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Paroxetine

PAROXETINE HYDROCHLORIDE HEMIHYDRATE

Manufacturer: Proficient Rx LP

Score: 144.0

Quick Summary

Paroxetine is an SSRI used for the treatment of major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder (PD), social anxiety disorder (SAD), generalized anxiety disorder (GAD), and posttraumatic stress disorder (PTSD). The recommended starting dose varies by condition, and dose adjustments may be necessary. Paroxetine has important safety information, including a boxed warning about suicidal thoughts and behaviors, and contraindications such as use with MAOIs or within 14 days of stopping MAOIs. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Major depressive disorder (MDD)
  • Obsessive-compulsive disorder (OCD)
  • Panic disorder (PD)
  • Social anxiety disorder (SAD)
  • Generalized anxiety disorder (GAD)
  • Posttraumatic stress disorder (PTSD)

Important Safety Information

Warning

Suicidal thoughts and behaviors

Contraindications

  • Use with MAOIs or within 14 days of stopping MAOIs
  • Use with pimozide or thioridazine
  • Known hypersensitivity to paroxetine or any of the inactive ingredients

Adverse Reactions

  • Abnormal ejaculation
  • Asthenia
  • Constipation
  • Decreased appetite
  • Diarrhea
  • Dizziness
  • Dry mouth
  • Female genital disorder
  • Impotence
  • Infection
  • Insomnia
  • Libido decreased
  • Male genital disorder
  • Nausea
  • Nervousness
  • Somnolence
  • Sweating
  • Tremor
  • Yawn

Dosing Recommendations

General Guidance

Dose adjustments may be necessary based on patient response and tolerability

MDD

Adult Dose

20 mg once daily

Pediatric Dose

Not established

OCD

Adult Dose

20 mg once daily

Pediatric Dose

Not established

PD

Adult Dose

10 mg once daily

Pediatric Dose

Not established

SAD

Adult Dose

20 mg once daily

Pediatric Dose

Not established

GAD

Adult Dose

20 mg once daily

Pediatric Dose

Not established

PTSD

Adult Dose

20 mg once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Use during pregnancy may increase the risk of congenital malformations
  • Use during the third trimester may increase the risk of persistent pulmonary hypertension of the newborn

Nursing Mothers

  • Paroxetine is secreted in human milk
  • A decision should be made whether to discontinue nursing or to discontinue the drug

Pediatric Use

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

Geriatric Use

  • In premarketing clinical trials, 17% of patients treated with paroxetine were 65 years of age or older
  • SSRIs, including paroxetine, have been associated with cases of clinically significant hyponatremia in elderly patients