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Treatment of major depressive disorder; treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD); treatment of panic disorder with or without agoraphobia; treatment of posttraumatic stress disorder (PTSD); treatment of premenstrual dysphoric disorder; treatment of social anxiety disorder (social phobia). Unlabeled Uses Cholestatic pruritus, hot flashes, nocturnal enuresis.


Hypersensitivity to any components; concomitant use in patients taking MAOIs or pimozide; oral concentrate is contraindicated with disulfiram because of the alcohol content in the oral concentrate.

Adverse reactions:

Cardiovascular Palpitations, chest pain (at least 1%); increased coagulation times, bradycardia, AV block, atrial arrhythmias, QT-interval prolongation, ventricular tachycardia. CNS Headache (25%); insomnia (21%); somnolence (13%); dizziness, fatigue (12%); malaise (9%); tremor (8%); decreased libido (6%); agitation, nervousness (5%); anxiety (4%); aggressive reaction, hyperkinesia (at least 2%); paresthesia (2%); asthenia, hypertonia, hypesthesia (at least 1%); extrapyramidal symptoms, NMS, oculogyric crisis, psychosis, serotonin syndrome Dermatologic Sweating (7%); rash (3%); photosensitivity, Stevens-Johnson syndrome, vasculitis. EENT Abnormal vision (3%); tinnitus (at least 1%); blindness, cataract, optic neuritis. GI Nausea (25%); diarrhea (20%); dry mouth (14%); dyspepsia (8%); abdominal pain, anorexia, constipation (6%); vomiting (4%); increased appetite (at least 1%); pancreatitis. Genitourinary Abnormal ejaculation (14%); sexual dysfunction, urinary incontinence (at least 2%); impotence (at least 1%); priapism; acute renal failure. Hematologic Purpura (at least 2%); agranulocytosis, aplastic anemia, leukopenia, lupus-like syndrome, pancytopenia, serum sickness, thrombocytopenia. Hepatic Elevated liver enzymes (1%); increased bilirubin, hepatomegaly, hepatitis, jaundice, liver failure. Lab Tests Decrease in serum uric acid (7%); increased triglycerides (5%); increase in total cholesterol (3%). Metabolic Increased weight (at least 1%); hyperglycemia, hypothyroidism. Respiratory Epistaxis, sinusitis (at least 2%); rhinitis (at least 1%). Miscellaneous Pain (6%); fever, pain, weight loss (at least 2%); back pain, myalgia, yawning (at least 1%); anaphylaxis, angioedema, galactorrhea, hyperprolactinemia, pulmonary hypertension


5-HT 1 agonists (eg, naratriptan, rizatriptan, sumatriptan, zolmitriptan) Weakness, hyperreflexia, and incoordination reported rarely. Alcohol, CNS depressants May enhance CNS depressant effects. Alcohol use is not recommended. Carbamazepine Sertraline plasma levels may be reduced, decreasing the pharmacologic effects. Cimetidine Increased sertraline AUC (50%), C max (24%), and half-life (26%). Cisapride Concurrent use reduced cisapride AUC and C max by approximately 35%. Clozapine Elevated serum clozapine levels have occurred. Closely monitor patients during coadministration. Cyclosporine Elevated cyclosporine levels may occur. Cyproheptadine May decrease the pharmacologic effects of sertraline. Diazepam IV Cl for diazepam decreased 32%. Disulfiram Sertraline oral concentrate is contraindicated with disulfiram because of the oral concentrate’s alcohol content. Drugs highly bound to plasma proteins (eg, warfarin, digitoxin) May cause a shift in plasma concentrations resulting in adverse reactions. Drugs interfering with hemostasis (eg, aspirin, non-selective NSAIDs [eg, ibuprofen], warfarin) Risk of bleeding may be increased. Drugs metabolized by CYP2D6 (eg, carvedilol, risperidone) Plasma concentrations of these drugs may be elevated, increasing the pharmacologic effects and adverse reactions. Hydantoins (eg, phenytoin) Plasma levels may be increased by sertraline, increasing the pharmacologic effects and adverse reactions. L-tryptophan Concurrent use is not recommended. Lithium, macrolide antibiotics (eg, erythromycin), metoclopramide, sibutramine, sympathomimetics, tramadol, trazodone Risk of serotonin syndrome may be increased. MAOIs, linezolid May cause serious, even fatal reactions. Concomitant use is contraindicated. Discontinue MAOIs at least 14 days before starting sertraline; at least 14 days should be allowed after stopping sertraline before starting an MAOI. Pimozide Increase in pimozide AUC and C max of about 40%; coadministration is contraindicated. St. John’s wort Sedative-hypnotic effects of sertraline may be increased. Avoid concurrent use. Tolbutamide Sertraline significantly decreased the Cl of tolbutamide (16%). Tricyclic antidepressants (eg, amitriptyline) Pharmacologic and toxic effects may be increased by sertraline; “serotonin syndrome” has been reported. Type 1C antiarrhythmics (eg, flecainide, propafenone) Plasma levels may be increased. Monitor cardiac function. Zolpidem Onset of action of zolpidem may be shortened and the effect increased.


Pregnancy Category C . Category D if taken in the third trimester per Briggs’ Drugs in Pregnancy and Lactation . Consider tapering dosing in the third trimester. Lactation Excreted. Children Safety and efficacy not established, except in children 6 to 18 yr of age with OCD. Elderly May be at greater risk of hyponatremia. Hepatic Function Use drug with caution. Lower or less frequent dosing schedule may be required. Special Risk Patients Use with caution in patients with diseases or conditions that could affect metabolism or hemodynamic responses. Abnormal bleeding Bleeding episodes have been reported in patients taking psychotropic drugs that interfere with serotonin reuptake. Activation of mania/hypomania Activation of mania/hypomania occurs infrequently in patients taking SSRIs. Discontinuation Serious adverse reactions (eg, dysphoric mood, irritability, anxiety, emotional lability, insomnia, hypomania) may occur upon sertraline discontinuation, particularly when abrupt. A gradual reduction in dose is recommended. Duration of therapy Periodically reassess patients to determine the need for maintenance treatment. Hyponatremia Several cases of sertraline-induced hyponatremia have occurred. Latex allergy The dropper dispenser supplied with the oral concentrate may contain dry natural rubber. Seizures Use drug with caution in patients with history of seizures. Serotonin syndrome May occur. Uricosuric effect May cause a decrease in serum uric acid. Weight loss Weight loss has been reported.



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