Dosing & Uses
Dosage Forms & Strengths
capsule, extended-release
- 100mg
- 150mg
- 200mg
Attention Deficit Hyperactivity Disorder
Indicated for attention deficit hyperactivity disorder (ADHD)
Initial: 200 mg PO qDay
After 1 week, may increase in weekly 200-mg increments; not to exceed 600 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
- No dosage adjustments are recommended in manufacturer's labeling
Dosing Considerations
Monitoring parameters
-
Before initiating
- 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
Dosage Forms & Strengths
capsule, extended-release
- 100mg
- 150mg
- 200mg
Attention Deficit Hyperactivity Disorder
Indicated for attention deficit hyperactivity disorder (ADHD) in patients aged ≥6 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
- No dosage adjustments recommended in manufacturer's labeling
Dosing Considerations
Monitoring parameters
-
Before initiating
- 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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- fezolinetant
viloxazine will increase the level or effect of fezolinetant by affecting hepatic enzyme CYP1A2 metabolism. Contraindicated. Fezolinetant AUC and peak plasma concentration are increased if coadministered with drugs that are weak, moderate, or strong CYP1A2 inhibitors
Serious - Use Alternative (1)
- melatonin
viloxazine will increase the level or effect of melatonin by affecting hepatic enzyme CYP1A2 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of melatonin with strong CYP1A2 inhibitors
Monitor Closely (3)
- atogepant
viloxazine will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- finerenone
viloxazine will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.
- isavuconazonium sulfate
viloxazine will increase the level or effect of isavuconazonium sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
Minor (0)
Adverse Effects
* Incidence for placebo was lower than viloxazine
>10%
Children aged 6-17 years
- Somnolence (12-19%)*
- Headache (10-11%)*
Adults
- Insomnia (23%)*
- Headache (17%)*
- Nausea (12%)*
- Fatigue (12%)*
1-10%
Children aged 6-17 years
- 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%)*
Adults
- Dry mouth (10%)*
- Decreased appetite (10%)*
- Somnolence (6%)*
- Constipation (6%)*
- Vomiting (4%)*
- Irritability (4%)*
- Dizziness (4%)*
- Tachycardia (4%)*
- Gastroesophageal reflux disease (2%)*
Warnings
Black Box Warnings
Suicidal thoughts and behaviors
- Higher rates of suicidal thoughts and behavior reported in viloxazine-treated patients compared with placebo
- Closely monitor all 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
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
- In animal reproduction studies, oral administration 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 maximum recommended human dose (MRHD) of 600 mg in adults, based on mg/m2
- Oral administration to pregnant rats and mice during pregnancy and lactation caused maternal toxicities and deaths and fetal toxicities at doses equal to or < MRHD of 600 mg in adults, based on mg/m2, respectively
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.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%)
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 pudding or applesauce
- Consume sprinkled applesauce in its entirety, without chewing, within 15 minutes for pudding, or 2 hr for applesauce; do not store for future use
Storage
Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
Images
Formulary
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