NDA 20-825 Approval Letter and Labeling Page 4 ATTACHMENT 1 Ziprasidone (Ziprasidone HCl) DESCRIPTION Ziprasidone is available as Ziprasidone Capsules (ziprasidone hydrochloride) for oral administration. Ziprasidone is an antipsychotic agent that is chemically unrelated to phenothiazine or butyrophenone
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چکیده
Ziprasidone Capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6chloro-1,3-dihydro-2H-indol-2-one, monohydrochloride, monohydrate The empirical formula is C21H21ClN4OS · HCl · H2O and its molecular weight is 467.42. Ziprasidone hydrochloride monohydrate is a white to slightly pink powder.
منابع مشابه
Metabolism and excretion of the novel antipsychotic drug ziprasidone in rats after oral administration of a mixture of 14C- and 3H-labeled ziprasidone.
The metabolism and excretion of ziprasidone (5-[2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-yl]ethyl]-6-++ +chloroindolin-2-one hydrochloride hydrate) were studied in Long Evans rats after oral administration of a single dose of a mixture of 14C- and 3H-labeled ziprasidone. The radioactive dose was quantitatively recovered over 7 days in both male and female rats. The percentage of the dose excre...
متن کاملMaintenance Treatment of Bipolar Disorder with Ziprasidone in Adjunctive Use with Lithium or Valproate
Ziprasidone is a second generation (“atypical”) antipsychotic drug that has been used alone and as an adjunct to standard mood stabilizers to reduce recurrence rates in bipolar disorder. Approval of ziprasidone as an adjunct to lithium or valproate in 2009 was based on an industry sponsored study of 584 outpatients with a current or recent manic episode; 240 of these subjects were randomized to...
متن کاملBehavioral and Metabolic Effects of the Atypical Antipsychotic Ziprasidone on the Nematode Caenorhabditis elegans
Atypical antipsychotics are associated with metabolic syndrome, primarily associated with weight gain. The effects of Ziprasidone, an atypical antipsychotic, on metabolic syndrome has yet to be evaluated. Here in, we evaluated lipid accumulation and behavioral changes in a new experimental model, the nematode Caenorhabditis elegans (C. elegans). Behavioral parameters in the worms were evaluated...
متن کاملLong-term safety of ziprasidone in schizophrenic patients: an open trial.
OBJECTIVES The Authors report the safety results of the extension phase of three multicenter, phase III studies, which evaluated ziprasidone in schizophrenic patients switching from another antipsychotic agent or who required a transition from intramuscular to oral ziprasidone. PATIENTS AND METHODS A total of 331 patients were evaluated, with a mean follow-up of 22 months (range: 3-73 months)...
متن کاملZiprasidone in the treatment of mania in bipolar disorder
Ziprasidone is an atypical antipsychotic with a unique receptor-binding profile. Currently, ziprasidone is approved by the US Food and Drug Administration for the acute treatment of psychosis in schizophrenia and mania in bipolar disorder. When compared to certain other atypical antipsychotics, ziprasidone appears to have a relatively benign side effect profile, especially as regards metabolic ...
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تاریخ انتشار 2001