DrugLib.com — Drug Information Portal

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

Zyprexa (Olanzapine) - Summary

 
 



BOXED WARNING

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. ZYPREXA (olanzapine) is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1, 5.14) and Patient Counseling Information].

When using ZYPREXA and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax.

 

 

ZYPREXA SUMMARY

ZYPREXA (olanzapine) is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H -thieno[2,3- b ] [1,5]benzodiazepine.

ZYPREXA® (olanzapine) is an atypical antipsychotic indicated:

As oral formulation for the:

  • Treatment of schizophrenia. (1.1) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. (14.1)
  • Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.1)
  • Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. (1.2)
      Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. (14.2)
    • Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder (14.2). The increased potential (in adolescents compared with adults) for weight gain and hyperlipidemia may lead clinicians to consider prescribing other drugs first in adolescents. (1.2)
  • Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks. (1.3)
  • Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. (1.2)
      Efficacy was established in two 6-week clinical trials in adults (14.2). Maintenance efficacy has not been systematically evaluated.

    As ZYPREXA IntraMuscular for the:

    • Treatment of acute agitation associated with schizophrenia and bipolar I mania. (1.4) Efficacy was established in three 1-day trials in adults. (14.3)

    As ZYPREXA and Fluoxetine in Combination for the:

    • Treatment of depressive episodes associated with bipolar I disorder. (1.5) Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.
  • Treatment of treatment resistant depression (major depressive disorder in patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). (1.6)
      Efficacy was established with Symbyax (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax.

    Oral ZYPREXA is indicated for the treatment of schizophrenia. Efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. In adolescent patients with schizophrenia (ages 13-17), efficacy was established in one 6-week trial [see Clinical Studies ].

    When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see Warnings and Precautions (5.5, 5.6)].

     

    Monotherapy — Oral ZYPREXA is indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. Efficacy was established in three clinical trials in adult patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one monotherapy maintenance trial. In adolescent patients with manic or mixed episodes associated with bipolar I disorder (ages 13-17), efficacy was established in one 3-week trial [see Clinical Studies ].

    When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see Warnings and Precautions (5.5, 5.6)].

     

    Adjunctive Therapy to Lithium or Valproate — Oral ZYPREXA is indicated for the treatment of manic or mixed episodes associated with bipolar I disorder as an adjunct to lithium or valproate. Efficacy was established in two 6-week clinical trials in adults. The effectiveness of adjunctive therapy for longer-term use has not been systematically evaluated in controlled trials [see Clinical Studies ].

     

    Pediatric schizophrenia and bipolar I disorder are serious mental disorders; however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, pediatric patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment. Medication treatment for both pediatric schizophrenia and bipolar I disorder should be part of a total treatment program that often includes psychological, educational and social interventions.

     

    ZYPREXA IntraMuscular is indicated for the treatment of acute agitation associated with schizophrenia and bipolar I mania.

    Efficacy was demonstrated in 3 short-term (24 hours of IM treatment) placebo-controlled trials in agitated adult inpatients with: schizophrenia or bipolar I disorder (manic or mixed episodes) [see Clinical Studies].

    “Psychomotor agitation” is defined in DSM-IV as “excessive motor activity associated with a feeling of inner tension.” Patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care, e.g., threatening behaviors, escalating or urgently distressing behavior, or self-exhausting behavior, leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the agitation.

     

    Oral ZYPREXA and fluoxetine in combination is indicated for the treatment of depressive episodes associated with bipolar I disorder, based on clinical studies in adult patients. When using ZYPREXA and fluoxetine in combination, refer to the Clinical Studies section of the package insert for Symbyax.

    ZYPREXA monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder.

     

    Oral ZYPREXA and fluoxetine in combination is indicated for the treatment of treatment resistant depression (major depressive disorder in patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode), based on clinical studies in adult patients. When using ZYPREXA and fluoxetine in combination, refer to the Clinical Studies section of the package insert for Symbyax.

    ZYPREXA monotherapy is not indicated for the treatment of treatment resistant depression.

     


    See all Zyprexa indications & dosage >>

  • NEWS HIGHLIGHTS

    Media Articles Related to Zyprexa (Olanzapine)

    Zyprexa in schizophrenia shown to prevent brain loss
    Source: The Doctors Lounge - Psychiatry
    Zyprexa (olanzapine) was found to decrease brain loss in schizophrenia patients according to the Archives of General Psychiatry.

    Medical News Today: Can speech patterns predict psychosis in young adults?
    Source: Featured Health News from Medical News Today [2015.08.27]
    Could computers analyzing speech find a place in the clinic as a means of picking out young people at risk of psychosis? A proof-of-principle study shows they could.

    Can speech patterns predict psychosis in young adults?
    Source: Medical Devices / Diagnostics News From Medical News Today [2015.08.27]
    Could computers analyzing speech find a place in the clinic as a means of picking out young people at risk of psychosis? A proof-of-principle study shows they could.

    Omega-3s May Protect Against Psychosis
    Source: MedicineNet Bipolar Disorder Specialty [2015.08.12]
    Title: Omega-3s May Protect Against Psychosis
    Category: Health News
    Created: 8/12/2015 12:00:00 AM
    Last Editorial Review: 8/12/2015 12:00:00 AM

    A way to predict whether children with DiGeorge syndrome will develop autism or psychosis
    Source: Autism News From Medical News Today [2015.07.28]
    New findings by UCLA and University of Pittsburgh isolate genetic differencesDoctors and researchers have long known that children who are missing about 60 genes on a certain chromosome are at a...

    more news >>

    Published Studies Related to Zyprexa (Olanzapine)

    A double-blind randomized Phase II study of olanzapine 10 mg versus 5 mg for emesis induced by highly emetogenic chemotherapy. [2015]
    A randomized Phase II dose-finding trial comparing olanzapine 10 mg with olanzapine 5 mg for patients receiving highly emetogenic chemotherapy with cisplatin was started in June 2014. The purpose of the trial is to evaluate the efficacy and safety of the two olanzapine doses and to determine which is more promising as a test arm for comparison with the current standard antiemetic care (a combination of aprepitant, a 5-HT3 receptor antagonist and dexamethasone) in a subsequent Phase III trial...

    Sleep architecture and cognitive changes in olanzapine-treated patients with depression: a double blind randomized placebo controlled trial. [2014]
    depression (e.g., illness severity and cognitive function) were also determined... CONCLUSIONS: Olanzapine augmentation treatment generally did not improve SWS but

    Efficacy of olanzapine monotherapy for treatment of bipolar I depression: a randomized, double-blind, placebo controlled study. [2014]
    CONCLUSIONS: Olanzapine is effective in the treatment of bipolar I depression but

    Long-term effects of asenapine or olanzapine in patients with persistent negative symptoms of schizophrenia: a pooled analysis. [2013]
    prompted a pooled analysis of the treatment effects of both drugs... CONCLUSION: In this pooled analysis, ASE and OLA did not differ significantly

    A randomized controlled trial of olanzapine improving memory deficits in Han Chinese patients with first-episode schizophrenia. [2013]
    Olanzapine is an atypical antipsychotic for the treatment of schizophrenia, in which memory impairment is a core deficit. The methods of positive and negative syndrome scale (PANSS), Wechsler memory scale-4th edition (WMS-IV) and event-related potential (ERP) were used to study the effects of olanzapine on the cognitive function in the first-episode schizophrenic patients...

    more studies >>

    Clinical Trials Related to Zyprexa (Olanzapine)

    Olanzapine Given in Combination With Zonisamide SR to Prevent Weight Gain in Schizophrenic Subjects [Terminated]
    The purpose of this study is to determine if zonisamide SR will prevent weight gain in schizophrenic subjects who take olanzapine (Zyprexa)

    Effects of Modafinil on Olanzapine Weight Gain [Completed]
    This study is designed as a 3 week, randomized, double blind, placebo controlled, trial. Olanzapine and modafinil will be titrated to 10mg and 200mg respectively. Feeding lab assessments will be conducted at baseline and endpoint. Assessments of hunger/satiety, kilocalories consumed and weight will be obtained. Plasma ghrelin and PYY3-36 levels will be drawn at baseline and endpoint prior to breakfast and two hours post. Study hypothesis: The modafinil/olanzapine group will gain less weight than the olanzapine/placebo group over three weeks of drug intake.

    Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder [Completed]
    The efficacy and safety of the extended treatment to patients with most recent episode manic or mixed who completed previous double blind study (F1D-JE-BMAC [Study BMAC]) will be examined.

    Comparison of Antipsychotic Combination Treatment of Olanzapine and Amisulpride to Monotherapy [Recruiting]
    A study to examine whether an antipsychotic combination treatment of olanzapine and amisulpride is more effective than olanzapine and amisulpride alone.

    Bioequivalence Study of Olanzapine Tablets, 5 mg Under Fed Study [Completed]
    The purpose of this study is to compare the bioequivalence and characterize the profile of the olanzapine tablets, 5 mg with zyprexa tablets, 5 mg in healthy, adult, human subjects under fed conditions and to monitor the adverse events and ensure the safety of the subjects.

    more trials >>

    Reports of Suspected Zyprexa (Olanzapine) Side Effects

    Weight Increased (199)OFF Label USE (147)Overdose (142)Diabetes Mellitus (117)Hospitalisation (77)Confusional State (68)Hypertension (68)Death (67)Somnolence (66)Pneumonia (61)more >>


    PATIENT REVIEWS / RATINGS / COMMENTS

    Based on a total of 7 ratings/reviews, Zyprexa has an overall score of 6. The effectiveness score is 7.71 and the side effect score is 6.86. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
     

    Zyprexa review by 20 year old female patient

      Rating
    Overall rating:  
    Effectiveness:   Highly Effective
    Side effects:   No Side Effects
      
    Treatment Info
    Condition / reason:   depression
    Dosage & duration:   10mg taken every night for the period of six years
    Other conditions:   anorexia nervosa
    Other drugs taken:   Lamictal, birth control (Jolessa)
      
    Reported Results
    Benefits:   Went from severely depressed before starting the medication to almost entirely free of depression a week after starting the medication; helped with insomnia.
    Side effects:   drowsiness in the beginning, but I quickly got used to it.
    Comments:   I entered a hospuital six years ago for suicidality; I wasn't sleeping, I wasn't eating (I had anorexia nervosa), and I was extremely depressed. I started taking 10mg of Zyprexa the first night I was there. I was really drowsy all the next day, but it waned over a few days (now it doesn't affect my energy level at all.) In about a week, my depression just lifted. This medicine has worked miracles for me- I've been depression-free since starting it- and I wouldn't go off it for any reason.

     

    Zyprexa review by care giver of 81 year old male patient

      Rating
    Overall rating:  
    Effectiveness:   Considerably Effective
    Side effects:   Severe Side Effects
      
    Treatment Info
    Condition / reason:   agitation management r/t Lewy Body Syndrome Demen
    Dosage & duration:   20mg taken x1 / daily for the period of 5 years
    Other conditions:   B/P ,Diabetes, obesity, SVT's,osteoporosis
    Other drugs taken:   ASA, Cardia, Fosamax, glyburide,Lorazepam, Metformin, Namenda,Razadyne, Simvastatin, Zetia, Plavix
      
    Reported Results
    Benefits:   The Zyprexa minimized agitative outbursts
    Side effects:   The pt developed severe "gait freezing" , gait shuffling, severe muscle weakness, and gereral stupor
    Comments:   Since many of these s/s are also s/s of the disease-Lewy Body Syndrome Demenia, it took research and experimentation by me and the MD to realize that it was the med adn not the disease in this case. The pt has been taken off the drug and no longer has these pronounced s/s.

     

    Zyprexa review by 43 year old female patient

      Rating
    Overall rating:  
    Effectiveness:   Ineffective
    Side effects:   Moderate Side Effects
      
    Treatment Info
    Condition / reason:   Bipolar Disorder Type II
    Dosage & duration:   15mg taken 3 times per day for the period of approximately 2 years
    Other conditions:   none
    Other drugs taken:   Effexor XR & Tegretol (Carbamazapine)
      
    Reported Results
    Benefits:   While taking Zyprexa, I never experienced any episodes of hypomania (low mania) which typically accompany Bipolar Type II; however, I attribute this mostly to the fact that Zyprexa is very sedating. It should be noted that although Zyprexa is classified as an A-typical antipsychotic, it is also used as a mood stabilizer in patients with Bipolar Disorder.
    Side effects:   Increased appetite which of course lead to weight gain which caused me to feel depressed! I am not exaggerating when I say my appetite was almost insatiable. Excessive sleepiness during the day which caused me to actually start falling asleep while talking to someone on several occassions. It also made me feel almost "numb" emotionally. Sedation along with an insatiable appetite caused me to gain over 25 pounds.
    Comments:   My psychiatrist prescribed Zyprexa to help with the mood swings of Bipolar Disorder. I am classified as Bipolar Type II because I do not experience the extreme highs of mania (manic episodes) that accompany Bipolar Type I. I do, however, experience hypomania (hypo meaning low) so my moods still swing from highs to the extreme lows of depression.

    See all Zyprexa reviews / ratings >>

    Page last updated: 2015-08-27

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

    All Rights reserved - Copyright DrugLib.com, 2006-2015