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Citalopram Hydrobromide

Pronunciation

Class: Selective Serotonin-reuptake Inhibitors
VA Class: CN609
Chemical Name: 1-[3-(Dimethylamino)-propyl]-1-(p-fluorophenyl)-5-phthalancarbonitrile
Molecular Formula: C20H21FN2O
CAS Number: 59729-33-8
Brands: Celexa

Warning(s)

  • 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.370 371 399 Citalopram is not approved for use in pediatric patients.399 (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.370 371 399

  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.370 371 376 399

  • Appropriately monitor and closely observe all patients who are started on citalopram therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.370 371 376 399 (See Worsening of Depression and Suicidality Risk under Cautions.)

Introduction

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

Uses for Citalopram Hydrobromide

Major Depressive Disorder

Management of major depressive disorder.1 62 69 78 89 99 116 117 118 119 120 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 136 137 138 140 141 142 163 187 341 361

Slideshow: Depression, the Risk of Suicide, and Treatment Options

Manufacturers state efficacy in hospital settings not established.1 399 However, efficacy has been demonstrated in hospitalized patients with depression, including severe depression,124 162 in several studies.62 69 99 120 121 122 123 124 125 126 162

APA states that effectiveness of antidepressants is generally comparable between and within classes of medications, including SSRIs, SNRIs, TCAs, MAO inhibitors, 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 CYP isoenzymes, 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

Has been used in the management of obsessive-compulsive disorder.172 173 174 175 176 183 184 186

Panic Disorder

Has been used in the management of panic disorder with or without agoraphobia.28 29 174 189 288 289

Social Phobia

Has been used in the management of social phobia (social anxiety disorder).350 351 352 353 354 355

Alcohol Dependence

Has been used in the management of alcohol dependence.40 42 43 44 45 46 47

Premenstrual Dysphoric Disorder

Has been used in the management of premenstrual dysphoric disorder (previously late luteal phase dysphoric disorder).181 182

Premature Ejaculation

Has been used for the management of premature ejaculation.273

May be less effective than some other SSRIs (e.g., paroxetine).273

Eating Disorders

Has been used in the management of bulimia nervosa or anorexia nervosa with equivocal efficacy.15 16

Diabetic Neuropathy

Has been used in the management of diabetic neuropathy.279 280

Posttraumatic Stress Disorder

Has been used in a limited number of adults with civilian- or combat-related posttraumatic stress disorder (PTSD).281 282

Citalopram Hydrobromide Dosage and Administration

General

  • Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of citalopram, and vice versa.399 (See Contraindications and also see Serotonin Syndrome or Neuroleptic Malignant Syndrome-like Reactions under Cautions.)

  • Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.370 371 376 399 (See Worsening of Depression and Suicidality Risk under Cautions.)

  • Correct hypokalemia and hypomagnesemia, if present, prior to initiating citalopram therapy; periodically monitor electrolytes during therapy as needed.399 416 (See QT-interval Prolongation and Torsades de Pointes under Cautions.)

  • Avoid abrupt discontinuance.13 14 17 399 Taper dosage gradually and monitor for withdrawal symptoms.13 14 17 399 407 If intolerable symptoms occur following dosage reduction or discontinuance, consider reinstituting previously prescribed dosage, then resume more gradual dosage reductions.399 (See Withdrawal of Therapy under Cautions.)

  • Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery.212 213 380 381 382 383 399 (See Pregnancy under Cautions.)

Administration

Oral Administration

Administer orally once daily (morning or evening) without regard to meals.1

Dosage

Available as citalopram hydrobromide; dosages expressed in terms of citalopram.1

Adults

Major Depressive Disorder
Oral

Recommended initial dosage is 20 mg once daily, with an increase to a maximum dosage of 40 mg once daily at an interval of not <1 week.399 424 Although prescribing information previously stated that certain patients may require 60 mg daily, dosages >40 mg once daily no longer are recommended because of risk of QT-interval prolongation and because they provide no additional therapeutic benefit.399 416 417 424 (See QT-interval Prolongation and Torsades de Pointes under Cautions.)

Optimum duration not established; may require several months of therapy or longer.13 107 108 109 110 111 112 113 187 399 Periodically reassess need for continued therapy.399

Obsessive-Compulsive Disorder
Oral

Initially, 20 mg once daily.172 173 174 183 Gradually increase dosage according to clinical response.172 173 174 183

Maintenance dosages of 40–60 mg daily have been used;21 172 173 174 183 however, dosages >40 mg once daily no longer recommended due to risk of QT-interval prolongation.399 416 417 424 (See QT-interval Prolongation and Torsades de Pointes under Cautions.)

Panic Disorder
Oral

Usual initial dosage: 10 mg daily.174 Increase dosage after ≥1 week in 10- or 20-mg increments up to a dosage of 20–40 mg daily, depending on individual patient response and tolerability.28 29 174 288 289

Usual maintenance dosage: 20–30 mg daily.28 29 289 Dosages >40 mg once daily no longer recommended due to risk of QT-interval prolongation.399 416 417 424 (See QT-interval Prolongation and Torsades de Pointes under Cautions.)

Prescribing Limits

Adults

Oral

Maximum recommended dosage is 40 mg once daily.399 416 417 424 (See QT-interval Prolongation and Torsades de Pointes under Cautions.)

Special Populations

Hepatic Impairment

Major Depressive Disorder
Oral

Maximum recommended dosage is 20 mg once daily.399 424 (See QT-interval Prolongation and Torsades de Pointes under Cautions.)

Renal Impairment

Major Depressive Disorder
Oral

No dosage adjustment necessary in patients with mild to moderate renal impairment.1 Dosage adjustment may not be necessary in patients with severe renal impairment, but caution is recommended.88 399 (See Elimination: Special Populations, under Pharmacokinetics.)

Geriatric Patients

In patients >60 years of age, maximum recommended dosage is 20 mg once daily.399 424 (See QT-interval Prolongation and Torsades de Pointes under Cautions.)

Poor CYP2C19 Metabolizers or Patients Receiving CYP2C19 Inhibitors

Maximum recommended dosage is 20 mg once daily.399 416 424 (See QT-interval Prolongation and Torsades de Pointes under Cautions and also see Interactions.)

Cautions for Citalopram Hydrobromide

Contraindications

  • Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor.399 (See Serotonin Syndrome or Neuroleptic Malignant Syndrome-like Reactions under Cautions and also see Specific Drugs under Interactions.)

  • Concurrent pimozide therapy.1 (See Interactions.)

  • Known hypersensitivity to citalopram, escitalopram, or any ingredient in the formulation.1 348 349 403

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.370 371 376 399 However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.370 371 376

Appropriately monitor and closely observe patients receiving citalopram for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.370 371 376 399 (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.370 376 399 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.370 371 376 399 If decision is made to discontinue therapy, taper citalopram dosage as rapidly as is feasible but consider risks of abrupt discontinuance.370 399 (See General under Dosage and Administration.)

Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.370 399

Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder) or nonpsychiatric disorders.370 399

QT-interval Prolongation and Torsades de Pointes

Causes dose-dependent QTc-interval prolongation; postmarketing cases of torsades de pointes, ventricular tachycardia, and sudden death reported.399 416 417 418 419 420 421 424

Do not use citalopram dosages >40 mg daily.399 416 417 424 Use not recommended in patients with congenital long QT syndrome, bradycardia, hypokalemia or hypomagnesemia, recent AMI, or uncompensated heart failure.399 424 Do not use in patients receiving other drugs known to prolong the QTc interval.399 424 (See Interactions.)

Maximum dosage of 20 mg daily in patients who are poor metabolizers of CYP2C19 and in patients receiving a CYP2C19 inhibitor, patients with hepatic impairment, and in patients >60 years of age since higher citalopram exposures increase risk of QT-interval prolongation and torsades de pointes.399 424

In patients at risk for clinically important electrolyte disturbances, obtain baseline and periodic serum potassium and magnesium measurements.399 424 Correct hypokalemia and/or hypomagnesemia before citalopram administration because of increased risk of QTc-interval prolongation and arrhythmias.399 416 424 ECG monitoring recommended in patients in whom citalopram is not recommended but considered essential (e.g., patients with cardiac conditions mentioned above, those receiving other drugs known to prolong the QTc interval).399 424

Discontinue citalopram in patients with persistent QTc measurements >500 msec.399 424 If patient experiences symptoms indicating cardiac arrhythmias (e.g., dizziness, palpitations, syncope), initiate further evaluation, including cardiac monitoring.399 424

Bipolar Disorder

May unmask bipolar disorder.1 370 (See Activation of Mania or Hypomania under Cautions.) Citalopram is not approved for use in treating bipolar depression.1

Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.1 370

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).1 316 317 (See Contraindications and also see Serotonin Syndrome or Neuroleptic Malignant Syndrome-like Reactions under Cautions.)

Serotonin Syndrome or Neuroleptic Malignant Syndrome-like Reactions

Potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions reported with SSRIs and SNRIs alone, including citalopram, 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.253 316 317 386 399 400 408 (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).316 317 386 399 400 408

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.399 400 408

Monitor patients receiving citalopram for the development of serotonin syndrome or NMS-like signs and symptoms.399 If such signs and symptoms occur, immediately discontinue treatment with citalopram and any concurrently administered serotonergic or antidopaminergic agents, including antipsychotic agents, and initiate supportive and symptomatic treatment.399

Sensitivity Reactions

Hypersensitivity Reactions

Possible anaphylaxis, allergic reactions, and angioedema.1

If hypersensitivity reaction occurs, discontinue immediately and institute appropriate therapy as indicated.1

General Precautions

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.17 212 218 219 220 221 223 224 225 226 227 228 229 230 231 232 233 234 235 399 Events generally self-limiting, but serious cases reported.17 205 225 229 230 232 399

Taper dosage gradually; monitor patients for withdrawal symptoms when discontinuing therapy.13 14 17 399 407 If intolerable symptoms occur following dosage reduction or discontinuance, consider reinstituting previously prescribed dosage then resume more gradual dosage reductions.399

Abnormal Bleeding

Possible increased risk of bleeding with SSRIs, including citalopram, and SNRIs; events ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages.54 55 205 283 284 285 287 377 378 399 Concomitant use of aspirin, NSAIAs, warfarin, or other anticoagulants may increase risk.54 55 377 399 (See Drugs Affecting Hemostasis under Interactions and also see Advice to Patients.)

Hyponatremia or SIADH

Possible hyponatremia during treatment with SSRIs, including citalopram, and SNRIs; in many cases, hyponatremia appears to be due to SIADH.8 9 206 207 208 344 363 399 Increased risk in patients who are volume depleted, elderly, or taking diuretics.201 202 203 204 205 208 209 210 344 363 399 Initiate appropriate medical intervention and consider drug discontinuance in patients with symptomatic hyponatremia.399

Activation of Mania or Hypomania

Possible activation of mania/hypomania; use with caution in patients with a history of mania.1 236 237 327 (See Bipolar Disorder under Cautions.)

Seizures

Risk of seizures not systematically evaluated; use with caution in patients with a history of seizure disorder.1

Cognitive/Physical Impairment

Citalopram did not impair intellectual function or psychomotor performance in healthy individuals.399 However, any psychoactive drug may impair judgment, thinking, or motor skills.399 (See Advice to Patients.)

Concomitant Disease

Limited experience with certain concurrent systemic diseases.399 (See QT-interval Prolongation and Torsades de Pointes under Cautions.)

Prescribing and Dispensing Precautions

Ensure accuracy of prescription; similarity in spelling of Celexa (citalopram hydrobromide), Celebrex (celecoxib), and Cerebyx (fosphenytoin sodium) may result in errors.346

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 citalopram, other SSRIs, or SNRIs late in the third trimester; may arise immediately upon delivery.212 213 380 381 382 383 399 (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 ) 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.399

Lactation

Distributed into milk;1 5 6 90 91 92 95 96 362 possible serious adverse reactions (e.g., excessive somnolence, decreased feeding, weight loss) in nursing infants.1 Discontinue nursing or the drug.1

Pediatric Use

Safety and efficacy not established in children <18 years of age.1 Results of 2 placebo-controlled trials in children and adolescents with major depressive disorder did not support a claim of efficacy for use of citalopram in pediatric patients with this condition.1 379

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, obsessive-compulsive disorder (OCD), or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).370 371 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.398 No suicides occurred in these pediatric trials.370 398 399

Carefully consider these findings when assessing potential benefits and risks of citalopram in a child or adolescent for any clinical use.1 370 371 376 398 399 (See Suicidality in the Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Decreased appetite and weight loss observed with use of SSRIs; monitor weight and growth regularly in children and adolescents treated with long-term citalopram therapy.399

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.399

Higher citalopram exposures may increase risk of QT-interval prolongation and torsades de pointes.83 85 399 424 (See Geriatric Patients under Dosage and Administration and also see Special Populations under Pharmacokinetics.)

Clinically important hyponatremia reported in geriatric patients, who may be at increased risk for this adverse effect.201 202 203 204 205 208 209 210 344 363 399 Some clinicians recommend periodic monitoring (especially during the first several months) of serum sodium concentrations in geriatric patients receiving SSRIs.207 208 209 344 348 349 (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.370 371 399 (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Hepatic Impairment

Higher citalopram exposures may increase risk of QT-interval prolongation and torsades de pointes.1 4 399 424 Use with caution.399 424 (See Hepatic Impairment under Dosage and Administration and also see Elimination: Special Populations, under Pharmacokinetics.)

Renal Impairment

Use with caution in patients with severe renal impairment.1 4 (See Renal Impairment under Dosage and Administration and also see Elimination: Special Populations, under Pharmacokinetics.)

Common Adverse Effects

Nausea, dry mouth, insomnia, sweating, sexual dysfunction (ejaculatory disorder, impotence, decreased libido), tremor, diarrhea, somnolence, dyspepsia, fatigue, upper respiratory tract infection, rhinitis.1

Interactions for Citalopram Hydrobromide

Extensively metabolized in liver, principally by CYP2C19 and 3A4.278 399 Does not inhibit CYP2C9, 2E1, or 3A4 in vitro and exhibits only weak inhibition against CYP1A2, CYP2D6, and CYP2C19.1 2 3 170 278

Drugs Affecting Hepatic Microsomal Enzymes

Inhibitors of 3A4: Clinically important pharmacokinetic interaction unlikely.399

Inhibitors of CYP2C19: Risk of QT-interval prolongation; maximum recommended dosage is 20 mg once daily in patients concurrently receiving cimetidine or another CYP2C19 inhibitor.399 416 424

Drugs Metabolized by Hepatic Microsomal Enzymes

Substrates of CYP1A2, CYP2D6, and CYP2C19: Citalopram expected to have little in vivo effect on substrate metabolism; however, clinical importance unknown.1

Drugs that Prolong the QT interval

Citalopram use not recommended in patients concurrently receiving other drugs known to prolong the QTc interval.399 424 If such use considered essential, ECG monitoring recommended.399 424 (See QT-interval Prolongation and Torsades de Pointes under Cautions.)

Drugs Affecting Hemostasis

Potential pharmacologic interaction (increased risk of bleeding) with concomitant use of drugs that affect hemostasis.54 55 377 399 Use with caution.399 (See Abnormal Bleeding under Cautions.)

Drugs Associated with Serotonin Syndrome

Potential pharmacologic interaction (potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions) with serotonergic agents.205 291 292 293 294 295 296 297 312 314 315 316 317 386 399 Avoid such use, or use with caution.299 300 386 399 (See Contraindications and see Serotonin Syndrome or Neuroleptic Malignant Syndrome-like Reactions under Cautions.) If serotonin syndrome or NMS occurs, immediately discontinue citalopram and any concurrently administered serotonergic or antidopaminergic agents and initiate supportive and symptomatic treatment.399

Specific Drugs

Drug

Interaction

Comment

Alcohol

Did not potentiate cognitive and motor effects of alcohol in one study;1 possible serotonergically-mediated pharmacodynamic interaction in CNS20 34 35 36 37 38 39 40 44 45 46 47

Concomitant use not recommended1

Antiarrhythmic agents, class IA (e.g., quinidine, procainamide) and class III (e.g., amiodarone, sotalol)

Increased risk of QTc-interval prolongation399 424

Avoid concomitant use;399 424 if concurrent use considered essential, monitor ECG399 424

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

Potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions399

Concomitant use not recommended399

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

Possible increased plasma TCA concentrations with TCAs that are substrates of CYP2D61 403

Use with caution1

Antipsychotic agents (e.g., chlorpromazine, clozapine, pimozide, thioridazine)

Increased risk of QTc-interval prolongation399 424

Potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions399 408

Clozapine: Substantial increases in trough plasma clozapine concentrations reported with concomitant citalopram402

Pimozide: Increased risk of QTc-interval prolongation.399 Pharmacokinetic interactions unlikely399

Avoid concomitant use;399 424 if concurrent use considered essential, monitor ECG399 424

If serotonin syndrome or NMS signs and symptoms occur, immediately discontinue citalopram and any concurrently administered antidopaminergic or serotonergic agents; initiate supportive and symptomatic treatment399

Clozapine: Caution advised; monitor closely and consider reduction in clozapine dosage if used concomitantly402

Pimozide: Concomitant use contraindicated399

Carbamazepine

Possible increased citalopram clearance1 336 337 348 349

Cimetidine

Increased citalopram AUC and peak plasma concentrations1 7

Maximum recommended citalopram dosage is 20 mg daily due to risk of QT-interval prolongation399 416 424

CNS drugs

Potentially additive CNS effects1

Use with caution1

Cyclosporine

Pharmacokinetic interaction unlikely326

Digoxin

Pharmacokinetic interaction unlikely1 188

Dopamine antagonists

Potentially life-threatening serotonin syndrome or NMS-like reactions399 408

If serotonin syndrome or NMS signs and symptoms occur, immediately discontinue citalopram and any concurrently administered antidopaminergic or serotonergic agents; initiate supportive and symptomatic treatment399

Escitalopram

Potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions399

Therapeutic duplication; escitalopram is the more active isomer of racemic citalopram403

Concomitant use not recommended399 403

Gatifloxacin

Increased risk of QTc-interval prolongation399 424

Avoid concomitant use;399 424 if concurrent use considered essential, monitor ECG399 424

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

Potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions205 294 304 386 399

Observe carefully if used concomitantly, particularly during treatment initiation, dosage increases, or when another serotonergic agent is initiated386 399

If serotonin syndrome or NMS signs and symptoms occur, immediately discontinue citalopram and any concurrently administered antidopaminergic or serotonergic agents; initiate supportive and symptomatic treatment399

Isoniazid

Potentially life-threatening serotonin syndrome320

Ketoconazole

Decreased peak concentrations and AUC of ketoconazole;325 399 pharmacokinetics of citalopram and demethylcitalopram not substantially affected325 399

Routine citalopram dosage adjustment not necessary325

Linezolid

Potentially serious, sometimes fatal serotonin syndrome396 399 411 412 413 414 415 611 612

Do not use concurrently;611 consider availability of alternative anti-infectives and weigh benefit of linezolid against risk of serotonin syndrome611

If emergency use of linezolid is considered necessary, immediately discontinue citalopram; monitor closely for symptoms of CNS toxicity for 2 weeks or until 24 hours after the last linezolid dose, whichever comes first611

If nonemergency use of linezolid is planned, withhold citalopram for at least 2 weeks prior to initiating linezolid;611 citalopram may be resumed 24 hours after last linezolid dose611

Do not initiate citalopram in patients receiving linezolid; when necessary, initiate 24 hours after last linezolid dose611

Lithium

Potentially life-threatening serotonin syndrome or NMS-like reactions169 399

Pharmacokinetic interaction unlikely168

Use concomitantly with caution168 399

If serotonin syndrome or NMS signs and symptoms occur, immediately discontinue citalopram and any concurrently administered antidopaminergic or serotonergic agents; initiate supportive and symptomatic treatment399

Monitor serum lithium concentrations; adjust dosage accordingly1

MAO inhibitors

Potentially life-threatening serotonin syndrome or NMS-like reactions316 317 318 399 403

Concomitant use contraindicated399

Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of citalopram, or vice versa399

Methadone

Increased risk of QTc-interval prolongation399 424

Avoid concomitant use;399 424 if concurrent use considered essential, monitor ECG399 424

Metoprolol

Increased plasma metoprolol concentrations possibly resulting in decreased cardioselectivity1

Moxifloxacin

Increased risk of QTc-interval prolongation399 424

Avoid concomitant use;399 424 if concurrent use considered essential, monitor ECG399 424

NSAIAs (e.g., aspirin)

Increased risk of bleeding1 54 55 377 378 403

Use with caution1 403

Pentamidine

Increased risk of QTc-interval prolongation399 424

Avoid concomitant use;399 424 if concurrent use considered essential, monitor ECG399 424

Ritonavir

Pharmacokinetic interactions unlikely403

Selegiline

Potentially life-threatening serotonin syndrome294 296 319

Avoid concomitant use303 319

Allow at least 2 weeks to elapse between discontinuance of selegiline and initiation of citalopram, or vice versa303 319

Sibutramine (no longer commercially available in US)

Potentially life-threatening serotonin syndrome or NMS-like reactions327 399 405

Use with caution399 405

St. John's Wort (Hypericum perforatum)

Potentially life-threatening serotonin syndrome or NMS-like reactions399

Use concomitantly with caution399

If serotonin syndrome or NMS signs and symptoms occur, immediately discontinue citalopram and any concurrently administered antidopaminergic or serotonergic agents; initiate supportive and symptomatic treatment399

Theophylline

No effects evident on theophylline pharmacokinetics 1 329

Tramadol

Potentially life-threatening serotonin syndrome or NMS-like reactions399

Use concomitantly with caution399

If serotonin syndrome or NMS signs and symptoms occur, immediately discontinue citalopram and any concurrently administered antidopaminergic or serotonergic agents; initiate supportive and symptomatic treatment399

Triazolam

Pharmacokinetic interactions unlikely1 316 328

Tryptophan and other serotonin precursors

Potentially serious, sometimes fatal serotonin syndrome or NMS-like reactions205 399

Concomitant use not recommended399

Warfarin

Possible increased PT and risk of bleeding190 399

Pharmacokinetic interactions unlikely190 399

Carefully monitor patients receiving warfarin during initiation and discontinuance of citalopram therapy399

Citalopram Hydrobromide Pharmacokinetics

Absorption

Bioavailability

Well absorbed following oral administration,1 18 62 80 82 97 100 101 339 with peak plasma concentration usually attained within 4 hours.1 349

Absolute oral bioavailability is approximately 80%.1 4

Commercially available tablets and oral solution are bioequivalent.1

Onset

Antidepressant effect usually occurs within 1–4 weeks.1 174

Food

Food does not affect absorption.1

Special Populations

In geriatric patients ≥60 years of age, AUC is increased by 23–30%.83 85 399

Poor metabolizers of CYP2C19: peak steady-state concentrations and AUCs increased by 68 and 107%, respectively.399

Steady-state citalopram concentrations not substantially different in healthy individuals with poor or extensive CYP2D6 metabolizer phenotypes.278 399

Distribution

Extent

Apparently widely distributed in body tissues.18 62 80 82 97 339

Crosses blood-brain barrier.62 86 87

Crosses the placenta.95 362 401

Distributed into breast milk.1 5 6 90 91 92 95 96 362

Plasma Protein Binding

Approximately 80%.1 349

Elimination

Metabolism

Extensively metabolized in the liver to less pharmacologically active metabolites by multiple enzyme systems, including CYP3A4 and CYP2C19.1 77 97 278

Elimination Route

Excreted principally in urine (75%) and feces (10%).100

Half-life

Approximately 35 hours.4 62 80 82 83 339

Special Populations

In geriatric patients ≥60 years of age, half-life is increased by 30–50%.83 399

Hepatic impairment decreases oral clearance by 37% and doubles half-life.1 4

Mild to moderate renal impairment decreases oral clearance by 17%.1 Severe renal impairment did not substantially alter pharmacokinetics in one study.88

Stability

Storage

Oral

Solution and Tablets

25°C; excursions permitted to 15–30°C.1

Actions

  • Racemic (50:50) mixture of the R- and S-enantiomers; inhibition of serotonin (5-HT) reuptake primarily due to the S-enantiomer (escitalopram).1 18 20 97

  • 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 5-HT.1 20

  • Highly selective SSRI with minimal effects on norepinephrine (NE) and dopamine (DA) neuronal reuptake and no or very low affinity for 5-HT1A, 5-HT2A, dopamine D1 and D2, α1-, α2-, and β-adrenergic, histamine (H1), GABA, muscarinic cholinergic, and benzodiazepine receptors.1 18 20 26 52

Advice to Patients

  • Importance of providing copy of written patient information (medication guide) each time citalopram is dispensed.370 371 376 399 Importance of advising patients to read the patient information before taking citalopram and each time the prescription is filled.399

  • Risk of suicidality; importance of patients, caregivers, and families 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.370 371 376 399 (See Worsening of Depression and Suicidality Risk under Cautions.)

  • Importance of instructing patients not to take citalopram with an MAO inhibitor or within 14 days of stopping the drug, and vice versa.399

  • Risk of QT prolongation and torsades de pointes.399 424 Importance of immediately contacting clinician if signs and symptoms of QT prolongation develop (e.g., chest pain, palpitations, bradycardia or tachycardia, shortness of breath, dizziness or fainting).399 424

  • Importance of informing patients of potential risk of serotonin syndrome and neuroleptic malignant syndrome (NMS)-like reactions, particularly with concurrent use of citalopram and 5-HT1 receptor agonists (also called triptans), tramadol, tryptophan, other serotonergic agents, or antipsychotic agents.386 399 Importance of immediately contacting clinician if signs and symptoms of these syndromes develop (e.g., restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, muscle stiffness, increased BP, diarrhea, coma, nausea, vomiting, confusion).386 399

  • 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.399

  • Importance of patients being aware that withdrawal effects may occur when stopping citalopram, especially with abrupt discontinuance of the drug.399

  • Importance of avoiding alcohol during citalopram therapy.399

  • Importance of continuing citalopram therapy even if a response is not evident within 1–4 weeks, unless directed otherwise.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.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 (e.g., cardiovascular disease [especially congenital long QT syndrome], liver disease, kidney disease, seizure disorder) or personal or family history of suicidality or bipolar disorder.399 Importance of advising patients about the risk of bleeding associated with concomitant use of citalopram with aspirin or other NSAIAs, warfarin, or other drugs that affect coagulation.399

  • 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.

Citalopram Hydrobromide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

10 mg (of citalopram)*

Celexa

Forest, (also promoted by Pfizer)

Citalopram Hydrobromide Film-coated Tablets

20 mg (of citalopram)*

Celexa (scored)

Forest, (also promoted by Pfizer)

Citalopram Hydrobromide Film-coated Tablets

40 mg (of citalopram)*

Celexa (scored)

Forest, (also promoted by Pfizer)

Citalopram Hydrobromide Film-coated Tablets

Solution

10 mg (of citalopram) per 5 mL*

Celexa

Forest, (also promoted by Pfizer)

Citalopram Hydrobromide Oral Solution

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

CeleXA 10MG Tablets (FOREST): 30/$120.43 or 90/$336.33

CeleXA 20MG Tablets (FOREST): 30/$125.99 or 90/$365.96

CeleXA 40MG Tablets (FOREST): 30/$135.61 or 90/$384.93

Citalopram Hydrobromide 10MG/5ML Solution (ROXANE): 240/$99.99 or 720/$249.95

Citalopram Hydrobromide 10MG Tablets (AMNEAL PHARMACEUTICALS): 30/$16.99 or 90/$37.97

Citalopram Hydrobromide 20MG Tablets (AMNEAL PHARMACEUTICALS): 30/$39.99 or 90/$89.97

Citalopram Hydrobromide 40MG Tablets (AMNEAL PHARMACEUTICALS): 30/$26.99 or 90/$74.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions February 14, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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

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