Viloxazine

Viloxazine is used to treat attention-deficit hyperactivity disorder (ADHD) in adults and children who are at least 6 years old.

Viloxazine may also be used for other reasons that are not mentioned in this medication guide.

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, or break it.

If you are unable to swallow the medicine, read and carefully follow the instructions provided to you on how to prepare and take viloxazine. Ask a doctor or pharmacist if you do not understand these instructions.

Your heart rate, blood pressure, and weight will need to be checked before and during treatment with viloxazine.

Your doctor will need to check your progress on a regular basis. Keep all follow-up visits to your doctor.

Store at room temperature away from moisture and heat.

Some people may have thoughts about suicide while taking viloxazine. Contact your doctor immediately if you experience any sudden changes in mood or behavior, or thoughts about suicide.

Inform your doctor about all the other medicines you are taking. Some medications should not be combined with viloxazine.

Some drugs should not be used with viloxazine. Your treatment plan may change if you are also taking any of these drugs: 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, and tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before you take viloxazine.

Tell your doctor if you have or have ever had:

• depression, mental illness, bipolar disorder, or suicidal thoughts or actions (in you or a family member);
• problems with blood pressure or heart rate; or
• severe kidney disease.

Viloxazine may harm an unborn baby. Tell your doctor if you are pregnant.

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 viloxazine. Viloxazine passes to your baby in your breast milk.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you notice any new or sudden changes in mood or behavior, including new or worsening depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

Viloxazine may cause serious side effects. Call your doctor immediately if you experience:

• manic episodes--racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative;
• extreme drowsiness or tiredness;
• fast heart rate; or
• severe headache, blurred vision, or pounding in your neck or ears.

Viloxazine can affect growth in children. Inform your doctor if your child is not growing at a normal rate while using viloxazine.

Common side effects of viloxazine may include:

• drowsiness;
• feeling tired or irritable;
• sleep problems (insomnia); or
• nausea, vomiting, and 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 the FDA at 1-800-FDA-1088.

Usual Adult Dose for Attention Deficit Disorder:

Initial dose: 200 mg-May titrate in increments of 200 mg weekly based on response and tolerabilityMaximum dose: 600 mg dailyComments:-Pharmacologic treatment of Attention-Deficit Hyperactivity Disorder (ADHD) may be needed for extended periods. Periodically reevaluate the long-term use of this drug and adjust dosage as needed.Use: For the treatment of ADHD in adults

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 tolerabilityMaximum 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 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.

Call your doctor for guidance if you miss a dose.

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

Avoid driving or doing dangerous activities until you understand how viloxazine will affect you. Your reactions might be affected.

Sometimes it is not safe to use certain medicines together. Some drugs can change how much of another drug is in your blood, which can increase side effects or make the medicines work less well.

Many drugs can affect viloxazine, and some drugs should not be used at the same time. Tell your doctor about all other medicines you are taking. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.