XR from time to time to see if you still need the medicine. Follow these instructions carefully.

If you are taking Dyanavel XR for narcolepsy, your doctor will likely prescribe a low dose of Dyanavel XR and increase it gradually, no more than once a week. Follow these instructions carefully.

The body absorbs the medicine from each product differently, so one Dyanavel XR product cannot be substituted for another product. If you are switching from one product to another, your doctor will prescribe the dose that is best for you.

Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking Dyanavel XR,

  • Tell your doctor and pharmacist if you are allergic to Dyanavel XR, other stimulant medications such as benzphetamine, dextroDyanavel XR (Dexedrine, in Adderall), lisdexamfetamine (Vyvanse), and methDyanavel XR (Desoxyn); any other medication; or any of the other ingredients in Dyanavel XR products. Ask your pharmacist or see the Medication Guide for a list of the ingredients.
  • Tell your doctor if you are taking the following medications or have stopped taking them in the past 14 days: monoamine oxidase (MAO) inhibitors including isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar) and tranylcypromine (Parnate). If you stop taking Dyanavel XR, you must wait at least 14 days before you start taking an MAO inhibitor.
  • Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and herbal products you are taking. Be sure to mention any of the following: acetazolamide (Diamox); ammonium chloride; anticoagulants (‘blood thinners’) such as warfarin (Coumadin, Jantoven); ascorbic acid (vitamin C); buspirone; medications for heartburn or ulcers such as cimetidine (Tagamet), esomeprazole (Nexium), omeprazole (Prilosec, in Zegerid), and pantoprazole (Protonix); antihistamines (medicines for colds and allergies); chlorpromazine; certain diuretics (‘water pills’); fentanyl (Actiq, Duragesic, Subsys, others); guanethidine (Ismelin; no longer available in the US); haloperidol (Haldol); medications for high blood pressure; lithium (Lithobid); methenamine salts (Hiprex, Urex); medications for migraines such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig); Narcotic pain relievers such as meperidine (Demerol) and propoxyphene (Darvon; no longer available in the US); quinidine (in Nuedexta); reserpine; ritonavir (Norvir, in Kaletra); medications for seizures such as ethosuximide (Zarontin), phenobarbital, and phenytoin (Dilantin, Phenytek); selective serotonin reuptake inhibitors such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Prozac, Pexeva), and sertraline (Zoloft); serotonin and norepinephrine reuptake inhibitors such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), milnacipran (Savella), and venlafaxine (Effexor); sodium acid phosphate; sodium bicarbonate (Arm and Hammer Baking Soda, Soda Mint); tramadol; or tricyclic antidepressants such as desipramine (Norpramin) and protriptyline (Vivactil). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • Tell your doctor what herbal products you are taking, especially St. John’s wort and tryptophan, or nutritional supplements you are taking, including glutamic acid (L-glutamine).
  • Tell your doctor if you have hyperthyroidism (a condition in which there is too much thyroid hormone in the body) or strong feelings of anxiety, tension, or agitation. Your doctor will probably tell you not to take Dyanavel XR.
  • Tell your doctor if anyone in your family has or has had an irregular heartbeat or has died suddenly. Also tell your doctor if you have recently had a heart attack or if you have or have ever had a heart defect, arteriosclerosis (hardening of the arteries), coronary artery disease (narrowing of the blood vessels that supply blood to the heart), blood pressure, irregular heartbeat, cardiomyopathy (thickening of the heart muscles), heart or blood vessel disease, or other heart problems. Your doctor will examine you to see if your heart and blood vessels are healthy. Your doctor will likely tell you not to take Dyanavel XRs if you have a heart condition or if there is a high risk that you could develop a heart condition.
  • Tell your doctor if you or anyone in your family has or has ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), mania (frantic, abnormally excited mood), psychosis, motor tics (repeated movements uncontrollable), tics (repetition of sounds or words that is difficult to control), Tourette syndrome (a condition characterized by the need to perform repeated movements or repeat sounds or words), or have thought or attempted suicide. Also tell your doctor if you have or have ever had seizures, an abnormal electroencephalogram (EEG; a test that measures electrical activity in the brain), or kidney disease.
  • Tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking Dyanavel XR, call your doctor.
  • Do not breastfeed while taking Dyanavel XR.
  • Do not drive a car or operate machinery until you know how this medicine affects you.
  • Do not drink alcohol while taking Dyanavel XR. Alcohol can make the side effects of Dyanavel XR worse.
  • You should know that Dyanavel XR should be used as part of a total treatment program for ADHD, which may include counseling and special education. Be sure to follow all instructions from your doctor and / or therapist.
  • You should know that Dyanavel XR can cause sudden death in children and adolescents, especially children and adolescents who have heart defects or serious heart problems. This drug can also cause sudden death, heart attack, or stroke in adults, especially adults with heart defects or serious heart problems. Call your / your child’s doctor right away if you or your child have signs of heart problems while taking this medicine, including: chest pain, trouble breathing, or fainting.

What special dietary instructions should I follow?
Talk to your doctor about drinking fruit juice while taking this medicine.

What should I do if I forget a dose?
Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Dyanavel XR may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • dry mouth
  • nausea
  • diarrhea
  • constipation
  • unpleasant taste
  • stomach cramps
  • weight loss
  • nose bleeding
  • headache
  • grinding or clenching teeth during sleep
  • nervousness
  • changes in sex drive or ability
  • painful menstruation
  • pain or burning when urinating

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking Dyanavel XR and call your doctor immediately:

  • dizziness
  • weakness or numbness of an arm or leg
  • motor or verbal tics
  • believing things that are not true
  • feeling unusually suspicious of others
  • hallucinating (seeing things or hearing voices that do not exist)
  • mania (frenzied or abnormally excited mood)
  • agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea
  • seizures
  • changes in vision or blurred vision
  • blistering or peeling skin
  • rash
  • hives
  • itching
  • swelling of the face, throat, tongue, lips, or eyes
  • difficulty breathing or swallowing
  • numbness, pain, or sensitivity to temperature in the fingers or toes
  • skin color change from pale to blue to red in the fingers or toes
  • unexplained wounds appearing on fingers or toes

Dyanavel XR can cause sudden death in children and adolescents, especially children and adolescents who have heart defects or serious heart problems. This drug can also cause sudden death, heart attack, or stroke in adults, especially adults who have heart defects or serious heart problems. Call your doctor right away if you or your child have any signs of heart problems while taking this medicine, including: chest pain, trouble breathing, or fainting. Talk to your doctor about the risks of taking this medicine.

Dyanavel XR can slow down growth or weight gain in children. Your child’s doctor will carefully watch her growth. Talk to your child’s doctor if you are concerned about your child’s growth or weight gain while taking this medicine. Talk to your child’s doctor about the risks of giving your child Dyanavel XR.

Dyanavel XR can cause other side effects. Call your doctor if you have any unusual problems while taking this medicine.

If you experience a serious side effect, you or your doctor can submit a report online to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about storage and disposal of this medication?
Keep this medicine in its container, tightly closed and out of the reach of children. Store the blister packs of orally disintegrating tablets in the plastic sleeves provided. Store the blister packs of orally disintegrating extended-release tablets in the rigid plastic travel case after removing them from the box. Store at room temperature and away from light, excess heat, and moisture (not in the bathroom).

It is important to keep all medicines out of the sight and reach of children, since many containers (such as those containing weekly pills and those for eye drops, creams, patches and inhalers) are not child-resistant and small children can easily open them. To protect young children from poisoning, always close the safety caps and immediately place the medicine in a safe place, one that is upright and out of their sight and reach. http://www.upandaway.org

Unnecessary medications must be disposed of in special ways to ensure that pets, children, and others cannot consume them. However, you should not flush this medicine down the toilet. Instead, the best way to dispose of your medications is through a drug take-back program. Talk to your pharmacist or contact your local recycling / trash department to find out about take-back programs in your community. Check out the FDA drug safe disposal website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim collapsed, had a seizure, is having trouble breathing, or cannot wake up, call 911 immediately.

Symptoms of overdose may include the following:

  • restlessness
  • confusion
  • aggressive behavior
  • shaking of a part of the body
  • tiredness or weakness
  • depression
  • fast or irregular heartbeat
  • nausea
  • vomiting
  • diarrhea
  • stomach cramps
  • seizures
  • coma (loss of consciousness for a period of time)

What other information should I know?
Keep all your appointments with your doctor. Your doctor may order certain tests to check your body’s response to Dyanavel XR and your blood pressure.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking Dyanavel XR.

This recipe is not refillable. Be sure to make regular appointments with your doctor so you don’t run out of medications.

It is important that you keep a written list of all prescription and over-the-counter (over-the-counter) medications you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should take this list with you every time you visit a doctor or if you are admitted to a hospital. It is also important information to take with you in case of emergencies.

Brand Names

  • Adzenys ER®
  • Adzenys XR®
  • Dyanavel XR®
  • Evekeo®
  • Evekeo® ODT

Disclaimer: We have made every effort to ensure that all information is factually accurate, comprehensive and up-to-date. However, this article should not be used as a licensed health care professional’s choice of knowledge and expertise. You should always consult your doctor or other health care professional before taking any medication. The information given here is subject to change and it has not been used to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions or adverse effects. The lack of warning or other information for any drug does not indicate that the combination of medicine or medication is safe, effective or appropriate for all patients or all specific uses.

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