viloxazine (Rx)

Brand and Other Names:Qelbree
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Dosing & Uses

AdultPediatric

See pediatric dosing

Dosage Forms & Strengths

capsule, extended-release

  • 100mg
  • 150mg
  • 200mg

Attention Deficit Hyperactivity Disorder

Indicated for attention deficit hyperactivity disorder (ADHD) in patients aged 6-17 years

<6 years: Safety and efficacy not established

6-11 years

  • Initial: 100 mg PO qDay
  • May increase in weekly 100-mg increments; not to exceed 400 mg/day, depending on response and tolerability

12-17 years

  • Initial: 200 mg PO qDay
  • After 1 week, may increase in weekly 200-mg increments; not to exceed 400 mg/day, depending on response and tolerability

ADHD may require pharmacological treatment for extended periods; periodically reevaluate long-term use and adjust dosage as needed

Dosage Modifications

Renal impairment

  • Mild-to-moderate (eGFR 30-89 mL/min/1.73m2): No dosage adjustment necessary
  • Severe (eGFR <30 mL/min/1.73m2): 100 mg qDay initially; may increase in weekly increments of 50-100 mg/day; not to exceed 200 mg/day

Hepatic impairment

  • Not recommended
  • Effects of hepatic impairment on pharmacokinetics of viloxazine are unknown

Dosing Considerations

Monitoring parameters

  • Prior to initiation
    • Heart rate (HR), blood pressure (BP)
    • Screen for a personal or family history of suicide, bipolar disorder, and depression
  • During therapy
    • HR, BP: Periodically and following increases in dosage
    • Clinical worsening and emergence of suicidal thoughts and behaviors: During therapy (especially during initial few months) and after dosage adjustments
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Interactions

Interaction Checker

and viloxazine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
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            Adverse Effects

            * Incidence for placebo was lower than viloxazine

            >10%

            Somnolence (12-19%)*

            Headache (10-11%)*

            1-10%

            Fatigue (4-9%)*

            Decreased appetite (5-8%)*

            Upper respiratory tract infections (5-8%)

            Abdominal pain (3-7%)

            Nausea (1-7%)

            Vomiting (3-6%)*

            Insomnia (2-5%)*

            Irritability (2-5%)*

            Pyrexia (1-3%)*

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            Warnings

            Black Box Warnings

            Suicidal thoughts and behaviors

            • Higher rates of suicidal thoughts and behavior were reported compared with placebo
            • Closely monitor all viloxazine-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors

            Contraindications

            Coadministration with monoamine oxidase inhibitors (MAOIs), or within 14 days following discontinuing an MAOI

            Coadministration of sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range

            Cautions

            May increase HR and diastolic BP

            Noradrenergic drugs, such as viloxazine, may induce mania or mixed episode in patients with bipolar disorder

            Somnolence and fatigue may occur; performing activities requiring mental alertness (eg, operating a motor vehicle, hazardous machinery) are not recommended

            Suicidal thoughts and ideation

            • Suicidal thoughts and behavior were reported
            • Causal link between emerging symptoms (eg, irritability, insomnia, depressed mood, anxiety, agitation, akathisia, mania, hypomania, panic attacks, impulsive behavior, aggression) and emergence of suicidal impulses not established
            • Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors, especially during initial few months of therapy and after dosage adjustments
            • Consider discontinuing or adjusting therapy in patients who are experiencing emergent suicidal thoughts and behaviors or symptoms, especially if symptoms are severe or abrupt in onset, or were not part of patient’s presenting symptoms
            • Consult family members or caregivers to monitor for emergence of suicidal ideation or behavior, and report such symptoms immediately to healthcare provider

            Drug interaction overview

            • Strong CYP1A2 inhibitor; weak CY2D6 and CYP3A4 inhibitor
            • MAOIs
              • Contraindicated with MAOIs and within 2 weeks after discontinuing an MAOI
              • Coadministration with an MAOI may lead to potentially life-threatening hypertensive crisis
            • CYP1A2 substrates
              • Sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range: Contraindicated
              • Moderately sensitive CYP1A2: Not recommended; dosage reduction recommended if coadministered
              • Viloxazine may significantly increase total exposure and risk of toxicities of these CYP1A2 substrates
            • CYP2D6 substrates
              • Viloxazine may increase exposure of CYP2D6 substrates
              • Monitor for adverse reactions and adjust dosages of substrates, as clinically indicated
            • CYP3A4 substrates
              • Viloxazine may increase exposure of CYP3A4 substrates
              • Monitor for adverse reactions and adjust dosages of substrates, as clinically indicated
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            Pregnancy & Lactation

            Pregnancy

            Based on findings from animal reproduction studies, maternal harm may occur when used during pregnancy

            Discontinue when pregnancy is recognized unless benefits of therapy outweigh potential risks to mother

            Insufficient data are available on use in pregnant females to determine a drug-associated risk of major birth defects, miscarriage, or adverse maternal outcomes

            Pregnancy registry

            • Registry monitors pregnancy outcomes in treated or exposed females
            • Encourage patients to register by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at www.womensmentalhealth.org/preg

            Animal data

            • Oral administration to pregnant rats and rabbits during organogenesis did not cause significant maternal toxicity but caused fetal toxicities and delayed fetal development in rats at doses up to 2x the maximum recommended human dose (MRHD) of 400 mg, based on mg/m2
            • In rabbits, viloxazine caused maternal toxicity without significant fetal toxicity at doses ≥7x the MRHD based on mg/m2
            • Oral administration to pregnant rats and mice during pregnancy and lactation caused maternal toxicities and deaths at doses ~2x and 1x the MRHD, respectively, based on mg/m2; these maternally toxic doses caused offspring toxicities

            Lactation

            There are no data on presence in human milk, effects on breastfed infants, or effects on milk production

            Viloxazine is likely present in rat milk; when present in animal milk, drug is likely present in human milk

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Mechanism by which viloxazine affects ADHD is unclear; however, it may be by selectively inhibiting norepinephrine reuptake

            Absorption

            Steady-state reached after 2 days

            No accumulation observed

            Peak plasma time: ~5 hr

            Bioavailability: 88%

            Effect of food

            • High-fat meal (800-1000 calories)
              • Decreased peak plasma concentration and AUC by about 9% and 8%, respectively
              • Peak plasma time increased by about 2 hr
            • Sprinkling contents of a capsule on applesauce
              • Decreased peak plasma concentration and AUC by about 10% and 5%, respectively

            Distribution

            Protein bound: 76-82%

            Metabolism

            Metabolized by CYP2D6, UGT1A9, and UGT2B15

            Major metabolite detected in plasma: 5-hydroxy-viloxazine glucuronide

            Elimination

            Half-life: 7.02 hr

            Excretion: Urine (90%), feces (<1%)

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            Administration

            Oral Administration

            Take with or without food

            Swallow capsule whole; do not cut, chew, or crush

            Unable to swallow capsule

            • Open capsule and sprinkle entire contents over teaspoonful of applesauce
            • Consume sprinkled applesauce in its entirety, without chewing, within 2 hr; do not store for future use

            Storag

            Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.