DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Fluvoxamine (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 Fluvoxamine Maleate Tablets 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. Fluvoxamine Maleate Tablets are not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD). (See WARNINGS AND PRECAUTIONS-Clinical Worsening and Suicide Risk [ 5.1 ].)

 

FLUVOXAMINE SUMMARY

Fluvoxamine maleate is a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones.

Obsessive-Compulsive Disorder

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

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 efficacy of Fluvoxamine Maleate Tablets, USP was established in three trials in outpatients with OCD: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8-17). (See CLINICAL STUDIES [ 14 ].)


See all Fluvoxamine indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to 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.

more studies >>

Clinical Trials Related to 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.

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.

Impact of Omeprazole and Fluvoxamine on Platelet Response to Clopidogrel [Completed]
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.

more trials >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 4 ratings/reviews, Fluvoxamine has an overall score of 8.50. The effectiveness score is 8 and the side effect score is 9. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
 

Fluvoxamine review by 51 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   ocd, bipolor disease
Dosage & duration:   300 mg taken 100 mg am, 200 mg at bedtime for the period of 7 years
Other conditions:   extreme chronic dysphasia
Other drugs taken:   depakote, wellbutrin
  
Reported Results
Benefits:   Stopped suicidal thoughts, stopped my constant worrying , my mind felt at peace for the first time in my life
Side effects:   wt. loss at first
Comments:   took about 2 weeks to work and then the results felt miraculous as the constant suicidal thoughts gradually disappeared.

 

Fluvoxamine review by 44 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Anxiety/worry
Dosage & duration:   25 mg taken once daily for the period of 4 mos
Other conditions:   Hormone changes - weaning baby at time
Other drugs taken:   None
  
Reported Results
Benefits:   None, especially surprising since the prescription name brand Luvox had been used previously, with great results. The Luvox stopped all ruminations and obsessive worry, while the generic fluvoxamine seemed to do nothing, and did not help with sleep.
Side effects:   Some vague nausea, which was not a problem with the name brand drug.
Comments:   At the time of weaning my second child, I was apparently experiencing some hot flashes/night sweats and worry/ panic and tried fluvoxamine, the generic version of Luvox (which I had used previously by about four years). I had successfully used Luvox and was able to discontinue it without any side effects or symptoms of worry returning. This time only the generic was available to me so I tried it - thinking that it would be the same drug and provide similar results. It did not. I experienced nausea, and did not get any sleep benefits, although I felt that the Luvox had improved my sleep when taken at night; neither version of the drug caused any drowsiness. I did not feel any improvement in symptoms with the generic version. Perhaps my hormones needed to balance on their own, and were too intense for the fluvoxamine to modify. I hope there will be something better available if menopause eventually causes a return of symptoms. Some generics are better than others, and individual reactions differ. It is useful to have this rating information available to access online.

 

Fluvoxamine review by 44 year old female patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   Anxiety/worry
Dosage & duration:   25 mg taken once daily for the period of 4 mos
Other conditions:   Hormone changes - weaning baby at time
Other drugs taken:   None
  
Reported Results
Benefits:   None, especially surprising since the prescription name brand Luvox had been used previously, with great results. The Luvox stopped all ruminations and obsessive worry, while the generic fluvoxamine seemed to do nothing, and did not help with sleep.
Side effects:   Some vague nausea, which was not a problem with the name brand drug.
Comments:   At the time of weaning my second child, I was apparently experiencing some hot flashes/night sweats and worry/ panic and tried fluvoxamine, the generic version of Luvox (which I had used previously by about four years). I had successfully used Luvox and was able to discontinue it without any side effects or symptoms of worry returning. This time only the generic was available to me so I tried it - thinking that it would be the same drug and provide similar results. It did not. I experienced nausea, and did not get any sleep benefits, although I felt that the Luvox had improved my sleep when taken at night; neither version of the drug caused any drowsiness. I did not feel any improvement in symptoms with the generic version. Perhaps my hormones needed to balance on their own, and were too intense for the fluvoxamine to modify. I hope there will be something better available if menopause eventually causes a return of symptoms. Some generics are better than others, and individual reactions differ. It is useful to have this rating information available to access online.

See all Fluvoxamine reviews / ratings >>

Page last updated: 2010-10-05

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017