Schizophrenia
When deciding among the alternative treatments available for schizophrenia, 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).
Initial Treatment
GEODON® Capsules should be administered at an initial
daily dose of 20 mg BID with food. In some patients, daily dosage may subsequently
be adjusted on the basis of individual clinical status up to 80 mg BID. Dosage adjustments,
if indicated, should generally occur at intervals of not less than 2 days, as steady-state
is achieved within 1 to 3 days. In order to ensure use of the lowest effective dose,
ordinarily patients should be observed for improvement for several weeks before
upward dosage adjustment.
Efficacy in schizophrenia was demonstrated in a dose range of 20 to 100 mg BID in
short-term, placebo-controlled clinical trials. There were trends toward dose response
within the range of 20 to 80 mg BID, but results were not consistent. An increase
to a dose greater than 80 mg BID is not generally recommended. The safety of doses
above 100 mg BID has not been systematically evaluated in clinical trials.
Maintenance Treatment
While there is no body of evidence available to answer the question of how long
a patient treated with ziprasidone should remain on it, systematic evaluation of
ziprasidone has shown that its efficacy in schizophrenia is maintained for periods
of up to 52 weeks at a dose of 20 to 80 mg BID (see CLINICAL PHARMACOLOGY).
No additional benefit was demonstrated for doses above 20 mg BID. Patients should
be periodically reassessed to determine the need for maintenance treatment.
Bipolar Mania
Initial Treatment
Oral ziprasidone should be administered at an initial daily dose of 40 mg BID with
food. The dose should then be increased to 60 mg or 80 mg BID on the second day
of treatment and subsequently adjusted on the basis of toleration and efficacy within
the range of 40-80 mg BID. In the flexible-dose clinical trials, the mean daily
dose administered was approximately 120 mg (see CLINICAL PHARMACOLOGY).
Maintenance Treatment
There is no body of evidence available from controlled trials to guide a clinician
in the longer-term management of a patient who improves during treatment of mania
with ziprasidone. While it is generally agreed that pharmacological treatment beyond
an acute response in mania is desirable, both for maintenance of the initial response
and for prevention of new manic episodes, there are no systematically obtained data
to support the use of ziprasidone in such longer-term treatment (i.e., beyond 3
weeks).
Intramuscular Administration for Acute Agitation in Schizophrenia
The recommended dose is 10 to 20 mg administered as required up to a maximum dose
of 40 mg per day. Doses of 10 mg may be administered every two hours; doses of 20
mg may be administered every four hours up to a maximum of 40 mg/day. Intramuscular
administration of ziprasidone for more than three consecutive days has not been
studied.
If long-term therapy is indicated, oral ziprasidone hydrochloride capsules should
replace the intramuscular administration as soon as possible.
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.
Dosing in Special Populations
Oral: Dosage adjustments are generally not required on the basis of age, gender,
race, or renal or hepatic impairment.
Intramuscular: Ziprasidone intramuscular has not been systematically evaluated in
elderly patients or in patients with hepatic or renal impairment. As the cyclodextrin
excipient is cleared by renal filtration, ziprasidone intramuscular should be administered
with caution to patients with impaired renal function. Dosing adjustments are not
required on the basis of gender or race.
Preparation for Administration
GEODON® for Injection (ziprasidone mesylate) should only
be administered by intramuscular injection and should not be administered intravenously.
Single-dose vials require reconstitution prior to administration.
Add 1.2 mL of Sterile Water for Injection to the vial and shake vigorously until
all the drug is dissolved. Each mL of reconstituted solution contains 20 mg ziprasidone.
To administer a 10 mg dose, draw up 0.5 mL of the reconstituted solution. To administer
a 20 mg dose, draw up 1.0 mL of the reconstituted solution. Any unused portion should
be discarded. Since no preservative or bacteriostatic agent is present in this product,
aseptic technique must be used in preparation of the final solution. This medicinal
product must not be mixed with other medicinal products or solvents other than Sterile
Water for Injection.
Parenteral drug products should be inspected visually for particulate matter and
discoloration prior to administration, whenever solution and container permit.