INDICATIONS

Depression

Sertraline HCl is indicated for the treatment of depression.

The efficacy of sertraline HCl in the treatment of a major depressive episode was established in six to eight week controlled trials of outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see CLINICAL STUDIES).

A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.

The antidepressant action of sertraline HCl in hospitalized depressed patients has not been adequately studied.

The efficacy of sertraline HCl in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline HCl for extended periods should be reevaluated periodically (see CLINICAL STUDIES).

Obsessive-Compulsive Disorder

Sertraline HCl is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R (i.e., the obsessions and compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.)

The efficacy of sertraline HCl was established in 12-week trials with obsessive-compulsive outpatients having diagnosis of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see CLINICAL STUDIES).

Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.

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

DOSAGE AND ADMINISTRATION

Panic Disorder


Sertraline HCl is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.

The efficacy of sertraline HCl was established in three 10-12 week trials in panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see CLINICAL STUDIES).

Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, [i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes.]

The effectiveness of sertraline HCl in long-term use, that is, for more than 12 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline HCl for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (seeDOSAGE AND ADMINISTRATION).


DOSAGE AND ADMINISTRATION

Initial Treatment

Dosage for Adults

Depression and Obsessive-Compulsive Disorder: Sertraline HCl treatment should be administered at a dose of 50 mg once daily.

Panic Disorder: Sertraline HCl treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily.

While a relationship between dose and effect has not been established for depression, OCD, or panic disorder, patients were dosed in a range of 50-200 mg/day in the clinical trials demonstrating the effectiveness of sertraline HCl for these indications. Consequently, a dose of 50 mg, administered once daily, is recommended as the initial dose. Patients not responding to a 50 mg dose may benefit from dose increases up to a maximum of 200 mg/day. Given the 24 hour elimination half-life of sertraline HCl, dose changes should not occur at intervals of less than 1 week.

Sertraline HCl should be administered once daily, either in the morning or evening.

Dosage for Pediatric Population (Children and Adolescents)

Obsessive-Compulsive Disorder: Sertraline HCl treatment should be initiated with a dose of 25 mg once daily in children (ages 6-12) and at a dose of 50 mg once daily in adolescents (ages 13-17).

While a relationship between dose and effect has not been established for OCD, patients were dosed in a range of 25-200 mg/day in the clinical trials demonstrating the effectiveness of sertraline HCl for pediatric patients (6-17 years) with OCD. Patients not responding to an initial dose of 25 or 50 mg/day may benefit from dose increases up to a maximum of 200 mg/day. For children with OCD, their generally lower body weights compared to adults should be taken into consideration in advancing the dose, in order to avoid excessive dosing. Given the 24 hour elimination half-life of sertraline HCl, dose changes should not occur at intervals of less than 1 week.

Sertraline HCl should be administered once daily, either in the morning or evening.

Dosage for Hepatically Impaired Patients

The use of sertraline in patients with liver disease should be approached with caution. The effects of sertraline in patients with moderate and severe hepatic impairment have not been studied. If sertraline is administered to patients with liver impairment, a lower or less frequent dose should be used (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

Maintenance/Continuation/Extended Treatment

Depression: It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Whether the dose of antidepressant needed to induce remission is identical to the dose needed to maintain and/or sustain euthymia is unknown. Systematic evaluation of sertraline HCl has shown that its antidepressant efficacy is maintained for periods of up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) at a dose of 50-200 mg/day (mean dose of 70 mg/day) (see CLINICAL STUDIES).

Obsessive-Compulsive Disorder and Panic Disorder: Although the efficacy of sertraline HCl beyond 10-12 weeks of dosing for OCD and panic disorder has not been documented in controlled trials, both are chronic conditions, and it is reasonable to consider continuation of a responding patient for either indication. Dosage adjustments may be needed to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Switching Patients to or from a Monoamine Oxidase Inhibitor

At least 14 days should elapse between discontinuation of a MAOI and initiation of therapy with sertraline HCl. In addition, at least 14 days should be allowed after stopping sertraline HCl before starting a MAOI (seeCONTRAINDICATIONSand WARNINGS).

Sertraline HCl Oral Concentrate

Sertraline HCl oral concentrate contains 12% alcohol. Sertraline HCl oral concentrate must be diluted before use. Just before taking, use the dropper provided to remove the required amount of sertraline HCl oral concentrate and mix with 4 oz (½ cup) of water, gingerale, lemon/lime soda, lemonade or orange juice ONLY. Do not mix sertraline HCl oral concentrate with anything other than the liquids listed. The dose should be taken immediately after mixing. Do not mix in advance. At times, a slight haze may appear after mixing; this is normal. Note that caution should be exercised for patients with latex sensitivity, as the dropper dispenser contains dry natural rubber.

Sertraline HCl oral concentrate is contraindicated with disulfuram (Antabuse) due to the alcohol content of the concentrate.

HOW SUPPLIED

Zoloft Tablets

Zoloft capsular-shaped scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline.

25 mg Tablets: Light green film coated tablets engraved on one side with Zoloft and on the back scored and engraved with 25 mg.

50 mg Tablets: Light blue film coated tablets engraved on the front with Zoloft and on the back scored and engraved with 50 mg.

100 mg Tablets: Light yellow film coated tablets engraved on the front with Zoloft and on the back scored and engraved with 100 mg.

Storage: Store at controlled room temperature of 59° to 86°F (15° to 30°C).

Zoloft Oral Concentrate

Zoloft oral concentrate is a clear, colorless solution with a menthol scent containing sertraline HCl equivalent to 20 mg of sertraline per ml and 12% alcohol.

Storage: Store at conrolled room temperature, 15-30°C (59-86°F).

PRODUCT LISTING