Viloxazine Hydrochloride (2 brand names, 1 dosage form, 1 route)
Available dosage forms: CAPSULE, EXTENDED RELEASE.
Routes of administration: ORAL.
Brand Names
- QELBREE
- VILOXAZINE HYDROCHLORIDE
Boxed Warning
In clinical studies, higher rates of suicidal thoughts and behavior were reported in patients with ADHD treated with Qelbree than in patients treated with placebo. Closely monitor all Qelbree-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1)] .
Indications and Usage
Qelbree is indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older.
Contraindications
Qelbree is contraindicated in patients: receiving concomitant treatment with monoamine oxidase inhibitors (MAOI), or within 14 days following discontinuing an MAOI, because of an increased risk of hypertensive crisis [see Drug Interactions (7.1)] . receiving concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range [see Drug Interactions (7.1)].
Adverse Reactions
The following serious adverse reactions are described in other sections of the labeling: Suicidal Thoughts and Behaviors [see Warnings and Precautions (5.1)] Blood Pressure and Heart Rate Increases [see Warnings and Precautions (5.2)] Activation of Mania or Hypomania [see Warnings and Precautions (5.3)] Somnolence and Fatigue [see Warnings and Precautions (5.4)]
Mechanism of Action
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.