viloxazine

Absorption: 88% absorbed following oral administration.

Distribution: Unknown.

Metabolism/Excretion: Primarily metabolized in the liver via the CYP2D6 isoenzyme as well as UGT1A9 and UGT2B15. Primarily excreted in the urine (90%), with less than 1% excreted in the feces.

Half-Life: 7 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	3–9 hr	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Concurrent or within 2 wk of therapy with monoamine oxidase (MAO) inhibitors;
Concurrent use of sensitive CYP1A2 substrates.
OB: Pregnancy.

Use Cautiously in:

Personal or family history of bipolar disorder, suicide, or depression;
Severe renal impairment (↓ dose);
Lactation: Safety not established in breastfeeding;
Pedi: Children <6 yr (safety and effectiveness not established).

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypertension, tachycardia

GI: dry mouth, nausea, abdominal pain, constipation, gastroesophageal reflux disease, vomiting

Metab: ↓appetite

Neuro: fatigue, headache, insomnia, sedation, dizziness, irritability, mania, SUICIDAL THOUGHTS/BEHAVIORS

Resp: upper respiratory tract infection

Misc: fever

Interactions ⬆ ⬇

Drug-drug:

Concurrent use with MAO inhibitors may result in hypertensive crisis; concurrent use of or within 2 wk of each other contraindicated.
May ↑ levels and risk of toxicity of sensitive CYP1A2 substrates; concurrent use contraindicated.
May ↑ levels and risk of toxicity of CYP2D6 substrates; monitor closely.
May ↑ levels and risk of toxicity of CYP3A4 substrates; monitor closely.

Route/Dosage ⬆ ⬇

PO (Adults ): 200 mg once daily; may ↑ by 200 mg on weekly basis based on clinical response and tolerability (max dose = 600 mg once daily).
PO (Children 12–17 yr): 200 mg once daily; may ↑ to 400 mg once daily after one wk based on clinical response and tolerability (max dose = 400 mg once daily).
PO (Children 6–11 yr): 100 mg once daily; may ↑ by 100 mg on weekly basis based on clinical response and tolerability (max dose = 400 mg once daily).

Renal Impairment

(Adults and Children ≥6 yr): Severe renal impairment (eGFR <30 mL/min/m²): 100 mg once daily; may ↑ by 50–100 mg on weekly basis based on clinical response and tolerability (max dose = 200 mg once daily).

Availability ⬆ ⬇

Extended-release capsules: 100 mg; 150 mg; 200 mg

Assessment ⬆ ⬇

Assess BP and HR before starting therapy, periodically, and following any ↑ in dosage. May ↑ diastolic BP and HR.
Assess baseline behaviors, attention span, and hyperactivity levels. Monitor throughout therapy.
Monitor for somnolence, fatigue, ↓ appetite, nausea, vomiting, and irritability.
Before starting therapy, screen patients to determine if they are at risk for bipolar disorder; such screenings should include a detailed psychiatric history, including a personal or family history of suicide, bipolar disorder, and depression. May induce a manic or mixed episode in patients with bipolar disorder.
Monitor for suicidal thoughts and/or behaviors (depression, anxiety, ↑ agitation, aggression), especially during the initial wks and few mo of therapy, and at times of dosage changes.

Lab Test Considerations:

Monitor baseline ALT, AST, bilirubin, BUN, serum creatinine, eGFR, and CBC.

Implementation ⬆ ⬇

PO: Administer with or without food. DNC: Do not cut, crush, or chew capsules. Capsules may be opened. Sprinkle the entire contents over a teaspoonful or tablespoonful of pudding or applesauce. Consume the food mixture in its entirety, without chewing, within 15 min for pudding or within 2 hr for applesauce; do not store for future use.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy. Take as directed. Do not stop abruptly without consulting a health care professional.
Advise patient to notify health care professional of all Rx or OTC medications, including MAOIs, CNS depressants, vitamins, or herbal products, being taken and to consult health care professional before taking other medications. Caution patients about the concurrent use of viloxazine and MAOIs or within 14 days after discontinuing an MAOI, because of an ↑ risk of hypertensive crisis.
Advise patient and caregivers to monitor for mania/hypomania and for the emergence of suicidal ideation or behavior and to report any symptoms immediately to health care professional.
Advise patient of the risk for somnolence and fatigue. Advise not to perform activities requiring mental alertness until response to medication is known.
Advise patient and caregivers that weight should be monitored.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed Qelbree during pregnancy. Health care providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or online at www.womensmentalhealth.org/preg.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇