LUVOX CR SUMMARY
Bioavailability:
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).
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NEWS HIGHLIGHTS
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.
Clinical Trials Related to Luvox CR (Fluvoxamine)
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.
Impact of Citalopharm and Fluvoxamine on Platelet Response to Clopidogrel [Not yet recruiting]
Clopidogrel is a platelets inhibitor that is widely used particularly during and after acute
coronary events and coronary interventions. Several studies have shown that some patients
are resistant to clopidogrel. The resistance mechanism is not entirely clear, but at least
in part it is related to interactions between medications. Clopidogrel is a pro-drug
converted in vivo to its active metabolite by CYP2C19 and CYP3A in the liver. Consequently
drugs that inhibit the CYP2C19 can affect the production of the active metabolite and cause
"clopidogrel resistance". Therefore the FDA has recently published a "safety alert" which
recommends avoiding cross treatment with clopidogrel and drugs that are expected to inhibit
CYP2C19 (including omeprazole, fluvoxamine, cimetidine, fluconazole and others).
Nevertheless there no clear evidence in the literature for clinical relevance of such
interactions.
Selective serotonin reuptake inhibitors (SSRIs) are group of antidepressant drugs that are
widely used for treatment of depression and anxiety. SSRIs are considered to be very safe
with favorable side effect profile, hence many patient after coronary events who suffers
from behavioral and emotional disturbances are treated with those drugs. However there are
several reports that SSRIs can inhibit platelet function and increase bleeding tendency
particularly in concomitant administration with aspirin. The proposed mechanism is blocking
of platelets serotonin reuptake that result in platelet dysfunction.
Fluvoxamine - is a member in the SSRI family and a potent inhibitor of the CYP2C19.
Theoretically fluvoxamine should have two conflicting effects on the response to
clopidogrel. Pharmacokinetically it is expected to decrease the clopidogrel responsiveness
due to inhibition of CYP2C19 and reduction in the production of the active metabolite. On
the other hand "pharmacodynamically" fluvoxamine may directly inhibit platelet aggregation
due its effect on serotonin reuptake, thus increasing the effect of clopidogrel. Other SSRIs
that do not interact with the CYP2C19 such as citalophram are expected to have only
pharmocodynamic effect on platelet aggregation.
Although both clopidogrel and SSRIs are widely used in the last decade and concomitant
treatment is quite common, no data is available about in influence of the interaction
between those drugs on platelet function and on clinical events. The net effect of
fluvoxamine and other SSRIs on platelet function in the presence of clopidogrel is not
known.
The aim of the investigators study is to assess the effect of two SSRIs fluvoxamine and
citalophram on platelet aggregation and to test the effect of these drugs on the laboratory
response to clopidogrel, in healthy individuals.
Study design: randomized, double blinded, controlled crossover trial. Primary study end
point: Change in % platelet aggregation and VASP phosphorylation after treatment with
clopidogrel + fluvoxamine or clopidogrel + citalophram as compared to each drug alone.
Impact of Omeprazole and Fluvoxamine on Platelet Response to Clopidogrel [Not yet recruiting]
Clopidogrel is a platelets inhibitor that is widely used particularly during and after acute
coronary events and coronary interventions. Several studies have shown that some patients
are resistant to clopidogrel. The resistance mechanism is not entirely clear yet, but at
least in part it is related to interactions between medications.
Omeprazole is a member in the family of gastric proton pump inhibitor (PPI) that are widely
used in patients who receive combination of aspirin and clopidogrel in order to protect the
stomach lining and prevent GI bleeding. Data from studies on platelet aggregation indicate
that treatment with omeprazole may cause partial resistance to clopidogrel and increase risk
for recurrent cardiovascular events in patients after coronary interventions. Recently the
FDA published struck to avoid cross clopidogrel and omeprazole treatment for fear of
reduction efficiency. Nevertheless there are several studies that do not support increased
risk of cardiovascular events among patients taking omeprazole and clopidogrel, as the
COGENT trial which is the single prospective controlled study that assessed the clinical
implication of this drugs interaction.
The accepted Mechanism of interaction between omeprazole and clopidogrel is disturbance to
create clopidogrel active metabolite through CYP2C19 inhibition by omeprazole. fluvoxamine -
is a member in SSRIs family and a potent inhibitor of the CYP2C19. In vivo studies compared
the degree of decomposition proguanil (a CYP2C19 indicator) by fluvoxamine and omeprazole
found constant inhibition- Ki = 10 Micromol / L for of Omeprazole versus constant
inhibition- Ki = 0. 69 Micromol / L for fluvoxamine. This indicates a more potent inhibition
of CYP2C19 in vivo of fluvoxamine compared to omeprazole. It is important to note that so
far there is no date in literature studies demonstrates that there is any interaction
between fluvoxamine and other CYP2C19 inhibitors and Clopidogrel.
Research goals:
- To assess the impact of fluvoxamine and omeprazole on platelet reactivity in healthy
individuals treated with clopidogrel.
- To verify weather the mechanism of omeprazole-clopidogrel interaction is related to
CYP2C19 inhibition.
Study design:
Randomized blinded placebo-controlled crossover trial on healthy volunteers. The response to
clopidogrel will be assessed using two methods in subjects receiving clopidogrel and one of
the study drugs: fluvoxamine, omeprazole or placebo.
Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-Marketing Clinical Study in Children and Adolescents [Recruiting]
This study is to verify the efficacy of fluvoxamine maleate given for 10 weeks in treatment
of children and adolescents with obsessive-compulsive disorder
Fluvoxamine Maleate in the Treatment of Depression/Depressive State: A Post-Marketing Clinical Study in Children and Adolescents [Recruiting]
This study is to verify the efficacy of fluvoxamine maleate given for 8 weeks in the
treatment of children and adolescents with depression or depressive state
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