Viloxazine is used to treat attention deficit hyperactivity disorder (ADHD) in children 6 to 17 years old.

Viloxazine may also be used for purposes not listed in this medication guide.

Some people have thoughts about suicide while taking viloxazine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

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.

You may take viloxazine with or without food.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you cannot swallow a capsule whole, open it and mix the medicine with applesauce. Swallow the mixture right away without chewing.

Your heart rate and blood pressure will need to be checked often.

Store at room temperature away from moisture and heat.

Usual Pediatric Dose for Attention Deficit Disorder:

6 to 11 years:
Initial dose: 100 mg orally once a day
-May titrate in increments of 100 mg per week based on response and tolerability
Maximum dose: 400 mg/day

12 to 17 years:
Initial dose: 200 mg orally once a day
-After 1 week, may titrate to 400 mg once a day based on response and tolerability
Maximum dose: 400 mg/day

Comments:
-Assess heart rate and blood pressure prior to initiating treatment.
-Screen patients for a personal or family history of suicide, bipolar disorder, and depression prior to initiating treatment.
-Pharmacologic treatment for Attention-Deficit Hyperactivity Disorder (ADHD) may be needed for extended periods; periodically reevaluate and adjust dosage as needed.

Use: For the treatment of ADHD in pediatric patients 6 years or older.

Some drugs should not be used with viloxazine. Your treatment plan may change if you also use:

• alosetron;

• duloxetine;

• ramelteon;

• tasimelteon;

• tizanidine; or

• theophylline.

Do not use viloxazine 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, tranylcypromine, and others.

Tell your doctor if you or anyone in your family has ever had:

• depression;

• bipolar disorder (manic depression);

• psychosis; or

• suicidal thoughts or actions.

Tell your doctor if you have ever had:

• heart problems;

• high blood pressure;

• liver disease; or

• severe kidney disease.

viloxazine may be harmful when taken during pregnancy. Tell your doctor right away if a pregnancy occurs.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of viloxazine on the baby and the mother.

Ask a doctor if it is safe to breastfeed while using this medicine.

Not approved for use by anyone younger than 6 years old.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

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

Avoid driving or hazardous activity until you know how viloxazine 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.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have symptoms of a manic episode:

• racing thoughts;

• increased energy, decreased need for sleep;

• risk-taking behavior; or

• being agitated or talkative.

Viloxazine can affect weight in children. Tell your doctor if your child loses weight or is not gaining weight at a normal rate.

Common side effects of viloxazine may include:

• drowsiness;

• feeling tired or irritable;

• trouble sleeping; or

• nausea, vomiting, loss of appetite.

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.

Other drugs may affect viloxazine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

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.