# Qelbree ### (viloxazine)
[**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=aedf408d-0f84-418d-9416-7c39ddb0d29a&type=display)[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=aedf408d-0f84-418d-9416-7c39ddb0d29a)
--- **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.