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lang="en"> <span id="Top"></span> <div class="govuk-grid-row"> <div class="govuk-grid-column-two-thirds responsive-top-margin"> <div class="gem-c-title govuk-!-margin-top-8 govuk-!-margin-bottom-8"> <h1 class="gem-c-title__text govuk-heading-l"> Citalopram and escitalopram: QT interval prolongation </h1> </div> </div> <div class="govuk-grid-column-two-thirds"> <p class="gem-c-lead-paragraph"> New maximum daily dose restrictions (including in elderly patients), contraindications, and warnings. </p> </div> </div> <div class="govuk-grid-row"> <div class="metadata-logo-wrapper"> <div class="govuk-grid-column-two-thirds metadata-column"> <div class="gem-c-metadata" data-module="gem-toggle metadata"> <dl class="gem-c-metadata__list"> <dt class="gem-c-metadata__term">From:</dt> <dd class="gem-c-metadata__definition"> <a class="govuk-link" href="/government/organisations/medicines-and-healthcare-products-regulatory-agency">Medicines and Healthcare products Regulatory Agency</a> </dd> <dt class="gem-c-metadata__term">Published</dt> <dd class="gem-c-metadata__definition">11 December 2014</dd> </dl> </div> </div> <div class="govuk-grid-column-one-third"> </div> </div> </div> <div class="govuk-grid-row"> <div class="govuk-grid-column-two-thirds"> <div class="app-c-important-metadata app-c-important-metadata--bottom-margin"> <dl class="app-c-important-metadata__list"> <dt class="app-c-important-metadata__term">Therapeutic area: </dt> <dd class="app-c-important-metadata__definition"><a class="govuk-link govuk-link--inverse" href="/drug-safety-update?therapeutic_area%5B%5D=psychiatry">Psychiatry</a></dd> </dl> </div> <div id="contents" class="app-c-contents-list-with-body" data-module="sticky-element-container"> <div class="responsive-bottom-margin"> <nav data-module="ga4-link-tracker" aria-label="Contents" class="gem-c-contents-list govuk-!-margin-bottom-4" role="navigation"> <h2 class="gem-c-contents-list__title"> Contents </h2> <ol class="gem-c-contents-list__list"> <li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--dashed"> <span class="gem-c-contents-list__list-item-dash" aria-hidden="true"></span> <a class="gem-c-contents-list__link govuk-link gem-c-force-print-link-styles govuk-link--no-underline" data-ga4-link='{"event_name":"select_content","section":"Contents","type":"contents list","index_total":5,"index_link":1}' href="#new-data-for-qt-prolongation-with-citalopram-and-escitalopram">New data for QT prolongation with citalopram and escitalopram</a> </li> <li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--dashed"> <span class="gem-c-contents-list__list-item-dash" aria-hidden="true"></span> <a class="gem-c-contents-list__link govuk-link gem-c-force-print-link-styles govuk-link--no-underline" data-ga4-link='{"event_name":"select_content","section":"Contents","type":"contents list","index_total":5,"index_link":2}' href="#citalopram">Citalopram</a> </li> <li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--dashed"> <span class="gem-c-contents-list__list-item-dash" aria-hidden="true"></span> <a class="gem-c-contents-list__link govuk-link gem-c-force-print-link-styles govuk-link--no-underline" data-ga4-link='{"event_name":"select_content","section":"Contents","type":"contents list","index_total":5,"index_link":3}' href="#escitalopram">Escitalopram</a> </li> <li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--dashed"> <span class="gem-c-contents-list__list-item-dash" aria-hidden="true"></span> <a class="gem-c-contents-list__link govuk-link gem-c-force-print-link-styles govuk-link--no-underline" data-ga4-link='{"event_name":"select_content","section":"Contents","type":"contents list","index_total":5,"index_link":4}' href="#drug-interactions">Drug interactions</a> </li> <li class="gem-c-contents-list__list-item gem-c-contents-list__list-item--dashed"> <span class="gem-c-contents-list__list-item-dash" aria-hidden="true"></span> <a class="gem-c-contents-list__link govuk-link gem-c-force-print-link-styles govuk-link--no-underline" data-ga4-link='{"event_name":"select_content","section":"Contents","type":"contents list","index_total":5,"index_link":5}' href="#further-information">Further information</a> </li> </ol> </nav> </div> <div class="responsive-bottom-margin"> <div data-module="govspeak" class="gem-c-govspeak govuk-govspeak govuk-!-margin-bottom-0"> <p>Article date: December 2011</p> <p>Citalopram, a racemic mixture of R and S citalopram, is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder, panic disorder, and obsessive compulsive disorder. Escitalopram is the S enantiomer of citalopram indicated for major depressive episodes, panic disorder with or without agoraphobia, social anxiety disorder (social phobia), generalised anxiety disorder, and obsessive compulsive disorder.</p> <h2 id="new-data-for-qt-prolongation-with-citalopram-and-escitalopram">New data for QT prolongation with citalopram and escitalopram</h2> <p>The potential for citalopram and escitalopram to cause QT interval prolongation has been known for some time and is reflected in the product information. However, recent data have further defined this risk and have clarified that their effects on the QT interval are dose dependent. All available data have been subject to a Europe-wide review.</p> <p>For both citalopram and escitalopram, elderly patients have a higher exposure due to age-related decline in metabolism and elimination. The maximum dose of both medicines has therefore been restricted in patients older than 65 years.</p> <h2 id="citalopram">Citalopram</h2> <p>The data for citalopram include double-blind placebo-controlled electrocardiogram (ECG) studies. A study showed a clear dose-dependent response: the change from baseline in QTc (Fridericia-correction) was 7.5 milliseconds (90% CI 5.9–9.1) at 20 mg/day, and 16.7 milliseconds (15.0–18.4) at 60 mg day.</p> <h2 id="escitalopram">Escitalopram</h2> <p>For escitalopram a dose-dependent increase in QT interval was also shown: the change from baseline in QTc (Fridericia correction) was 4.3 (90% CI: 2.2–6.4) milliseconds with 10 mg/day and 10.7 milliseconds (90% CI: 8.6–12.8) with 30 mg/day.</p> <p>Cases of QT prolongation and ventricular arrhythmia, including Torsade de Pointes (TdP), have been reported via <a rel="external" href="http://yellowcard.mhra.gov.uk/">the Yellow Card Scheme</a> with citalopram and escitalopram, mainly in women, those with hypokalaemia, or in those with pre-existing QT prolongation or other cardiac diseases.</p> <h2 id="drug-interactions">Drug interactions</h2> <h4 id="use-with-drugs-known-to-prolong-qt-interval">Use with drugs known to prolong QT Interval</h4> <p>Citalopram and escitalopram may have an additive effect to other drugs that prolong the QT interval. Coadministration of citalopram and escitalopram with medicines that prolong the QT interval is therefore contraindicated. These include:</p> <ul> <li>class IA and III antiarrhythmics (eg, amiodarone, dronedarone, quinidine)</li> <li>antipsychotics (eg, phenothiazine derivatives, pimozide, haloperidol)</li> <li>tricyclic antidepressants</li> <li>some antimicrobial agents (eg, sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalaria treatment—particularly halofantrine)</li> <li>some antihistamines (astemizole, mizolastine)</li> <li>some antiretrovirals (eg, ritonavir, saquinavir, lopinavir)</li> </ul> <h4 id="use-with-drugs-that-increase-escitalopram-and-citalopram-levels">Use with drugs that increase escitalopram and citalopram levels</h4> <p>Patients taking concomitant medications known to increase plasma levels of escitalopram and citalopram may require a dose reduction in light of these most recent QT data. Drugs known to increase plasma concentrations of escitalopram and citalopram include some antiretroviral medications, and omeprazole and cimetidine. Details of specific interactions can be found in individual Summaries of Product Characteristics (see <a rel="external" href="http://www.medicines.org.uk/emc/">the electronic Medicines Compendium</a>).</p> <div class="call-to-action"> <p>Advice for healthcare professionals:</p> <p>Maximum daily dose schedule is as follows:</p> <table> <thead> <tr> <td></td> <td></td> <th scope="col">Adults</th> <td></td> <th scope="col">Adults >65 years</th> <td></td> <th scope="col">Adults with hepatic impairment</th> </tr> </thead> <tbody> <tr> <th scope="row">Citalopram</th> <td> </td> <td>40 mg*</td> <td> </td> <td>20 mg*</td> <td> </td> <td>20 mg*</td> </tr> <tr> <th scope="row">Escitalopram</th> <td> </td> <td>20 mg</td> <td> </td> <td>10 mg*</td> <td> </td> <td>10 mg</td> </tr> </tbody> </table> <p>*New (restricted) maximum daily dose.</p> </div> <p>Patients who currently take doses higher than the new recommended daily maximum should have their treatment reviewed</p> <p>Contraindications in patients at greatest risk of QT interval prolongation:</p> <ul> <li>Citalopram and escitalopram should not be used: <ul> <li>in patients with congenital long QT syndrome or known pre-existing QT interval prolongation</li> <li>in combination with other medicines known to prolong the QT interval (see above)</li> </ul> </li> </ul> <h4 id="cautions-for-use">Cautions for use</h4> <p>The balance of benefits and risks of citalopram and escitalopram should be considered carefully, particularly at higher doses, in patients with pre-existing risk factors for QT interval prolongation—including patients with significant bradycardia; recent acute myocardial infarction; or decompensated heart failure.</p> <h4 id="monitoring-recommendations">Monitoring recommendations</h4> <ul> <li>in patients with cardiac disease, an ECG review should be considered before treatment with citalopram and escitalopram</li> <li>electrolyte disturbances (eg, hypokalaemia and hypomagnesaemia) should be corrected before treatment with citalopram and escitalopram. Monitoring of serum magnesium is advised, particularly in elderly patients, who may be taking diuretics or proton pump inhibitors</li> <li>if cardiovascular symptoms, such as palpitations, vertigo, syncope, or seizures develop during treatment, cardiac evaluation including an ECG should be undertaken to exclude a possible malignant cardiac arrhythmia.</li> <li>if QTc interval is >500 milliseconds, treatment should be withdrawn gradually.</li> <li>if QTc interval duration is between 480 milliseconds and 500 milliseconds, the balance of benefits and risks of continued treatment should be carefully considered, alongside options for dose reduction or gradual withdrawal</li> </ul> <h2 id="further-information">Further information</h2> <p>BNF section 4.3.3 <a rel="external" href="http://bnf.org/bnf/bnf/62/3351.htm?q=SSRI&t=search&ss=text&p=1">Selective serotonin re-uptake inhibitors</a></p> <p><a rel="external" href="http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/10/WC500117061.pdf">October</a> and <a rel="external" href="http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/11/WC500117988.pdf">November</a> reports of the European Pharmacovigilance Working Party</p> <p>See letter sent to healthcare professionals, Oct 2011 for <a rel="external" href="http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/Monthlylistsofinformationforhealthcareprofessionalsonthesafetyofmedicines/CON134744">citalopram</a></p> <p>Article citation: Drug Safety Update Vol 5 Issue 5, Dec 2011: A1.</p> </div> </div> <div class="responsive-bottom-margin"> <h2 class="govuk-visually-hidden">Updates to this page</h2> <div class="app-c-published-dates" lang="en"> Published 11 December 2014 </div> </div> <div data-sticky-element class="app-c-contents-list-with-body__link-wrapper"> <div class="app-c-contents-list-with-body__link-container"> 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src="/assets/static/application-8b506a2d97561cfc27d896eb0ff908d7687d034da7eaee59dd291c6c00bf5595.js" type="module"></script> <script src="/assets/government-frontend/application-01a60bd9634d5b54b3f79c12cb1b2d95f8b00bbd24b9b2cf897066f58f75f432.js" type="module"></script><script type="application/ld+json"> { "@context": "http://schema.org", "@type": "Article", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://www.gov.uk/drug-safety-update/citalopram-and-escitalopram-qt-interval-prolongation" }, "name": "Citalopram and escitalopram: QT interval prolongation", "datePublished": "2014-12-11T14:32:21+00:00", "dateModified": "2014-12-11T14:32:21+00:00", "text": "New maximum daily dose restrictions (including in elderly patients), contraindications, and warnings.", "publisher": { "@type": "Organization", "name": "GOV.UK", "url": "https://www.gov.uk", "logo": { "@type": "ImageObject", "url": 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"https://www.gov.uk/health-and-social-care/medicines-medical-devices-blood-vigilance-safety-alerts-alerts-and-recalls" } ], "headLine": "Citalopram and escitalopram: QT interval prolongation", "description": "New maximum daily dose restrictions (including in elderly patients), contraindications, and warnings.", "articleBody": "\u003cp\u003eArticle date: December 2011\u003c/p\u003e\n\n\u003cp\u003eCitalopram, a racemic mixture of R and S citalopram, is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder, panic disorder, and obsessive compulsive disorder. Escitalopram is the S enantiomer of citalopram indicated for major depressive episodes, panic disorder with or without agoraphobia, social anxiety disorder (social phobia), generalised anxiety disorder, and obsessive compulsive disorder.\u003c/p\u003e\n\n\u003ch2 id=\"new-data-for-qt-prolongation-with-citalopram-and-escitalopram\"\u003eNew data for QT prolongation with citalopram and escitalopram\u003c/h2\u003e\n\n\u003cp\u003eThe potential for citalopram and escitalopram to cause QT interval prolongation has been known for some time and is reflected in the product information. However, recent data have further defined this risk and have clarified that their effects on the QT interval are dose dependent. All available data have been subject to a Europe-wide review.\u003c/p\u003e\n\n\u003cp\u003eFor both citalopram and escitalopram, elderly patients have a higher exposure due to age-related decline in metabolism and elimination. The maximum dose of both medicines has therefore been restricted in patients older than 65 years.\u003c/p\u003e\n\n\u003ch2 id=\"citalopram\"\u003eCitalopram\u003c/h2\u003e\n\n\u003cp\u003eThe data for citalopram include double-blind placebo-controlled electrocardiogram (ECG) studies. A study showed a clear dose-dependent response: the change from baseline in QTc (Fridericia-correction) was 7.5 milliseconds (90% CI 5.9–9.1) at 20 mg/day, and 16.7 milliseconds (15.0–18.4) at 60 mg day.\u003c/p\u003e\n\n\u003ch2 id=\"escitalopram\"\u003eEscitalopram\u003c/h2\u003e\n\n\u003cp\u003eFor escitalopram a dose-dependent increase in QT interval was also shown: the change from baseline in QTc (Fridericia correction) was 4.3 (90% CI: 2.2–6.4) milliseconds with 10 mg/day and 10.7 milliseconds (90% CI: 8.6–12.8) with 30 mg/day.\u003c/p\u003e\n\n\u003cp\u003eCases of QT prolongation and ventricular arrhythmia, including Torsade de Pointes (TdP), have been reported via \u003ca rel=\"external\" href=\"http://yellowcard.mhra.gov.uk/\"\u003ethe Yellow Card Scheme\u003c/a\u003e with citalopram and escitalopram, mainly in women, those with hypokalaemia, or in those with pre-existing QT prolongation or other cardiac diseases.\u003c/p\u003e\n\n\u003ch2 id=\"drug-interactions\"\u003eDrug interactions\u003c/h2\u003e\n\n\u003ch4 id=\"use-with-drugs-known-to-prolong-qt-interval\"\u003eUse with drugs known to prolong QT Interval\u003c/h4\u003e\n\n\u003cp\u003eCitalopram and escitalopram may have an additive effect to other drugs that prolong the QT interval. Coadministration of citalopram and escitalopram with medicines that prolong the QT interval is therefore contraindicated. These include:\u003c/p\u003e\n\n\u003cul\u003e\n \u003cli\u003eclass IA and III antiarrhythmics (eg, amiodarone, dronedarone, quinidine)\u003c/li\u003e\n \u003cli\u003eantipsychotics (eg, phenothiazine derivatives, pimozide, haloperidol)\u003c/li\u003e\n \u003cli\u003etricyclic antidepressants\u003c/li\u003e\n \u003cli\u003esome antimicrobial agents (eg, sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalaria treatment—particularly halofantrine)\u003c/li\u003e\n \u003cli\u003esome antihistamines (astemizole, mizolastine)\u003c/li\u003e\n \u003cli\u003esome antiretrovirals (eg, ritonavir, saquinavir, lopinavir)\u003c/li\u003e\n\u003c/ul\u003e\n\n\u003ch4 id=\"use-with-drugs-that-increase-escitalopram-and-citalopram-levels\"\u003eUse with drugs that increase escitalopram and citalopram levels\u003c/h4\u003e\n\n\u003cp\u003ePatients taking concomitant medications known to increase plasma levels of escitalopram and citalopram may require a dose reduction in light of these most recent QT data. Drugs known to increase plasma concentrations of escitalopram and citalopram include some antiretroviral medications, and omeprazole and cimetidine. Details of specific interactions can be found in individual Summaries of Product Characteristics (see \u003ca rel=\"external\" href=\"http://www.medicines.org.uk/emc/\"\u003ethe electronic Medicines Compendium\u003c/a\u003e).\u003c/p\u003e\n\n\u003cdiv class=\"call-to-action\"\u003e\n \u003cp\u003eAdvice for healthcare professionals:\u003c/p\u003e\n\n \u003cp\u003eMaximum daily dose schedule is as follows:\u003c/p\u003e\n\n \u003ctable\u003e\n \u003cthead\u003e\n \u003ctr\u003e\n \u003ctd\u003e\u003c/td\u003e\n \u003ctd\u003e\u003c/td\u003e\n \u003cth scope=\"col\"\u003eAdults\u003c/th\u003e\n \u003ctd\u003e\u003c/td\u003e\n \u003cth scope=\"col\"\u003eAdults \u0026gt;65 years\u003c/th\u003e\n \u003ctd\u003e\u003c/td\u003e\n \u003cth scope=\"col\"\u003eAdults with hepatic impairment\u003c/th\u003e\n \u003c/tr\u003e\n \u003c/thead\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003cth scope=\"row\"\u003eCitalopram\u003c/th\u003e\n \u003ctd\u003e \u003c/td\u003e\n \u003ctd\u003e40 mg*\u003c/td\u003e\n \u003ctd\u003e \u003c/td\u003e\n \u003ctd\u003e20 mg*\u003c/td\u003e\n \u003ctd\u003e \u003c/td\u003e\n \u003ctd\u003e20 mg*\u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003cth scope=\"row\"\u003eEscitalopram\u003c/th\u003e\n \u003ctd\u003e \u003c/td\u003e\n \u003ctd\u003e20 mg\u003c/td\u003e\n \u003ctd\u003e \u003c/td\u003e\n \u003ctd\u003e10 mg*\u003c/td\u003e\n \u003ctd\u003e \u003c/td\u003e\n \u003ctd\u003e10 mg\u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n \u003c/table\u003e\n\n \u003cp\u003e*New (restricted) maximum daily dose.\u003c/p\u003e\n\u003c/div\u003e\n\n\u003cp\u003ePatients who currently take doses higher than the new recommended daily maximum should have their treatment reviewed\u003c/p\u003e\n\n\u003cp\u003eContraindications in patients at greatest risk of QT interval prolongation:\u003c/p\u003e\n\n\u003cul\u003e\n \u003cli\u003eCitalopram and escitalopram should not be used:\n \u003cul\u003e\n \u003cli\u003ein patients with congenital long QT syndrome or known pre-existing QT interval prolongation\u003c/li\u003e\n \u003cli\u003ein combination with other medicines known to prolong the QT interval (see above)\u003c/li\u003e\n \u003c/ul\u003e\n \u003c/li\u003e\n\u003c/ul\u003e\n\n\u003ch4 id=\"cautions-for-use\"\u003eCautions for use\u003c/h4\u003e\n\n\u003cp\u003eThe balance of benefits and risks of citalopram and escitalopram should be considered carefully, particularly at higher doses, in patients with pre-existing risk factors for QT interval prolongation—including patients with significant bradycardia; recent acute myocardial infarction; or decompensated heart failure.\u003c/p\u003e\n\n\u003ch4 id=\"monitoring-recommendations\"\u003eMonitoring recommendations\u003c/h4\u003e\n\n\u003cul\u003e\n \u003cli\u003ein patients with cardiac disease, an ECG review should be considered before treatment with citalopram and escitalopram\u003c/li\u003e\n \u003cli\u003eelectrolyte disturbances (eg, hypokalaemia and hypomagnesaemia) should be corrected before treatment with citalopram and escitalopram. Monitoring of serum magnesium is advised, particularly in elderly patients, who may be taking diuretics or proton pump inhibitors\u003c/li\u003e\n \u003cli\u003eif cardiovascular symptoms, such as palpitations, vertigo, syncope, or seizures develop during treatment, cardiac evaluation including an ECG should be undertaken to exclude a possible malignant cardiac arrhythmia.\u003c/li\u003e\n \u003cli\u003eif QTc interval is \u0026gt;500 milliseconds, treatment should be withdrawn gradually.\u003c/li\u003e\n \u003cli\u003eif QTc interval duration is between 480 milliseconds and 500 milliseconds, the balance of benefits and risks of continued treatment should be carefully considered, alongside options for dose reduction or gradual withdrawal\u003c/li\u003e\n\u003c/ul\u003e\n\n\u003ch2 id=\"further-information\"\u003eFurther information\u003c/h2\u003e\n\n\u003cp\u003eBNF section 4.3.3 \u003ca rel=\"external\" href=\"http://bnf.org/bnf/bnf/62/3351.htm?q=SSRI\u0026amp;t=search\u0026amp;ss=text\u0026amp;p=1\"\u003eSelective serotonin re-uptake inhibitors\u003c/a\u003e\u003c/p\u003e\n\n\u003cp\u003e\u003ca rel=\"external\" href=\"http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/10/WC500117061.pdf\"\u003eOctober\u003c/a\u003e and \u003ca rel=\"external\" href=\"http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/11/WC500117988.pdf\"\u003eNovember\u003c/a\u003e reports of the European Pharmacovigilance Working Party\u003c/p\u003e\n\n\u003cp\u003eSee letter sent to healthcare professionals, Oct 2011 for \u003ca rel=\"external\" href=\"http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/Safetywarningsandmessagesformedicines/Monthlylistsofinformationforhealthcareprofessionalsonthesafetyofmedicines/CON134744\"\u003ecitalopram\u003c/a\u003e\u003c/p\u003e\n\n\u003cp\u003eArticle citation: Drug Safety Update Vol 5 Issue 5, Dec 2011: A1.\u003c/p\u003e\n" } </script><script type="application/ld+json"> { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "item": { "name": "Home", "@id": "https://www.gov.uk/" } }, { "@type": "ListItem", "position": 2, "item": { "name": "Drug Safety Update", "@id": "https://www.gov.uk/drug-safety-update" } } ] } </script> </body> </html>

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