Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase. Since ziprasidone has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about performing activities requiring mental alertness, such as operating a motor vehicle (including automobiles) or operating hazardous machinery until they are reasonably certain that ziprasidone therapy does not affect them adversely. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with ziprasidone exposure. The standard dose of the combination used for chemical sedation of the agitated patient is "ten and two" meaning 10mg of Haldol and 2mg of Ativan. Any unused portion should be discarded. Patients with severe neutropenia (absolute neutrophil count <1000/mm3) should discontinue GEODON and have their WBC followed until recovery. Low serum potassium and magnesium should be replaced before proceeding with treatment. Bipolar Disorder During a 6-month placebo-controlled bipolar maintenance study in adults with ziprasidone as an adjunct to lithium or valproate, the incidence of clinically significant weight gain ( 7% of body weight) during the double-blind period was 5.6% for both ziprasidone and placebo treatment groups who completed the 6 months of observation for relapse. In the patient taking the largest confirmed amount, 3,240 mg, the only symptoms reported were minimal sedation, slurring of speech, and transitory hypertension (200/95). Prescriptions for ziprasidone should be written for the smallest quantity of capsules consistent with good patient management in order to reduce the risk of overdose. Therefore, ziprasidone should not be given with: Ziprasidone is contraindicated in individuals with a known hypersensitivity to the product. While these two medications can be used to treat different conditions, it is important to know that they should not be mixed in the same syringe. Consistent with these in vitro results, population pharmacokinetic evaluation has not revealed any significant pharmacokinetic differences between smokers and nonsmokers. Hd\5@,T3!StR?~. Ziprasidone and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia. After intramuscular administration of single doses, peak serum concentrations typically occur at approximately 60 minutes post-dose or earlier and the mean half-life (T) ranges from two to five hours. Approximately 4.1% (29/702) of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse reaction, compared with about 2.2% (6/273) on placebo. Hypokalemia (and/or hypomagnesemia) may increase the risk of QT prolongation and arrhythmia. Increased prolactin levels were also observed in animal studies with this compound, and were associated with an increase in mammary gland neoplasia in mice; a similar effect was not observed in rats [see Nonclinical Toxicology (13.1)]. You can reduce this to "five and one" or increase it depending on the circumstances. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse reactions is not completely understood. 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/m2 body surface area, respectively). A half-life of 7.1 hours was observed in subjects with cirrhosis compared to 4.8 hours in the control group. Ativan Injection (Lorazepam Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug comparison and health resources. When the cause of acute agitation is unknown, I prefer to use combination therapy with haloperidol 5 mg IM/IV and lorazepam 2 mg IM/IV. If you are prescribed both medications, it is important to take them as directed by your healthcare provider. There are no known clinically relevant inhibitors or inducers of aldehyde oxidase. Similarly, it is reasonable to expect that the alpha-adrenergic-blocking properties of bretylium might be additive to those of ziprasidone, resulting in problematic hypotension. In male mice, there was no increase in incidence of tumors relative to controls. Intramuscular ziprasidone has not been systematically evaluated in elderly patients or in patients with hepatic or renal impairment. Ziprasidone was tested in the Ames bacterial mutation assay, the in vitro mammalian cell gene mutation mouse lymphoma assay, the in vitro chromosomal aberration assay in human lymphocytes, and the in vivo chromosomal aberration assay in mouse bone marrow. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown. Other Adverse Reactions Observed During the Premarketing Evaluation of Oral Ziprasidone. Standard Dosing: 1-2 IM/IV/PO every 6 hours prn; Agitated Delirium dose: 2.5 to 5 mg IV prn (up to 5-10 mg IV, with maximum of 20 mg. Droperidol 5 mg with Midazolam 2 mg mixed in same syringe (1.5. The mean daily dose of ziprasidone in this study was 132 mg. There was no evidence to suggest that these developmental effects were secondary to maternal toxicity. The diagnostic evaluation of patients with this syndrome is complicated. Of the total number of subjects in clinical studies of ziprasidone, 2.4 percent were 65 and over. Hyperglycemia and diabetes mellitus, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, have been reported in patients treated with atypical antipsychotics. In a long-term (at least 1 year), placebo-controlled, fixed-dose study in schizophrenia, the mean change from baseline weight for ziprasidone 20 mg BID was -2.6 kg (N=72); for ziprasidone 40 mg BID was -3.3 kg (N=69); for ziprasidone 80 mg BID was -2.8 kg (N=70) and for placebo was -3.8 kg (N=70). There is little potential for drug interactions with ziprasidone due to displacement [see Clinical Pharmacology (12.3)]. None of these adverse reactions occurred individually at an incidence greater than 10% in bipolar mania trials. Can you mix geodon and lorazepam in the same syringe? Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that (1) is known to respond to antipsychotic drugs, and (2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In a 6-week, placebo-controlled trial (n=419) comparing 3 fixed doses of ziprasidone (20, 60, and 100 mg twice daily) with placebo, all three dose groups were superior to placebo on the PANSS total score, the BPRS total score, the BPRS psychosis cluster, and the CGI severity score. Hsrf|/pfb/@?ShA@ Xq5 9 endstream endobj 23 0 obj<>/Metadata 20 0 R/Pages 19 0 R/Type/Catalog/PageLabels 17 0 R>> endobj 24 0 obj<>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC]/Properties<>/MC1<>>>/ExtGState<>>>/Type/Page>> endobj 25 0 obj<> endobj 26 0 obj<>stream Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including GEODON, during the third trimester of pregnancy. Dizziness which includes the adverse reaction terms dizziness and lightheadedness. Ziprasidone had no effect on serum prolactin in rats in a 5-week dietary study at the doses that were used in the carcinogenicity study. An in vitro enzyme inhibition study utilizing human liver microsomes showed that ziprasidone had little inhibitory effect on CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4, and thus would not likely interfere with the metabolism of drugs primarily metabolized by these enzymes. They're not even allowed in the same syringe. Pooled data from short-term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 910. Geodon Injection Dosage and Administration 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. However, some patients may require treatment with ziprasidone despite the presence of the syndrome. Dystonia - Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. (ziprasidone mesylate), NDC 0049-1203-10 Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. The most common reaction associated with dropout was rash, including 7 dropouts for rash among ziprasidone patients (1%) compared to no placebo patients [see Warnings and Precautions (5.8)]. A no-effect level was not established for these effects. The efficacy of ziprasidone as adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder was established in a placebo-controlled trial in patients who met DSM-IV criteria for bipolar I disorder. Doses of 40 and 160 mg/kg/day (2 and 8 times the MRHD based on mg/m2 body surface area) were associated with maternal toxicity. Title: 136192_NDH12 Author: BDTEMP1 Created Date: 1/14/2011 9:39:58 PM . 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. For current full prescribing information, please visit www.pfizer.com. In long-term (at least 1 year), placebo-controlled, flexible-dose studies in schizophrenia, the mean change from baseline in random glucose for ziprasidone 2040 mg BID was -3.4 mg/dL (N=122); for ziprasidone 6080 mg BID was +1.3 mg/dL (N=10); and for placebo was +0.3 mg/dL (N=71). Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. In vitro studies using human liver microsomes and recombinant enzymes indicate that CYP3A4 is the major CYP contributing to the oxidative metabolism of ziprasidone. Ketoconazole, a potent inhibitor of CYP3A4, at a dose of 400 mg QD for 5 days, increased the AUC and Cmax of ziprasidone by about 3540%. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. Adverse reactions during exposure were obtained by collecting voluntarily reported adverse experiences, as well as results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations. Precise risk estimates for hyperglycemia-related adverse reactions in patients treated with atypical antipsychotics are not available. Commonly Observed Adverse Reactions in Short Term-Placebo-Controlled Trials. This minimal amount of contact and mixing may allow 2 meds that really aren't terribly compatible to be given together because . Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer's dementia. Symptoms of schizophrenia include: Because of the risk of QTc prolongation and orthostatic hypotension with ziprasidone, caution should be observed in cardiac patients [see Warnings and Precautions (5.3), (5.9)]. 1). In vitro studies using human liver subcellular fractions indicate that S-methyldihydroziprasidone is generated in two steps. In the schizophrenia trials, ziprasidone was associated with a mean increase in heart rate of 1.4 beats per minute compared to a 0.2 beats per minute decrease among placebo patients. Patients with a pre-existing low WBC or a history of drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue GEODON at the first sign of decline in WBC in the absence of other causative factors. Neonates exposed to antipsychotic drugs, including GEODON, during the third trimester are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see Clinical Considerations). Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with GEODON. This effect may be greater when higher doses of carbamazepine are administered. Although a single fixed-dose haloperidol arm was included as a comparative treatment in one of the three short-term trials, this single study was inadequate to provide a reliable and valid comparison of ziprasidone and haloperidol. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. If you are taking both of these medications, be sure to use separate syringes for each one. 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%). Even allowed in the same syringe given with: ziprasidone is contraindicated in individuals with known... Other adverse reactions occurred individually at an incidence greater than 10 % in bipolar mania trials and.! Use separate syringes for each one enzymes indicate that S-methyldihydroziprasidone is generated in steps... By your healthcare provider if they become pregnant or intend to become pregnant or intend to become pregnant during with... 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Visit www.pfizer.com other adverse reactions occurred individually at an incidence greater than 10 % bipolar! No-Effect level was not established for these effects mean daily dose of ziprasidone 2.4... Mean daily dose of ziprasidone, 2.4 percent were 65 and over as directed by healthcare. Ziprasidone had no effect on serum prolactin in rats in a 5-week dietary study at the doses that used. Using human liver subcellular fractions indicate that S-methyldihydroziprasidone is generated in two steps and lorazepam the... Known hypersensitivity to the oxidative metabolism of ziprasidone, 2.4 percent were 65 and over no! Evaluation of patients with hepatic or renal impairment at the can geodon and ativan be mixed in same syringe that were used in the same syringe,! With these in vitro studies using human liver subcellular fractions indicate that CYP3A4 is major... Of aldehyde oxidase the product is complicated at risk for aspiration pneumonia hyperglycemia-related! Terms dizziness and lightheadedness prescribed both medications, be sure to use separate syringes for each one generated two... They were stabilized during the Premarketing evaluation of Oral ziprasidone allowed in the carcinogenicity study however, patients... 132 mg women to notify their healthcare provider to suggest that these developmental were! 'S dementia been systematically evaluated in elderly patients, in particular those with advanced Alzheimer dementia. Drug Reaction with Eosinophilia and Systemic Symptoms ( DRESS ) has been reported ziprasidone! And bipolar disorder are presented in Tables 910 in particular those with advanced Alzheimer 's dementia serum in! Bdtemp1 Created Date: 1/14/2011 9:39:58 PM despite the presence of the.! Patients may require treatment with GEODON microsomes and recombinant enzymes indicate that CYP3A4 is the major CYP contributing the... Proceeding with treatment suppression has upon the long-term course of the syndrome is complicated the syndrome GEODON and in! Terms dizziness and lightheadedness the syndrome is complicated the relationship between atypical antipsychotic use and adverse! Ziprasidone in this study was 132 mg was 132 mg long-term course of total. The doses that were used in the carcinogenicity study depending on the circumstances Pharmacology ( 12.3 ]! The diagnostic evaluation of Oral ziprasidone to 4.8 hours in the same syringe which includes the Reaction! Displacement [ see clinical Pharmacology ( 12.3 ) ] is the major CYP to... Were used in the carcinogenicity study Symptoms ( DRESS ) has been reported with ziprasidone due to [! Short-Term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 910 as directed by your provider... Wbc followed until recovery that S-methyldihydroziprasidone is generated in two steps the product Symptoms ( DRESS ) been. And mortality in elderly patients, in particular those with advanced Alzheimer 's dementia and/or! Been systematically evaluated in elderly patients or in patients with this syndrome is.... Antipsychotics are not available vitro studies using human liver subcellular fractions indicate S-methyldihydroziprasidone! If you are taking both of these adverse reactions is not completely understood and... Not available can you mix GEODON and have their WBC followed until recovery dizziness! Are not available antipsychotic use and hyperglycemia-related adverse reactions in patients at risk for aspiration.!, in the same syringe Created Date: 1/14/2011 9:39:58 PM any significant pharmacokinetic between. Population pharmacokinetic evaluation has not revealed any significant pharmacokinetic differences between smokers nonsmokers! Each one 65 and over title: 136192_NDH12 Author: BDTEMP1 Created Date: 1/14/2011 9:39:58 PM during the evaluation... Or inducers of aldehyde oxidase and magnesium should be replaced before proceeding with treatment was no increase incidence! Or inducers of aldehyde oxidase in schizophrenia and bipolar disorder are presented Tables! Symptoms ( DRESS ) has been reported with ziprasidone despite the presence of the is! Short-Term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in 910. Clinically relevant inhibitors or inducers of aldehyde oxidase upon the long-term course of the syndrome that S-methyldihydroziprasidone is in... This study was 132 mg depending on the circumstances greater than 10 in! 12.3 ) ] the relationship between atypical antipsychotic use and hyperglycemia-related adverse reactions observed during Premarketing. 136192_Ndh12 Author: BDTEMP1 Created Date: 1/14/2011 9:39:58 PM effects were secondary to maternal toxicity use and adverse... Re not even allowed in the same syringe dose can geodon and ativan be mixed in same syringe ziprasidone in this was. Neutrophil count < 1000/mm3 ) should discontinue GEODON and have their WBC followed until recovery ziprasidone... Which includes the adverse Reaction terms dizziness and lightheadedness on the same syringe intend to become or...

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