Viloxazine
Generic name: viloxazine [ vye-LOX-a-zeen ]
Brand name: Qelbree
Dosage form: oral capsule, extended release (100 mg; 150 mg; 200 mg)
Drug class: Adrenergic uptake inhibitors for ADHD
What is viloxazine?
Viloxazine is used to treat attention-deficit hyperactivity disorder (ADHD) in adults and children at least 6 years old.
Viloxazine may also be used for purposes not listed in this medication guide.
Viloxazine side effects
Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.
Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse 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 at once if you have:
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manic episodes--racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative;
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extreme drowsiness or tiredness;
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fast heart rate; or
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severe headache, blurred vision, pounding in your neck or ears.
Viloxazine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using viloxazine.
Common side effects of viloxazine may include:
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drowsiness;
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feeling tired or irritable;
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sleep problems (insomnia); or
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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.
Related/similar drugs
Warnings
Some people have thoughts about suicide while taking viloxazine. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.
Tell your doctor about all your other medicines. Some drugs should not be used with viloxazine.
Before taking this medicine
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:
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depression, mental illness, bipolar disorder, or suicidal thoughts or actions (in you or a family member);
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problems with blood pressure or heart rate; or
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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.
How should I take viloxazine?
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.
Viloxazine dosing information
Usual Adult Dose for Attention Deficit Disorder:
Initial dose: 200 mg
-May titrate in increments of 200 mg weekly based on response and tolerability
Maximum dose: 600 mg daily
Comments:
-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 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 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.
What happens if I miss a dose?
Call your doctor for instructions if you miss a dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking viloxazine?
Avoid driving or hazardous activity until you know how viloxazine will affect you. Your reactions could be impaired.
What other drugs will affect viloxazine?
Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.
Many drugs can affect viloxazine, and some drugs should not be used at the same time. Tell your doctor about all other medicines you use. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.
Popular FAQ
How long does it take Qelbree to work?
Qelbree works in as little as 1 to 2 weeks with trials showing significant reductions in ADHD symptoms in children aged 6 to 11 years by 1 week, and those aged 12 to 17 years by week 2. Mean changes in baseline ADHD-RS-5 Total Scores of -16 to -17.7 to were reported across 3 studies after 6 weeks.
Qelbree is an extended-release tablet and one single daily dose provides 24-hour coverage.
How long does it take Qelbree to work?
In some people, Qelbree reduces the frequency and severity of ADHD symptoms (including inattention, hyperactivity, and impulsivity) in as little as 1 week. Clinical trials have reported a significant reduction in ADHD symptoms scores:
- At 1 week for children aged 6 thru 11 years taking 100mg and 200mg doses
- At 2 weeks for adolescents aged 12 thru 17 years taking 400mg doses.
Some patients may take up to 6 weeks to respond to Qelbree.
Qelbree is taken once a day and lasts for 24 hours. It is usually prescribed for months to years, although you can ask your doctor for a trial off medication at any time to see if you can manage without it.
Qelbree vs. Strattera: How do they compare?
Qelbree and Strattera are both oral nonstimulant medicines shown in clinical studies to be effective in treating ADHD in children 6 years and older and adults. They are not controlled substances. Strattera is available as generic option known as atomoxetine, which may save you money. Continue reading
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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.
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