Viloxazine

Viloxazine is a prescription medicine used to treat attention hyperactivity disorder (ADHD) in children 6 to 17 years of age.

• Viloxazine is available under the following different brand names: Qelbreex

Pediatric dosage

Capsule, extended-release

• 100mg
• 150mg
• 200mg

Attention Deficit Hyperactivity Disorder

Pediatric dosage

• Children below 6 years: Safety and efficacy not established
• Children between 6 to 11 years: 
• Initial: 100 mg orally once daily
• May increase in weekly 100-mg increments; not to exceed 400 mg/day, depending on response and tolerability
• Children between 12 to 17 years: 
• Initial: 200 mg orally once daily
• After 1 week, may increase in weekly 200-mg increments; not to exceed 400 mg/day, depending on response and tolerability

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Viloxazine include:

• sleepiness,
• tiredness,
• vomiting,
• irritability,
• decreased appetite,
• nausea,
• trouble sleeping,
• headache,
• upper respiratory tract infection, 
• abdominal pain, and
• fever.

Serious side effects of Viloxazine include:

• increased blood pressure and heart rate,
• manic episodes: greatly increased energy, racing thoughts, unusually grand ideas, talking more or faster than usual, reckless behavior, excessive happiness or irritability, and
• severe trouble sleeping.

Rare side effects of Viloxazine include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Viloxazine has severe interactions with no other drugs.
• Viloxazine has serious interactions with no other drugs.
• Viloxazine has moderate interactions with the following drugs:
  • atogepant
  • finerenone
  • isavuconazonium sulfate
• Viloxazine has minor interactions with no other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Coadministration with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuing an MAOI
• Coadministration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Viloxazine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Viloxazine?”

Cautions

• May increase HR and diastolic BP
• Noradrenergic drugs, such as viloxazine, may induce mania or mixed episodes in patients with bipolar disorder
• Somnolence and fatigue may occur; performing activities requiring mental alertness (eg, operating a motor vehicle, hazardous machinery) are not recommended
• Suicidal thoughts and ideation
  • Suicidal thoughts and behavior were reported
  • A causal link between emerging symptoms (eg, irritability, insomnia, depressed mood, anxiety, agitation, akathisia, mania, hypomania, panic attacks, impulsive behavior, aggression) and the emergence of suicidal impulses not established
  • Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of therapy and after dosage adjustments
  • Consider discontinuing or adjusting therapy in patients who are experiencing emergent suicidal thoughts and behaviors or symptoms, especially if symptoms are severe or abrupt in onset, or were not part of the patient’s presenting symptoms
  • Consult family members or caregivers to monitor for the emergence of suicidal ideation or behavior, and report such symptoms immediately to a healthcare provider
• Drug interaction overview
  • Strong CYP1A2 inhibitor; weak CY2D6 and CYP3A4 inhibitor
  • MAOIs
    • Contraindicated with MAOIs and within 2 weeks after discontinuing an MAOI
    • Coadministration with an MAOI may lead to a potentially life-threatening hypertensive crisis
  • CYP1A2 substrates
    • Sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range: Contraindicated
    • Moderately sensitive CYP1A2: Not recommended; dosage reduction recommended if coadministered
    • Viloxazine may significantly increase total exposure and risk of toxicities of these CYP1A2 substrates
  • CYP2D6 substrates
    • Viloxazine may increase the exposure of CYP2D6 substrates
    • Monitor for adverse reactions and adjust dosages of substrates, as clinically indicated
  • CYP3A4 substrates
    • Viloxazine may increase the exposure of CYP3A4 substrates
    • Monitor for adverse reactions and adjust dosages of substrates, as clinically indicated

Pregnancy and Lactation

• Based on findings from animal reproduction studies, maternal harm may occur when used during pregnancy
• Discontinue when pregnancy is recognized unless the benefits of therapy outweigh potential risks to the mother
• Insufficient data are available on use in pregnant females to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal outcomes
• Pregnancy registry
  • Registry monitors pregnancy outcomes in treated or exposed females
  • Encourage patients to register by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at www.womensmentalhealth.org/preg
• Lactation
  • There are no data on presence in human milk, effects on breastfed infants, or effects on milk production
  • Viloxazine is likely to present in rat milk; when present in animal milk, the drug is likely to present in human milk