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
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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.
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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.
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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
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Contraindications:
- Hypersensitivity to viloxazine or formulation components.
- Use within 14 days of MAOI therapy (risk of hypertensive crisis).
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Pregnancy:
- Category Not Assigned; safety in pregnancy has not been fully established.
- Use only if the benefits outweigh the potential risks.
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Lactation:
- Unknown if excreted in breast milk; use with caution.
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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.