Viloxazine drug information

IMPORTANT WARNING

Studies have shown that children and teenagers with attention-deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) who take viloxazine are more likely to think about killing themselves than children and teenagers with ADHD who do not take viloxazine.

While your child is taking viloxazine, you should watch his or her behavior very carefully, especially at the beginning of treatment and any time his or her dose is increased or decreased. Your child may develop serious symptoms very suddenly, so it is important to pay attention to his or her behavior every day. Ask other people who spend a lot of time with your child, such as brothers, sisters, and teachers to tell you if they notice changes in your child's behavior. Call your child's doctor right away if your child experiences any of these symptoms: acting more subdued or withdrawn than usual; feeling helpless, hopeless, or worthless; new or worsening depression; thinking or talking about harming or killing him- or herself or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; irritability; aggressive or violent behavior; acting without thinking; extreme increase in activity or talking; frenzied, abnormal excitement; or any other sudden or unusual changes in behavior.

Your child's doctor will want to see your child often while he or she is taking viloxazine, especially at the beginning of his or her treatment. Your child's doctor may also want to speak with you or your child by telephone from time to time. Be sure that your child keeps all appointments for office visits or telephone conversations with his or her doctor.

Talk to your doctor about the risks of giving viloxazine to your child, of using other treatments for your child's condition, and of not treating your child's condition.

Why is this medication prescribed?

Viloxazine is used as part of a total treatment program to increase the ability to pay attention and decrease impulsiveness and hyperactivity in children 6 to 17 years of age with attention deficit hyperactivity disorder (ADHD). Viloxazine is in a class of medications called selective norepinephrine reuptake inhibitors. It works by increasing the levels of norepinephrine, a natural substance in the brain that is needed to control behavior.

How should this medicine be used?

Viloxazine comes as a capsule to take by mouth. It is usually taken either once a day with or without food. Take viloxazine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take viloxazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them.

If the capsules cannot be swallowed whole, open the capsule and sprinkle the contents onto a teaspoonful of applesauce. Swallow all of the mixture right away; do not chew the mixture. Swallow the mixture within two hours of mixing; do not store the mixture for future use.

Your doctor will probably start you on a low dose of viloxazine and increase your dose after at least 7 days.

Viloxazine may help to control the symptoms of ADHD but will not cure the condition. Continue to take viloxazine even if you feel well. Do not stop taking viloxazine without talking to your doctor.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with viloxazine and each time you refill your prescription. 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) or the manufacturer's website to obtain the Medication Guide.

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 viloxazine,

tell your doctor and pharmacist if you are allergic to viloxazine, any other medications, or any of the ingredients in viloxazine capsules. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

tell your doctor if you are taking monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), safinamide (Xadago), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking them within the past 2 weeks. Also, tell your doctor if you are taking alosetron (Lotronex), duloxetine (Cymbalta), ramelteon (Rozerem), tasimelteon (Hetlioz), tizanidine (Zanaflex), or theophylline. Your doctor will probably tell you not to take viloxazine with any of these medications.

tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: atomoxetine (Strattera), avanafil (Stendra), buspirone, clozapine (Clozaril, Versacloz), conivaptan (Vaprisol), darifenacin (Enablex), darunavir (Prezista), desipramine (Norpramin), dextromethorphan (found in many cough medications; in Nuedexta), everolimus (Afinitor), ibrutinib (Imbruvica), lomitapide (Juxtapid), lovastatin (Altoprev), lurasidone (Latuda), metoprolol, midazolam, naloxegol (Movantik), nebivolol (Bystolic), nisoldipine (Sular), nortriptyline (Pamelor), perphenazine, pirfenidone (Esbriet), risperidone (Perseris, Risperdal), saquinavir (Invirase), simvastatin (Flolipid, in Vytorin), sirolimus (Rapamune), tacrolimus (Prograf), tipranavir (Aptivus), tolterodine (Detrol), triazolam (Halcion), vardenafil (Levitra), and venlafaxine (Pristiq). Many other medications may also interact with viloxazine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

tell your doctor if you or anyone in your family has or has ever had depression, bipolar disorder (manic depressive disorder; a condition that causes episodes of depression, episodes of frenzied, abnormal excitement and other abnormal moods), or has ever thought about or attempted suicide. Also tell your doctor if you have or have ever had high blood pressure, or heart, liver or kidney disease.

tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking viloxazine, call your doctor.

you should know that viloxazine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

you should know that viloxazine should be used as part of a total treatment program for ADHD, which may include counseling and special education. Make sure to follow all of your doctor's and/or therapist's instructions.

you should know that your blood pressure may increase during your treatment with viloxazine. Your doctor will monitor your blood pressure during your treatment.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. 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?

Viloxazine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- loss of appetite
- tiredness
- nausea
- vomiting
- headache

Viloxazine may affect children's weight gain. Your child's doctor will probably monitor your child carefully during his or her treatment with viloxazine. Talk to your child's doctor about the risks of giving this medication to your child.
Viloxazine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (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 medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of 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 has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

drowsiness
loss of consciousness
fast or irregular heartbeat
muscle weakness

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will check your blood pressure and heart rate and order certain lab tests to check your body's response to viloxazine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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

Viloxazine

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