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Escitalopram Oxalate

ESCITALOPRAM OXALATE

Manufacturer: Amneal Pharmaceuticals of New York LLC

Score: 144.0

Quick Summary

Escitalopram oxalate is a selective serotonin reuptake inhibitor (SSRI) used for the treatment of major depressive disorder (MDD) in adults and adolescents, and generalized anxiety disorder (GAD) in adults. The recommended dose is 10 mg once daily, with a maximum dose of 20 mg once daily. Escitalopram has been shown to be effective in clinical trials, but it also carries important safety information, including warnings about suicidal thoughts and behaviors, serotonin syndrome, and discontinuation symptoms. Special population considerations include use during pregnancy, nursing, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of major depressive disorder (MDD) in adults and adolescents
  • Treatment of generalized anxiety disorder (GAD) in adults
  • Effective in clinical trials with a recommended dose of 10 mg once daily

Important Safety Information

Warning

Increased risk of suicidal thoughts and behaviors, serotonin syndrome, and discontinuation symptoms

Contraindications

  • Use of MAOIs intended to treat psychiatric disorders
  • Use of pimozide
  • Known hypersensitivity to escitalopram or citalopram

Adverse Reactions

  • Insomnia
  • Ejaculation disorder
  • Nausea
  • Sweating increased
  • Fatigue
  • Somnolence

Dosing Recommendations

General Guidance

Dose adjustments may be necessary for elderly patients, patients with hepatic impairment, and patients with severe renal impairment

MDD in adolescents

Adult Dose

10 mg once daily

Pediatric Dose

10 mg once daily

MDD in adults

Adult Dose

10 mg once daily

Pediatric Dose

Not applicable

GAD in adults

Adult Dose

10 mg once daily

Pediatric Dose

Not applicable

Special Population Considerations

Pregnancy

  • Use during pregnancy only if the potential benefit justifies the potential risk to the fetus
  • Increased risk of persistent pulmonary hypertension of the newborn (PPHN)

Nursing Mothers

  • Escitalopram is excreted in human breast milk
  • Caution should be exercised when escitalopram is administered to a nursing woman

Pediatric Use

  • Safety and effectiveness have been established in adolescents (12 to 17 years of age) for the treatment of MDD
  • Safety and effectiveness have not been established in pediatric patients less than 12 years of age

Geriatric Use

  • Approximately 6% of patients in clinical trials were 60 years of age or older
  • Greater sensitivity to effects of escitalopram cannot be ruled out in elderly individuals

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