Generic Name

Vortioxetine

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Classification

FDA Approved Indications

• Major depressive disorder (MDD)

Mechanism of Action

Vortioxetine functions as a serotonin modulator and stimulator. It inhibits the reuptake of serotonin and modulates serotonergic activity through multiple receptor actions, including antagonism at 5-HT3 and 5-HT7 receptors, and agonism at 5-HT1A receptors, contributing to its antidepressant effects.

Dosage and Administration

Adult: Typically 10-20 mg once daily, with or without food. Dose adjustments may be considered based on clinical response and tolerability.

Pediatric: Not approved for pediatric use.

Geriatric: No specific dosage adjustment necessary, but elderly patients should be monitored closely.

Renal Impairment: No dosage adjustment needed for mild to moderate impairment; caution advised in severe impairment.

Hepatic Impairment: Start with lower doses, as hepatic impairment may affect metabolism.

Pharmacokinetics

Absorption: Well absorbed orally, peak plasma levels in about 6-8 hours.

Distribution: Extensive protein binding (~98%).

Metabolism: Primarily hepatic via CYP2D6; minor involvement of CYP3A4/5 and CYP2C19.

Excretion: Excreted mainly via urine and feces.

Half Life: Approximately 66 hours, allowing once-daily dosing.

Contraindications

• Known hypersensitivity to vortioxetine or excipients.

Precautions

• Use with caution in patients with a history of seizures, bipolar disorder, or bleeding disorders. Monitor for bleeding, especially when combined with other medications that increase bleeding risk. Caution advised in patients taking other serotonergic drugs due to risk of serotonin syndrome.

Adverse Reactions - Common

• Nausea (High)
• Headache (Moderate)
• Dizziness (Moderate)
• Dry mouth (Moderate)

Adverse Reactions - Serious

• Serotonin syndrome (Rare)
• Bleeding events (e.g., gastrointestinal bleeding) (Rare)
• Hyponatremia (Rare)
• Suicidal thoughts or behavior in young adults and adolescents (black box warning) (Not established)

Drug-Drug Interactions

• Other serotonergic agents (SSRIs, SNRIs, triptans, MAOIs) due to serotonin syndrome risk.
• CYP2D6 inhibitors (e.g., fluoxetine, quinidine) which may increase vortioxetine levels.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Take medication exactly as prescribed.
• Report any unusual changes in mood, behavior, or thoughts of self-harm.
• Be aware of signs of serotonin syndrome (agitation, hallucinations, coma) and bleeding.
• Avoid concurrent use of other serotonergic drugs unless advised by healthcare provider.
• Do not discontinue abruptly without consulting healthcare provider.

Special Considerations

Black Box Warnings:

• Suicidality in children, adolescents, and young adults

Genetic Factors: No specific genetic testing required but CYP2D6 metabolic status can influence drug levels.

Lab Test Interference: No significant interference with routine laboratory tests.

Overdose Management

Signs/Symptoms: Symptoms may include nausea, vomiting, dizziness, tremor, and serotonin syndrome.

Treatment: Supportive care, stabilization of vital signs, and monitoring. No specific antidote; activated charcoal may be used if ingestion was recent.

Storage and Handling

Storage: Store at room temperature, 15-30°C (59-86°F).

Stability: Stable under recommended storage conditions until expiration date.