Is Viloxazine approved by the FDA?

Viloxazine, marketed under the brand name Qelbree, is an oral medication used to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 to 17 years. Viloxazine (Qelbree) was approved by the U.S. Food and Drug Administration (FDA) on April 2, 2021. This approval marked the introduction of a novel treatment option for pediatric ADHD, providing an alternative to traditional stimulant medications.

Mechanism of Action

Viloxazine works by inhibiting the reuptake of norepinephrine, a neurotransmitter, thereby increasing its levels in the brain. This action helps improve attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Usage and Administration

Dosage Form: Viloxazine is available as an extended-release oral capsule in three strengths: 100 mg, 150 mg, and 200 mg.

Dosage Instructions:

• Children (6 to 11 years): The initial dose is 100 mg once daily, which may be increased weekly by 100 mg based on response and tolerability, up to a maximum of 400 mg per day.
• Adolescents (12 to 17 years): The initial dose is 200 mg once daily, which may be increased to 400 mg after one week based on response and tolerability.

Administration:

• Viloxazine can be taken with or without food.
• The capsule should be swallowed whole; if the patient cannot swallow it, the capsule can be opened, and the contents mixed with applesauce. The mixture should be swallowed immediately without chewing.
• Regular monitoring of heart rate and blood pressure is recommended during treatment.

Side Effects and Warnings

Common Side Effects:

• Drowsiness
• Fatigue
• Irritability
• Insomnia
• Nausea
• Vomiting
• Loss of appetite

Serious Side Effects:

• Mood or behavior changes, including anxiety, panic attacks, and suicidal thoughts
• Symptoms of a manic episode, such as racing thoughts, increased energy, and risk-taking behavior
• Weight loss or failure to gain weight in children

Warnings:

• Some patients may experience suicidal thoughts while taking viloxazine. It is important to monitor for changes in mood or symptoms and report any new or worsening symptoms to a doctor.
• Viloxazine should not be used with MAO inhibitors or within 14 days of stopping an MAO inhibitor due to the risk of serious drug interactions.
• Inform your doctor if you have a history of depression, bipolar disorder, psychosis, heart problems, high blood pressure, liver disease, or severe kidney disease.
• Viloxazine may be harmful during pregnancy. Pregnant women should consult their doctor immediately.

Conclusion

With its unique mechanism of action and extended-release formulation, viloxazine provides an alternative to traditional ADHD medications, helping to manage symptoms and improve the quality of life for young patients.

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