Patients being considered for ziprasidone treatment that are at risk of significant electrolyte disturbances should have baseline serum potassium and magnesium measurements. In a 6-week, placebo-controlled trial (n=302) comparing 2 fixed doses of ziprasidone (40 and 80 mg twice daily) with placebo, both dose groups were superior to placebo on the BPRS total score, the BPRS psychosis cluster, the CGI severity score and the PANSS total and negative subscale scores. Ativan Injection (Lorazepam Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug comparison and health resources. In cases of severe extrapyramidal symptoms, anticholinergic medication should be administered. The absolute bioavailability of a 20 mg dose under fed conditions is approximately 60%. Geodon An additional 127 patients with bipolar disorder participated in a long-term maintenance treatment study representing approximately 74.7 patient-years of exposure to ziprasidone. 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. and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). In the ziprasidone-treated patients, neither case suggested a role of ziprasidone. The patient should be carefully monitored, since recurrences of NMS have been reported. Following reconstitution, GEODON for Injection can be stored, when protected from light, for up to 24 hours at 15C to 30C (59F to 86F) or up to 7 days refrigerated, 2C to 8C (36F to 46F). CYP1A2 may contribute to a much lesser extent. It is greater than 99% bound to plasma proteins, binding primarily to albumin and 1-acid glycoprotein. In premarketing trials with ziprasidone, about 5% of patients developed rash and/or urticaria, with discontinuation of treatment in about one-sixth of these cases. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. Ziprasidone has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile. 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. Following is a list of COSTART terms that reflect treatment-emergent adverse reactions as defined in the introduction to the ADVERSE REACTIONS section reported by patients treated with ziprasidone in schizophrenia trials at multiple doses >4 mg/day within the database of 3834 patients. Several instruments were used for assessing psychiatric signs and symptoms in these studies. 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)]. If you are prescribed both medications, it is important to take them as directed by your healthcare provider. It is not known if this is a direct result of the illness or other comorbid factors. Extrapyramidal Symptoms which includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. In vivo studies have revealed no effect of ziprasidone on the pharmacokinetics of estrogen or progesterone components. Ativan is oily and hard to draw up by itself but by instilling the Haldol it causes it to draw up much easier! It is recommended that patients being considered for ziprasidone treatment who are at risk for significant electrolyte disturbances, hypokalemia in particular, have baseline serum potassium and magnesium measurements. During clinical trials, seizures occurred in 0.4% of patients treated with ziprasidone. In the double-blind randomization period, 127 subjects were treated with ziprasidone, and 112 subjects were treated with placebo. 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). If circumstances are so compelling as to warrant mixing any A person should not mix Ativan and Xanax. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. We mix Haldol and Ativan in a syringe together for combative patients and the benadryl potentiates the effect of all these. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. The effect on fertility appeared to be in the female since fertility was not impaired when males given 160 mg/kg/day (8 times the MRHD based on mg/m2 body surface area) were mated with untreated females. 2) Undifferentiated but routine drunk agitation: 5-10 mg Versed, also . GEODON intramuscular is indicated for acute agitation in schizophrenic patients. Consistent with in vitro results, a study in normal healthy volunteers showed that ziprasidone did not alter the metabolism of dextromethorphan, a CYP2D6 model substrate, to its major metabolite, dextrorphan. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. You can mix them, yes. Ziprasidone intramuscular has not been systematically evaluated in elderly patients (65 years and over). The efficacy of intramuscular ziprasidone in the management of agitated schizophrenic patients was established in two short-term, double-blind trials of schizophrenic subjects who were considered by the investigators to be "acutely agitated" and in need of IM antipsychotic medication. Ziprasidone may antagonize the effects of levodopa and dopamine agonists. Contains 10 of NDC 0049-1203-01, Geodon for Injection 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. Pooled data from short-term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 14. Ziprasidone is a medication that works in the brain to treat schizophrenia. Of the total number of subjects in clinical studies of ziprasidone, 2.4 percent were 65 and over. Based on in vivo abundance of excretory metabolites, less than one-third of ziprasidone metabolic clearance is mediated by cytochrome P450 catalyzed oxidation and approximately two-thirds via reduction. Reproductive System and Breast Disorders: ziprasidone mesylate injection, powder, lyophilized, for solution. Ziprasidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias [see Contraindications (4)]. 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. 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). Ziprasidone dosed adjunctively to valproate in a maintenance trial of bipolar patients did not affect mean therapeutic valproate levels. Conclusion While some general principles can be applied to the mixing of injection solutions, they are fraught with exception and applicability varies with circumstance. As with other drugs that antagonize dopamine D2 receptors, ziprasidone elevates prolactin levels in humans. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. After a 3-day single-blind placebo run-in, subjects were randomized to one of 3 fixed doses of ziprasidone (20 mg, 40 mg, or 80 mg twice daily) or placebo and observed for relapse. The safety and effectiveness of Geodon have not been established in pediatric patients. 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. yes. Although torsade de pointes has not been observed in association with the use of ziprasidone in premarketing studies and experience is too limited to rule out an increased risk, there have been rare post-marketing reports (in the presence of multiple confounding factors) [see Adverse Reactions (6.2)]. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias. In long-term (at least 1 year), placebo-controlled, flexible-dose studies in schizophrenia, the mean change from baseline weight for ziprasidone 2040 mg BID was -2.3 kg (N=124); for ziprasidone 6080 mg BID was +2.5 kg (N=10); and for placebo was -2.9 kg (N=72). Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with GEODON. Generic name: ziprasidone hydrochloride This can cause low blood pressure, shallow breathing, weak pulse, muscle weakness, drowsiness, dizziness and slurred speech. Ziprasidone should be used with particular caution in patients with known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications). When deciding among the alternative treatments available for the condition needing treatment, 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 and Precautions (5.3)]. In the same long-term studies, the proportion of subjects with 7% increase in weight from baseline for ziprasidone 2040 mg BID was 5.6% (N=124); for ziprasidone 6080 mg BID was 20.0% (N=10), and for placebo was 5.6% (N=72). for Injection 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. Evidence for the use of chemical sedation is limited to small trials of at most a few hundred patients. Ziprasidone has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence. For current full prescribing information, please visit www.pfizer.com. 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. Patients with these diagnoses were excluded from premarketing clinical studies. Pooled data from short-term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 58. Appropriate care is advised when prescribing ziprasidone for patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration. Roerig Given the primary CNS effects of ziprasidone, caution should be used when it is taken in combination with other centrally acting drugs. As for mixing in some benadryl in the same syringe, it could maybe have something to do with the solutions becoming unstable when mixed together as to not putting it in there. Published data from observational studies, birth registries, and case reports on the use of atypical antipsychotics during pregnancy do not report a clear association with antipsychotics and major birth defects. Close medical supervision and monitoring should continue until the patient recovers. Ziprasidone rebalances dopamine and serotonin to improve thinking, mood, and behavior. Answer (1 of 3): Generally, any two antipsychotics can be taken together. Although there are no reports of adverse effects on a breastfed infant exposed to ziprasidone via breast milk, there are reports of excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements) in infants exposed to other atypical antipsychotics through breast milk (see Clinical Considerations). There was no statistically significant change in the urinary dextromethorphan/dextrorphan ratio. The mean increase in QTc from baseline for ziprasidone ranged from approximately 9 to 14 msec greater than for four of the comparator drugs (risperidone, olanzapine, quetiapine, and haloperidol), but was approximately 14 msec less than the prolongation observed for thioridazine. In female mice, there were dose-related increases in the incidences of pituitary gland adenoma and carcinoma, and mammary gland adenocarcinoma at all doses tested (50 to 200 mg/kg/day or 1 to 5 times the MRHD based on mg/m2 body surface area). A half-life of 7.1 hours was observed in subjects with cirrhosis compared to 4.8 hours in the control group. Some drugs that prolong the QT/QTc interval have been associated with the occurrence of torsade de pointes and with sudden unexplained death. In animal studies, ziprasidone administration to pregnant rats and rabbits during organogenesis caused developmental toxicity at doses similar to recommended human doses, and was teratogenic in rabbits at 3 times the maximum recommended human dose (MRHD). There is no general agreement about specific pharmacological treatment regimens for NMS. If long-term therapy is indicated, oral ziprasidone hydrochloride capsules should replace the intramuscular administration as soon as possible. Proliferative changes in the pituitary and mammary glands of rodents have been observed following chronic administration of other antipsychotic agents and are considered to be prolactin-mediated. The empirical formula is C21H21ClN4OS CH3SO3H 3H2O and its molecular weight is 563.09. When meds are run together at a Y site, there is actually very little surface area of mixture between the two. Some people, especially the elderly, may also experience impairment in thinking, judgment, and motor coordination. Reconstitution of vial: Using aseptic technique, add 1.2 mL of Sterile Water for Injection, USP to the single-dose vial and shake vigorously until all the drug is dissolved. In male mice, there was no increase in incidence of tumors relative to controls. Mixing solutions of parenteral drugs is generally not recommended because of the potential for incompatibility and consequent loss of activity of one or both drugs. Advise females of reproductive potential that GEODON may impair fertility due to an increase in serum prolactin levels. In many cases this would lead to the conclusion that other drugs should be tried first. Ziprasidone use should be avoided in combination with other drugs that are known to prolong the QTc interval [see Contraindications (4.1) and Drug Interactions (7.4)]. This may be more likely to occur in older adults or those with a debilitating condition. In arriving at a diagnosis, it is important to exclude cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs. Carbamazepine is an inducer of CYP3A4; administration of 200 mg twice daily for 21 days resulted in a decrease of approximately 35% in the AUC of ziprasidone. 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. 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. Based upon the pharmacodynamic and pharmacokinetic profile of ziprasidone, possible interactions could be anticipated: Approximately two-thirds of ziprasidone is metabolized via a combination of chemical reduction by glutathione and enzymatic reduction by aldehyde oxidase. Most patients improved promptly with adjunctive treatment with antihistamines or steroids and/or upon discontinuation of ziprasidone, and all patients experiencing these reactions were reported to recover completely. There was a mean weight gain of 1.4 kg for those patients with a "low" baseline BMI, no mean change for patients with a "normal" BMI, and a 1.3 kg mean weight loss for patients who entered the program with a "high" BMI. Nevertheless, ziprasidone's larger prolongation of QTc length compared to several other antipsychotic drugs raises the possibility that the risk of sudden death may be greater for ziprasidone than for other available drugs for treating schizophrenia. The following findings are based on the short-term placebo-controlled premarketing trials for schizophrenia (a pool of two 6-week, and two 4-week fixed-dose trials) and bipolar mania (a pool of two 3-week flexible-dose trials) in which ziprasidone was administered in doses ranging from 10 to 200 mg/day. Additionally, population pharmacokinetic evaluation of patients in controlled trials has revealed no evidence of clinically significant age or gender-related differences in the pharmacokinetics of ziprasidone. . While the relationship of the reaction to ziprasidone use has not been established, other drugs with alpha-adrenergic blocking effects have been reported to induce priapism, and it is possible that ziprasidone may share this capacity. Positive results were obtained in both the in vitro mammalian cell gene mutation assay and the in vitro chromosomal aberration assay in human lymphocytes. There are no known clinically relevant inhibitors or inducers of aldehyde oxidase. Syncope was reported in 0.6% of the patients treated with ziprasidone. A median weight gain of 0.5 kg was observed in ziprasidone patients compared to no median weight change in placebo patients. There is risk to the mother from untreated schizophrenia or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide. Depressive, manic, and mixed episodes accounted for 53%, 34%, and 13%, respectively, of the total number of relapse events in the study. A retrospective cohort study from a Medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk for major birth defects. Adverse Findings Observed in Short-Term, Placebo-Controlled Trials with Oral Ziprasidone. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown. The syndrome is unknown torsade de pointes and with sudden unexplained death geodon may impair fertility due an... 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