Celexa Contraindications/Precautions
Celexa (Citalopram) Contraindications/Precautions
- abrupt discontinuation
- bipolar disorder
- bleeding
- breast-feeding
- cardiac disease
- children
- dehydration
- driving or operating machinery
- elderly
- electroconvulsive therapy (ECT)
- hepatic disease
- hyponatremia
- mania
- neonates
- pregnancy
- renal failure
- renal impairment
- seizure disorder
- suicidal ideation
Celexa (Citalopram) Contraindications/Precautions
Citalopram is contraindicated in those patients with a hypersensitivity to the drug, hypersensitivity to the related drug escitalopram, or any of the formulation components.
Avoid abrupt discontinuation of any SSRI if possible. Gradual tapering is recommended during discontinuation of any SSRI to decrease or prevent the occurrence of potential withdrawal-like symptoms.
Citalopram is not FDA-approved for the treatment of depression in pediatric patients. The possibility of a suicide attempt is inherent in patients with depressive symptoms, whether these occur in primary depression or in association with another primary disorder such as OCD. Patients with suicidal ideation, including both adult and pediatric patients, should be closely supervised, whether or not they are taking an antidepressant. In addition, all antidepressants should be prescribed in the smallest quantity consistent with good patient management in order to reduce the risk of overdose. In October, 2004, the FDA directed manufacturers of all antidepressants to include a Black Box warning detailing the risk of suicide in pediatric patients. A causal role for antidepressants in inducing suicidality has been established in pediatric patients. The risk of suicidality for these drugs was identified in a pooled analysis of 24 placebo-controlled trials (n=4400) lasting up to 16 weeks in pediatric patients with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders. The analysis showed a greater risk of suicidality during the first few months of treatment in those receiving antidepressants (SSRIs and others). The average risk of such events on drug was 4% and 2% for placebo; however, no suicides occurred in these trials. Based on these data, FDA has determined that the following points are appropriate for inclusion in the boxed warning: antidepressants increase the risk of suicidal thinking and behavior (suicidality) in pediatric patients with MDD and other psychiatric disorders (OCD, social anxiety disorder); anyone considering the use of an antidepressant in a pediatric patient for any clinical use must balance the risk of increased suicidality with the clinical need; patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior, particularly within the first few months of starting therapy or at the time of dose increases or decreases; such observation would generally include at least weekly face-to-face contact with patients, family members or caregivers during the first 4 weeks of treatment, then every other week visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks; additional contact by telephone may be appropriate between face-to-face visits; adults with MDD or co-morbid depression in the setting of other psychiatric illness being treated with antidepressants should be observed similarly for clinical worsening and suicidality, especially during the initial few months of a course of drug therapy, or at times of dose changes; families and caregivers should be advised to closely observe the patient (adult or child) on a daily basis for the emergence of agitation, irritability, unusual changes in behavior, emergence of suicidality, and to communicate immediately with the prescriber. It is unknown if the suicidality risk in pediatric patients extends to longer-term therapy (i.e., beyond several months) or to adult patients. In patients who exhibit changes in symptoms, worsening of depression or emergent suicidality, a decision should be made to change or discontinue treatment. If discontinuing, medication should be tapered as rapidly as possible, but with recognition that abrupt discontinuation can also cause adverse symptoms. A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described represent such a conversion is unknown. Patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder prior to initiating treatment. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that citalopram is not approved for use in treating bipolar depression.
Citalopram is contraindicated for concomitant use in patients receiving MAO inhibitor (MAOI) therapy.
Citalopram’s effects during electroconvulsive therapy (ECT) have not been evaluated in clinical studies to date.
All effective antidepressants can transform depression into mania or hypomania in predisposed individuals. If a patient develops symptoms suggestive of mania, citalopram should be held and the appropriate therapy to treat the manic symptoms initiated.
Citalopram has demonstrated anticonvulsant effects in animal studies. However, since citalopram has not been systematically evaluated in patients with a history of seizure disorder, it should be used cautiously in such patients. In clinical trials, seizures occurred in 0.3% of patients treated with citalopram and 0.5% of patients treated with placebo.
Although clinical trial data indicate that citalopram is not associated with the development of clinically significant ECG abnormalities, the use of citalopram has not been systematically evaluated in patients with a recent history of myocardial infarction or unstable cardiac disease.
Excretion of unchanged citalopram in the urine is a minor route of elimination. However, citalopram should be used with caution in patients with severe renal impairment (i.e., CrCl < 20 ml/min) until this population has been evaluated during chronic treatment with citalopram. There is no information on the use of citalopram in patients with chronic renal failure who receive hemodialysis.
Citalopram should be used with caution in patients with hepatic disease because the drug is extensively metabolized in the liver, resulting in decreased clearance and increased plasma concentrations in patients with hepatic dysfunction. A lower maximum dosage is recommended for such patients.
Citalopram can rarely precipitate a syndrome of inappropriate secretion of antidiuretic hormone (SIADH) that presents as hypoosmolarity of serum and urine, and hyponatremia. The incidence reported with other SSRIs was highest among elderly patients and/or patients on diuretics, or patients with significant dehydration. Therefore, such patients are at increased risk and should be monitored appropriately.
Citalopram should be used with caution in lactating women because of the excretion of the drug into human breast milk. The manufacturer has noted a few cases of somnolence, decreased feeding and weight loss in breast-feeding infants. Another published case report has noted infant sleep disturbances. The breast-milk concentrations of citalopram were comparible to those of the maternal serum in this case. Quantifiable levels of citalopram were also noted in the serum of the infant. The sleep disturbance in the infant subsided after dividing the mothers medication in 2 doses daily and replacing 2 of the daily infant feeds with formula. The American Academy of Pediatrics has suggested that SSRI use during breast-feeding may be of concern. Patients should advise their physician of their intention to breast-feed. If citalopram must be continued during lactation due to the benefit of the drug to the mother, infant breast-feedings should be avoided during the times of maximum maternal serum concentrations (i.e., within 4 hours of the daily dose). Substitution of formula during times of maximal drug concentrations should help limit the potential for adverse effects in the infant. Alternatively, discontinuation of citalopram during lactation or the use of formula for all feeds may be indicated.
In October, 2004, the FDA directed manufacturers of all antidepressants to include a Black Box warning detailing the risk of suicide in children and adolescents. A causal role for antidepressants in inducing suicidality has been established in pediatric patients . Pediatric patients should be monitored closely for the risk of suicide with any antidepressant medication. Among the antidepressants, only fluoxetine is approved for use in treating depression in pediatric patients. Fluoxetine, sertraline, fluvoxamine, and clomipramine are approved for OCD in pediatric patients. None of the drugs is approved for other psychiatric indications in children. Pediatric patients being treated with antidepressants for any indication should be observed daily by caregivers for clinical worsening, as well as agitation, irritability, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. If concerns arise, contact with health care providers should be made immediately. Antidepressants should be prescribed in the smallest quantity consistent with good patient management in order to reduce the risk of overdose. A patient Medication Guide about using antidepressants in children and adolescents is available. Health care providers should instruct patients and caregivers to read the guide and discuss any questions with them.
Citalopram is classified as FDA pregnancy category C. In animal studies, citalopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects, when administered at doses greater than human maximum therapeutic doses. In general, animal studies have shown that SSRIs downregulate the serotonin receptors in the fetal cortex and that these changes can be present for a period of time after birth. One prospective, cohort study was conducted to evaluate the the outcome of newborns from 267 women who took an SSRI during pregnancy. Compared with a neonatal control group, SSRI-exposed newborns had similar rates of major malformation, spontaneous and elective abortion, and stillbirth. Mean birth weight and gestational age were also similar. None of the patients in this study of the SSRIs were exposed to citalopram. There are no well-controlled studies of citalopram in pregnant women; therefore, citalopram should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The effect of citalopram on labor and delivery is unknown.
Neonates exposed to citalopram and other SSRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Symptoms have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of serotonergic agents or, possibly, a neonatal abstinence syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome. When treating a pregnant woman with an SSRI or other serotonergic agent during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. If clinically feasible, gradual tapering of the medication prior to delivery may be considered.
Citalopram did not produce impairment of intellectual function or psychomotor performance in studies in normal volunteers. However, because any psychoactive drug may impair judgement, thinking, or motor skills, patients should use caution when driving or operating machinery, until the full effect of citalopram on the patient is determined. The US Olympic Committee has only banned the use of the SSRI-type antidepressants in sporting events that involve rifelry.
Use caution when combining SSRIs with NSAIDs, including aspirin. GI bleeding has been noted in 2 epidemiological studies when SSRIs were combined with NSAIDs. Bleeding may occur at other sites. GI hemorrhage has been reported in SSRI post-marketing reports.
[ Last revised: 2/4/2005 2:10:00 PM ]
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