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Luvox CR (Fluvoxamine Maleate) - Summary


Suicidality and Antidepressant Drugs

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of LUVOX CR (fluvoxamine maleate) Extended-Release Capsules or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. (See WARNINGS AND PRECAUTIONS-Clinical Worsening and Suicide Risk [ 5.1 ]  and USE IN SPECIFIC POPULATIONS-Pediatric Use [ 8.4 ].)



LUVOX® CR is an extended-release capsule for oral administration that contains fluvoxamine maleate, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the distinct chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate is chemically unrelated to other SSRIs and clomipramine.

LUVOX CR is indicated for the following:

Social Anxiety Disorder:

LUVOX CR Capsules are indicated for the treatment of social anxiety disorder, also known as social phobia, as defined in DSM-IV (300.23). Social anxiety disorder is characterized by a marked and persistent fear of one or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person’s normal routine, occupational or academic functioning, or social activities or relationships, or there is marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment.

The efficacy of LUVOX CR Capsules was demonstrated in two 12-week trials in adult patients with social anxiety disorder (DSM-IV). LUVOX CR Capsules have not been studied in children or adolescents with social anxiety disorder (see Clinical Trials under CLINICAL PHARMACOLOGY).

The effectiveness of LUVOX CR Capsules in long-term treatment of social anxiety disorder, i.e., for more than 12 weeks, has not been systematically evaluated in adequate and well-controlled trials. Therefore, the health care provider who elects to prescribe LUVOX CR Capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

Obsessive Compulsive Disorder:

LUVOX CR Capsules are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD), as defined in the DSM-IV. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.

The efficacy of LUVOX CR Capsules was demonstrated in one 12-week trial with obsessive compulsive outpatients with the diagnosis of OCD as defined in DSM-IV (see Clinical Trials under CLINICAL PHARMACOLOGY).

The efficacy of the immediate-release fluvoxamine maleate tablets in the treatment of OCD was demonstrated in two 10-week multicenter, parallel-group studies of adult outpatients.

Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable.

The effectiveness of LUVOX CR Capsules for long-term use, i.e., for more than 12 weeks, has not been systematically evaluated in placebo-controlled trials. Therefore, the health care provider who elects to prescribe LUVOX CR Capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

See all Luvox CR indications & dosage >>


Published Studies Related to Luvox CR (Fluvoxamine)

Extended-release fluvoxamine and improvements in quality of life in patients with obsessive-compulsive disorder. [2010.07]
OBJECTIVE: We hypothesized that subjects with obsessive-compulsive disorder (OCD) who received extended-release fluvoxamine (fluvoxamine ER) in a 12-week placebo-controlled trial would exhibit improvements in psychosocial domains of health-related quality of life (HRQOL) and that additional improvements would occur after a 40-week open-label extension trial. We also hypothesized that greater OCD symptom improvement in the first 12 weeks of treatment would be associated with greater HRQOL improvement after 52 weeks of treatment... CONCLUSION: Improvement in Yale-Brown Obsessive-Compulsive Scale severity scores during treatment with fluvoxamine ER was associated with improvements in psychosocial aspects of HRQOL that increased over an extended period of treatment. Copyright 2010 Elsevier Inc. All rights reserved.

Pharmacokinetics and efficacy of fluvoxamine and amitriptyline in depression. [2009.05]
Although often necessary for obtaining remission following major depressive disorder, combined antidepressant treatment is frequently associated with drug interactions and enhanced adverse drug effects. We investigated pharmacokinetic interactions following combined fluvoxamine and amitriptyline treatment and their impact on therapeutic efficacy and tolerability...

Activation adverse events induced by the selective serotonin reuptake inhibitor fluvoxamine in children and adolescents. [2009.04]
OBJECTIVE: The aim of this study was to examine the prevalence of activation cluster adverse events (AC-AEs) in youths treated with the selective serotonin reuptake inhibitor (SSRI) fluvoxamine for anxiety and the relationship of AC-AEs to SSRI blood levels... CONCLUSIONS: AC-AEs were common side effects of fluvoxamine, often appeared during the first 8 weeks of treatment, and were associated with higher fluvoxamine blood levels. Close monitoring for AC-AEs, not only when initiating SSRI treatment but also throughout dose titration, is recommended for early identification of activation.

Controlled-release fluvoxamine in obsessive-compulsive disorder and social phobia. [2008.12]
Specific serotonin reuptake inhibitors are currently recommended as first-line treatments for obsessive-compulsive disorder (OCD) and social phobia or social anxiety disorder (SAD)...

[Additional treatment in chronic pain syndrome due to hip and knee arthritis with the selective serotonin reuptake inhibitor fluvoxamine (Fevarin] [2008.11]
OBJECTIVE: The aim of this study was to investigate the effectiveness and safety of the selective serotonin reuptake inhibitor fluvoxamine (Flevarin) in patients with a chronic pain syndrome due to hip and knee arthritis... CONCLUSION: Considering the good effects in combination with very few side effects, a positive cost-effectiveness relation for the usage of fluvoxamine can be stated in patients with chronic pain syndrome due to hip and knee arthritis.

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Clinical Trials Related to Luvox CR (Fluvoxamine)

The Effect of Fluvoxamine on Polysonogram in Depressed Patients With Insomnia [Recruiting]
Major depressive disorder is associated with several sleep Polysomnograph (PSG) findings: (1) impaired sleep continuity; (2) non-REM (NREM) changes; and (3) enhanced rapid eye movement (REM) sleep. The first two patterns are common in other psychiatric disorders, while the REM pattern is very characteristic in depression, so the phase-advance theory was accepted by most of psychiatrists. Many researchers have focused on the biological rhythm to investigate the etiological and pathophysiology of depression, and they think depression can be cured if its sleep abnormality is ameliorated. It is well known that most of antidepressants treat depression through 5-hydroxytryptamine (5-HT) neurons. 5-HT also affects the regulation of the sleep-wake cycle and the sleep microarchitecture. Many all-night PSG studies have shown tricyclic antidepressants can ameliorate the sleep architecture abnormality in depression by producing rapid suppression of REM sleep. Compared to TCAs, SSRIs are generally less sedating because of its high selectivity for serotonin receptors. On the other hand, it is known that, although all of SSRIs mainly increase the extracellular serotonin level by inhibiting serotonin transport in the presynaptic neuron, each SSRI has its unique pharmacological characteristics. For example, it was reported by accumulating researches that the serum melatonin level increased markedly after ingestion of fluvoxamine. The mechanism behind this effect is unknown, but one possibility is increased melatonin synthesis, caused by effects on serotonin, which is a melatonin precursor. Another possibility is that fluvoxamine inhibits the metabolism of melatonin in the liver. Thus, the property of fluvoxamine to increase serum melatonin level, or even recover the circadian rhythm of melatonin in depressed patients, might improve the clinical outcome by improving the sleep quality and quantity. By now, the changes of sleep architecture in fluvoxamine treatment were assessed by only three clinical trials, and their results were contradictive. This discrepancy might be due to the small sample size and different study design, such as clinical trial duration. Moreover, two of three researches applied home-based PSG assessment, which might have distorted the results of sleep architecture to some extent. Thus, the effects of fluvoxamine on sleep architecture need to be clarified by more clinical trials with standard PSG assessment.

Study to Evaluate the Effect of Multiple-dose of Fluvoxamine on the Plasma Concentration of Quetiapine (FK949E) in Healthy Male Volunteers [Completed]
The objective of the study was to assess the effect of multiple-dose fluvoxamine on the pharmacokinetics of quetiapine (FK949E) in healthy adult male subjects. The safety of FK949E in the population was also evaluated.

Cost-Effectiveness of Adding Web-Based Cognitive-Behavioral Therapy (CBT) to Luvox CR for Obsessive Compulsive Disorder (OCD) [Not yet recruiting]
This study will test the hypotheses that: 1. 12 weeks of Luvox-CR plus web-based Cognitive-Behavioral Therapy (CBT) [CT-STEPS] will produce greater symptom relief of OCD than treatment with Luvox-CR alone; and, 2. subjects receiving 12 weeks of CT-STEPS added to Luvox-CR treatment after 12-weeks of Luvox-CR monotherapy will experience greater OCD symptom relief (from weeks 12-24) than those continuing Luvox-CR treatment and having access to CT-STEPS from week one. 3. subjects who begin CT-STEPS at week 12 will be more likely to complete it than those who begin CT-STEPS at baseline.

Safety and Pharmacokinetics of ASA404 When Given Together With Fluvoxamine, a Selective Serotonin Receptor Reuptake Inhibitor and CYP1A2 Inhibitor [Terminated]
This trial is designed to study the drug-drug interaction between ASA404 and fluvoxamine, an inhibitor of its metabolic pathway (CYP1A2). The study will consist of two phases. The purpose of the Core Phase is to study the drug drug interaction between fluvoxamine and ASA404. The purpose of the Extension Phase is to provide continued treatment for those patients that have not progressed during the Core Phase and to collect safety data on ASA404 when given in combination with paclitaxel, docetaxel or the paclitaxel plus carboplatin chemotherapy regimen.

Treatment Strategy for Refractory Schizophrenia: Drug Interaction Between Clozapine and Fluvoxamine [Completed]
Clozapine has been virtually the only psychopharmacological choice in patients with schizophrenia who either did not response to typical neuroleptics or experienced severe extrapyramidal side effects and consequently did not tolerate this medication. There are patients who do not respond to clozapine, and the need to treat these severely ill patients frequently compels clinicians to adopt therapeutic innovations that lack a sound empirical basis. One strategy is the combination of various other somatic treatments with clozapine. Recently, the investigators conduct a preliminary open trial to evaluate the safety and efficacy of fluvoxamine coadministration with clozapine in refractory schizophrenic patients. The combined treatment is well tolerated, and clinical improvement is observed in our patients. And the concomitant fluvoxamine could attenuate the clozapine-induced weight gain and metabolic disturbance. However, the effects of fluvoxamine on the safety and therapeutic efficacy of clozapine need to be further clarified in double-blind study.

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Page last updated: 2010-10-05

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