Application Nr Approved Date Route Status External Links
ANDA077562 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Ziprasidone Hydrochloride Capsules Are Indicated For The Treatment Of Schizophrenia. 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 ( 5.2 ) ]. 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 ( 5.2 ) ] Ziprasidone Hydrochloride Capsules Are An Atypical Antipsychotic. In Choosing Among Treatments, Prescribers Should Be Aware Of The Capacity Of Ziprasidone Hydrochloride Capsules To Prolong The Qt Interval And May Consider The Use Of Other Drugs First ( 5.2 ) Ziprasidone Hydrochloride Capsules Are Indicated As An Oral Formulation For The: Treatment Of Schizophrenia. ( 1.1 ) • Adults: Efficacy Was Established In Four 4 To 6 Week Trials And One Maintenance Trial In Adult Patients With Schizophrenia ( 14.1 ) 1.1 Schizophrenia Ziprasidone Hydrochloride Capsules Are 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 ( 14.1 ) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Ziprasidone Hydrochloride ZIPRASIDONE HYDROCHLORIDE ZINC538550

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