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PAROXETINE

PAROXETINE HYDROCHLORIDE

Manufacturer: Aphena Pharma Solutions - Tennessee, LLC

Score: 144.0

Quick Summary

Paroxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI) used in adults for the treatment of major depressive disorder (MDD), panic disorder (PD), social anxiety disorder (SAD), and premenstrual dysphoric disorder (PMDD). The mechanism of action is unknown but is presumed to be linked to potentiation of serotonergic activity in the central nervous system. Important safety information includes warnings about suicidal thoughts and behaviors, serotonin syndrome, and embryofetal and neonatal toxicity. Contraindications include concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of discontinuing a MAOI, concomitant use of pimozide or thioridazine, and known hypersensitivity to paroxetine or any of the inactive ingredients. Main dosing recommendations vary by condition, with initial dosing and titration details provided for each condition. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Paroxetine hydrochloride is used for the treatment of major depressive disorder (MDD), panic disorder (PD), social anxiety disorder (SAD), and premenstrual dysphoric disorder (PMDD) in adults.
  • The mechanism of action is unknown but is presumed to be linked to potentiation of serotonergic activity in the central nervous system.
  • Paroxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI).

Important Safety Information

Warning

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies.

Contraindications

  • Concomitant use of monoamine oxidase inhibitors (MAOIs) or use within 14 days of discontinuing a MAOI.
  • Concomitant use of pimozide or thioridazine.
  • Known hypersensitivity to paroxetine or to any of the inactive ingredients in paroxetine extended-release tablets.

Adverse Reactions

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

Dosing Recommendations

General Guidance

Dosage should be adjusted based on individual patient response and tolerability.

Major Depressive Disorder (MDD)

Adult Dose

25 mg/day, with a maximum dose of 62.5 mg/day

Pediatric Dose

Not established

Panic Disorder (PD)

Adult Dose

12.5 mg/day, with a maximum dose of 75 mg/day

Pediatric Dose

Not established

Social Anxiety Disorder (SAD)

Adult Dose

12.5 mg/day, with a maximum dose of 37.5 mg/day

Pediatric Dose

Not established

Premenstrual Dysphoric Disorder (PMDD)

Adult Dose

12.5 mg/day, with a maximum dose of 25 mg/day

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Epidemiological studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations.
  • Paroxetine should only be used during pregnancy if the potential benefits justify the potential risks to the fetus.

Nursing Mothers

  • Paroxetine is secreted in human milk.
  • A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

  • The safety and effectiveness of paroxetine extended-release tablets in pediatric patients have not been established.
  • Three placebo-controlled trials in 752 pediatric patients with MDD have been conducted with immediate-release paroxetine, and effectiveness was not established in pediatric patients.

Geriatric Use

  • SSRIs and SNRIs, including paroxetine extended-release tablets, have been associated with cases of clinically significant hyponatremia in elderly patients.
  • A lower starting dose is recommended for elderly patients, and dosage should be adjusted based on individual patient response and tolerability.

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