Names and pronunciation
(ser′tra-leen) Zoloft
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Drug reference
(ser′tra-leen) Zoloft
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Func. class.: Antidepressant
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Chem. class.: SSRI
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Do not confuse: Sertraline/cetirizine Zoloft/Zocor
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ACTION: Inhibits serotonin reuptake in CNS; increases action of serotonin; does not affect dopamine, norepinephrine
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USES: Major depressive disorder, obses- sive-compulsive disorder (OCD), post traumatic stress disorder (PTSD), panic disorder, social anxiety disorder, premen- strual dysphoric disorder (PMDD)
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Unlabeled uses: Generalized anxiety dis- order, premature ejaculation, pruritus (cholestatic liver disease), separation anxi- ety disorder
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CONTRAINDICATIONS: Hyper- sensitivity to this product or SSRIs Precautions: Pregnancy, breastfeeding, geriatric patients, renal/hepatic disease, epilepsy, recent MI, latex sensitivity (dropper of oral concentration)
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Black Box Warning: Children, suicidal ideation Black Box Warning: Depression/OCD/ PTSD: mood, sensorium, affect, suicidal tendencies (child/young adult), increase in psychiatric symptoms, depression, panic attacks, OCD, PTSD, social anxiety disorder; symptoms usually occur in first few months of treatment • Premenstrual dysphoric disorder: emotional lability, sad, hopelessness, insomnia, anxiety, food cravings, breast pain/tenderness • Serotonin syndrome (hyperthermia, hypertension, rigidity, delirium, coma, myoclonus) or neuroleptic malignant syndrome–like reaction (muscle cramps, fever, unstable B/P, agitation, tremors, men- tal changes) • Bleeding (platelet serotonin deple- tion): GI bleeding, ecchymoses, epistaxis, hematomas, petechiae, hemorrhage • LFTs, thyroid function tests, growth rate, weight at baseline and periodically • Hypotension: B/P (lying/standing), pulse q4hr; if systolic B/P drops 20 mm Hg, hold product, notify prescriber; VS q4hr in patients with CV disease • Weight weekly; appetite may decrease with product • Urinary retention, constipation, espe- cially in geriatric patients • Alcohol consumption; hold dose until morning • Beers: avoid in older adults unless safer alternatives are unavailable; may cause ataxia, impaired psychomotor function • Pregnancy/breastfeeding: use only if benefits outweigh fetal risk; serious com- plications may occur in neonates; cautious use in breastfeeding, excretion unknown Black Box Warning: Suicidal idea- tion: that suicidal thoughts/behaviors may occur in children/adolescents; to notify prescriber immediately if suicidal thoughts, panic attacks, severe anxiety occur • To notify prescriber if pregnant or if planning to become pregnant, or if breastfeeding
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SIDE EFFECTS CNS: Insomnia, agitation, dizziness, headache, fatigue, confusion, gait abnor- mality (geriatric patients), neuroleptic malignant syndrome–like reaction, sero- tonin syndrome, suicidal ideation, anxiety, drowsiness CV: Palpitations, chest pain EENT: Vision abnormalities, yawning, tin- nitus, intraocular pressure ENDO: SIADH (geriatric patients); diabe- tes mellitus GI: Diarrhea, nausea, constipation, anorexia, dry mouth, dyspepsia, vomit- ing, flatulence, weight gain/loss GU: Male sexual dysfunction, menstrual disorders, urinary frequency INTEG: Increased sweating, rash, hot flashes MISC: Hyponatremia, neonatal absti- nence syndrome
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INTERACTIONS • Altered lithium levels: lithium • Disulfiram reaction: disulfiram and oral concentration due to alcohol content • Fatal reactions: MAOIs, pimozide; avoid use within 2 wk Increase: sertraline levels—cimetidine, war- farin, other highly protein-bound products Increase: effects of antidepressants (tricy- clics), diazepam, TOLBUTamide, warfarin, benzodiazepines, SUMAtriptan, phenytoin, cloZAPine Increase: bleeding risk—anticoagulants, NSAIDs, thrombolytic, platelet inhibitors, salicylates Increase: serotonin syndrome, neuroleptic malignant syndrome—SSRIs, SNRIs, sero- tonin-receptor agonists, tricyclics, cycloben- zaprine, sibutramine, traZODone, busPIRone, linezolid, traMADol; avoid concurrent use Drug/Herb Increase: SSRI, serotonin syndrome—St. John’s wort, SAM-e, tryptophan; do not use together Increase: CNS effect—kava, valerian Drug/Lab Test Increase: AST, ALT False positive: urine screen for benzodi azepines
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DOSAGE AND ROUTES Major depression/OCD • Adult/geriatric patient/adolescent (un- labeled): PO 25-50 mg/day; may increase to max of 200 mg/day; do not change dose at intervals of <1 wk; administer daily in AM or PM • Child 6-12 yr (unlabeled): PO 25 mg/ day, increase by 25-50 mg/wk PTSD/social anxiety disorder/panic disorder • Adult: PO 25 mg/day, may increase by 50 mg/day after 7 days, range 50-200 mg Premenstrual dysphoric disorder • Adult: PO 50-150 mg nightly Hepatic dose • Adult: PO use lower dose or less fre- quent dosing intervals
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Available forms: Tabs 25, 50, 100 mg; concentrate 20 mg/mL; capsules 25 , 50 , 100 mg
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Administer: • Store at room temperature; do not freeze • Increased fluids, bulk in diet for con- stipation, urinary retention • With food, milk for GI symptoms • Tablets crushed if patient is unable to swallow medication whole • Sugarless gum, hard candy, frequent sips of water for dry mouth • Oral concentration: dilute before use with 4 oz (½ cup) of water, orange juice, ginger ale, or lemon/lime soda; do not mix with other liquids • Avoid use with other CNS depressants • Dropper contains latex
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Assess:
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Evaluate: • Therapeutic response: significant im- provement in depression, OCD, PTSD, PMDD
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That therapeutic effect may take ≥1 wk • To use caution when driving, perform- ing other activities requiring alertness because drowsiness, dizziness, blurred vision may occur • Not to discontinue medication quickly after long-term use; may cause nausea, headache, malaise • To avoid alcohol S • May be taken without regard to food • That follow-up exams will be needed • Serotonin syndrome: agitation, nau- sea, vomiting, diarrhea, twitching, sweating, shivering; report to prescriber immediately
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PHARMACOKINETICS PO: Peak 4.5-8.4 hr; protein binding 98%; distribution to tissues, half-life 26 hr; extensively metabolized; metabolite excreted in urine, bile; weak inhibitor of CYP3A4, moderate inhibitor of CYP2D6
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• Adult/geriatric patient/adolescent (un- labeled): PO 25-50 mg/day; may increase to max of 200 mg/day; do not change dose at intervals of <1 wk; administer daily in AM or PM
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• Adult: PO 25 mg/day, may increase by 50 mg/day after 7 days, range 50-200 mg Premenstrual dysphoric disorder
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• Adult: PO 50-150 mg nightly Hepatic dose
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• Adult: PO use lower dose or less fre- quent dosing intervals
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