Qelbree

Generic name: Viloxazine
Dosage form: extended-release capsules
Drug class: Adrenergic uptake inhibitors for ADHD

Usage of Qelbree

Qelbree is a prescription medicine used to treat attention deficit hyperactivity disorder (ADHD) in adults and children 6 years of age and older.

It is not known if this medicine is safe and effective in children less than 6 years of age.

Qelbree side effects

Qelbree can cause serious side effects, including:

See Important information

Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate before starting and during treatment.

Manic episodes. Manic episodes may happen in people with bipolar disorder who take Qelbree. Symptoms may include:

greatly increased energy

racing thoughts

unusually grand ideas

talking more or faster than usual

severe trouble sleeping

reckless behavior

excessive happiness or irritability

Sleepiness and tiredness. See What should I avoid while taking Qelbree?

The most common side effects in children 6 to 17 years of age include:

sleepiness

tiredness

vomiting

irritability

decreased appetite

nausea

trouble sleeping

The most common side effects in adults include:

insomnia

sleepiness

nausea

dry mouth

headache

tiredness

decreased appetite

constipation

Effects on weight. Your healthcare provider should check you or your child’s weight before starting, and during treatment.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Qelbree

Do not take Qelbree if you or your child:

takes a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you or your child takes an MAOI.

stopped taking an MAOI in the last 14 days.

takes alosetron, duloxetine, Ramelteon, Tasimelteon, tizanidine, or theophylline.

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How to use Qelbree

Usual Adult Dose for ADHD

- recommended starting doSage is 200 mg once daily. May titrate in increments of 200 mg weekly, to maximum recommended dosage of 600 mg once daily

Use: treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults

Usual Pediatric Dose for ADHD

- 6 to 11 years of age: Recommended starting dosage is 100 mg once daily. May titrate in increments of 100 mg weekly to the maximum recommended dosage of 400 mg once daily - 12 to 17 years of age: Recommended starting dosage is 200 mg once daily. May titrate after 1 week, by an increment of 200mg, to the maximum recommended dosage of 400 mg once daily

- Use: treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 years and older

Warnings

Qelbree can cause serious side effects, including:

Increased risk of suicidal thoughts or actions. Qelbree may increase suicidal thoughts and actions in children and adults with attention deficit hyperactivity disorder (ADHD), especially within the first few months of treatment or when the dose is changed. How can I watch for and try to prevent suicidal thoughts and actions?

Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts, or feelings or if you or your child develops suicidal thoughts or actions. This is very important when Qelbree treatment is started or when the dose is changed.

Call your healthcare provider right away if you or your child has any new or sudden changes in mood, behavior, thoughts, or feelings, or if you or your child develops suicidal thoughts or actions.

Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call your healthcare provider or get emergency help right away if you or your child has any of the following symptoms, especially if they are new, worse, or worry you:

attempts to commit suicide

new or worse depression

feeling very agitated or restless

trouble sleeping (insomnia)

acting aggressive, being angry, or violent

an extreme increase in activity and talking (mania)

thoughts about suicide or dying

new or worse anxiety

panic attacks

new or worse irritability

acting on dangerous impulses

other unusual changes in behavior or mood

See Qelbree side effects for more information about side effects.

What other drugs will affect Qelbree

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

Disclaimer

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