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Safety Information

ZOLOFT® (sertraline hydrochoride)

Indications and Clinical Use:

ZOLOFT is indicated for the symptomatic relief of:1

  • Panic Disorder (PD), with or without agoraphobia
  • Depressive illness
  • Obsessive-Compulsive Disorder (OCD)

Depression: Antidepressant action of ZOLOFT in hospitalized depressed patients has not been adequately studied. A placebo-controlled study carried out over 44 weeks, in patients who were responders to ZOLOFT, has indicated that ZOLOFT may be useful in continuation treatment suppressing reemergence of depressive symptoms. However, because of methodological limitations, these findings on continuation treatment have to be considered tentative at this time.

Panic Disorder: Efficacy was established in 10-week and 12-week controlled trials of patients with PD as defined according to DSM-III-R criteria. The effectiveness in long-term use for the symptomatic relief of PD (i.e., for more than 12 weeks) has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use ZOLOFT for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Obsessive-Compulsive Disorder: The effectiveness in long-term use for the symptomatic relief of OCD (i.e., for more than 12 weeks) has not been systematically evaluated in placebo-controlled trials. Therefore, the physician who elects to use ZOLOFT for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Not indicated for use in children under 18 years of age.

Contraindications:

  • In combination with Monoamine Oxidase Inhibitors (MAOIs) or within two weeks of terminating treatment with MAOIs
  • Concomitant use with pimozide

Most serious warnings and precautions:

  • Risk of potential association with behavioural and emotional changes, including self-harm:
    • Rigorous clinical monitoring for suicidal ideation or other indicator of potential for suicidal behaviour is advised in patients of all ages. This includes monitoring for agitation-type emotional and behavioural changes
    • Patients, families, and caregivers should watch for the emergence of unusual behavioural changes, depression worsening, and suicidal ideation, especially during treatment initiation or change in dose/dose regimen
  • Discontinuation symptoms: dosage should be tapered gradually and the patient monitored
  • Bone fractures: increased risk of bone fractures have been shown with some antidepressants, including selective serotonin reuptake inhibitors/serotonin norepinephrine reuptake inhibitors (SSRIs/SNRIs)

Relevant warnings and precautions:

  • Risk of bleeding; concomitant use with NSAIDs, ASA or other drugs affecting coagulation may add to the risk; caution in patients with a history of bleeding disorder or predisposing conditions
  • Cases of mania/hypomania have been reported
  • Use of sertraline has been associated with the development of akathisia; in patients who develop these symptoms, increasing the dose may be detrimental
  • Risk of QTc prolongation, Torsade de Pointes (TdP)
    • Caution in patients with cardiovascular disease or family history of QT prolongation, or in patients taking medicines known to increase QT interval, especially for patients with increased risk of QT prolongation
  • Cases of new onset diabetes mellitus have been reported; loss of glycemic control including both hyperglycemia and hypoglycemia have also been reported in patients with and without pre-existing diabetes
    • Patients, especially patients with diabetes, should be monitored for signs and symptoms of glucose fluctuations
  • Use with caution in patients with hepatic disease; lower or less frequent dose should be considered
  • Risk of hyponatremia and syndrome of inappropriate antidiuretic hormone (SIADH) secretion, usually in volume-depleted or dehydrated patients
  • Caution in patients operating machinery or engaging in tasks requiring alertness
  • Can cause mydriasis; caution in patients with raised intraocular pressure or narrow angle glaucoma
  • Risk of serotonin syndrome or neuroleptic malignant syndrome (NMS)
    • Careful observation if concomitant treatment with other agents affecting serotonergic and/or dopaminergic neurotransmitter systems is clinically warranted
    • Concomitant use with serotonin precursors is not recommended
  • Caution in patients with a history of seizures; promptly discontinue if seizure develops
  • Caution in the treatment of pregnant women, especially during the third trimester
    • Exposure late in the third trimester may result in discontinuation symptoms and complications requiring prolonged hospitalization, respiratory support and tube feeding
  • Not recommended for use in women of childbearing potential or nursing mothers
  • Caution in patients with diseases or conditions that could affect hemodynamic responses or metabolism

For more information:

Please consult the product monograph by clicking here for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this site.

ZOLOFT ® Pfizer Products Inc, owner/Pfizer Canada Inc., Licensee