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.
|
|
NEWS HIGHLIGHTSMedia Articles Related to Geodon (Ziprasidone)
Schizophrenia Quiz: What is Schizophrenia? Source: MedicineNet Schizophrenia Specialty [2017.09.19] Title: Schizophrenia Quiz: What is Schizophrenia? Category: MedicineNet Quiz Created: 1/26/2011 12:00:00 AM Last Editorial Review: 9/19/2017 5:20:02 PM
Magnetic Brain Stimulation May Quiet 'Voices' in Schizophrenia Source: MedicineNet Schizophrenia Specialty [2017.09.08] Title: Magnetic Brain Stimulation May Quiet 'Voices' in Schizophrenia Category: Health News Created: 9/7/2017 12:00:00 AM Last Editorial Review: 9/8/2017 12:00:00 AM
'Recovery-Oriented' Talk Therapy May Help Curb Schizophrenia Source: MedicineNet Schizophrenia Specialty [2017.06.07] Title: 'Recovery-Oriented' Talk Therapy May Help Curb Schizophrenia Category: Health News Created: 6/6/2017 12:00:00 AM Last Editorial Review: 6/7/2017 12:00:00 AM
Bipolar Disorder vs. Schizophrenia Source: MedicineNet Schizophrenia Specialty [2017.05.18] Title: Bipolar Disorder vs. Schizophrenia Category: Diseases and Conditions Created: 5/18/2017 12:00:00 AM Last Editorial Review: 5/18/2017 12:00:00 AM
Schizophrenia Source: MedicineNet Electroconvulsive Therapy Specialty [2016.10.24] Title: Schizophrenia Category: Diseases and Conditions Created: 12/31/1997 12:00:00 AM Last Editorial Review: 10/24/2016 12:00:00 AM
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
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
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 / COMMENTSBased 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. |
|
|
Page last updated: 2017-09-19
|