Drug Detail:Viloxazine (Viloxazine [ vye-lox-a-zeen ])
Drug Class: Adrenergic uptake inhibitors for ADHD
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
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
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 Attention-Deficit Hyperactivity Disorder (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.
Renal Dose Adjustments
Mild to moderate (estimated glomerular filtration rate [eGFR] 30 to 89 mL/min/1.73 m2): No adjustment recommended
Severe renal impairment (eGFR less than 30 mL/min/1.73 m2):
- Initial dose: 100 mg orally once a day
- May titrate in increments of 50 to 100 mg weekly based on response and tolerability
- Maximum dose: 200 mg/day
Liver Dose Adjustments
Not recommended
Precautions
US BOXED WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
- In clinical studies, higher rates of suicidal thoughts and behavior were reported in pediatric patients with ADHD receiving this drug than in patients treated with placebo.
- Closely monitor patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.
CONTRAINDICATIONS:
- Concomitant treatment with monoamine oxidase inhibitors (MAOI), or within 14 days following discontinuing an MAOI, because of an increased risk of hypertensive crisis
- Concomitant use of sensitive CYP450 1A2 substrates or CYP450 1A2 substrates with a narrow therapeutic range
Safety and efficacy have not been established in patients younger than 6 years or older than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Take orally once a day with or without food; do not cut, crush, or chew the capsules
- May open capsule and sprinkle contents over a teaspoon of applesauce; consume in its entirety within 2 hours without chewing
Storage requirements:
- If mixed with applesauce, use within 2 hours; do not store for future use
Monitoring:
- Assess heart rate and blood pressure prior to therapy, following any dose increase, and periodically during therapy
- Screen for personal or family history of suicide, bipolar disorder, and depression prior to therapy
- Monitor weight
- Monitor for clinical worsening and emergence of suicidal thoughts and behaviors, especially during therapy initiation and with dose changes
Patient advice:
- Patients/caregivers should be instructed to read the US FDA-approved patient labeling (Medication Guide).
- Family members and caregivers should be informed of the possibility of suicidal thoughts and behaviors and instructed to report behavioral changes or emergence of suicidal thoughts and behaviors promptly.
- Patients/caregivers should understand that there is a potential for somnolence and fatigue; they should understand how this drug affects them prior to engaging in activities requiring mental alertness.
Frequently asked questions
- Qelbree vs. Strattera: How do they compare?