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Qelbree Generic Name & Formulations
Legal Class
Rx
General Description
Viloxazine 100mg, 150mg, 200mg; ext-rel caps.
Pharmacological Class
SNRI.
How Supplied
Caps—30, 60, 90, 100
Manufacturer
Generic Availability
NO
Qelbree Indications
Indications
Attention deficit hyperactivity disorder (ADHD).
Qelbree Dosage and Administration
Adult
Swallow whole or sprinkle contents onto applesauce or pudding. ≥18yrs: initially 200mg once daily; may titrate in increments of 200mg at weekly intervals, based on response and tolerability; max 600mg once daily. Severe renal impairment (eGFR <30mL/min/1.73m2): initially 100mg once daily; may titrate in weekly increments of 50–100mg once daily; max 200mg once daily.
Children
<6yrs: not established. Swallow whole or sprinkle contents onto applesauce or pudding. 6–11yrs: initially 100mg once daily; may titrate in increments of 100mg at weekly intervals, based on response and tolerability; max 400mg once daily. 12–17yrs: initially 200mg once daily; after 1 week, may increase in increments of 200mg to a max dose of 400mg once daily, based on response and tolerability. Severe renal impairment (eGFR <30mL/min/1.73m2): initially 100mg once daily; may titrate in weekly increments of 50–100mg once daily; max 200mg once daily.
Qelbree Contraindications
Contraindications
Concomitant MAOIs or within 14 days of discontinuing an MAOI (eg, selegiline, isocarboxazid, phenelzine, tranylcypromine, safinamide, rasagiline). Concomitant sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range (eg, alosetron, duloxetine, ramelteon, tasimelteon, tizanidine, theophylline).
Qelbree Boxed Warnings
Boxed Warning
Suicidal thoughts and behaviors.
Qelbree Warnings/Precautions
Warnings/Precautions
Increased risk of suicidal thoughts and behavior; monitor closely for clinical worsening and unusual behaviors (esp. during the first few months, at times of dosage changes). Screen for history of suicide, bipolar disorder, and depression prior to initiation. Assess HR and BP prior to initiation, after dose increases, and periodically during therapy. Monitor for weight changes. Reevaluate periodically. Severe renal impairment (eGFR <30mL/min/1.73m2): reduce dose. Hepatic impairment: not recommended. Pregnancy. Nursing mothers.
Qelbree Pharmacokinetics
See Literature
Qelbree Interactions
Interactions
See Contraindications. Potentiates moderate sensitive CYP1A2 substrates (eg, clozapine, pirfenidone): not recommended. Potentiates CYP2D6 substrates (eg, atomoxetine, desipramine, dextromethorphan, nortriptyline, metoprolol, nebivolol, perphenazine, tolterodine, venlafaxine, risperidone) and CYP3A4 substrates (eg, alfentanil, avanafil, buspirone, conivaptan, darifenacin, darunavir, ebastine, everolimus, ibrutinib, lomitapide, lovastatin, midazolam, naloxegol, nisoldipine, saquinavir, simvastatin, sirolimus, tacrolimus, tipranavir, triazolam, vardenafil, lurasidone); monitor and adjust dose of substrates as clinically indicated.
Qelbree Adverse Reactions
Adverse Reactions
Somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, irritability, dry mouth, constipation; mania/hypomania.
Qelbree Clinical Trials
See Literature
Qelbree Note
Not Applicable
Qelbree Patient Counseling
See Literature
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