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Symbyax (Olanzapine / Fluoxetine Hydrochloride) - Summary

 
 



WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS AND INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

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 SYMBYAX 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. SYMBYAX is not approved for use in pediatric patients. [See Warnings and Precautions Use in Specific Populations (8.4), and Patient Counseling Information].

Increased Mortality in Elderly Patients with Dementia-Related Psychosis   — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. SYMBYAX (olanzapine and fluoxetine HCl) is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.2, 5.18) and Patient Counseling Information].

 

SYMBYAX SUMMARY

SYMBYAX™ (olanzapine and fluoxetine HCl capsules) combines 2 psychotropic agents, olanzapine (the active ingredient in Zyprexa®, and Zyprexa Zydis®) and fluoxetine hydrochloride (the active ingredient in Prozac®, Prozac Weekly™, and Sarafem®).

SYMBYAX is indicated for the treatment of depressive episodes associated with bipolar disorder. The efficacy of SYMBYAX was established in 2 identically designed, 8-week, randomized, double-blind clinical studies.

Unlike with unipolar depression, there are no established guidelines for the length of time patients with bipolar disorder experiencing a major depressive episode should be treated with agents containing antidepressant drugs.

The effectiveness of SYMBYAX for maintaining antidepressant response in this patient population beyond 8 weeks has not been established in controlled clinical studies. Physicians who elect to use SYMBYAX for extended periods should periodically reevaluate the benefits and long-term risks of the drug for the individual patient.


See all Symbyax indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Symbyax (Olanzapine / Fluoxetine)

Talking therapy hope for people with a recent Bipolar Disorder diagnosis
Source: Bipolar News From Medical News Today [2014.09.12]
Cognitive Behavioural Therapy could give people with a recent Bipolar Disorder diagnosis a better chance of recovery, a new study published in the British Journal of Psychiatry suggests.

Pioneering online treatment for people with Bipolar Disorder
Source: Bipolar News From Medical News Today [2014.08.13]
The first effective web-based treatment for Bipolar Disorder based on the latest research evidence has been developed by psychologists.

Bipolar disorder: brain scans show excitable pleasure response
Source: Bipolar News From Medical News Today [2014.07.09]
People with bipolar disorder showed a more active reward center in their brains when scanned with functional MRI, and poorer prefrontal cortex ability to modulate impulses.

Stress system and cortisol levels play role in bipolar disorder related depression
Source: Bipolar News From Medical News Today [2014.06.20]
Depression is almost twice as common, and poor quality of life almost five times as common, in people with bipolar disorder who have elevated or low levels of the stress hormone cortisol in the blood.

Regulation process identified of protein linked to bipolar disorder
Source: Bipolar News From Medical News Today [2014.06.13]
Researchers from Tufts have gained new insight into a protein associated with bipolar disorder.

more news >>

Published Studies Related to Symbyax (Olanzapine / Fluoxetine)

Association of common variations in the norepinephrine transporter gene with response to olanzapine-fluoxetine combination versus continued-fluoxetine treatment in patients with treatment-resistant depression: a candidate gene analysis. [2012]
CONCLUSIONS: Our findings further support the hypothesis that the synergistic

Genetic association study of treatment response with olanzapine/fluoxetine combination or lamotrigine in bipolar I depression. [2010.05]
CONCLUSIONS: SNPs in specific candidate genes were associated with symptomatic improvement in a treatment-specific fashion. These results suggest the importance of dopaminergic effects in the treatment of patients with bipolar I depression and the potential utility of genotyping in selection of pharmacologic treatments for bipolar depression.

Genetic associations of prolactin increase in olanzapine/fluoxetine combination-treated patients. [2010.01.30]
In patients from two clinical trials, we investigated the associations of single nucleotide polymorphisms (SNPs) in candidate genes with prolactin level changes during treatment with olanzapine/fluoxetine combination. In both cohorts, three dopamine receptor D2 (DRD2) SNPs were associated with prolactin changes.

Olanzapine/fluoxetine combination in patients with treatment-resistant depression: rapid onset of therapeutic response and its predictive value for subsequent overall response in a pooled analysis of 5 studies. [2010]
CONCLUSIONS: Olanzapine/fluoxetine combination is superior to fluoxetine and

Genetic associations of prolactin increase in olanzapine/fluoxetine combination-treated patients. [2010]
In patients from two clinical trials, we investigated the associations of single nucleotide polymorphisms (SNPs) in candidate genes with prolactin level changes during treatment with olanzapine/fluoxetine combination. In both cohorts, three dopamine receptor D2 (DRD2) SNPs were associated with prolactin changes.

more studies >>

Clinical Trials Related to Symbyax (Olanzapine / Fluoxetine)

A Study for Assessing Treatment of Patients Ages 10-17 With Bipolar Depression [Recruiting]
The main goal of this study is to help answer the following research question(s) and not to treat the child's illness.

- Can this study drug make children with bipolar depression feel better?

- Does this study drug work better than a placebo (sugar pill)?

- Does this study drug cause side effects in children who take it?

- Is this drug safe to use in children? (The study drug is a mixture of olanzapine and

fluoxetine)

Olanzapine in Patients With Advanced Cancer and Weight Loss [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of the drug Olanzapine that can be given to patients with advanced cancer who are experiencing weight loss. Researchers want to find out if Olanzapine can help decrease weight loss in patients who are experiencing it because of cancer. How this drug affects performance status, cancer-related symptoms, and nutritional status in patients with advanced cancer will also be studied.

A Study in Relapse Prevention of Treatment-resistant Depression [Recruiting]
The purpose of this study is to determine whether olanzapine and fluoxetine combination (OFC) if used for a long time (47 weeks) makes patients suffering from Treatment Resistant Depression stable, determine if OFC is safe when used to treat patients with Treatment Resistant Depression for a long time (up to 47 weeks), to determine whether olanzapine and fluoxetine combination or fluoxetine alone is better to treat Treatment Resistant Depression when treated for a long time ( up to 47 weeks) and to assess the quality of life during treatment.

Reducing Weight Gain and Improving Metabolic Function in Children Being Treated With Antipsychotics [Recruiting]
This study will test the effectiveness of two different treatments for children and adolescents who have gained weight on their antipsychotic medications.

more trials >>

Reports of Suspected Symbyax (Olanzapine / Fluoxetine) Side Effects

OFF Label USE (7)Asphyxia (3)Completed Suicide (3)Fall (2)Suicidal Ideation (2)Decreased Appetite (2)Insomnia (2)Withdrawal Syndrome (2)Blood Bilirubin Increased (1)Intentional Overdose (1)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 3 ratings/reviews, Symbyax has an overall score of 4. The effectiveness score is 4 and the side effect score is 6.67. The scores are on ten point scale: 10 - best, 1 - worst.
 

Symbyax review by 18 year old female patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   No Side Effects
  
Treatment Info
Condition / reason:   Bipolar disorder
Dosage & duration:   6mg/25mg taken every night for the period of two months
Other conditions:   Schitzophrenia
Other drugs taken:   Seroquil
  
Reported Results
Benefits:   The benefits were great. I really liked Symbyax because it didn't give me side effects like the other medication I used to take did. I would wake up in the day feeling refreshed. As I was taking Seroquil for my Schitzophrenia, I would always wake up feeling exhausted and tired;still, even though I would take the medicine during the nights! I used to be stressed and aggravated all the time before Symbyax and Seroquil. Now that I'm on Symbyax, I'm emotionally numb and the voices in my head vanished. So I had a good nights sleep and didn't wake up as tired as Seroquil used to make me. :]
Side effects:   I didn't really have many side effects besides the medicine making me want to go to sleep. But I'm not complaining, since it does help the voices and the shadows go away for a while. Besides that, my psychiatrist wanted me to take advantage of the other side effect, and that side effect is that Symbyax might make you gain a little weight. So I wouldn't suggest it to people who want to lose weight. I still didn't seen any change in the weight gain and it was about a month when I started taking the lowest dose of Symbyax. Now that that month is over, I just started taking a higher dosage and I have noticed an increase in my appetite. I recommend this drug for the depressed ones who are a little underweight and the Schitzophrenics.
Comments:   As I was being diagnosed for my Bipolar disorder, I would say the medication did more for me than my therapist. The drug, Symbyax, made me more calm than I have ever been. It took about a week for the medicine to kick in and when it did, it really did work its magic even though Seroquil was pretty good at knocking me out to sleep, it didn't help me with my anxiety and depression like Symbyax has.

 

Symbyax review by 20 year old male patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   6/25 12/25 (dosage frequency: 6/25 in the morning 12/25 at night) for the period of one year
Other conditions:   anxiety
Other drugs taken:   n/a
  
Reported Results
Benefits:   the benefits were i was still depressed but not as bad and anything was better then that all in all i should of had the anti bipolar med the damn doc thought i was bipolar
Side effects:   i had a racing heart beat but extreme tiredness really strage it was the worst thing i had experianced took my mind off being depressed but i didnt know any diffrent It was the first anti depressant iv ever taken i thought it was supposed to be like that
Comments:   i think this med sould be for very severe bipolar and depression combonation or i probably should of took the bear minimum dose it mite of worked but not for me

 

Symbyax review by 20 year old male patient

  Rating
Overall rating:  
Effectiveness:   Ineffective
Side effects:   Moderate Side Effects
  
Treatment Info
Condition / reason:   depression
Dosage & duration:   6/25 12/25 (dosage frequency: 6/25 in the morning 12/25 at night) for the period of one year
Other conditions:   anxiety
Other drugs taken:   n/a
  
Reported Results
Benefits:   the benefits were i was still depressed but not as bad and anything was better then that all in all i should of had the anti bipolar med the damn doc thought i was bipolar
Side effects:   i had a racing heart beat but extreme tiredness really strage it was the worst thing i had experianced took my mind off being depressed but i didnt know any diffrent It was the first anti depressant iv ever taken i thought it was supposed to be like that
Comments:   i think this med sould be for very severe bipolar and depression combonation or i probably should of took the bear minimum dose it mite of worked but not for me

See all Symbyax reviews / ratings >>

Page last updated: 2014-09-12

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