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VILAZODONE HYDROCHLORIDE

VILAZODONE HYDROCHLORIDE

Manufacturer: Alembic Pharmaceuticals Limited

Score: 144.0

Quick Summary

Vilazodone Hydrochloride is a selective serotonin reuptake inhibitor and 5HT 1A receptor partial agonist used for the treatment of major depressive disorder in adults. The recommended target dosage is 20 mg to 40 mg once daily with food, with a gradual titration and dosing adjustments based on clinical response and patient characteristics. Important safety considerations include the risk of suicidal thoughts and behaviors, serotonin syndrome, increased risk of bleeding, and discontinuation syndrome. The drug has specific contraindications, including concomitant use of monoamine oxidase inhibitors, and requires careful consideration in special populations such as pregnant women, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

  • Treatment of major depressive disorder in adults
  • Selective serotonin reuptake inhibitor and 5HT 1A receptor partial agonist
  • Recommended target dosage: 20 mg to 40 mg once daily with food

Important Safety Information

Warning

Suicidal thoughts and behaviors, serotonin syndrome, increased risk of bleeding, and discontinuation syndrome

Contraindications

  • Concomitant use of monoamine oxidase inhibitors
  • Use within 14 days of stopping monoamine oxidase inhibitors

Adverse Reactions

  • Diarrhea
  • Nausea
  • Vomiting
  • Insomnia
  • Abnormal dreams
  • Restlessness

Dosing Recommendations

General Guidance

Dose adjustments may be necessary based on clinical response, patient characteristics, and concomitant use of other medications, including strong CYP3A4 inhibitors or inducers

Major depressive disorder

Adult Dose

Start with 10 mg once daily for 7 days, then increase to 20 mg once daily, and may be increased up to 40 mg once daily after a minimum of 7 days between dosage increases

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Use during pregnancy may increase the risk of postpartum hemorrhage
  • Exposure to SSRIs in late pregnancy may increase the risk of neonatal complications

Nursing Mothers

  • Vilazodone is excreted in human milk, and caution should be exercised when administering to nursing women

Pediatric Use

  • The safety and effectiveness of vilazodone have not been established in pediatric patients
  • Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients

Geriatric Use

  • No dosage adjustment is recommended based on age
  • Geriatric patients may be at greater risk for hyponatremia