Qelbree (viloxazine) Prescribing Information
Qelbree, with the active ingredient viloxazine, is a medication prescribed for the treatment of attention-deficit/hyperactivity disorder (ADHD) in pediatric patients aged 6 to 17 years [1]. It is available in capsule form [1].
What is the active ingredient in Qelbree?
The active ingredient in Qelbree is viloxazine [1].
How does Qelbree work for ADHD?
The exact mechanism of action for viloxazine in treating ADHD is not fully understood [1]. However, it is believed to modulate the activity of norepinephrine [1]. Viloxazine is a selective norepinephrine reuptake inhibitor (SNRI) [1].
What doses of Qelbree are available?
Qelbree is available in various strengths of capsules, including 100 mg, 150 mg, and 200 mg [1]. The dosage is determined by a healthcare professional based on the patient's age and response [1].
What are the common side effects of Qelbree?
Common side effects reported in clinical trials for Qelbree include decreased appetite, insomnia, nausea, vomiting, fatigue, and somnolence [1]. It is important to discuss any side effects with a doctor [1].
Are there any black box warnings for Qelbree?
Qelbree carries a black box warning regarding the risk of suicidal thoughts and behaviors in children and adolescents [1]. Patients starting treatment with Qelbree should be closely monitored for any changes in mood or behavior [1].
What is the recommended dosing for Qelbree?
The recommended starting dosage for Qelbree is 100 mg once daily [1]. The dosage can be titrated up to 200 mg once daily over a period of at least one week [1]. Dosing adjustments may be necessary based on tolerability and efficacy [1].
Can Qelbree be used with other ADHD medications?
The use of Qelbree with other ADHD medications has not been extensively studied [1]. Co-administration with strong CYP1A2 inhibitors is not recommended, as this can increase viloxazine exposure [1].
What are the drug interactions with Qelbree?
Qelbree can interact with certain medications. It is a moderate inhibitor of CYP1A2, and strong inhibitors of this enzyme should be avoided [1]. Additionally, Qelbree should not be used with monoamine oxidase inhibitors (MAOIs) or within 14 days of stopping an MAOI due to the risk of hypertensive crisis [1].
When is Qelbree expected to lose patent protection?
Information regarding patent expiry for Qelbree can be found on DrugPatentWatch.com [2]. Patent protection is crucial for pharmaceutical companies, as it allows them to recoup research and development costs [2].
Where can I find the full FDA prescribing information for Qelbree?
The complete FDA prescribing information for Qelbree is available from the U.S. Food and Drug Administration (FDA) and is typically included with the medication packaging [1].
What are the clinical trials that led to Qelbree's approval?
The approval of Qelbree was based on data from clinical trials evaluating its efficacy and safety in pediatric patients with ADHD [1]. These trials assessed various outcome measures related to ADHD symptoms [1].
Sources:
[1] https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215413s000lbl.pdf
[2] https://drugpatentwatch.com/