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Celexa
Generic Name: Citalopram Hydrobromide
Drug Category: SSRI
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 18 years old for a maximum duration of 32 weeks.
| Approved Uses |
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Indicated for the treatment of major depressive disorder (MDD) in adults. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CELEXA have not been established in pediatric patients. Dosages above 40 mg once daily are not recommended due to the risk of QT prolongation. The maximum recommended dosage of CELEXA for patients who are greater than 60 years of age, patients with hepatic impairment, and for CYP2C19 poor metabolizers is 20 mg once daily. The maximum recommended dosage of CELEXA when used concomitantly with a CYP2C19 inhibitor is 20 mg once daily. Adverse reactions may occur upon discontinuation of CELEXA. Gradually reduce the dosage rather than stopping CELEXA abruptly whenever possible. Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that Celexa is not approved for use in treating bipolar depression. Electrolyte and/or ECG monitoring is recommended in certain circumstances. Patients being considered for treatment with CELEXA 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 arrhythmia, and should be corrected prior to initiation of treatment and periodically monitored. ECG monitoring is recommended in patients for whom CELEXA use is not recommended unless the benefits clearly outweigh the risks for a particular patient (see above). These include those patients with the cardiac conditions noted above, and those taking other drugs that may prolong the QTc interval.T he pupillary dilation that occurs following use of many antidepressant drugs, including CELEXA, may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use of antidepressants, including CELEXA, in patients with untreated anatomically narrow angles. Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including CELEXA. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH), and was reversible when CELEXA was discontinued. Like other antidepressants, CELEXA be introduced with care in patients with a history of seizure disorder. 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, tryptophan, buspirone, amphetamines, 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). CELEXA causes dose-dependent QTc prolongation an ECG abnormality that has been associated with Torsade de Pointes (TdP), ventricular tachycardia, and sudden death, all of which have been observed in postmarketing reports for citalopram. CELEXA should be avoided in patients with congenital long QT syndrome, bradycardia, hypokalemia or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure unless the benefits outweigh the risks for a particular patient. CELEXA should also be avoided 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). Discontinue CELEXA in patients who are found to have persistent QTc measurements >500 ms. If patients taking CELEXA experience symptoms that could indicate the occurrence of cardiac arrhythmias, e.g., dizziness, palpitations, or syncope, the prescriber should initiate further evaluation, including cardiac monitoring. SSRIs and SNRIs, including CELEXA, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to the risk. Inform patients about the increased risk of bleeding associated with the concomitant use of CELEXA and antiplatelet agents or anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio. Priapism has been reported with all SSRIs. Use of SSRIs, including CELEXA, may cause symptoms of sexual dysfunction In male patients, SSRI use may result in ejaculatory delay or failure, decreased libido,and erectile dysfunction. In female patients, SSRI use may result in decreased libido and delayed or absent orgasm. CELEXA is contraindicated in patients:
Given the primary CNS effects of citalopram, caution should be used when it is taken in combination with other centrally acting drugs. Because lithium may enhance the serotonergic effects of citalopram, caution should be exercised when CELEXA and lithium are co-administered. There have been rare postmarketing reports describing patients with weakness, hyperreflexia, and incoordination following the use of a SSRI and sumatriptan. If concomitant treatment with sumatriptan and an SSRI (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram) is clinically warranted, appropriate observation of the patient is advised. The possibility that carbamazepine might increase the clearance of citalopram should be considered if the two drugs are co-administered. Caution is indicated in the co-administration of TCAs with CELEXA. Infants exposed to SSRIs in pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). Animal studies: teratogenic effects. Neonates exposed to CELEXA and other SSRIs late in third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Citalopram is excreted in human breast milk. |
| Off-label Uses |
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• Generalized anxiety disorder, premature ejaculation, migraine headache, diabetic neuropathy, fibromyalgia and neurocardiogenic syncope. GoToSource • Agitation in alzheimer’s disease. GoToSource • Autism spectrum disorders. GoToSource • Premenstrual syndrome. GoToSource • Stroke recovery. GoToSource • Panic disorder. GoToSource • Hot flashes. GoToSource • Alcoholism. GoToSource • Dementia. GoToSource • Eating and obsessive-compulsive disorders. GoToSource • Post-traumatic stress disorder. GoToSource • Social anxiety disorder. GoToSource • Use in patients under 18 years of age. GoToSource |
| Adverse Events |
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⚠️ Patients with CYP2C19 gene variation results in higher systemic concentrations and adverse reaction risk (QT prolongation). Birth defects such as persistent pulmonary hypertension. GoToSource Serotonin syndrome (life-threatening drug reaction). GoToSource Sudden cardiac death, torsade de pointes and prolonged QT. GoToSource Suicidal thinking and behavior (suicidality). GoToSource Withdrawal symptoms and premature ejaculation. GoToSource Subacute cutaneous lupus erythematosus (skin lesions). GoToSource Thrombocytopenia (deficiency of blood platelets). GoToSource Hallucinations and delusions. GoToSource Acute angle-closure glaucoma. GoToSource Increased risk of bleeding. GoToSource Hyponatremia (low sodium level in blood). GoToSource Hypomanic or manic episodes. GoToSource Seizures. GoToSource |
| Litigation |
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Lawsuits filed for birth defects and suicidality. |
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