Viloxazine

What is Viloxazine?

• Viloxazine (Qelbree) is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

What are the uses of this medicine?

• This medicine is used to treat Attention deficit hyperactivity disorder (ADHD) in children 6 to 17 years of age.

How does this medicine work?

• The mechanism of action of viloxazine in the treatment of ADHD is unclear; however, it is thought to be through inhibiting the reuptake of norepinephrine.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• 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 your child takes an MAOI.
• stopped taking an MAOI in the last 14 days.
• takes alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, or theophylline.

What drug interactions can this medicine cause?

• Concomitant use of Qelbree with an MAOI (eg:Selegiline, isocarboxazid, phenelzine, tranylcypromine, safinamide, rasagiline) or within 2 weeks after discontinuing an MAOI is contraindicated.
• Avoid coadministration with moderate sensitive CYP1A2 substrates (eg: Alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, theophylline).

Is this medicine FDA approved?

• It was approved for use in the United States in 2021.

How should this medicine be used?

• Assess heart rate and blood pressure prior to initiating treatment with Qelbree.
• Prior to initiating treatment with Qelbree, screen patients for a personal or family history of suicide, bipolar disorder, and depression.

Recommended dosage

Pediatric patients 6 to 11 years of age

• The recommended starting dosage for pediatric patients 6 to 11 years of age is 100 mg orally once daily.
• Dosage may be titrated in increments of 100 mg at weekly intervals to the maximum recommended dosage of 400 mg once daily, depending on response and tolerability.

Pediatric patients 12 to 17 years of age

• The recommended starting dosage for pediatric patients 12 to 17 years of age is 200 mg orally once daily.
• After 1 week, dosage may be titrated by an increment of 200 mg to the maximum recommended dosage of 400 mg once daily, depending on response and tolerability.

Administration

• Take QELBREE exactly as your healthcare provider tells you to take it.
• Take QELBREE 1 time each day with or without food.
• Swallow QELBREE capsules whole. Do not cut, crush, or chew the capsules.
• If QELBREE capsules cannot be swallowed whole, the capsule may be opened and the entire contents sprinkled onto a teaspoonful of applesauce.
• Swallow all the applesauce mixture right away, without chewing, or within 2 hours of mixing.
• Do not chew the applesauce mixture.
• Do not store applesauce mixture.
• Talk to your healthcare provider about what you should do if your child misses a dose.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As extended-release capsules: 100 mg, 150 mg and 200 mg

This medicine is available in fallowing brand namesː

• QELBREE

What side effects can this medication cause?

The most common side effects of this medicine include:

• sleepiness
• tiredness
• vomiting
• irritability
• decreased appetite
• nausea
• trouble sleeping

QELBREE can cause serious side effects, including:

• Increased blood pressure and heart rate

Manic episodes which includes:

• 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
• Increased risk of suicidal thoughts or actions

What special precautions should I follow?

• Do not drive or operate heavy machinery until you know how QELBREE will affect you.
• QELBREE may cause you to feel sleepy or tired.
• Assess heart rate and blood pressure prior to initiating treatment, following increases in dosage, and periodically while on therapy.
• Screen patients for bipolar disorder.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• The most reported symptom was drowsiness.
• Impaired consciousness, diminished reflexes, and increased heart rate have also been reported.

Management of Overdose

• There is no specific antidote for Qelbree overdose. Administer symptomatic and supportive treatment as appropriate. In case of overdose, consult a Certified Poison Control Center (1-800-222-1222 or www.poison.org).

Can this medicine be used in pregnancy?

• Available data from case series with viloxazine use in pregnant women are insufficient to determine a drug-associated risk of major birth defects, miscarriage or adverse maternal outcomes.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed Qelbree during pregnancy.
• Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at www.womensmentalhealth.org/preg.

Can this medicine be used in children?

• The safety and effectiveness of Qelbree in pediatric patients 6 to 17 years of age with ADHD have been established based on randomized, placebo-controlled studies in pediatric patients.
• The safety and effectiveness of Qelbree have not been established in pediatric patients younger than 6 years old.

What are the active and inactive ingredients in this medicine?

• Active ingredient : viloxazine
• Inactive ingredients: ammonium hydroxide, black iron oxide, butyl alcohol, corn starch, ethylcellulose, FD&C Blue #1, FD&C Red #28, FD&C Yellow #5, FD&C Yellow #6, FD&C Yellow #10, gelatin, hypromellose, isopropyl alcohol, lactose monohydrate, medium chain triglycerides, oleic acid, polyethylene glycol, potassium hydroxide, propylene glycol, shellac, strong ammonia solution, sucrose, talc, triacetin, titanium dioxide.

Who manufactures and distributes this medicine?

• Manufactured by: Catalent Pharma Solutions, LLC, 1100 Enterprise Drive, Winchester KY 40391, USA
• Distributed by: Supernus Pharmaceuticals, Inc., Rockville, MD USA 20850

What should I know about storage and disposal of this medication?

• Store QELBREE capsules at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep QELBREE and all medicines out of the reach of children.

The following are antidepressant subclasses and drugs

MAO Inhibitors Isocarboxazid, Phenelzine, Tranylcypromine

SNRIs Duloxetine, Levomilnacipran, Venlafaxine

SSRIs Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Vilazodone, Vortioxetine

Tricyclics Amitriptyline, Amoxapine, Clomipramine, Desipramine, Doxepin, Imipramine, Nortriptyline, Protriptyline, Trimipramine

Miscellaneous Bupropion, Flibanserin, Mirtazapine, Nefazodone, Trazodone

• Dailymed label info on Viloxazine
• FDA Viloxazine