Uses
Schizophrenia
Symptomatic management of schizophrenia.
Should be reserved for patients whose disease fails to respond adequately to appropriate courses of other antipsychotic agents because of a greater capacity to prolong the QT/QTc-interval compared with that of several other antipsychotic agents. (See Prolongation of QT Interval under Cautions)
IM injection used for rapid control of behaviors that interfere with diagnosis and care (e.g., threatening behaviors, escalating or urgently distressing behavior, self-exhausting behavior).
Bipolar Disorder
Treatment of acute manic and mixed epsiodes (with or without psychotic features) associated with bipolar 1 disorder.
Dosage and Administration
Administration
Administer orally or by IM injection.
Concomitant use of oral and IM ziprasidone not recommended by manufacturer.
Oral Administration
Administer orally twice daily with food.
IM Administration
Vials are for single use only.
Reconstitution
Reconstitute vial containing 20 mg with 1.2 mL of sterile water for injection to provide a solution containing 20 mg/mL. Do not use other solutions to reconstitute the injection, and do not admix with other drugs. Shake vigorously to ensure complete dissolution.
Observe strict aseptic technique since the drug contains no preservative. Discard unused portions.
Dosage
Available as ziprasidone hydrochloride or ziprasidone mesylate; oral dosage expressed in terms of hydrochloride monohydrate and IM dosage expressed in terms of ziprasidone.
Adults
Schizophrenia
Oral
Initially, 20 mg twice daily.
Dosage may be increased after a minimum of 2 days. Observe patients for several weeks prior to upward titrations of dosage to ensure use of the lowest effective dosage.
In patients responding to ziprasidone therapy, continue the drug as long as clinically necessary and tolerated, but at lowest possible effective dosage; periodically reassess need for continued therapy. Efficacy maintained for up to 52 weeks in clinical trials, but optimum duration of therapy currently is not known.
Acute Agitation in Schizophrenia
IM
Initially, 10–20 mg given as a single dose.
Repeat doses of 10 mg every 2 hours or 20 mg every 4 hours, up to a maximum cumulative dosage of 40 mg daily.
Oral therapy should replace IM therapy as soon as possible; safety and efficacy of administering ziprasidone IM injection for longer than 3 consecutive days not evaluated.
Bipolar Disorder
Oral
Initially, 40 mg twice daily on day 1. Increase dosage to 60 or 80 mg twice daily on the second day.
Subsequent dosage adjustments based on efficacy and tolerability may be made within a dosage range of 40–80 mg twice daily.
Efficacy for long-term use (i.e., >3 weeks) or for prophylactic use in patients with bipolar disorder not systematically evaluated. If used for extended periods, periodically reevaluate the long-term risks and benefits for the individual patient.
Prescribing Limits
Adults
Schizophrenia
Oral
Maximum 80 mg twice daily.
Acute Agitation
IM
Maximum cumulative dosage of 40 mg daily.
Bipolar Disorder
Oral
Maximum 80 mg twice daily.
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