Ziprasidone (oral): Difference between revisions
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{{DrugProjectFormSinglePage | {{DrugProjectFormSinglePage | ||
|authorTag= | |authorTag={{DB}} | ||
|genericName=Ziprasidone | |||
|aOrAn=an | |||
|drugClass=antipsychotic agent | |||
|indicationType=treatment | |||
|indication=schizophrenia, bipolar I disorder (acute mixed or manic episodes and maintenance treatment as an adjunct to lithium or valproate) and acute treatment of agitation in schizophrenia | |||
|hasBlackBoxWarning=Yes | |||
|adverseReactions=somnolence, respiratory tract infection, extrapyramidal symptoms, dizziness, akathisia, abnormal vision, asthenia, vomiting, nausea, headache | |||
|blackBoxWarningTitle=<span style="color:#FF0000;">WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS</span> | |||
|blackBoxWarningBody=<i><span style="color:#FF0000;">Increased mortality in elderly patients with dementia-related psychosis: </span></i> | |||
* 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. | |||
|fdaLIADAdult======Condition1===== | |||
a | |||
|fdaLIADAdult= | |||
=====Condition1===== | |||
* Dosing Information | * Dosing Information | ||
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<!--Guideline-Supported Use (Adult)--> | <!--Guideline-Supported Use (Adult)--> | ||
|offLabelAdultGuideSupport======Condition1===== | |||
|offLabelAdultGuideSupport= | |||
=====Condition1===== | |||
* Developed by: | * Developed by: | ||
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<!--Non–Guideline-Supported Use (Adult)--> | <!--Non–Guideline-Supported Use (Adult)--> | ||
|offLabelAdultNoGuideSupport======Condition1===== | |||
|offLabelAdultNoGuideSupport= | |||
=====Condition1===== | |||
* Dosing Information | * Dosing Information | ||
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<!--FDA-Labeled Indications and Dosage (Pediatric)--> | <!--FDA-Labeled Indications and Dosage (Pediatric)--> | ||
|fdaLIADPed======Condition1===== | |||
|fdaLIADPed= | |||
=====Condition1===== | |||
* Dosing Information | * Dosing Information | ||
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<!--Guideline-Supported Use (Pediatric)--> | <!--Guideline-Supported Use (Pediatric)--> | ||
|offLabelPedGuideSupport======Condition1===== | |||
|offLabelPedGuideSupport= | |||
=====Condition1===== | |||
* Developed by: | * Developed by: | ||
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<!--Non–Guideline-Supported Use (Pediatric)--> | <!--Non–Guideline-Supported Use (Pediatric)--> | ||
|offLabelPedNoGuideSupport======Condition1===== | |||
|offLabelPedNoGuideSupport= | |||
=====Condition1===== | |||
* Dosing Information | * Dosing Information | ||
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<!--Contraindications--> | <!--Contraindications--> | ||
|contraindications=* Condition1 | |||
|contraindications= | |||
* Condition1 | |||
<!--Warnings--> | <!--Warnings--> | ||
|warnings=* Description | |||
|warnings= | |||
* Description | |||
====Precautions==== | ====Precautions==== | ||
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<!--Clinical Trials Experience--> | <!--Clinical Trials Experience--> | ||
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label. | |||
|clinicalTrials= | |||
There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label. | |||
=====Body as a Whole===== | =====Body as a Whole===== | ||
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<!--Postmarketing Experience--> | <!--Postmarketing Experience--> | ||
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | |||
|postmarketing= | |||
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label. | |||
=====Body as a Whole===== | =====Body as a Whole===== | ||
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<!--Drug Interactions--> | <!--Drug Interactions--> | ||
|drugInteractions=* Drug | |||
|drugInteractions= | |||
* Drug | |||
:* Description | :* Description | ||
<!--Use in Specific Populations--> | <!--Use in Specific Populations--> | ||
|useInPregnancyFDA=* '''Pregnancy Category''' | |||
|useInPregnancyFDA= | |useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category''' | ||
* '''Pregnancy Category''' | |||
|useInPregnancyAUS= | |||
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category''' | |||
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant. | There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant. | ||
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery. | |||
|useInLaborDelivery= | |useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers. | ||
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery. | |useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients. | ||
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients. | |||
|useInNursing= | |useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations. | ||
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers. | |useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations. | ||
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment. | |||
|useInPed= | |useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment. | ||
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients. | |useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males. | ||
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised. | |||
|useInGeri= | |||
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients. | |||
|useInGender= | |||
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations. | |||
|useInRace= | |||
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations. | |||
|useInRenalImpair= | |||
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment. | |||
|useInHepaticImpair= | |||
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment. | |||
|useInReproPotential= | |||
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males. | |||
|useInImmunocomp= | |||
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised. | |||
<!--Administration and Monitoring--> | <!--Administration and Monitoring--> | ||
|administration=* Oral | |||
|administration= | |||
* Oral | |||
* Intravenous | * Intravenous | ||
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | |||
|monitoring= | |||
There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label. | |||
* Description | * Description | ||
<!--IV Compatibility--> | <!--IV Compatibility--> | ||
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label. | |||
|IVCompat= | |||
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label. | |||
<!--Overdosage--> | <!--Overdosage--> | ||
|overdose====Acute Overdose=== | |||
|overdose= | |||
===Acute Overdose=== | |||
====Signs and Symptoms==== | ====Signs and Symptoms==== | ||
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<!--Drug box 2--> | <!--Drug box 2--> | ||
|drugBox=<!--Mechanism of Action--> | |||
|drugBox= | |mechAction=* | ||
<!--Mechanism of Action--> | |||
|mechAction= | |||
* | |||
<!--Structure--> | <!--Structure--> | ||
|structure=* | |||
|structure= | |||
* | |||
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]] | : [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]] | ||
<!--Pharmacodynamics--> | <!--Pharmacodynamics--> | ||
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label. | |||
|PD= | |||
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label. | |||
<!--Pharmacokinetics--> | <!--Pharmacokinetics--> | ||
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label. | |||
|PK= | |||
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label. | |||
<!--Nonclinical Toxicology--> | <!--Nonclinical Toxicology--> | ||
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label. | |||
|nonClinToxic= | |||
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label. | |||
<!--Clinical Studies--> | <!--Clinical Studies--> | ||
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label. | |||
|clinicalStudies= | |||
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label. | |||
<!--How Supplied--> | <!--How Supplied--> | ||
|howSupplied=* | |||
|howSupplied= | |||
* | |||
<!--Patient Counseling Information--> | <!--Patient Counseling Information--> | ||
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label. | |||
|fdaPatientInfo= | |||
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label. | |||
<!--Precautions with Alcohol--> | <!--Precautions with Alcohol--> | ||
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | |||
|alcohol= | |||
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | |||
<!--Brand Names--> | <!--Brand Names--> | ||
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref> | |||
|brandNames= | |||
* ®<ref>{{Cite web | title = | url = }}</ref> | |||
<!--Look-Alike Drug Names--> | <!--Look-Alike Drug Names--> | ||
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref> | |||
|lookAlike= | |||
* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref> | |||
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|drugShortage= | |drugShortage= | ||
}} | }} | ||
{{PillImage | |||
|fileName=No image.jpg | |||
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{{LabelImage | |||
|fileName={{PAGENAME}}11.png | |||
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{{LabelImage | |||
|fileName={{PAGENAME}}11.png | |||
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[[Category:Drug]] | [[Category:Drug]] |
Revision as of 16:48, 10 October 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]
Disclaimer
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Black Box Warning
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
See full prescribing information for complete Boxed Warning.
Increased mortality in elderly patients with dementia-related psychosis:
|
Overview
Ziprasidone (oral) is an antipsychotic agent that is FDA approved for the treatment of schizophrenia, bipolar I disorder (acute mixed or manic episodes and maintenance treatment as an adjunct to lithium or valproate) and acute treatment of agitation in schizophrenia. There is a Black Box Warning for this drug as shown here. Common adverse reactions include somnolence, respiratory tract infection, extrapyramidal symptoms, dizziness, akathisia, abnormal vision, asthenia, vomiting, nausea, headache.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
- Dosing Information
- Dosage
Condition2
- Dosing Information
- Dosage
Condition3
- Dosing Information
- Dosage
Condition4
- Dosing Information
- Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Ziprasidone (oral) in adult patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ziprasidone (oral) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Ziprasidone (oral) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
- Developed by:
- Class of Recommendation:
- Strength of Evidence:
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Ziprasidone (oral) in pediatric patients.
Non–Guideline-Supported Use
Condition1
- Dosing Information
- Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ziprasidone (oral) in pediatric patients.
Contraindications
- Condition1
Warnings
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
See full prescribing information for complete Boxed Warning.
Increased mortality in elderly patients with dementia-related psychosis:
|
- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Ziprasidone (oral) in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Ziprasidone (oral) in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
- Drug
- Description
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ziprasidone (oral) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ziprasidone (oral) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Ziprasidone (oral) with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Ziprasidone (oral) with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Ziprasidone (oral) with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Ziprasidone (oral) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ziprasidone (oral) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Ziprasidone (oral) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Ziprasidone (oral) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ziprasidone (oral) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ziprasidone (oral) in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Ziprasidone (oral) in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Ziprasidone (oral) in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Ziprasidone (oral) in the drug label.
Pharmacology
There is limited information regarding Ziprasidone (oral) Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Ziprasidone (oral) in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Ziprasidone (oral) in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Ziprasidone (oral) in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Ziprasidone (oral) in the drug label.
How Supplied
Storage
There is limited information regarding Ziprasidone (oral) Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Ziprasidone (oral) |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Ziprasidone (oral) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Ziprasidone (oral) in the drug label.
Precautions with Alcohol
- Alcohol-Ziprasidone (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ Empty citation (help)
- ↑ "http://www.ismp.org". External link in
|title=
(help)
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