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U.S. Department of Health and Human Services

Safety

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Celexa (citalopram hydrobromide) Tablets and Oral Solution

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

December 2012

Summary View

 

(Serotonin Toxicity associated with co-administration with Linezolid and Methylene Blue)

 

CONTRAINDICATIONS

  • The use of MAOIs intended to treat psychiatric disorders with Celexa or within 14 days of stopping treatment with Celexa is contraindicated because of an increased risk of serotonin syndrome. The use of Celexa within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated…
 

WARNINGS

Serotonin Syndrome
  • The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including Celexa, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, trytophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue)…

 

March 2012

Summary View

WARNINGS

QT-Prolongation and Torsade de Pointes
  • Because of the risk of QTc prolongation at higher citalopram doses, it is recommended that citalopram should not be given at doses above 40 mg/day. It is recommended that citalopram should not be used in patients with congenital long QT syndrome, bradycardia, hypokalemia or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure. Citalopram should also not be used in patients who are taking other drugs that prolong the QTc interval. Such drugs include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications, antipsychotic medications (e.g., chlorpromazine, thioridazine), antibiotics (e.g., gatifloxacin, moxifloxacin), or any other class of medications known to prolong the QTc interval (e.g., pentamidine, levomethadyl acetate, methadone).
  • The citalopram dose should be limited in certain populations. The maximum dose should be limited to 20 mg/day in patients who are CYP2C19 poor metabolizers or those patients who may be taking concomitant cimetidine or another CYP2C19 inhibitor, since higher citalopram exposures would be expected. The maximum dose should also be limited to 20 mg/day in patients with hepatic impairment and in patients who are greater than 60 years of age because of expected higher exposures….
  • Electrolyte and/or ECG monitoring is recommended in certain circumstances. Patients being considered for citalopram treatment who are at risk for significant electrolyte disturbances should have baseline serum potassium and magnesium measurements with periodic monitoring. Hypokalemia (and/or hypomagnesemia) may increase the risk of QTc prolongation and Citalopram should be discontinued in patients who are found to have persistent QTc measurements >500 ms. ...


PRECAUTIONS

  • Use in Patients with Concomitant Illness. Clinical experience with Celexa in patients with certain concomitant systemic illnesses is limited. Due to the risk of QT prolongation, citalopram use should be avoided in patients with certain cardiac conditions, and ECG monitoring is advised if Celexa must be used in such patients. Electrolytes should be monitored in treating patients with disease...

 

 

 

August 2011 

Summary View

 

CONTRAINDICATIONS

  • Celexa is contraindicated in patients with congenital long QT syndrome (see WARNINGS, PRECAUTIONS, and Drug Interactions).

WARNINGS

QT-Prolongation and Torsade de Pointes
  • Citalopram causes dose-dependent QT prolongation and should not be dosed above 40 mg/day. Torsade de Pointes has been reported postmarketing. Celexa should not be used in patients with congenital long QT syndrome. Hypokalemia and hypomagnesemia should be corrected prior to initiation of treatment….

PRECAUTIONS

QT-Prolongation and Torsade de Pointes
  • Citalopram causes dose dependent QT prolongation and should not be dosed above 40 mg/day. Torsade de Pointes has been reported postmarketing. Celexa should not be used in patients with congenital long QT syndrome. Hypokalemia and hypomagnesemia should be corrected prior to initiation of treatment and periodically monitored. ECG monitoring is recommended in patients with congestive heart failure, bradyarrhythmias, or patients on concomitant medications that prolong the QT interval. Dose escalations over 20 mg/day in CYP2C19 poor metabolizers or patients taking concomitant cimetidine or another CYP2C19 inhibitor are not recommended.

Drug Interactions

Drugs that Prolong the QT interval
  • ECG monitoring is recommended with concomitant medications that have demonstrated prolongation of the QT interval (see WARNINGS- QT-Prolongation and Torsade de Pointes)

ADVERSE REACTIONS

ECG Changes
  • In a thorough QT study, Celexa was found to be associated with a dose-dependent increase in the QTc interval (see WARNINGS - QT-Prolongation and Torsade de Pointes).