vilazodone

ROUTE	ONSET	PEAK	DURATION
PO	unknown	4–5 hr	unknown

Contraindicated in:

Concurrent use of MAO inhibitors or MAO inhibitor-like drugs (linezolid or methylene blue).

Use Cautiously in:

History of seizure disorder;
History of suicide attempt/suicidal ideation;
Bipolar disorder (may ↑ risk of mania/hypomania);
Angle-closure glaucoma;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children; risk of suicidal thinking/behavior in children, adolescents, and young adults;
Geri: Appears on Beers list. May worsen or cause syndrome of inappropriate antidiuretic hormone (SIADH) secretion and/or hyponatremia in older adults. Use with caution in older adults and closely monitor sodium concentrations when starting therapy or dose.

Adv. Reactions/Side Effects ⬆ ⬇

Endo: SIADH

F and E: hyponatremia

GI: diarrhea, nausea, dry mouth, PANCREATITIS, vomiting

GU: ↓libido, delayed/absent orgasm, ejaculatory delay/failure, erectile dysfunction

Hemat: BLEEDING

Neuro: insomnia, abnormal dreams, dizziness, NEUROLEPTIC MALIGNANT-LIKE SYNDROME, restlessness, SEIZURES, sleep paralysis, SUICIDAL THOUGHTS

Misc: SEROTONIN SYNDROME

Interactions ⬆ ⬇

Drug-drug:

Concurrent use with, or use within 14 days of starting or stopping, MAO inhibitors may ↑ risk of neuroleptic malignant syndrome or serotonin syndrome and should be avoided.
Concurrent use with MAO-inhibitor like drugs, such as linezolid or methylene blue, may ↑ risk of serotonin syndrome; concurrent use contraindicated; do not start therapy in patients receiving linezolid or methylene blue; if linezolid or methylene blue need to be started in a patient receiving vilazodone, immediately discontinue vilazodone and monitor for signs/symptoms of serotonin syndrome for 2 wk or until 24 hr after last dose of linezolid or methylene blue, whichever comes first (may resume vilazodone therapy 24 hr after last dose of linezolid or methylene blue)
Drugs that affect serotonergic neurotransmitter systems, including tricyclic antidepressants, SNRIs, fentanyl, lithium, buspirone, tramadol, meperidine, methadone, amphetamines, and triptans, ↑ risk of serotonin syndrome.
↑risk of bleeding with NSAIDs, aspirin, clopidogrel, prasugrel, ticagrelor, dabigatran, apixaban, edoxaban, rivaroxaban, or warfarin.
Strong CYP3A4 inhibitors, including ketoconazole, may ↑ levels and the risk of toxicity.
Moderate CYP3A4 inhibitors, including erythromycin, may ↑ levels and the risk of toxicity; ↓ dose to 20 mg daily if toxicity occurs.
Strong CYP3A4 inducers, including carbamazepine, may ↓ levels and effectiveness.

Drug-Natural Products:

↑risk of serotonin syndrome with St. John’s wort.

Route/Dosage ⬆ ⬇

PO (Adults ): 10 mg once daily for one wk, then 20 mg once daily for one wk; dose may be ↑ to 40 mg once daily (recommended dose = 20–40 mg/day). Concurrent use of strong CYP3A4 inhibitors: not to exceed 20 mg/day; Concurrent use of strong CYP3A4 inducers (if used for >14 days): may need to ↑ dose up to 2-fold (daily dose should not exceed 80 mg).

Availability ⬆ ⬇

(Generic available)

Tablets: 10 mg; 20 mg; 40 mg

Assessment ⬆ ⬇

Assess mental status and mood changes. Inform health care professional if patient demonstrates significant ↑ in anxiety, nervousness, or insomnia.
Prior to starting therapy, screen patient for bipolar disorder (detailed psychiatric history, including family/personal history of suicide, bipolar disorder, depression). Use cautiously in patients with a positive history.
Assess suicidal tendencies, especially in early therapy. Restrict amount of drug available to patient. Risk may be ↑ in children, adolescents, and adults ≤24 yr.
Assess for signs and symptoms of hyponatremia (headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness). May require discontinuation of therapy.
Assess for serotonin syndrome (mental changes [agitation, hallucinations, coma], autonomic instability [tachycardia, labile BP, hyperthermia], neuromuscular aberrations [hyper-reflexia, incoordination], and/or GI symptoms [nausea, vomiting, diarrhea]), especially in patients taking other serotonergic drugs (SSRIs, SNRIs, triptans).
Monitor for development of neuroleptic malignant syndrome (fever, muscle rigidity, altered mental status, respiratory distress, tachycardia, seizures, diaphoresis, hypertension or hypotension, pallor, tiredness, loss of bladder control). Discontinue vilazodone and notify health care professional immediately if these symptoms occur.
Assess sexual function before starting vilazodone. Assess for changes in sexual function during treatment, including timing of onset; patient may not report.

Lab Test Considerations:

Monitor serum sodium concentrations periodically during therapy. May cause hyponatremia potentially as a result of SIADH.
- May cause altered anticoagulant effects. Monitor patients receiving warfarin, NSAIDs, or aspirin concurrently.

Implementation ⬆ ⬇

PO: Administer vilazodone with food; administration without food can result in inadequate drug concentrations and may ↓ effectiveness.
- When discontinuing therapy, decrease dose gradually; 40 mg once daily to 20 mg once daily for 4 days, followed by 10 mg once daily for 3 days. Taper patients taking 20 mg once daily dose to 10 mg once daily for 7 days. Stopping abruptly may cause flu-like symptoms (headache, sweating, and nausea), anxiety, high or low mood, irritability, feeling restless or sleepy, dizziness, electric shock-like sensations, tremor, and confusion.

Patient/Family Teaching ⬆ ⬇

Instruct patient to take vilazodone as directed at the same time each day. Take missed doses as soon as possible unless almost time for next dose. Do not double doses or discontinue abruptly. Gradually ↓ dose before discontinuation. Advise patient to read Medication Guide before starting therapy and with each Rx refill; new information may be available.
Advise patient, family, and caregivers to look for activation of mania/hypomania and suicidality, especially during early therapy or dose changes. Notify health care professional immediately if thoughts about suicide or dying, attempts to commit suicide; new or worse depression or anxiety; agitation or restlessness; panic attacks; insomnia; new or worse irritability; aggressiveness; acting on dangerous impulses, mania, or other changes in mood or behavior or if symptoms of serotonin syndrome occur.
Caution patient of the risk of serotonin syndrome and neuroleptic malignant syndrome, especially when taking triptans, tramadol, tryptophan supplements, and other serotonergic or antipsychotic agents.
May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to the drug is known.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of Rx, OTC, and herbal products, especially NSAIDs, aspirin, and warfarin, without consulting health care professional.
Caution patient to avoid taking alcohol or other CNS-depressant drugs, including opioids, during therapy.
Inform patient that vilazodone may cause symptoms of sexual dysfunction. In males, ejaculatory delay or failure, decreased libido, and erectile dysfunction may occur. In female patients, may result in decreased libido and delayed or absent orgasm. Advise patient to notify health care professional if symptoms occur.
Rep: Advise females of reproductive potential to notify health care professional immediately if pregnancy is planned or suspected or if breastfeeding. Use during last month of pregnancy increases risk of postpartum hemorrhage. If used during pregnancy, should be tapered during 3rd trimester to avoid neonatal serotonin syndrome. Monitor infants exposed to vilazodone for excess sedation, restlessness, agitation, poor feeding, poor weight gain, respiratory distress; may risk of persistent pulmonary hypertension of the newborn. Inform patient of pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.
Emphasize the importance of follow-up exams to monitor progress. Encourage patient participation in psychotherapy.

Evaluation/Desired Outcomes ⬆ ⬇

↑sense of well-being.
- Renewed interest in surroundings. Need for therapy should be periodically reassessed. Therapy is usually continued for several mo.
↓anxiety.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

0456- Allergan, Inc.
- 0456-1100- VIIBRYD
  - 0456-1100-31- 1 KIT in 1 BLISTER PACK (0456-1100-31)

0456- Allergan, Inc.
- 0456-1101- VIIBRYD
  - 0456-1101-30- 1 KIT in 1 BLISTER PACK (0456-1101-30)

0456- Allergan, Inc.
- 0456-1110- VIIBRYD
  - 0456-1110-30- 30 TABLET in 1 BOTTLE (0456-1110-30)

0456- Allergan, Inc.
- 0456-1120- VIIBRYD
  - 0456-1120-30- 30 TABLET in 1 BOTTLE (0456-1120-30)

0456- Allergan, Inc.
- 0456-1140- VIIBRYD
  - 0456-1140-30- 30 TABLET in 1 BOTTLE (0456-1140-30)

55154- Cardinal Health
- 55154-4624- VIIBRYD
  - 55154-4624-2- 960 TABLET in 1 BOTTLE, PLASTIC (55154-4624-2)

55154- Cardinal Health
- 55154-4627- VIIBRYD
  - 55154-4627-8- 2520 TABLET in 1 BOTTLE, PLASTIC (55154-4627-8)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇