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Viloxazine Hydrochloride

Also known as: Qelbree

Route: Oral

Check Viloxazine Hydrochloride Interactions →

3 interactions on record⛔ Black Box Warning

Viloxazine Hydrochloride has 3 known drug interactions based on U.S. FDA drug labeling data. Of these, 2 are contraindicated combinations that should be avoided entirely. Notable interactions include combinations with Monoamine Oxidase Inhibitors (Maois), Sensitive Cyp3a Substrates With Narrow Therapeutic Index, Sensitive Cyp3a Substrates. Patients taking Viloxazine Hydrochloride should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 3
Contraindicated: 2
Moderate: 1

Contraindicated (2)

Viloxazine Hydrochloride + Monoamine Oxidase Inhibitors (Maois)— Concomitant use may lead to potentially life-threatening hypertensive crisis. Concomitant use or use within 2 weeks afte…
Viloxazine Hydrochloride + Sensitive Cyp3a Substrates With Narrow Therapeutic Index— Viloxazine is a strong CYP1A2 inhibitor that significantly increases total exposure of these substrates, increasing risk…

Moderate (1)

Viloxazine Hydrochloride + Sensitive Cyp3a Substrates— Viloxazine significantly increases total exposure of these substrates, which may increase adverse reaction risk. Not rec…

Viloxazine Hydrochloride + Monoamine Oxidase Inhibitors (Maois)⛔Contraindicated

Concomitant use may lead to potentially life-threatening hypertensive crisis. Concomitant use or use within 2 weeks after discontinuing an MAOI is contraindicated.

Viloxazine Hydrochloride + Sensitive Cyp3a Substrates With Narrow Therapeutic Index⛔Contraindicated

Viloxazine is a strong CYP1A2 inhibitor that significantly increases total exposure of these substrates, increasing risk of adverse reactions. Coadministration is contraindicated.

Viloxazine Hydrochloride + Sensitive Cyp3a Substrates🟡Moderate

Viloxazine significantly increases total exposure of these substrates, which may increase adverse reaction risk. Not recommended for coadministration; dose reduction may be warranted if coadministered.

⛔ FDA Black Box Warning

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS In clinical studies, higher rates of suicidal thoughts and behavior were reported in patients with ADHD treated with Qelbree than in patients treated with placebo . Closely monitor all Qelbree-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. In clinical trials, higher rates of suicidal thoughts and behavior were reported in patients treated with Qelbree than in patients treated with placebo. Closely monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 ).

Contraindications

4 CONTRAINDICATIONS Qelbree is contraindicated in patients: receiving concomitant treatment with monoamine oxidase inhibitors (MAOI), or within 14 days following discontinuing an MAOI, because of an increased risk of hypertensive crisis [see Drug Interactions (7.1) ] . receiving concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range [see Drug Interactions (7.1) ]. Concomitant administration of monoamine oxidase inhibitors (MAOI), or dosing within 14 days after discontinuing an MAOI ( 4 , 7.1 ) Concomitant administration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range ( 4 , 7.1 )

Pregnancy & Breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed Qelbree during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at www.womensmentalhealth.org/preg. Risk Summary Based on findings from animal reproduction studies, viloxazine may cause maternal harm when used during pregnancy. Discontinue Qelbree when pregnancy is recognized unless the benefits of therapy outweigh the potential risk to the mother. Available data from case series with viloxazine use in pregnant women are insufficient to determine a drug-associated risk of major birth defects, miscarriage or adverse maternal outcomes. In animal reproduction studies, oral administration of viloxazine during the period of organogenesis caused fetal toxicities and delayed fetal development in the rat and maternal toxicities in the rabbit at doses approximately equal to the maximum recommended human dose (MRHD) of 600 mg in adults, based on mg/m 2 .Oral administration of viloxazine to pregnant rats and mice during pregnancy and lactation caused maternal toxicities and deaths and fetal toxicities at doses equal to or less than the MRHD of 600 mg in adults, based on mg/m 2 , respectively (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Viloxazine was administered orally to pregnant rats during the period of organogenesis at doses of 13, 33, and 82 mg/kg/day. The high dose is approximately equal to the MRHD of 600 mg in adults, based on mg/m 2 . Viloxazine did not cause

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine, supplemented with a small number of well-established interactions from curated clinical references. For informational purposes only. Always consult your pharmacist or physician.