It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2GEODON Capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Note that a 30 mg dose of intramuscular ziprasidone is 50% higher than the recommended therapeutic dose. The mean increase in QTc from baseline for ziprasidone was 4.6 msec following the first injection and 12.8 msec following the second injection. The absorption of ziprasidone is increased up to two-fold in the presence of food There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including GEODON, during pregnancy. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final solution. 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 40 mg–80 mg twice daily. In the flexible-dose clinical trials, the mean daily dose administered was approximately 120 mg 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. Persistently prolonged QTc intervals may also increase the risk of further prolongation and arrhythmia, but it is not clear that routine screening ECG measures are effective in detecting such patients. Following reconstitution, GEODON for Injection can be stored, when protected from light, for up to 24 hours at 15°C to 30°C (59°F to 86°F) or up to 7 days refrigerated, 2°C to 8°C (36°F to 46°F).Advise the patient to read the FDA-approved patient labeling (Patient Information).Instruct patients to take GEODON Capsules with food for optimal absorption. In the open-label phase, patients were required to be stabilized on ziprasidone plus lithium or valproic acid for at least 8 weeks in order to be randomized. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2GEODON 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. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase. GEODON Capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. GEODON can be used to treat symptoms of schizophrenia and acute manic or mixed episodes associated with bipolar disorder. Low serum potassium and magnesium should be replaced before proceeding with treatment. Agranulocytosis (including fatal cases) has also been reported.Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug induced leukopenia/neutropenia.


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. Ziprasidone was administered for 24 months in the diet at doses of 2, 6, or 12 mg/kg/day to rats, and 50, 100, or 200 mg/kg/day to mice (0.1 to 0.6 and 1 to 5 times the (MRHD) of 200 mg/day based on mg/mZiprasidone was tested in the Ames bacterial mutation assay, the Ziprasidone was shown to increase time to copulation in Sprague-Dawley rats in two fertility and early embryonic development studies at doses of 10 to 160 mg/kg/day (0.5 to 8 times the MRHD of 200 mg/day based on mg/mThe efficacy of oral ziprasidone in the treatment of schizophrenia was evaluated in 5 placebo-controlled studies, 4 short-term (4- and 6-week) trials and one maintenance trial. The most common reactions associated with dropout in the ziprasidone-treated patients were akathisia, anxiety, depression, dizziness, dystonia, rash and vomiting, with 2 dropouts for each of these reactions among ziprasidone patients (1%) compared to one placebo patient each for dystonia and rash (1%) and no placebo patients for the remaining adverse reactions.Table 12 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy (up to 3 weeks) in patients with bipolar mania, including only those reactions that occurred in 2% or more of patients treated with ziprasidone and for which the incidence in patients treated with ziprasidone was greater than the incidence in placebo-treated patients.Explorations for interactions on the basis of gender did not reveal any clinically meaningful differences in the adverse reaction occurrence on the basis of this demographic factor.Table 13 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy with intramuscular ziprasidone in 1% or more of patients.In these studies, the most commonly observed adverse reactions associated with the use of intramuscular ziprasidone (incidence of 5% or greater) and observed at a rate on intramuscular ziprasidone (in the higher dose groups) at least twice that of the lowest intramuscular ziprasidone group were headache (13%), nausea (12%), and somnolence (20%).The following adverse reactions have been identified during post-approval use of GEODON.

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