No

Antidepressant, Selective Serotonin Reuptake Inhibitor

Treatment of major depression; obsessive-compulsive disorder; panic disorder

C

Hypersensitivity to sertraline; use of MAO inhibitors within 14 days

Potential for severe reaction when used with MAO inhibitors - serotonin syndrome (hyperthermia, muscular rigidity, mental status changes/agitation, autonomic instability) may occur. May precipitate a shift to mania or hypomania in patients with bipolar disease. Has a very low potential to impair cognitive or motor performance. Does not appear to potentiate the effects of alcohol, however, alcohol use is not advised. Use caution in patients with depression, particularly if suicidal risk may be present. Use caution in patients with a previous seizure disorder or condition predisposing to seizures such as brain damage, alcoholism, or concurrent therapy with other drugs which lower the seizure threshold. Use with caution in patients with hepatic or dysfunction and in elderly patients. May cause hyponatremia/SIADH. Use with caution in patients with renal insufficiency or other concurrent illness (due to limited experience). Sertraline acts as a mild uricosuric - use with caution in patients at risk of uric acid nephropathy. Use with caution in patients at risk of bleeding or receiving anticoagulant therapy - may cause impairment in platelet aggregation. Use with caution in patients where weight loss is undesirable. May cause or exacerbate sexual dysfunction.

>10%:

Central nervous system: Insomnia, somnolence, dizziness, headache, fatigue

Gastrointestinal: Xerostomia, diarrhea, nausea

Genitourinary: Ejaculatory disturbances

1% to 10%:

Cardiovascular: Palpitations

Central nervous system: Agitation, anxiety, nervousness

Dermatologic: Rash

Endocrine & metabolic: Decreased libido

Gastrointestinal: Constipation, anorexia, dyspepsia, flatulence, vomiting

Genitourinary: Micturition disorders

Neuromuscular & skeletal: Tremors, paresthesia

Ocular: Visual difficulty, abnormal vision

Otic: Tinnitus

Miscellaneous: Diaphoresis (increased)

Symptoms of overdose include serious toxicity has not yet been reported, monitor cardiovascular, gastrointestinal, and hepatic functions

Establish and maintain an airway, ensure adequate oxygenation and ventilation. Activated charcoal with 70% sorbitol may be as or more effective than emesis or lavage. Monitoring of cardiac and vital signs is recommended along with general symptomatic and supportive measures. There is no specific antidote for sertraline. Treatment should be aimed at first decontamination, then symptomatic and supportive care; forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to enhance elimination due to sertraline's large volume of distribution.

CYP3A3/4 enzyme substrate, CYP2D6 enzyme substrate (minor); CYP1A2 and 2D6 enzyme inhibitor (weak); CYP2C19 and 3A3/4 enzyme inhibitor

Dexfenfluramine, fenfluramine, and sibutramine in combination with an SSRI may result in serotonin syndrome; these combinations should generally be avoided

SSRIs in combination with selegiline have resulted in mania and hypertension; these combinations are best avoided

SSRIs in combination with nonselective MAO inhibitors have resulted in severe or fatal reactions; these combinations should be avoided

Sertraline may increase the hypoprothrombinemia response to warfarin; monitor

Tablets should be stored at controlled room temperature (15°C to 30°C or 59°F to 86°F)

Antidepressant with selective inhibitory effects on presynaptic serotonin (5-HT) reuptake and only very weak effects on norepinephrine and dopamine neuronal uptake

Steady-state: 7 days; therapeutic effect: >2 weeks

Absorption: Slow

Protein binding: High

Metabolism: Extensive

Half-life: Parent: 24 hours; Metabolites: 66 hours

Elimination: In both urine and feces

Oral:

Elderly: Start treatment with 25 mg/day in the morning and increase by 25 mg/day increments every 2-3 days if tolerated to 50-100 mg/day; additional increases may be necessary; maximum dose: 200 mg/day

Hemodialysis: Not removed by hemodialysis

Dosage comments in hepatic impairment: Sertraline is extensively metabolized by the liver; caution should be used in patients with hepatic impairment

Minor triglycerides (S), LFTs, uric acid (S)

Although caution should be used in patients taking tricyclic antidepressants, no interactions have been reported with vasoconstrictor and sertraline, a nontricyclic antidepressant which acts to increase serotonin

No effects or complications reported

Take exactly as directed (do not increase dose or frequency); may take 2-3 weeks to achieve desired results; may cause physical and/or psychological dependence. Take in the morning to reduce the incidence of insomnia. Avoid excessive alcohol, caffeine, and other prescription or OTC medications not approved by prescriber. Maintain adequate hydration (2-3 L/day of fluids unless instructed to restrict fluid intake). You may experience drowsiness, dizziness, or lightheadedness (use caution when driving or engaging in tasks requiring alertness until response to drug is known); nausea, vomiting, anorexia, or dry mouth (small frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); postural hypotension (use caution when climbing stairs or changing position from sitting or lying to standing); urinary pattern changes (void before taking medication); or male sexual dysfunction (reversible). Report persistent insomnia or daytime sedation, agitation, nervousness, fatigue; muscle cramping, tremors, weakness, or change in gait; chest pain, palpitations, or swelling of extremities; vision changes or eye pain; changes in hearing or ringing in ears; difficulty breathing or breathlessness; skin rash or irritation; or worsening of condition. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to be pregnant. Breast-feeding is not recommended.

If patient becomes anxious or overstimulated, notify physician; if somnolent, administer dose at bedtime; offer hard, sugarless candy or ice chips for dry mouth.

Monitor nutritional intake and weight

Concentrate, oral: 20 mg/mL

Tablet, as hydrochloride: 25 mg, 50 mg, 100 mg

Brown DF and Kerr HD, "Sertraline Overdose," Ann Pharmacother, 1994, 28(11):1307.

Cohn CK, Shrivastava R, Mendels J, et al, "Double-Blind, Multicenter Comparison of Sertraline and Amitriptyline in Elderly Depressed Patients," J Clin Psychiatry, 1990, 51(Suppl B):28-33.

Doogan DP and Caillard V, "Sertraline: A New Antidepressant," J Clin Psychiatry, 1988, 49(Suppl):46-51.

Grimsley SR and Jann MW, "Paroxetine, Sertraline, and Fluvoxamine: New Selective Serotonin Reuptake Inhibitors," Clin Pharm, 1992, 11(11):930-57.

Harel Z, Biro FM, and Tedford WL, "Effects of Long Term Treatment With Sertraline (Zoloft™) Simulating Hypothyroidism in an Adolescent," J Adolesc Health, 1995, 16(3):232-4.

Hoaken PC, "An Alert to Extrapyramidal Side-Effects From SSRIs," Can J Psychiatry, 1995, 40(1):51.

Jackson C, Carson W, Markowitz J, et al, "SIADH Associated With Fluoxetine and Sertraline Therapy," Am J Psychiatry, 1995, 152(5):809-10.

Llorente MD, Gorelick M, and Silverman MA, "Sertraline as the Cause of Inappropriate Antidiuretic Hormone Secretion," J Clin Psychiatry, 1994, 55(12):543-4.

Markel H, Lee A, Holmes RD, et al, "LSD Flashback Syndrome Exacerbated by Selective Serotonin Reuptake Inhibitor Antidepressants in Adolescents," J Pediatr, 1994, 125(5 Pt 1):817-9.

Reimherr FW, Chouinard G, Cohn CK, et al, "Antidepressant Efficacy of Sertraline: A Double-Blind Placebo- and Amitriptyline-Controlled, Multicenter Comparison Study in Outpatients With Major Depression," J Clin Psychiatry, 1990, 51(Suppl B):18-27.

Roose SP, Glassman AH, Attia E, et al, "Comparative Efficacy of Selective Serotonin Reuptake Inhibitors and Tricyclics in the Treatment of Melancholia," Am J Psychiatry, 1994, 151(12):1735-9.

Thornton SL and Resch DS, "SIADH Associated With Sertraline Therapy," Am J Psychiatry, 1995, 152(5):809.

Tueth MJ, "The Serotonin Syndrome in the Emergency Department," Ann Emerg Med, 1993, 22(8):1369.