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Sertraline Hydrochloride

Class: Selective Serotonin-reuptake Inhibitors
VA Class: CN609
Molecular Formula: C17H17C12N•ClH
CAS Number: 79559-97-0
Brands: Zoloft

Medically reviewed on February 15, 2018

Warning

    Suicidality
  • Antidepressants increased risk of suicidal thinking and behavior (suicidality) compared with placebo 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.1 304 305 344 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 was reduced in adults ≥65 years of age with antidepressants compared with placebo.1 304 305 344

  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.1 304 305 310 344

  • 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.1 304 305 310 344 (See Worsening of Depression and Suicidality Risk under Cautions.)

Introduction

See also: Ingrezza

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

Uses for Sertraline Hydrochloride

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

APA states that effectiveness of antidepressants is generally comparable between and within classes of medications, including SSRIs, SNRIs, TCAs, MAOIs, and other antidepressants (e.g., bupropion, mirtazapine, trazodone).a Choose antidepressant based mainly on patient preference; nature of prior response to medication; safety, tolerability, and anticipated adverse effects; concurrent psychiatric and medical conditions; and specific properties of the medication (e.g., half-life, actions on CYP450 enzymes, other drug interactions).a For most patients, an SSRI, SNRI, mirtazapine, or bupropion is considered optimal.a Consult APA’s Practice Guidelines for the Treatment of Patients with Major Depressive Disorder for additional information.a

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.1 140 160

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

Sertraline Hydrochloride 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 (See Contraindicationsand Serotonin Syndrome or Neuroleptic Malignant Syndrome [NMS]-like Reactions under Cautions and see also Interactions.)

  • 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 34 304 305 310 (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.59 108 110 208 601 Taper dosage gradually and monitor for withdrawal symptoms.59 108 351 601 If intolerable symptoms occur following dosage reduction or discontinuance, consider reinstituting previously prescribed dosage, then resume more gradual dosage reductions.601 (See Withdrawal of Therapy under Cautions.)

  • Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery.1 301 302 316 317 (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 Sertraline Hydrochloride

Contraindications

  • Concomitant use with pimozide or an MAO inhibitor.1 35 207 322 (See Contraindications and Serotonin Syndrome or Neuroleptic Malignant Syndrome [NMS]-like Reactions under Cautions and see also 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 patients with major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs.1 304 305 310 344 345 However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.1 304 305 310 344

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.1 304 305 310 344 (See Boxed Warning and also see Pediatric Use under Cautions.)

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.1 304 310 344 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.1 304 344 If decision is made to discontinue therapy, taper sertraline dosage as rapidly as is feasible but consider risks of abrupt discontinuance.1 304 344 (See General under Dosage and Administration.)

Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.1 304 344

Observe these precautions for patients with psychiatric (e.g., major depressive disorder, OCD) and nonpsychiatric disorders.1 304 344

Bipolar Disorder

May unmask bipolar disorder.304 601 (See Activation of Mania/Hypomania under Cautions.) Sertraline is not approved for use in treating bipolar depression.601

Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.1 304 601

MAO Inhibitors Interaction

Concomitant use of SSRIs and MAO inhibitors associated with serious, sometimes fatal reactions, including hyperthermia, rigidity, myoclonus, autonomic instability, and mental status changes; these reactions have resembled serotonin syndrome or neuroleptic malignant syndrome (NMS).601 (See Contraindications and Serotonin Syndrome or Neuroleptic Malignant Syndrome [NMS]-like Reactions under Cautions and also see Interactions.)

Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions

Potentially life-threatening serotonin syndrome or NMS-like reactions reported with SSRIs and SNRIs, including sertraline, but particularly with concurrent administration of other serotonergic drugs (e.g., 5-HT1 receptor agonists [triptans]), drugs that impair serotonin metabolism (e.g., MAO inhibitors), or antipsychotics or other dopamine antagonists.174 177 178 179 189 198 323 348 349 350 (See Contraindications under Cautions and also see Interactions.)

Symptoms of serotonin syndrome 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).323 348 349 350

Severe serotonin syndrome may resemble NMS, which is characterized by hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuations in vital signs, and mental status changes.348 349 350

Monitor patients receiving sertraline for the development of serotonin syndrome or NMS-like signs and symptoms.348 If such signs and symptoms occur, immediately discontinue treatment with sertraline and any concurrently administered serotonergic or antidopaminergic agents, including antipsychotic agents, and initiate supportive and symptomatic treatment.348

Sensitivity Reactions

Latex Sensitivity

Dropper dispenser provided with Zoloft 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

Withdrawal of Therapy

Withdrawal effects (e.g., dysphoric mood, irritability, agitation, dizziness, sensory disturbances [e.g., paresthesias, such as electric shock sensations], anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania) reported following discontinuance of serotonergic antidepressants, particularly when discontinuance was abrupt.59 108 110 208 601 Events generally self-limiting, but serious cases reported.601

Taper dosage gradually; monitor patients for withdrawal symptoms when discontinuing therapy.59 108 110 208 351 601 If intolerable symptoms occur following dosage reduction or discontinuance, consider reinstituting previously prescribed dosage then resume more gradual dosage reductions.601

Abnormal Bleeding

Possible increased risk of bleeding with SSRIs, including sertraline, and SNRIs; events ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.289 311 312 601 Concomitant use of aspirin, NSAIAs, warfarin, or other anticoagulants may increase risk.83 289 311 312 601 (See Drugs Affecting Hemostasis and Specific Drugs under Interactions.)

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 or SIADH

Possible hyponatremia during treatment with SSRIs, including sertraline, and SNRIs; in many cases, hyponatremia appears to be due to SIADH.23 27 69 125 126 127 128 129 131 132 133 363 601 Increased risk in patients who are volume depleted, elderly, or taking diuretics.23 69 125 126 128 363 601 Initiate appropriate medical intervention and consider drug discontinuance in patients with symptomatic hyponatremia.601

Angle-Closure Glaucoma

SSRIs, including sertraline, may affect pupil size resulting in mydriasis; this effect may narrow the eye angle resulting in increased IOP and angle-closure glaucoma.601 Use with caution in patients with angle-closure glaucoma or history of glaucoma.601

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

Possible complications, sometimes severe and requiring prolonged hospitalization, respiratory support, enteral nutrition, and other forms of supportive care, reported 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 (See General under Dosage and Administration.)

Conflicting findings from available studies evaluating possible risk of persistent pulmonary hypertension of the newborn (PPHN) following in utero exposure to SSRIs; currently unclear whether SSRI use during pregnancy can cause PPHN.600 601 602 603 604 605 606 610

Consult joint APA and ACOG guidelines (at [Web]) for additional information on management of depression in women prior to conception and during pregnancy, including treatment algorithms.600 608

Effect on labor and delivery unknown.601

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 Decreased appetite and weight loss observed with use of SSRIs; monitor weight and growth regularly during long-term sertraline therapy.601

FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during the first few months of antidepressant treatment compared with placebo 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).1 304 344 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.345 No suicides occurred in these pediatric trials.1 304 344

Carefully consider these findings when assessing potential benefits and risks of sertraline for any clinical use.1 304 305 310 345 (See Suicidality in the Boxed Warning and also 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

Clinically important hyponatremia reported in geriatric patients, who may be at increased risk for this adverse effect.23 69 125 126 128 348 363 Some clinicians recommend periodic monitoring (especially during the first several months) of serum sodium concentrations in geriatric patients receiving SSRIs.128 229 359 360 361 (See Hyponatremia or SIADH 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.1 304 305 (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 Sertraline Hydrochloride

Apparently metabolized by multiple CYP isoenzymes, with none contributing more than 40% to overall metabolism.358 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 (See Abnormal Bleeding under Cautions.)

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 interaction (potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions) with serotonergic agents.173 174 175 176 177 189 207 323 601 Avoid such use, or use with caution.179 198 323 601 (See Contraindications and see Serotonin Syndrome or Neuroleptic Malignant Syndrome [NMS]-like Reactions under Cautions.) If serotonin syndrome or NMS occurs, immediately discontinue sertraline and any concurrently administered serotonergic or antidopaminergic agents and initiate supportive and symptomatic treatment.601

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, other SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine) or SNRIs (e.g., desvenlafaxine, duloxetine, milnacipran, venlafaxine)

Potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions601

Concomitant use not recommended601

Antidepressants, tricyclic (TCAs) (e.g., desipramine, imipramine)

Decreased TCA metabolism1 186

Monitor plasma TCA concentrations and adjust dosage as needed1

Antipsychotic agents

Potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions350 601

Clozapine: Increased plasma clozapine concentrations278

Pimozide: Increased plasma pimozide concentrations; risk of QT prolongation1 322

Thioridazine: Increased plasma thioridazine concentrations; risk of serious, potentially fatal, adverse cardiac effects (e.g., cardiac arrhythmias)269

If serotonin syndrome or NMS signs and symptoms occur, immediately discontinue sertraline and any concurrently administered antidopaminergic or serotonergic agents; initiate supportive and symptomatic treatment601

Clozapine: Monitor closely; consider reduction in clozapine dosage278

Pimozide: Concomitant use contraindicated1 322

Thioridazine: Concomitant use not recommended269

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

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

Dopamine antagonists

Potentially life-threatening serotonin syndrome or NMS-like reactions350 601

If serotonin syndrome or NMS signs and symptoms occur, immediately discontinue sertraline and any concurrently administered antidopaminergic or serotonergic agents; initiate supportive and symptomatic treatment601

5-HT1 receptor agonists (triptans; e.g., almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan)

Potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions174 240 323 601

Observe carefully if used concomitantly, particularly during treatment initiation, dosage increases, or when another serotonergic agent is initiated323 601

If serotonin syndrome or NMS signs and symptoms occur, immediately discontinue sertraline and any concurrently administered antidopaminergic or serotonergic agents; initiate supportive and symptomatic treatment601

Isoniazid

Potentially life-threatening serotonin syndrome204

Linezolid

Potentially serious, sometimes fatal serotonin syndrome324 325 342 364 365 366 367 368 369 601

Do not use concurrently;324 consider availability of alternative anti-infectives and weigh benefit of linezolid against risk of serotonin syndrome324

If emergency use of linezolid is considered necessary, immediately discontinue sertraline; monitor closely for symptoms of CNS toxicity for 2 weeks or until 24 hours after the last linezolid dose, whichever comes first324

If nonemergency use of linezolid is planned, withhold sertraline for at least 2 weeks prior to initiating linezolid;324 sertraline may be resumed 24 hours after last linezolid dose324

Do not initiate sertraline in patients receiving linezolid; when necessary, initiate 24 hours after last linezolid dose324

Lithium

Potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions1 174 175 177

Pharmacokinetic interaction unlikely1

Use with caution1

Monitor serum lithium concentrations; adjust dosage accordingly1

If serotonin syndrome or NMS signs and symptoms occur, immediately discontinue sertraline and any concurrently administered antidopaminergic or serotonergic agents; initiate supportive and symptomatic treatment601

MAO inhibitors (e.g., moclobemide [not commercially available in the US], selegiline)

Potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions1 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

Methylene blue

Increased risk of serotonin syndrome370 371

Generally avoid concurrent use370

In emergencies necessitating immediate use of methylene blue, consider availability of alternative interventions and weigh benefits of methylene blue against risk of serotonin syndrome370

If emergency use of methylene blue is considered necessary, immediately discontinue sertraline and monitor closely for symptoms of CNS toxicity for 2 weeks or until 24 hours after last methylene blue dose, whichever comes first370

If nonemergency use of methylene blue is planned, withhold sertraline for at least 2 weeks prior to administering methylene blue;370 sertraline may be resumed 24 hours after last methylene blue dose370

Do not initiate sertraline in patient receiving methylene blue; when necessary, initiate 24 hours after last methylene blue dose370

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

Propranolol

Pharmacokinetic interaction unlikely1 83

Sibutramine (no longer commercially available in US)

Potentially life-threatening serotonin syndrome or NMS-like reactions177 196 323 330 331

Use with caution323 348 356

St. John's Wort (Hypericum perforatum)

Potentially life-threatening serotonin syndrome or NMS-like reactions601

Avoid concomitant use, or use with caution601

If serotonin syndrome or NMS signs and symptoms occur, immediately discontinue sertraline and any concurrently administered antidopaminergic or serotonergic agents; initiate supportive and symptomatic treatment601

Tolbutamide

Decreased tolbutamide clearance1 138

Clinical importance unknown1

Tramadol

Potentially life-threatening serotonin syndrome or NMS-like reactions601

Use concomitantly with caution601

If serotonin syndrome or NMS signs and symptoms occur, immediately discontinue sertraline and any concurrently administered antidopaminergic or serotonergic agents; initiate supportive and symptomatic treatment601

Tryptophan and other serotonin precursors

Potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions601

Concomitant use not recommended601

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

Sertraline Hydrochloride 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.358

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

Actions

  • 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 dopamine1 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

  • Importance of providing copy of written patient information (medication guide) each time sertraline is dispensed.304 305 310 601 Importance of advising patients to read the patient information before taking sertraline and each time the prescription is filled.601

  • 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.304 305 310 601 (See Worsening of Depression and Suicidality Risk under Cautions.)

  • Importance of instructing patients not to take sertraline with an MAO inhibitor or within 14 days of stopping the drug, and vice versa.601

  • Importance of informing patients of potential risk of serotonin syndrome and neuroleptic malignant syndrome (NMS)-like reactions, particularly with concurrent use of sertraline and 5-HT1 receptor agonists (also called triptans), tramadol, tryptophan, other serotonergic agents, or antipsychotic agents.323 601 Importance of immediately contacting clinician if signs and symptoms of these syndromes develop (e.g., agitation, hallucinations, coma, mental status changes, loss of coordination, muscle twitching, fast heart beat, increased or decreased BP, sweating, increased body temperature, muscle rigidity, diarrhea, nausea, vomiting, confusion).323 601

  • Risk of cognitive and motor impairment, importance of exercising caution while operating hazardous machinery, including automobile driving, until patients gain experience with the drug’s effects.601

  • Importance of patients being aware that withdrawal effects may occur when stopping sertraline, especially with abrupt discontinuance of the drug.601

  • Importance of informing patients that if they receive diuretics, or are otherwise volume-depleted, or are elderly, that they may be at greater risk of developing hyponatremia during sertraline therapy.601

  • Risks associated with concomitant use with alcohol; concomitant use not recommended.601

  • 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

  • Importance of advising patients, their families, and caregivers to observe sertraline-treated patients for signs of activation of mania/hypomania.601

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

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription (e.g., pimozide, MAO inhibitors) and OTC drugs or herbal supplements, as well as any concomitant illnesses or personal or family history of suicidality or bipolar disorder.601 Importance of advising patients about the risk of bleeding associated with concomitant use of sertraline with aspirin or other NSAIAs, warfarin, or other drugs that affect coagulation.601

  • 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.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* 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*

Sertraline Hydrochloride Oral Solution

Zoloft (with calibrated dropper dispenser containing latex rubber)

Pfizer

Tablets, film-coated

25 mg (of sertraline)*

Sertraline Hydrochloride Tablets

Zoloft (scored)

Pfizer

50 mg (of sertraline)*

Sertraline Hydrochloride Tablets

Zoloft (scored)

Pfizer

100 mg (of sertraline)*

Sertraline Hydrochloride Tablets

Zoloft (scored)

Pfizer

150 mg (of sertraline)*

Sertraline Hydrochloride Tablets

Ranbaxy

200 mg (of sertraline)*

Sertraline Hydrochloride Tablets

Ranbaxy

AHFS DI Essentials. © Copyright 2018, Selected Revisions February 15, 2013. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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