ZOLOFT (sertraline) Indications And Clinical Use

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Adults

Depression:

ZOLOFT (sertraline hydrochloride) is indicated for the symptomatic relief of depressive illness. However, the antidepressant action of ZOLOFT in hospitalized depressed patients has not been adequately studied.

A placebo-controlled European 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:

ZOLOFT is indicated for the symptomatic relief of panic disorder, with or without agoraphobia. The efficacy of ZOLOFT was established in 10-week and 12-week controlled trials of patients with panic disorder as defined according to DSM-III-R criteria.

The effectiveness of ZOLOFT in long-term use for the symptomatic relief of panic disorder (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:

ZOLOFT is indicated for the symptomatic relief of obsessive-compulsive disorder (OCD). The obsessions or compulsions must be experienced as intrusive, markedly distressing, time-consuming, or significantly interfering with the person’s social or occupational functioning.

The effectiveness of ZOLOFT 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.

Pediatrics (<18 years of age)

ZOLOFT (sertraline hydrochloride) is not indicated for use in children under 18 years of age (see WARNINGS: POTENTIAL ASSOCIATION WITH BEHAVIORAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION).