Zoloft

Generic Name: Sertraline Hydrochloride
Class: Selective Serotonin-reuptake Inhibitors
VA Class: CN609
Molecular Formula: C₁₇H₁₇C₁₂N•ClH
CAS Number: 79559-97-0

• 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.^{e f} Sertraline is not approved for use in pediatric patients except for patients with obsessive-compulsive disorder.^{1 235} (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.^{e f}

  
  


• 
  

  Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.^{e f g}

  
  


• 
  

  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.^{1 e f g} (See Worsening of Depression and Suicidality Risk under Cautions.)

  
  

Introduction

Antidepressant; selective serotonin-reuptake inhibitor (SSRI).^{1 2 3}

Uses for Zoloft

Major Depressive Disorder

Management of major depressive disorder.^{1 3 4 5 10 11 33 59 62 148 149 150 151 152 158 159 339 341}

Efficacy in hospital settings not established.¹

Obsessive-Compulsive Disorder (OCD)

Management of OCD; reduces but does not completely eliminate obsessions and compulsions.^{1 29 156 235 236}

Panic Disorder

Management of panic disorder with or without agoraphobia.¹

Posttraumatic Stress Disorder (PTSD)

Management of PTSD;^{1 2 268 270} more effective in women than in men.¹

Not effective for combat- or war-related PTSD.^{2 255}

Premenstrual Dysphoric Disorder (PMDD)

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.^{1 140}

Efficacy when used in conjunction with oral contraceptives for the treatment of PMDD is unknown.^{1 140}

Social Phobia

Management of social phobia (social anxiety disorder).^{1 281 282}

Premature Ejaculation

Has been used in the management of premature ejaculation†.^{67 217 218 219}

Vascular Headaches

Has been used in the management of vascular headaches† with equivocal efficacy.^{220 221}

Zoloft Dosage and Administration

General

• 
  

  Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of sertraline and vice versa.^{1 207} A washout period also is advisable when transferring from another antidepressant (e.g., fluoxetine) to sertraline.^{104 105 111 157 229}

  
  


• 
  

  Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.^{1 e f g} (See Worsening of Depression and Suicidality Risk under Cautions.)

  
  


• 
  

  Sustained therapy may be required; monitor periodically for need for continued therapy.¹

  
  


• 
  

  Avoid abrupt discontinuance of therapy.^{1 59 108 110 208} To avoid withdrawal reactions, taper dosage gradually.^{1 59 108} (See Worsening of Depression and Suicidality Risk under Cautions.)

  
  


• 
  

  Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery.^{1 301 302 316 317} (See Fetal/Neonatal Morbidity and Mortality and also see Pregnancy under Cautions.)

  
  

Administration

Oral Administration

Administer orally once daily (morning or evening).^{1 3 4 5}

With oral concentrate solution, measure doses carefully using the calibrated dropper provided by the manufacturer.¹ (See Sensitivity Reactions under Cautions.) Oral concentrate solution must be diluted just prior to administration.¹ 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.¹

Dosage

Available as sertraline hydrochloride; dosage is expressed in terms of sertraline.¹

Pediatric Patients

OCD

Oral

Children 6–12 years of age: Initially, 25 mg once daily.¹

Adolescents 13–17 years of age: Initially, 50 mg once daily.¹

Dosage may be increased at weekly intervals according to clinical response.^{1 3 5 235}

Avoid excessive dosages in children.¹

Optimum duration not established; may require several months of therapy or longer.¹

Adults

Major Depressive Disorder

Oral

Initially, 50–100 mg once daily.^{1 3 4 5 59 239} Dosage may be increased at weekly intervals according to clinical response.^{1 3 5 239}

Optimum duration not established; may require several months of therapy or longer.¹

OCD

Oral

Initially, 50 mg once daily.¹ Dosage may be increased at weekly intervals according to clinical response.^{1 3 5 235}

Optimum duration not established; may require several months of therapy or longer.¹

Panic Disorder

Oral

Initially, 25 mg once daily.¹ After 1 week, increase to 50 mg once daily.¹ Dosage may be increased at weekly intervals according to clinical response.¹

Optimum duration not established; may require several months of therapy or longer.¹

PTSD

Oral

Initially, 25 mg once daily.¹ After 1 week, increase to 50 mg once daily.¹ Dosage may then be increased at weekly intervals according to clinical response.¹

Optimum duration not established; may require several months of therapy or longer.¹

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).¹

Dosage may be increased in 50-mg increments at the onset of each new menstrual cycle.¹

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.¹

Optimum duration not established; periodically assess need for dosage adjustment and continued therapy.¹

Social Phobia

Oral

Initially, 25 mg once daily.³⁰⁴ After 1 week, increase to 50 mg once daily.³⁰⁴ Dosage may be increased at weekly intervals according to clinical response.³⁰⁴

Optimum duration not established; may require several months of therapy or longer.¹

Premature Ejaculation†

Oral

25–50 mg daily.²⁷² Alternatively, 25–50 mg daily on an “as needed” basis.²⁷²

Prescribing Limits

Pediatric Patients

OCD

Oral

Maximum 200 mg daily.^{1 3 5}

Adults

Major Depressive Disorder

Oral

Maximum 200 mg daily.¹

OCD

Oral

Maximum 200 mg daily.^{1 3 5}

Panic Disorder

Oral

Maximum 200 mg daily.¹

PTSD

Oral

Maximum 200 mg daily.¹

PMDD

Oral

Maximum 150 mg daily when administered continuously or 100 mg daily when administered during the luteal phase only.¹

Social Phobia

Oral

Maximum 200 mg daily.¹

Special Populations

Hepatic Impairment

Decreased clearance;^{1 83 137} lower dosages or less frequent administration recommended.¹

Renal Impairment

No dosage adjustments needed.¹ Not substantially removed by dialysis; supplemental doses may be unnecessary after dialysis.^{1 83 185}

Cautions for Zoloft

Contraindications

• 
  

  Concomitant use with pimozide or an MAO inhibitor.^{1 35 207 322} (See Interactions.)

  
  


• 
  

  Concomitant use of sertraline oral concentrate solution (contains alcohol 12%) and disulfiram or other agents likely to produce disulfiram-like reactions (e.g., metronidazole).¹

  
  


• 
  

  Known hypersensitivity to sertraline or any ingredient in the formulation.¹

  
  

Warnings/Precautions

Warnings

Worsening of Depression and Suicidality Risk

Possible worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patientswith major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs.^{1 e f g h} However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.^{e f g}

Appropriately monitor and closely observe patients receiving sertraline for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.^{e f g} (See Boxed Warning and also see Pediatric Use under Cautions.)

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or maniamay be precursors to emerging suicidality.^{f g} Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.^{e f g} If decision is made to discontinue therapy, taper sertraline dosage as rapidly as is feasible but consider risks of abrupt discontinuance.^{1 f} (See General under Dosage and Administration.)

Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.^{1 f}

Observe these precautions for patients with psychiatric (e.g., major depressive disorder, OCD) and nonpsychiatric disorders.^{1 f}

Drug Interactions

Concomitant use with MAO inhibitors associated with serious, sometimes fatal reactions, including manifestations resembling serotonin syndrome (e.g., hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes) or neuroleptic malignant syndrome (NMS).¹ (See Serotonin Syndrome under Cautions and also see Contraindications.)

Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported during concurrent therapy with SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs) and other serotonergic drugs (e.g., 5-HT₁ receptor agonists [“triptans”]) or drugs that impair serotonin metabolism (e.g., MAO inhibitors).^{1 323} Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).^{1 323} (See Interactions.)

Bipolar Disorder

May unmask bipolar disorder.^{1 f} (See Activation of Mania/Hypomania under Cautions.) Sertraline is not approved for use in treating bipolar depression.^a

Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.^{1 f}

Fetal/Neonatal Morbidity and Mortality

Possible complications, sometimes severe and requiring prolonged hospitalization, respiratory support, enteral nutrition, and other forms of supportive care, in neonates exposed to sertraline, other SSRIs, or SNRIs late in the third trimester; may arise immediately upon delivery.^{1 301 302 314 315 316 317 318}

Increased risk of persistent pulmonary hypertension of the newborn (PPHN) in infants exposed to SSRIs during late pregnancy; PPHN is associated with substantial neonatal morbidity and mortality.^{1 324 326}

Carefully consider potential risks and benefits of treatment when used during third trimester of pregnancy.^{1 301 302 316 317 324 326} Consider cautiously tapering dosage during third trimester prior to delivery.^{1 301 302 316 317} (See Pregnancy under Cautions.)

Sensitivity Reactions

Latex Sensitivity

Dropper dispenser provided with oral concentrate solution contains natural latex proteins in the form of dry natural rubber; possible sensitivity reactions in susceptible individuals.¹

General Precautions

Activation of Mania/Hypomania

Possible activation of mania or hypomania.^{1 7 12 28 34 35 59 167} Use with caution in patients with history of mania or hypomania.^{1 4 59 60} (See Bipolar Disorder under Cautions.)

Weight Loss

Possible anorexia and weight loss.^{1 8 10 11 33 35} Use with caution in patients who may be adversely affected (e.g., underweight patients).¹

Seizures

Limited experience in patients with a history of seizures; use with caution in such patients.¹

Uricosuric Effect

Decrease in serum uric acid concentrations possible.¹ Use with caution in patients who may be adversely affected (e.g., those at risk for acute renal failure).⁶⁰

Concomitant Illnesses

Experience in patients with concomitant diseases is limited.¹ Patients with recent history of MI or unstable heart disease generally were excluded from premarketing clinical studies, but a postmarketing controlled study suggests that sertraline therapy is well tolerated in these patients.^{1 313}

Use with caution in patients with altered metabolism or hemodynamics.¹

Hyponatremia

Reported principally in geriatric patients, those receiving concomitant therapy with a diuretic, and in volume depleted patients; reversible following discontinuance of the drug.^{1 23 27 69} May be due to SIADH secretion.¹ Monitor serum sodium concentration periodically in geriatric patients.^{128 229}

Abnormal Bleeding

Possible increased risk of bleeding, including upper GI bleeding;^{1 289 311 312} use with caution.¹

Concomitant use of an NSAIA (e.g., aspirin) or warfarin may potentiate such risk.^{1 83 289 311 312} (See Interactions.)

Endocrine Effects

Possible hypothyroidism, elevated serum thyrotropin, and/or reduced serum thyroxine concentrations.^{81 96 97} Monitor thyroid function periodically in patients with thyroid disease.⁹⁷

Electroconvulsive Therapy (ECT)

Effects of concomitant use with ECT have not been systematically evaluated.¹

Specific Populations

Pregnancy

Category C.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Increased risk of depression relapse observed in women who discontinued antidepressant therapy during pregnancy compared with those who remained on antidepressant therapy.^{1 324 326}

Lactation

Distributed into milk;^{99 216} use with caution.¹

Pediatric Use

Safety and efficacy for OCD not established in children <6 years of age.^{1 235}

Safety and efficacy for other disorders (e.g., major depressive disorder, panic disorder, PTSD, PMDD, social phobia) not established in pediatric patients.^{1 304} Results of 2 placebo-controlled trials in children and adolescents with major depressive disorder did not support a claim of efficacy for use of sertraline in pediatric patients with this condition.¹

Adverse effect profile generally similar to that seen in adults.¹ Weight loss, usually slight, reported in children and adolescents receiving sertraline for major depressive disorder; manufacturer recommends periodic monitoring of weight and growth during long-term therapy with sertraline and other SSRIs.¹

FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, OCD, or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).^{1 f} However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.^h No suicides occurred in these pediatric trials.^{1 f h}

Carefully consider these findings when assessing potential benefits and risks of sertraline for any clinical use.^{1 e f g h} (See Worsening of Depression and Suicidality Risk under Cautions.)

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.^{1 10 12} (See Hyponatremia under Cautions.)

In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.^{e f} (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Hepatic Impairment

Decreased clearance; use with caution.^{1 137} (See Hepatic Impairment under Dosage and Administration.)

Common Adverse Effects

Nausea, diarrhea/loose stools, dyspepsia, dry mouth, somnolence, dizziness, insomnia, tremor, ejaculatory delay, sweating.^{1 3 4 5 12}

Adverse effects in children are similar to those reported in adults.¹ (See Pediatric Use under Cautions.)

Interactions for Zoloft

Apparently metabolized by multiple CYP isoenzymes, with none contributing more than 40% to overall metabolism.^c Inhibits CYP2D6 and 3A4, but less potent as an inhibitor than many other drugs.¹

Drugs Metabolized by Hepatic Microsomal Enzymes

Potential pharmacokinetic interactions (increased plasma concentrations of CYP2D6 substrates).¹

Clinically important pharmacokinetic interactions with substrates of 3A4 unlikely.^{1 100}

Drugs Affecting Hepatic Microsomal Enzymes

Clinically important pharmacokinetic interactions with inhibitors or inducers of CYP2D6 or 3A4 unlikely.^{1 100}

Drugs Affecting Hemostasis

Potential pharmacologic interaction (increased risk of bleeding) with concomitant use of drugs that affect hemostasis.^{1 83 289 311 312} Use with caution.¹

Protein-bound Drugs

Potential for displacement of sertraline or other protein-bound drugs from binding sites.¹ Monitor patients for potential adverse effects.¹

Drugs Associated with Serotonin Syndrome

Potential pharmacologic (serotonin syndrome) interaction with serotonergic agents.^{1 173 174 175 176 177 189 207 323} Avoid such use, or use with caution.^{1 179 198 323} (See Serotonin Syndrome under Cautions.)

Specific Drugs

Drug	Interaction	Comments
Alcohol	Does not potentiate cognitive and motor effects of alcohol1 3 19 34 35 83 146	Concomitant use not recommended1
Antiarrhythmic agents (e.g., encainide, flecainide, propafenone)	Potential for increased plasma antiarrhythmic concentrations; may result in increased risk of serious, potentially fatal, adverse cardiac effects (e.g., cardiac arrhythmias)1 100	Adjust dosages as needed1
Antidepressants, tricyclic (TCAs) (e.g., desipramine, imipramine)	Decreased TCA metabolism1 186	Monitor plasma TCA concentrations and adjust dosage as needed1
Atenolol	β-adrenergic blocking activity not affected by sertraline1 83 84
Benzodiazepines (e.g., diazepam)	Decreased diazepam clearance1 136
Carbamazepine	Pharmacokinetic interaction unlikely1
Cimetidine	Increased AUC, peak concentration, and elimination half-life of sertraline1
Cisapride	Increased cisapride metabolism1	Clinical importance unlikely 1
Clozapine	Increased plasma clozapine concentrations278	Monitor closely; consider reduction in clozapine dosage278
Digoxin	No change in digoxin pharmacokinetics1 83 172
Disulfiram or other agents likely to produce disulfiram-like reactions (e.g., metronidazole)	Possible disulfiram reaction due to alcohol content in sertraline oral concentrate solution1	Concomitant use with sertraline oral concentrate contraindicated1
Fluoxetine	Potential for serotonin syndrome104 105 111 157	Allow appropriate period of time to elapse between discontinuance of fluoxetine and initiation of sertraline and vice versa104 105 111 157
5-HT1 receptor agonists (“triptans”)	Potentially life-threatening serotonin syndrome1 174 240 323	Observe carefully if used concomitantly, particularly during treatment initiation, dosage increases, or when another serotonergic agent is initiated1 323
Isoniazid	Potential for serotonin syndrome204
Linezolid	Possible serotonin syndrome1 342	Use with caution1
Lithium	Possible serotonin syndrome1 174 175 177 Pharmacokinetic interaction unlikely1	Use with caution1 Monitor serum lithium concentrations; adjust dosage accordingly1
MAO inhibitors (e.g., moclobemide [not commercially available in the US], selegiline)	Potentially fatal serotonin syndrome or NMS1 174 177 189 192 208	Concomitant use contraindicated1 Allow at least 2 weeks to elapse between discontinuance of MAO inhibitor and initiation of sertraline and vice versa1 189 207
NSAIAs (e.g., aspirin)	Increased risk of bleeding1 289 311 312	Use with caution1
Phenytoin	No change in phenytoin pharmacokinetics or pharmacodynamics observed in one study1 135 However, potential increase in plasma phenytoin concentrations and subsequent toxicity reported with sertraline and other SSRIs336 Decreased plasma sertraline concentrations reported during concurrent phenytoin therapy337	Monitor plasma phenytoin concentrations and adjust phenytoin dosage as necessary, particularly in patients with multiple medical conditions and/or those receiving multiple medications concomitantly 1 336
Pimozide	Increased plasma pimozide concentrations; risk of QT prolongation1 322	Concomitant use contraindicated1 322
Propranolol	Pharmacokinetic interaction unlikely1 83
Sibutramine	Possible serotonin syndrome177 196 323 330 331	Use with caution323
SSRIs and SNRIs	Possible serotonin syndrome1	Avoid concomitant use1
Thioridazine	Increased plasma thioridazine concentrations; risk of serious, potentially fatal, adverse cardiac effects (e.g., cardiac arrhythmias)269	Concomitant use not recommended269
Tolbutamide	Decreased tolbutamide clearance1 138	Clinical importance unknown1
Tramadol	Possible serotonin syndrome1	Use with caution1
Tryptophan and other serotonin precursors	Possible serotonin syndrome1	Concomitant use not recommended1
Valproic acid	Possible interaction not systematically evaluated1	Monitor plasma valproate concentrations and adjust valproic acid dosage accordingly1
Warfarin	Possible increased PT and risk of bleeding1 83	Use with caution1 Monitor PT whenever sertraline is initiated or discontinued1 83

Zoloft Pharmacokinetics

Absorption

Bioavailability

Oral bioavailability in humans has not been fully elucidated to date,^{1 4} but ranges from 22–36% in animals.^{4 95}

Commercially available tablets and oral concentrate solution are bioequivalent.¹

Food

Food increases the extent of absorption.^{1 3}

Distribution

Extent

Crosses the blood-brain barrier.³

Distributes into breast milk.^{1 99 216}

Plasma Protein Binding

Approximately 98% bound to plasma proteins, principally to albumin and α₁-acid glycoprotein.^{1 3 4 5 95}

Elimination

Metabolism

Extensively metabolized, probably in the liver to N-desmethylsertraline and several other metabolites.^{1 3 5 19 100 225} Apparently metabolized by multiple CYP isoenzymes, with none contributing more than 40% to overall metabolism.^c

N-Desmethylsertraline is approximately 5–10 times less potent an inhibitor of serotonin reuptake than sertraline.^{1 76 100}

Elimination Route

Excreted in both urine and feces.^{1 5}

Half-life

Averages approximately 25–26 hours for sertraline and 62–104 hours for N-desmethylsertraline.^{1 3 5}

Special Populations

Because sertraline is extensively metabolized by the liver, hepatic impairment can affect the elimination of the drug.^{1 83 137}

No clinically important decreases in sertraline clearance observed in patients with renal impairment.¹

Geriatric patients may have reduced sertraline plasma clearance.¹

Stability

Storage

Oral

Concentrate Solution or Tablets

25°C (may be exposed to 15–30°C).¹

ActionsActions

• 
  

  Mechanism of action as an antidepressant is presumed to be linked to potentiation of serotonergic activity in the CNS resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).^{1 3 19 59 62 75 76 82 88 93}

  
  


• 
  

  Has very weak effects on the reuptake of norepinephrine or dopamine^{1 3 76} and does not exhibit clinically important anticholinergic, antihistaminic, or adrenergic (α₁, α₂, β) blocking activity at usual therapeutic dosages.^{1 3 82 88}

  
  

Advice to Patients

• 
  

  Risk of suicidality; importance of patients, family, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.^{1 e f g} FDA recommends providing written patient information (medication guide) explaining risks of suicidality each time the drug is dispensed.^{1 e f g}

  
  


• 
  

  Although not shown to affect psychomotor performance in healthy individuals, importance of exercising caution while operating hazardous machinery, including automobile driving, until gain experience with the drug’s effects in the individual patient.¹

  
  


• 
  

  Risks associated with concomitant use with alcohol; concomitant use not recommended.¹

  
  


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  Importance of continuing sertraline therapy even if improvement is evident within 1–4 weeks, unless directed otherwise by their clinician.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


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  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.¹

  
  


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  Importance of informing patients of risk of serotonin syndrome with concurrent use of sertraline and 5-HT₁ receptor agonists (“triptans”) or other serotonergic agents.^{1 323} Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.^{1 323}

  
  


• 
  

  Importance of diluting oral concentrate solution with appropriate liquid just prior to administration.¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Sertraline Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	For solution, concentrate	20 mg (of sertraline) per mL*	Zoloft (with alcohol 12%; with calibrated dropper dispenser containing latex rubber)	Pfizer
	Tablets, film-coated	25 mg (of sertraline)*	Zoloft (scored)	Pfizer
		50 mg (of sertraline)*	Zoloft (scored)	Pfizer
		100 mg (of sertraline)*	Zoloft (scored)	Pfizer

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Sertraline HCl 100MG Tablets (GREENSTONE): 30/$15.99 or 90/$29.97

Sertraline HCl 20MG/ML Concentrate (GREENSTONE): 60/$59.99 or 180/$159.98

Sertraline HCl 25MG Tablets (GREENSTONE): 30/$19.99 or 90/$35.98

Sertraline HCl 50MG Tablets (GREENSTONE): 30/$14.99 or 90/$22.97

Zoloft 100MG Tablets (PFIZER U.S.): 30/$131.99 or 90/$361.95

Zoloft 20MG/ML Concentrate (PFIZER U.S.): 60/$108.44 or 180/$310.74

Zoloft 25MG Tablets (PFIZER U.S.): 30/$124.99 or 90/$367.97

Zoloft 50MG Tablet