Qelbree

(viloxazine) 

 

 

 

 Full Prescribing Information 

 DailyMed Drug Information 

 

 

 

 

 Forms/Strengths 

 

  Capsules: 100 mg, 150 mg, 200 mg 

 

 

 Dosing 

 

 Age: ≥ 6 y/o 

 Duration: ~ 24 hours 

 Considerations: Bubblegum-flavored; may be taken with or without food. Shake bottle before administering. Store at room temperature. 

 Initial Dose: 

 

 6-11 y/o: 100 mg once daily 

 12+ y/o: 200 mg once daily 

 

 

 Titration: 

 

 6-11 y/o: 100 mg weekly 

 12+ y/o: 200 mg weekly 

 

 

 Max Dose: 

 

 6-17 y/o: 400 mg daily 

 17+ y/o: 600 mg daily 

 

 

 

 

 Quick Facts 

 

 Non-stimulant; modulates norepinephrine (and possibly serotonin) to improve ADHD symptoms 

 Enhances focus, attention, and impulse control 

 Extended-release capsule for once-daily dosing 

 Unique alternative for patients intolerant of stimulants 

 Common side effects: decreased appetite, somnolence, fatigue, gastrointestinal discomfort, irritability 

 

 

 Indications 

 

   ADHD (ICD-10: F90.0) 

 

 

 Off-Label Uses 

 

  N/A 

 

 

 How to Take 

 

 Take once daily at the same time each day. 

 Can be taken with or without food . 

 Swallow the capsule whole ; do not crush, chew, or open. 

 If a dose is missed , take it as soon as possible unless it is close to the next dose—do not double up. 

 Do not abruptly stop taking; consult a healthcare provider before discontinuation. 

 

 

 Side Effects 

 

 Common: Somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, irritability 

 Serious: Suicidal thoughts and behaviors, blood pressure and heart rate increases, activation of mania or hypomania 

 

 

 Monitoring / Labs 

 

 Cardiovascular : Baseline and routine monitoring of heart rate and blood pressure. 

 Growth in Pediatrics : Regular monitoring of height and weight to detect growth suppression. 

 Psychiatric Symptoms : Observe for mood changes, anxiety, or psychosis. 

 Abuse Potential : Monitor for misuse or diversion. 

 

 

 Education 

 

 

 When to Call the Doctor: 

 

 Severe mood changes, aggression, or suicidal thoughts . 

 Symptoms of serotonin syndrome (e.g., rapid heart rate, hallucinations, severe agitation, muscle rigidity, fever). 

 Unusual bruising or bleeding. 

 Signs of liver dysfunction (e.g., yellowing of the skin/eyes, dark urine, persistent nausea). 

 Excessive drowsiness, fainting, or difficulty waking. 

 

 

 

 Safety Tips: 

 

 Monitor blood pressure and heart rate , as Qelbree may cause changes in vital signs. 

 Use caution in patients with history of depression, bipolar disorder, or suicidal thoughts . 

 Avoid alcohol and sedatives , as they may increase drowsiness. 

 Be cautious when driving or operating heavy machinery until the effects of the medication are known. 

 Tapering may be needed if discontinuing after long-term use. 

 

 

 

 Parent Tips for Pediatric Patients: 

 

 Monitor for behavioral changes, increased agitation, or suicidal thoughts , particularly in the first few weeks. 

 May cause drowsiness or fatigue —observe how the child responds to the medication. 

 Encourage hydration and balanced meals to minimize side effects. 

 If taken for ADHD , track progress with teachers and caregivers to assess effectiveness. 

 

 

 

 

 Additional Information 

 

 

 Contraindications: 

 

 Hypersensitivity to viloxazine or formulation components. 

 Use within 14 days of MAOI therapy (risk of hypertensive crisis). 

 

 

 

 Pregnancy: 

 

 Category Not Assigned ; safety in pregnancy has not been fully established. 

 Use only if the benefits outweigh the potential risks. 

 

 

 

 Lactation: 

 

 Unknown if excreted in breast milk ; use with caution. 

 

 

 

 Drug Interactions: 

 

 CYP1A2 and CYP2D6 inhibitors (e.g., fluvoxamine, paroxetine) may increase viloxazine levels. 

 Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs, St. John’s Wort) increase serotonin syndrome risk . 

 CYP3A4 inducers (e.g., rifampin, carbamazepine) may reduce efficacy. 

 May increase the effects of blood pressure medications , leading to hypotension.