DOSAGE AND ADMINISTRATION
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 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.
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. 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.
|
