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GEODON®Index Section (ziprasidone HCl)

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Administration Information for GEODON Capsules

2.2 Schizophrenia

2.3 Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)

2.4 Acute Treatment of Agitation in Schizophrenia

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

4.1 QT Prolongation

4.2 Hypersensitivity

5 WARNINGS AND PRECAUTIONS

5.1 Increased Mortality in Elderly Patients With Dementia-Related Psychosis

5.2 Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients With Dementia-Related Psychosis

5.3 QT Prolongation and Risk of Sudden Death

5.4 Neuroleptic Malignant Syndrome (NMS)

5.5 Severe Cutaneous Adverse Reactions

5.6 Tardive Dyskinesia

5.7 Metabolic Changes

5.8 Rash

5.9 Orthostatic Hypotension

5.10 Falls

5.11 Leukopenia, Neutropenia, and Agranulocytosis

5.12 Seizures

5.13 Dysphagia

5.14 Hyperprolactinemia

5.15 Potential for Cognitive and Motor Impairment

5.16 Priapism

5.17 Body Temperature Regulation

5.18 Suicide

5.19 Patients With Concomitant Illnesses

5.20 Laboratory Tests

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Metabolic Pathway

7.2 In Vitro Studies

7.3 Pharmacodynamic Interactions

7.4 Pharmacokinetic Interactions

7.5 Lithium

7.6 Oral Contraceptives

7.7 Dextromethorphan

7.8 Valproate

7.9 Other Concomitant Drug Therapy

7.10 Food Interaction

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

8.8 Age and Gender Effects

8.9 Smoking

9 DRUG ABUSE AND DEPENDENCE

9.3 Dependence

10 OVERDOSAGE

10.1 Human Experience

10.2 Management of Overdosage

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Schizophrenia

14.2 Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)

14.3 Acute Treatment of Agitation in Schizophrenia

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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