An SSRI Antidepressant - It is used to treat depression
FDA Alerts
Suicidality
Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Sertraline is not approved for use in pediatric patients except for patients with obsessive-compulsive disorder. (See Pediatric Use under Cautions.)
In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressants compared with placebo.
Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
Appropriately monitor and closely observe all patients who are started on sertraline therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk under Cautions.)
Management of PMDD; improves symptoms (e.g., depressed mood, premenstrual anger/irritability) and functional impairment (e.g., difficulty in concentrating, lethargy) associated with this disorder.
Efficacy when used in conjunction with oral contraceptives for the treatment of PMDD is unknown.
Social Phobia
Management of social phobia (social anxiety disorder).
Premature Ejaculation
Has been used in the management of premature ejaculation†.
Vascular Headaches
Has been used in the management of vascular headaches† with equivocal efficacy.
Dosage and Administration
General
Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of sertraline and vice versa. A washout period also is advisable when transferring from another antidepressant (e.g., fluoxetine) to sertraline.
Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments. (See Worsening of Depression and Suicidality Risk under Cautions.)
Sustained therapy may be required; monitor periodically for need for continued therapy.
Avoid abrupt discontinuance of therapy. To avoid withdrawal reactions, taper dosage gradually. (See Worsening of Depression and Suicidality Risk under Cautions.)
Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery. (See Fetal/Neonatal Morbidity and Mortality and also see Pregnancy under Cautions.)
Administration
Oral Administration
Administer orally once daily (morning or evening).
With oral concentrate solution, measure doses carefully using the calibrated dropper provided by the manufacturer. (See Sensitivity Reactions under Cautions.) Oral concentrate solution must be diluted just prior to administration. Dilute in 120 mL of water, ginger ale, lemon/lime soda, lemonade, or orange juice just prior to administration; do not mix in advance or use anything other than these liquids.
Children 6–12 years of age: Initially, 25 mg once daily.
Adolescents 13–17 years of age: Initially, 50 mg once daily.
Dosage may be increased at weekly intervals according to clinical response.
Avoid excessive dosages in children.
Optimum duration not established; may require several months of therapy or longer.
Adults
Major Depressive Disorder
Oral
Initially, 50–100 mg once daily. Dosage may be increased at weekly intervals according to clinical response.
Optimum duration not established; may require several months of therapy or longer.
OCD
Oral
Initially, 50 mg once daily. Dosage may be increased at weekly intervals according to clinical response.
Optimum duration not established; may require several months of therapy or longer.
Panic Disorder
Oral
Initially, 25 mg once daily. After 1 week, increase to 50 mg once daily. Dosage may be increased at weekly intervals according to clinical response.
Optimum duration not established; may require several months of therapy or longer.
PTSD
Oral
Initially, 25 mg once daily. After 1 week, increase to 50 mg once daily. Dosage may then be increased at weekly intervals according to clinical response.
Optimum duration not established; may require several months of therapy or longer.
PMDD
Oral
Initially, 50 mg once daily given continuously throughout the menstrual cycle or just during the luteal phase (i.e., starting 2 weeks prior to the anticipated onset of menstruation and continuing through the first full day of menses).
Dosage may be increased in 50-mg increments at the onset of each new menstrual cycle.
If a dosage of 100 mg daily has been established with luteal phase dosing, titrate dosage using a 50 mg daily dosage for the first 3 days of each luteal phase dosing period.
Optimum duration not established; periodically assess need for dosage adjustment and continued therapy.
Social Phobia
Oral
Initially, 25 mg once daily. After 1 week, increase to 50 mg once daily. Dosage may be increased at weekly intervals according to clinical response.
Optimum duration not established; may require several months of therapy or longer.
Premature Ejaculation
Oral
25–50 mg daily. Alternatively, 25–50 mg daily on an “as needed” basis.†
Prescribing Limits
Pediatric Patients
OCD
Oral
Maximum 200 mg daily.
Adults
Major Depressive Disorder
Oral
Maximum 200 mg daily.
OCD
Oral
Maximum 200 mg daily.
Panic Disorder
Oral
Maximum 200 mg daily.
PTSD
Oral
Maximum 200 mg daily.
PMDD
Oral
Maximum 150 mg daily when administered continuously or 100 mg daily when administered during the luteal phase only.
Social Phobia
Oral
Maximum 200 mg daily.
Special Populations
Hepatic Impairment
Decreased clearance; lower dosages or less frequent administration recommended.
Renal Impairment
No dosage adjustments needed. Not substantially removed by dialysis; supplemental doses may be unnecessary after dialysis.
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