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Safety Information

PRISTIQ®(desvenlafaxine succinate)

Indications and Clinical Use:

  • PRISTIQ is indicated for the symptomatic relief of major depressive disorder
  • PRISTIQ is not indicated for use in children under the age of 18
  • The short-term efficacy of PRISTIQ has been demonstrated in placebo-controlled trials of up to 8 weeks
  • The efficacy of PRISTIQ in maintaining an antidepressant response for up to 26 weeks, following response during 20 weeks of acute, open-label treatment, was demonstrated in a placebo-controlled trial

Contraindications:

  • Concomitant use with monoamine oxidase inhibitors (MAOIs) or within the preceding 14 days
  • Hypersensitivity to venlafaxine hydrochloride

Most serious warnings and precautions:

  • Behavioural and emotional changes, including self-harm: SSRIs and other newer antidepressants may be associated with:
    • Behavioural and emotional changes including an increased risk of suicidal ideation and behaviour
    • Severe agitation-type adverse events coupled with self-harm or harm to others
    • Suicidal ideation and behaviour; rigorous monitoring advised
  • Discontinuation symptoms: should not be discontinued abruptly. Gradual dose reduction is recommended

Other relevant warnings and precautions:

  • Concomitant use with venlafaxine not recommended
  • Allergic reactions such as rash, hives or a related allergic phenomenon
  • Bone fracture risk with SSRI/SNRI
  • Increases in blood pressure and heart rate (measurement prior to and regularly during treatment)
  • Increases cholesterol and triglycerides (consider measurement during treatment)
  • Hyponatremia or Syndrome of Inappropriate Antidiuretic Hormone (SIADH) with SSRI/SNRI
  • Potential for GI obstruction
  • Abnormal bleeding with SSRI/SNRI
  • Interstitial lung disease and eosinophilic pneumonia with venlafaxine
  • Seizures
  • Narrow angle glaucoma
  • Mania/hypomania
  • Serotonin syndrome or neuroleptic malignant syndrome-like reactions

For more information:

Please consult the product monograph by clicking here for important information relating to adverse reactions, drug interactions, and dosing information.

PRISTIQ ® Wyeth LLC, owner/Pfizer Canada Inc., Licensee