vilazodone

vilazodone

(vil-az-oh-done) ,

Viibryd

(trade name)

Classification

Therapeutic: antidepressants
Pharmacologic: selective serotonin reuptake inhibitors ssris
Pregnancy Category: C

Indications

Treatment of major depressive disorder.

Action

Increases serotonin activity in the CNS by inhibiting serotonin reuptake. Also binds selectively with high affinity to 5-HT1A receptors and is a 5-HT1A receptor partial agonist.

Therapeutic effects

Improvement in symptoms of depression.

Pharmacokinetics

Absorption: 72% absorbed following oral administration with food.
Distribution: Unknown.
Protein Binding: 96–99%.
Metabolism and Excretion: Mostly metabolized by the liver, primarily by the CYP3A4 enzyme system; 1% excreted unchanged in urine.
Half-life: 25 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
POunknown4–5 hrunknown

Contraindications/Precautions

Contraindicated in: Concurrent use of MAO inhibitors or MAO-like drugs (linezolid or methylene blue);Severe hepatic impairment.
Use Cautiously in: History of seizure disorder;History of suicide attempt/suicidal ideation;Bipolar disorder; may ↑ risk of mania/hypomania; Obstetric: Use only if maternal benefit outweighs fetal risk; use during third trimester may result in need for prolonged hospitalization, respiratory support and tube feeding; Lactation: Breast feed only if maternal benefit outweighs newborn risk; Pediatric: Safety and effectiveness not established; ↑ risk of suicidal thinking/behavior in children, adolescents and young adults.

Adverse Reactions/Side Effects

Central nervous system

  • neuroleptic malignant-like syndrome (life-threatening)
  • seizures (life-threatening)
  • suicidal thoughts (life-threatening)
  • insomnia (most frequent)
  • abnormal dreams
  • dizziness

Gastrointestinal

  • diarrhea (most frequent)
  • nausea (most frequent)
  • dry mouth
  • restlessness
  • vomiting

Endocrinologic

  • ↓ libido
  • sexual dysfunction
  • syndrome of inappropriate antidiuretic hormone (SIADH)

Fluid and Electrolyte

  • hyponatremia

Hematologic

  • bleeding

Miscellaneous

  • serotonin syndrome (life-threatening)

Interactions

Drug-Drug interaction

Concurrent use with, or use within 14 days of starting or stopping MAOIs 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, buspirone, tramadol and triptans ↑ risk of serotonin syndromeConcurrent use with NSAIDs, aspirin, antiplatelet drugs, or other drugs that affect coagulation may ↑ risk of bleeding.Concurrent use of strong inhibitors of CYP3A4, including ketoconazole ↑ blood levels and the risk of adverse reactions/toxicity; daily dose should not exceed 20 mg.Concurrent use of moderate inhibitors of CYP3A4, including erythromycin may require dose ↓ to 20 mg daily if adverse reactions/toxicity occurs.Use cautiously with other CNS-active drugs.

Route/Dosage

Oral (Adults) 10 mg once daily for one week, then 20 mg once daily for one week, then 40 mg once daily. Concurrent use of strong inhibitors of CYP3A4—daily dose should not exceed 20 mg.

Availability

Tablets: 10 mg, 20 mg, 40 mg

Nursing implications

Nursing 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 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.
  • Lab Test Considerations: Monitor serum sodium concentrations periodically during therapy. May cause hyponatremia potentially as a result of syndrome of inappropriate antidiuretic hormone secretion (SIADH).
    • May cause altered anticoagulant effects. Monitor patients receiving warfarin, NSAIDs, or aspirin concurrently.

Potential Nursing Diagnoses

Ineffective coping (Indications)
Risk for injury (Side Effects)

Implementation

  • Oral: Administer vilazodone with food; administration without food can result in inadequate drug concentrations and may ↓ effectiveness.

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 maina/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 during therapy.
  • Instruct female patients to inform health care professional if pregnancy is planned or suspected or if breast feeding.
  • 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 months.
  • ↓ anxiety.
References in periodicals archive ?
* Vilazodone (Viibryd), which may have fewer sexual side effects than some of the other antidepressants.
Table 1 Medications that can cause serotonin syndrome Action Medications Increases serotonin Tryptophan formation Increases release of Amphetamines and amphetamine derivatives serotonin Cocaine MDMA Impairs serotonin Cocaine, MDMA, meperidine, reuptake tramadol, pentazocine SSRIs (citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline) SNRIs (desvenlafaxine, duloxetine, milnacipran, venlafaxine, levomilnacipran) Dopamine-norepinephrine reuptake inhibitors (bupropion) Serotonin modulators (nefazodone, trazodone, vilazodone, vortioxetine) TCAs (amitriptyline, amoxapine, clomipramine, desipramine, doxepin) St.
The National Pregnancy Registry for Antidepressants (844-405-6185) is studying amitriptyline (Elavil), amoxapine (Asendin), bupropion (Forfivo XL and Wellbutrin), Citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), desvenlafaxine (Prisiq), doxepin (Sinequan), escitalopram (Lexapro), fluvoxamine (Luvox), fluoxetine (Prozac), imipramine (Tofranil), isocarboxazid (Marplan), levomilnacipran (Fetzima), maprotiline (Ludiomil), mirtazapine (Remeron), nefazodone (Serzone), nortriptyline (Pamelor), paroxetine (Paxil), phenelzine (Nardill), protriptyline (Vivactil), selegiline (Emsam), sertraline (Zoloft), tranylcypromine (Parnate), trazodone (Desyrel), trimipramine (Surmontil), venlafaxine (Effexor), and vilazodone (Viibryd).
Vilazodone is a new antidepressant with a unique mechanism of action whereby it simultaneously acts as an SSRI and a 5 [HT.sub.1A] receptor partial agonist.
In parallel, molecules with multimodal action, such as vortioxetine (in 2013) and vilazodone (in 2011), the partial antagonists of the 5-HT1A receptor and SERT inhibitors were being approved.
Tarazi, "Differential effects of vilazodone versus citalopram and paroxetine on sexual behaviors and serotonin transporter and receptors in male rats," Psychopharmacology, vol.
Did not observe use of the following antidepressants: Amoxapine, Clomipramine, Imipramine, Maprotiline, Protriptyline, Trimipramine, Vilazodone, Vortioxetine, and Nefazodone.
Bottcher, A New Synthesis of indole 5-carboxylic acids and 6-hydroxy-indole- 5-carboxylic acids in the Preparation of an o- Hydroxylated Metabolite of Vilazodone. Bioorg.
Based on this approach, in the past three years the US Food and Drug Administration (USFDA) approved the marketing of three new combination agents: vilazodone, levomilnacipran, and vortioxetine.
TABLE 5 Antidepressants with nontraditional mechanisms of action (58-60) Agents Safety and efficacy of drug class Examples: Bupropion inhibits both norepinephrine and dopamine; bupropion, associated adverse effects include anxiety, insomnia, vilazodone, and tremor vortioxetine Vilazodone is a novel 5-HT1A partial agonist and serotonin reuptake inhibitor; adverse effects include nausea, diarrhea, headache, and weight gain Vortioxetine is a multiple serotonin modulator and uptake inhibitor; adverse effects are similar to those of SSRIs, with lower risk of sexual dysfunction SSRIs, selective serotonin reuptake inhibitors.
The United States Food and Drug Administration has approved Ireland-based Actavis' lower therapeutic dose of VIIBRYD (vilazodone HCl) (20mg) designed to treat adults with major depressive disorder, it was reported yesterday.
That list includes vilazodone, desvenlafaxine, levomilnacipran, vortioxetine, as well as the less-traditional choices of I-methylfolate and ketamine.