Indications : התוויות

1     INDICATIONS AND USAGE

GEODON® intramuscular
Ziprasidone powder for solution for injection is indicated for the rapid control of agitation in adult patients with schizophrenia, when oral therapy is not appropriate, for a maximum of 3 consecutive days.

Treatment with ziprasidone powder for solution for injection should be discontinued, and the use of oral ziprasidone should be initiated, as soon as clinically appropriate.

GEODON® oral capsules
Ziprasidone hydrochloride monohydrate oral capsules are indicated for: 
Schizophrenia.
Treatment of schizophrenia and for maintenance of clinical improvement during continuation therapy in adults.

Bipolar mania.
Ziprasidone is indicated as monotherapy in the treatment of adults with manic or mixed episodes associated with bipolar disorder with or without psychotic features.
Bipolar Disorder
Maintenance treatment of bipolar disorder, as an adjunct to lithium or valproate in adults.

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 (4.3)]. 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 (4.3)]

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 (13.1)].

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

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 (13.2)].
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 (13.2)].

1.3   Acute Treatment of Agitation in Schizophrenia
GEODON® intramuscular is indicated for the rapid control of agitation in patients with schizophrenia, when oral therapy is not appropriate, for a maximum of 3 consecutive days. The efficacy of intramuscular ziprasidone for acute agitation in schizophrenia was established in single day controlled trials of agitated schizophrenic inpatients [see Clinical Trials (13.1)]
“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.