Schizophrenia
Dose Selection
GEODON Capsules should be administered at an initial
daily dose of 20 mg twice daily with food. In some patients, daily dosage may subsequently
be adjusted on the basis of individual clinical status up to 80 mg twice daily. 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,
patients should ordinarily 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 twice daily in
short-term, placebo-controlled clinical trials. There were trends toward dose response
within the range of 20 to 80 mg twice daily, but results were not consistent. An increase
to a dose greater than 80 mg twice daily is not generally recommended. The safety of doses
above 100 mg twice daily has not been systematically evaluated in clinical trials [see Clinical Studies].
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, a maintenance study in patients who had been symptomatically stable and then randomized to continue ziprasidone or switch to placebo demonstrated a delay in time to relapse for patients receiving Geodon. [see Clinical Studies].
No additional benefit was demonstrated for doses above 20 mg twice daily. Patients should
be periodically reassessed to determine the need for maintenance treatment.
Bipolar I Disorder
Acute Treatment of Manic or Mixed Episodes
Dose Selection--Oral ziprasidone should be administered at an initial daily dose of 40 mg twice daily with
food. The dose may then be increased to 60 mg or 80 mg twice daily on the second day
of treatment and subsequently adjusted on the basis of tolerance and efficacy within
the range of 40 mg-80 mg twice daily. In the flexible-dose clinical trials, the mean daily
dose administered was approximately 120 mg [see Clinical Studies].
Maintenance Treatment (as an adjunct to lithium or valproate)
Continue treatment at the same dose on which the patient was initially stabilized, within the range of 40 mg-80 mg twice daily with food. Patients should be periodically reassessed to determine the need for maintenance treatment. [see Clinical Studies]
Acute Treatment of Agitation in Schizophrenia
Intramuscular Dosing
The recommended dose is 10 mg 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.
Intramuscular 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.
Dosing in Special Populations
Oral: Dosage adjustments are generally not required on the basis of age, gender,
race, or renal or hepatic impairment.Geodon is not approved for use in children or adolescents.
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 [see Use in Specific Populations].
DOSAGE FORMS AND STRENGTHS
GEODON Capsules are differentiated by capsule color/size and are imprinted in black ink with “Pfizer” and a unique number. GEODON Capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. They are supplied in the following strengths and package configurations:
| GEODON Capsules |
| Capsule Strength (mg) | Imprint |
| 20 | 396 |
| 40 | 397 |
| 60 | 398 |
| 80 | 399 |
GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration]. Each mL of ziprasidone mesylate for injection (when reconstituted) affords a colorless to pale pink solution that contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether ß-cyclodextrin sodium (SBECD).