Generic Name

Vortioxetine Hydrobromide

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Classification

FDA Approved Indications

• Major depressive disorder (MDD) in adults

Mechanism of Action

Vortioxetine is a serotonin modulator and stimulator. It acts as a serotonin reuptake inhibitor and also modulates various serotonin receptors, including antagonism at 5-HT3, 5-HT7, and partial agonism at 5-HT1B, which results in increased serotonergic activity in the brain.

Dosage and Administration

Adult: Initial dose is 10 mg once daily, adjustable to 5-20 mg based on response and tolerability.

Pediatric: Not approved for pediatric use.

Geriatric: Start at 10 mg once daily; adjust as needed, considering renal function and tolerability.

Renal Impairment: Use with caution; consider lower starting dose.

Hepatic Impairment: Use with caution; lower initial dose recommended.

Pharmacokinetics

Absorption: Well absorbed orally, peak plasma levels in about 7 hours.

Distribution: Binding to plasma proteins approximately 98%.

Metabolism: Primarily metabolized in the liver via CYP2D6, CYP3A4/5.

Excretion: Excreted mainly as metabolites via urine and feces.

Half Life: Approximately 66 hours.

Contraindications

• Known hypersensitivity to vortioxetine or components.
• Use with monoamine oxidase inhibitors (MAOIs) due to risk of serotonin syndrome.

Precautions

• History of bipolar disorder, suicide risk, or seizures.
• Consideration in patients taking other serotonergic drugs to prevent serotonin syndrome.

Adverse Reactions - Common

• Nausea (11-20%)
• Headache (10-20%)
• Dizziness (5-10%)
• Dry mouth (5-10%)

Adverse Reactions - Serious

• Serotonin syndrome (Rare)
• Hyponatremia (Rare)
• Bleeding complications (Rare)
• Suicidal thoughts or behaviors (Monitor especially early in treatment)

Drug-Drug Interactions

• Serotonergic agents (e.g., SSRIs, SNRIs, triptans)

Drug-Food Interactions

N/A

Drug-Herb Interactions

• St. John's Wort

Nursing Implications

Patient/Family Teaching

• Take medication as directed, even if feeling better.
• Report any signs of serotonin syndrome (confusion, hallucinations, agitation).
• Avoid alcohol and other CNS depressants.
• Notify healthcare provider about all medications being taken.

Special Considerations

Black Box Warnings:

• Suicidality in children, adolescents, and young adults with MDD or other psychiatric disorders.

Genetic Factors: Metabolized by CYP2D6; poor metabolizers may have higher drug levels.

Lab Test Interference: None documented.

Overdose Management

Signs/Symptoms: Dizziness, nausea, vomiting, somnolence, serotonin syndrome symptoms.

Treatment: Supportive care, activated charcoal if recent ingestion, monitoring of vital signs, and symptomatic treatment; no specific antagonist available.

Storage and Handling

Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F).

Stability: Stable under recommended storage conditions.