Escitalopram (Lexapro) is the active s-enantiomer of the selective serotonin reuptake inhibitor (SSRI), citalopram (Celexa). It is labeled for the treatment of major depressive disorder.
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Generic agents do not require large clinical trials of safety and efficacy to enter the market, although they must demonstrate both pharmacological and bioequivalence to the brand name drug. Bioequivalence is attained when the extent of absorption of the generic falls within an FDA predefined range relative to the brand name drug. This potential variation in bioequivalence is not thought to be clinically meaningful, however, there are reports of a lack of therapeutic equivalence between some generic medications and the brand name. This study examines the potential risks posed by a switch from Celexa to generic citalopram. Twenty patients at an Anxiety Disorders Clinic who were unknowingly switched to generic citalopram, from Celexa (Lundbeck, Montreal, Quebec, Canada) and experienced a re-emergence of their anxiety symptoms or development of new adverse events are described in this case series report. The mean time for re-emergence of symptoms or development of adverse events was 3.4 +/- 1.6 weeks (range 0.5-8 weeks). All patients reestablished previous treatment response with a change back to Celexa in a mean time of 3.8 +/- 2.6 weeks (range 0.7-12 weeks). Given these results, it is important for clinicians to be aware of the potential for loss of treatment effect or symptom re-emergence posed by a switch to a generic agent. Randomized, double blind, controlled investigations would likely provide useful information as current bioequivalence and pharmacological equivalence do not necessarily translate into clinical equivalence.
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To evaluate the economic impact of implementing a sertraline (Zoloft--Pfizer) tablet-splitting program on the Nebraska Medicaid program based on the change in total and per-member-per-month (PMPM) prescription drug costs and to identify any real or perceived problems with tablet splitting using switches among selective serotonin reuptake inhibitors (SSRIs) as a proxy indicator.
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A 31-year-old man ingested 400 mg of citalopram (Celexa) after an argument with his parents and girlfriend 13 h before presentation. Paramedics witnessed the patient having a generalized clonic seizure. The electrocardiogram (EKG) revealed a wide QRS complex, prolongation of the QTc interval, and left bundle branch pattern. He was treated with sodium bicarbonate with resolution of these changes. The patient was continued on a sodium bicarbonate infusion and demonstrated no further EKG abnormalities. Sodium bicarbonate should be considered as a treatment modality in patients with EKG abnormalities of prolongation of QRS or QTc interval after citalopram overdose.
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The Nebraska Medicaid program implemented a mandatory tablet-splitting program for sertraline. Pharmacists were paid a supplemental fee to split tablets.
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Previous reviews have focused on the potential cardiac toxicity of the racemic drug citalopram (Celexa(®)). Evaluating the safety of escitalopram (Lexapro(®)) is an important issue to consider, since it is the S-enantiomer of citalopram. Escitalopram has a small effect on the QTc interval. A prolonged QTc was seen in 2% to 14% of escitalopram overdose cases, without serious cardiac sequelae. The QTc prolongation effect of citalopram in beagle dogs has been attributed to the minor metabolite racemic didemethylcitalopram (DDCT). Whether the escitalopram minor metabolite S-DDCT has this effect is not known. Concentrations of S-DDCT are lower than DDCT, but for a broad range of doses of escitalopram and citalopram, the S-DDCT and DDCT concentrations are well below the QTc prolonging concentrations reported in dogs. There is no strong evidence from human and animal studies that the cardiac safety of escitalopram is significantly superior to that of citalopram.
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Background: Cataplexy is a disabling component of the narcolepsy tetrad that is sometimes resistant to standard treatment.Case reports: Three of our patients with narcolepsy, including one who had post-traumatic narcolepsy, suffered from intractable cataplexy with failure of treatment with established drugs due to unacceptable side-effects.Results: We explored the use of citalopram (Celexa), the newest and most specific of the serotonin reuptake inhibitors, and were successful in treating cataplexy without significant side-effects. Stimulant drugs remained necessary for controlling symptoms of excessive drowsiness.Conclusions: Citalopram was effective in relieving the symptoms of resistant cataplexy in out patients.
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Diseases and symptoms dominate UpToDate searches. Some searches result in page views of only short duration, while others consistently result in longer-than-average page views. The response to an FDA alert for Celexa, characterized by a change in UpToDate search activity, differed considerably from general online media activity. Changes in search activity appeared later and persisted longer in UpToDate logs. The volume of searches and page view durations related to Celexa before the alert also differed from those after the alert.
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Gen-citalopram appeared to be bioequivalent to Celexa, whereas Novo-venlafaxine XR was not bioequivalent to Effexor XR. Consequently, the Novo-venlafaxine formulation released its active ingredient more rapidly and outside the acceptable norm.
Typically, studies measure symptoms immediately after the initiation of drug treatment and then at a sequence of later time points. In this study, we develop a statistical mixture model for analyzing such longitudinal data. Our method estimates the onset of drug effect and assesses the association between the probability distribution of the onset times and possible contributing factors. Our mixture model treats the timing of onset as missing for each individual but restricts it, for simplicity, to two possible onset points, early or late. To estimate the model, we use an expectation-maximization-based approach and provide the general formulas of the variance and covariance matrix for the estimated parameters.
In August 2011, the U.S. Food and Drug Administration issued a drug safety communication that the antidepressant drug citalopram (Celexa®) should not be used at dosages greater than 40 mg per day (or greater than 20 mg per day for patients 60 and older) because higher doses have been associated with abnormal heart rhythms. Clinical studies using citalopram in patients with cardiac disease and in older patients do not confirm such a risk. The major metabolite of citalopram is demethylcitalopram, which is subsequently metabolized to the minor metabolite didemethylcitalopram (DDCT). High DDCT concentrations have been associated with QT interval prolongation in beagle dogs. Therapeutic drug monitoring study data suggest that routine or even high oral doses of citalopram are unlikely to result in cardiotoxic concentrations of the DDCT metabolite. Based on evidence taken from a wide variety of studies, the citalopram dose limitations described in the safety announcement do not have strong clinical justification.
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The prognosis for SSRI ingestion in this population of cats was excellent. Decontamination and supportive care for at least 12-24 hours can be considered in cats with SSRI ingestion, particularly venlafaxine to monitor resolution of clinical signs.
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The analytical measuring range for all analytes spanned from 5 to 1000ng/mL. Intra- and inter-assay precision across four quality control levels were ≤9.2% and ≤14.8%, respectively. A comparison to other LC-MS/MS methods resulted in a strong correlation with correlation coefficients ranging from 0.9929 to 0.9971. Carryover, stability, recovery, matrix effects, extraction and processing efficiency were also deemed acceptable in accordance with FDA recommendations.
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Retrospective study of prescription claims before and after the tablet-splitting program was implemented.
In this article, we explore the accelerated penetration of generic antidepressants in the United States market following the availability of generic citalopram and sertraline. Analysis suggests that overall, generic penetration into the antidepressant market has grown from approximately 41 percent in January 2004 to over 73 percent in January 2010. Similar trends are uncovered when branded and generic prescriptions are analyzed by specialty.