VILOXAZINE CAP,SPRINKLE,SA
Clinical Criteria Summary
Indications
- Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.
Dosing & Administration
- Extended-release capsules available in 100 mg, 150 mg, and 200 mg strengths.
- Initial dosing: 200 mg once daily for week 1.
- Titration: Increase to 400 mg once daily during week 2.
- Maintenance titration: Adjust by 200 mg per day once weekly to a minimum of 200 mg once daily and maximum of 600 mg once daily.
Contraindications
- Concomitant treatment with MAOIs or within 14 days following discontinuation of an MAOI.
- Concomitant use with sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range.
Warnings & Precautions
- Boxed warning for suicidal thoughts and behaviors (observed in 0.9% of pediatric patients vs 0.4% placebo; 1.6% of adults vs 0% placebo).
- Blood pressure and heart rate increases.
- Activation of mania or hypomania.
- Somnolence and fatigue.
- Pregnancy: May cause maternal harm; discontinue when pregnancy is recognized.
Formulary Status & Clinical Guidance
- Non-formulary (NF) status for ADHD in adults and pediatric patients 6 years and older.
- Recommended as a second-line non-stimulant option for patients unable to tolerate or not good candidates for stimulant therapy.
- Does not appear to provide advantages over other nonstimulants (e.g., atomoxetine).
- Not addressed in current clinical guidelines due to availability timing.