ZOLOFT®
(sertraline hydrochloride)
Tablets and Oral Concentrate
(sertraline hydrochloride)
Tablets and Oral Concentrate
DESCRIPTION
ZOLOFT® (sertraline hydrochloride) is a selective serotonin reuptake inhibitor (SSRI) for oral
administration. It has a molecular weight of 342.7. Sertraline hydrochloride has the following
chemical name: (1S-cis)-4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-1-naphthalenamine
hydrochloride. The empirical formula C17H17NCl2•HCl
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INDICATIONS AND USAGE
Major Depressive Disorder–ZOLOFT (sertraline hydrochloride) is indicated for the treatment
of major depressive disorder in adults.
The efficacy of ZOLOFT in the treatment of a major depressive episode was established in six to
eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to
the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL
PHARMACOLOGY).
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 ZOLOFT in hospitalized depressed patients has not been adequately
studied.
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The efficacy of ZOLOFT 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 ZOLOFT for extended periods should be
reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY).
Obsessive-Compulsive Disorder–ZOLOFT 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 or compulsions cause marked distress, are time-consuming, or
significantly interfere with social or occupational functioning.
The efficacy of ZOLOFT 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 ZOLOFT for extended periods should be
reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY).
Obsessive-Compulsive Disorder–ZOLOFT 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 or compulsions cause marked distress, are time-consuming, or
significantly interfere with social or occupational functioning.
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The efficacy of ZOLOFT was established in 12-week trials with obsessive-compulsive
outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III
or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY).
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.
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The efficacy of ZOLOFT in maintaining a response, in patients with OCD who responded during
a 52-week treatment phase while taking ZOLOFT and were then observed for relapse during a
period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials
under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use ZOLOFT
for extended periods should periodically re-evaluate the long-term usefulness of the drug for the
individual patient (see DOSAGE AND ADMINISTRATION).
The efficacy of ZOLOFT in maintaining a response, in patients with OCD who responded during
a 52-week treatment phase while taking ZOLOFT and were then observed for relapse during a
period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials
under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use ZOLOFT
for extended periods should periodically re-evaluate the long-term usefulness of the drug for the
individual patient (see DOSAGE AND ADMINISTRATION).
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DOSAGE AND ADMINISTRATION
Initial Treatment
Dosage for Adults
Major Depressive Disorder and Obsessive-Compulsive Disorder–ZOLOFT treatment should
be administered at a dose of 50 mg once daily.
Panic Disorder, Posttraumatic Stress Disorder and Social Anxiety Disorder–ZOLOFT
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 major depressive
disorder, OCD, panic disorder, PTSD or social anxiety disorder, patients were dosed in a range of
50-200 mg/day in the clinical trials demonstrating the effectiveness of ZOLOFT for the treatment
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of these indications. Consequently, a dose of 50 mg, administered once daily, is recommended as
the initial therapeutic 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 ZOLOFT,
dose changes should not occur at intervals of less than 1 week.
Premenstrual Dysphoric Disorder–ZOLOFT treatment should be initiated with a dose of
50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the
menstrual cycle, depending on physician assessment.
of these indications. Consequently, a dose of 50 mg, administered once daily, is recommended as
the initial therapeutic 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 ZOLOFT,
dose changes should not occur at intervals of less than 1 week.
Premenstrual Dysphoric Disorder–ZOLOFT treatment should be initiated with a dose of
50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the
menstrual cycle, depending on physician assessment.
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While a relationship between dose and effect has not been established for PMDD, patients were
dosed in the range of 50-150 mg/day with dose increases at the onset of each new menstrual
cycle (see Clinical Trials under CLINICAL PHARMACOLOGY). Patients not responding to a
50 mg/day dose may benefit from dose increases (at 50 mg increments/menstrual cycle) up to
150 mg/day when dosing daily throughout the menstrual cycle, or 100 mg/day when dosing
during the luteal phase of the menstrual cycle. If a 100 mg/day dose has been established with
luteal phase dosing, a 50 mg/day titration step for three days should be utilized at the beginning
of each luteal phase dosing period.
OVERDOSAGE
Human Experience– Of 1,027 cases of overdose involving sertraline hydrochloride worldwide,
alone or with other drugs, there were 72 deaths (circa 1999).
Among 634 overdoses in which sertraline hydrochloride was the only drug ingested, 8 resulted in
fatal outcome, 75 completely recovered, and 27 patients experienced sequelae after overdosage to
include alopecia, decreased libido, diarrhea, ejaculation disorder, fatigue, insomnia, somnolence
and serotonin syndrome. The remaining 524 cases had an unknown outcome. The most common
signs and symptoms associated with non-fatal sertraline hydrochloride overdosage were
somnolence, vomiting, tachycardia, nausea, dizziness, agitation and tremor.
The largest known ingestion was 13.5 grams in a patient who took sertraline hydrochloride alone
and subsequently recovered. However, another patient who took 2.5 grams of sertraline
hydrochloride alone experienced a fatal outcome.
Other important adverse events reported with sertraline hydrochloride overdose (single or
multiple drugs) include bradycardia, bundle branch block, coma, convulsions, delirium,
hallucinations, hypertension, hypotension, manic reaction, pancreatitis, QT-interval prolongation,
serotonin syndrome, stupor and syncope.
serotonin syndrome, stupor and syncope.
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