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Geodon (Ziprasidone Hydrochloride) - Summary

 
 



BOXED WARNING

BOXED WARNINGWARNING: 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. GEODON (ziprasidone) is not approved for the treatment of patients with Dementia-Related Psychosis [see Warnings and Precautions]).

 

GEODON SUMMARY

GEODON is available as capsules (ziprasidone hydrochloride) for oral administration and as an injection (ziprasidone mesylate) for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents.

GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [ see Warnings and Precautions ]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions]

1.1 Schizophrenia

Geodon is indicated for the treatment of schizophrenia. The efficacy of oral ziprasidone was established in four short-term (4- and 6-week) controlled trials of adult schizophrenic inpatients and in one maintenance trial of stable adult schizophrenic inpatients [see Clinical Studies].

1.2 Bipolar I Disorder

    Geodon is indicated as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder. Efficacy was established in two 3-week monotherapy studies in adult patients. [see Clinical Studies].

Geodon is indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder. Efficacy was established in a maintenance trial in adult patients. The efficacy of Geodon as monotherapy for the maintenance treatment of bipolar I disorder has not been systematically evaluated in controlled clinical trials. [see Clinical Studies].

1.3 Acute Agitation in Schizophrenic Patients

GEODON intramuscular is indicated for the treatment of acute agitation in schizophrenic patients for whom treatment with ziprasidone is appropriate and who need intramuscular antipsychotic medication for rapid control of agitation. The efficacy of intramuscular ziprasidone for acute agitation in schizophrenia was established in single day controlled trials of agitated schizophrenic inpatients. [see Clinical Trials]

"Psychomotor agitation" is defined in DSM-IV as "excessive motor activity associated with a feeling of inner tension." Schizophrenic 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.

Since there is no experience regarding the safety of administering ziprasidone intramuscular to schizophrenic patients already taking oral ziprasidone, the practice of co-administration is not recommended.

Ziprasidone intramuscular is intended for intramuscular use only and should not be administered intravenously.


See all Geodon indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Geodon (Ziprasidone)

Medical News Today: Link found between throat microbes and schizophrenia
Source: Featured Health News from Medical News Today [2015.08.26]
Researchers have revealed that the microscopic organisms found in the back of the throats of people with schizophrenia are different to those found in healthy individuals.

Link found between throat microbes and schizophrenia
Source: Biology / Biochemistry News From Medical News Today [2015.08.26]
Researchers have revealed that the microscopic organisms found in the back of the throats of people with schizophrenia are different to those found in healthy individuals.

Researchers identify signature of microbiomes associated with schizophrenia
Source: Ear, Nose and Throat News From Medical News Today [2015.08.25]
Studying microbiomes in throat may help identify causes and treatments of brain disorderIn the most comprehensive study to date, researchers at the George Washington University have identified a...

Retinal changes may serve as measures of brain pathology in schizophrenia
Source: Eye Health / Blindness News From Medical News Today [2015.08.19]
Schizophrenia is associated with structural and functional alterations of the visual system, including specific structural changes in the eye.

Retinal changes may serve as measures of brain pathology in schizophrenia
Source: Eye Health / Blindness News From Medical News Today [2015.08.18]
Schizophrenia is associated with structural and functional alterations of the visual system, including specific structural changes in the eye.

more news >>

Published Studies Related to Geodon (Ziprasidone)

A randomized, double-blind, placebo-controlled study of ziprasidone monotherapy in bipolar disorder with co-occurring lifetime panic or generalized anxiety disorder. [2014]
CONCLUSIONS: Results suggest that ziprasidone monotherapy was not associated with

Psychomotor symptoms and treatment outcomes of ziprasidone monotherapy in patients with major depressive disorder: a 12-week, randomized, double-blind, placebo-controlled, sequential parallel comparison trial. [2014]
The aim of this study was to evaluate efficacy of ziprasidone monotherapy for major depressive disorder (MDD) with and without psychomotor symptoms. In accordance with the sequential parallel comparison design, 106 MDD patients (age 44.0±10.7 years; female, 43.4%) were recruited and a post-hoc analysis was carried out on 12-week double-blind treatment with either ziprasidone (40-160 mg/day) or placebo, divided into two phases of 6 weeks each to the assigned treatment sequences, drug/drug, placebo/placebo, and placebo/drug...

Sleep architecture in ziprasidone-treated bipolar depression: a pilot study. [2013]
therapy on sleep architecture in bipolar depression... CONCLUSION: Adjunctive ziprasidone treatment alters sleep architecture in

Risk for adverse events and discontinuation due to adverse events of ziprasidone monotherapy relative to placebo in the acute treatment of bipolar depression, mania, and schizophrenia. [2013]
bipolar mania (BPM), and schizophrenia... CONCLUSIONS: Ziprasidone was associated with significant differential adverse

Characterizing relapse prevention in bipolar disorder with adjunctive ziprasidone: clinical and methodological implications. [2013]
in bipolar disorder compared with lithium or valproate treatment alone... CONCLUSIONS: These analyses confirm the effectiveness of ziprasidone

more studies >>

Clinical Trials Related to Geodon (Ziprasidone)

A 12-Week, Placebo Controlled Trial of Ziprasidone as Monotherapy for Major Depressive Disorder [Completed]
This is a study on the effectiveness, tolerability and safety of oral ziprasidone as monotherapy in patients with major depressive disorder (MDD). Outpatients suffering from MDD will be treated with either ziprasidone or placebo for 12 weeks. Hypothesis: There will be a statistically significant difference in the magnitude of response, as measured by a decrease in baseline 17-item Hamilton Depression Rating Scale (HAM-D-17) scores, between the two treatment groups; the reduction in HAM-D-17 scores will be greater in the ziprasidone monotherapy group than in the placebo group.

Geodon in Weight Loss Study for Bipolar Disorders [Completed]
This research study is designed to determine if replacing your current antipsychotic and/or mood stabilizer with ziprasidone (Geodon) will impact weight. This research is being conducted because Geodon has a documented effect on mood. Additionally, we believe Geodon to be an effective medication for overweight or obese patients with bipolar disorder. There will be approximately 25 patients enrolled in this study.

Bioequivalence Study of Ziprasidone HCL Capsules, 20 mg Under Fasting Conditions [Completed]

Bioequivalence Study of Ziprasidone HCL Capsules, 20 mg of Dr. Reddy's Under Fed Conditions [Completed]

Geodon for the Treatment of Refractory Social Anxiety Disorder [Completed]
The purpose of this study is to examine the effectiveness and tolerability of augmentation treatment of ziprasidone to achieve remission among patients with social anxiety disorder (SAD) who did not remit on sertraline treatment alone

more trials >>

Reports of Suspected Geodon (Ziprasidone) Side Effects

Drug Ineffective (64)Feeling Abnormal (64)Somnolence (61)Depression (55)Malaise (52)Insomnia (52)Weight Increased (46)Anxiety (43)Tremor (41)Fatigue (38)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 2 ratings/reviews, Geodon has an overall score of 10. The effectiveness score is 10 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Geodon review by 39 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   bi-polar disorder
Dosage & duration:   80 mg taken 2x/daily for the period of 3 yrs.
Other conditions:   OCD, Post Traumatic Stress Disorder, Panic/Anxiety attacks
Other drugs taken:   hydrocodone, esgic plus tabs
  
Reported Results
Benefits:   The benefits are numerous. With the Geodon I haven't suffered from a bout of depression in app. 2 1/2 yrs.. Before the Geodon I suffered from depression for months at a time. I haven't been or felt suicidal at all since beginning the drug. With Geodon I am on an even keel. By that I mean that I do not suffer from the peaks and valleys of typical bi-polar disorder. I no longer have manic episodes for days and then sink into a dark depression. It has made most of my bi-polar traits go away.
Side effects:   The side effects are: dry mouth, possible headache,
Comments:   The treatment for me is to take 2 80mg capsules of Geodon daily and follow up with a psychiatrist.

 

Geodon review by 39 year old female patient

  Rating
Overall rating:  
Effectiveness:   Highly Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   bi-polar disorder
Dosage & duration:   80 mg taken 2x/daily for the period of 3 yrs.
Other conditions:   OCD, Post Traumatic Stress Disorder, Panic/Anxiety attacks
Other drugs taken:   hydrocodone, esgic plus tabs
  
Reported Results
Benefits:   The benefits are numerous. With the Geodon I haven't suffered from a bout of depression in app. 2 1/2 yrs.. Before the Geodon I suffered from depression for months at a time. I haven't been or felt suicidal at all since beginning the drug. With Geodon I am on an even keel. By that I mean that I do not suffer from the peaks and valleys of typical bi-polar disorder. I no longer have manic episodes for days and then sink into a dark depression. It has made most of my bi-polar traits go away.
Side effects:   The side effects are: dry mouth, possible headache,
Comments:   The treatment for me is to take 2 80mg capsules of Geodon daily and follow up with a psychiatrist.

See all Geodon reviews / ratings >>

Page last updated: 2015-08-26

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