Clinical trials for intramuscular ziprasidone included 570 patients and/or normal subjects who received one or more injections of ziprasidone. And for two, Benadryl never gets mixed with Haldol in the same syringe: precipitate forms in about 5 minutes. Table 11 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy (up to 6 weeks) in predominantly patients with schizophrenia, 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. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of the suspect drug. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. 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 (2.1)]. Ziprasidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias [see Contraindications (4)]. To administer a 20 mg dose, draw up 1.0 mL of the reconstituted solution. Discontinue ziprasidone if DRESS is suspected. It is not known if this is a direct result of the illness or other comorbid factors. 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/m2 body surface area). Schizophrenia - The proportions of patients meeting a weight gain criterion of 7% of body weight were compared in a pool of four 4- and 6-week placebo-controlled schizophrenia clinical trials, revealing a statistically significantly greater incidence of weight gain for ziprasidone (10%) compared to placebo (4%). New York, NY 10017. 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. An analysis for dose response in the schizophrenia 4-study pool revealed an apparent relation of adverse reaction to dose for the following reactions: asthenia, postural hypotension, anorexia, dry mouth, increased salivation, arthralgia, anxiety, dizziness, dystonia, hypertonia, somnolence, tremor, rhinitis, rash, and abnormal vision. This is because the two drugs work with the body in the same. These patients include: (1) 4331 patients who participated in multiple-dose trials, predominantly in schizophrenia, representing approximately 1698 patient-years of exposure as of February 5, 2000; and (2) 472 patients who participated in bipolar mania trials representing approximately 133 patient-years of exposure. dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol or tacrolimus. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. There is risk to the mother from untreated schizophrenia or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide. Population pharmacokinetic analysis of schizophrenic patients enrolled in controlled clinical trials has not revealed evidence of any clinically significant pharmacokinetic interactions with benztropine, propranolol, or lorazepam. Geodon was studied in one 4-week, placebo-controlled trial in patients 10 to 17 years of age with bipolar I disorder. 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). 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 meds are run together at a Y site, there is actually very little surface area of mixture between the two. ECG Changes - Ziprasidone is associated with an increase in the QTc interval [see Warnings and Precautions (5.3)]. Ziprasidone should be discontinued in patients who are found to have persistent QTc measurements >500 msec. Although not reported with ziprasidone in premarketing trials, disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. DRESS is sometimes fatal. These medications may be given alone or in combination. The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula: GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. 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. It is important to emphasize that, although the reactions reported occurred during treatment with ziprasidone, they were not necessarily caused by it. 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. However, the data were insufficient to fully assess the safety of Geodon in pediatric patients. There is little potential for drug interactions with ziprasidone due to displacement [see Clinical Pharmacology (12.3)]. My preferred agitation regimen is the following: 1) Known or suspected psychosis: 5mg Droperidol +/- 5-10 mg Versed, generally IM pending IV access--takes 5-10 min. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology. Ziprasidone is primarily cleared via three metabolic routes to yield four major circulating metabolites, benzisothiazole (BITP) sulphoxide, BITP-sulphone, ziprasidone sulphoxide, and S-methyldihydroziprasidone. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. In the other study, the higher dose was 10 mg, which could be given up to 4 times in the 24 hours of the study, at interdose intervals of no less than 2 hours. Yes, you can mix both in the same syringe Can you mix xanax and Ativan? Ziprasidone may induce orthostatic hypotension associated with dizziness, tachycardia, and, in some patients, syncope, especially during the initial dose-titration period, probably reflecting its 1-adrenergic antagonist properties. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown. Ziprasidone has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence. Drug-drug interactions can be pharmacodynamic (combined pharmacologic effects) or pharmacokinetic (alteration of plasma levels). Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias. Elimination of ziprasidone is mainly via hepatic metabolism with a mean terminal half-life of about 7 hours within the proposed clinical dose range. The mean increase in QTc from baseline for haloperidol was 6.0 msec following the first injection and 14.7 msec following the second injection. 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. In the same long-term fixed-dose schizophrenia study, the proportion of subjects with 7% increase in weight from baseline for ziprasidone 20 mg BID was 5.6% (N=72); for ziprasidone 40 mg BID was 2.9% (N=69); for ziprasidone 80 mg BID was 5.7% (N=70) and for placebo was 2.9% (N=70). Such drugs should not be prescribed with ziprasidone. The recommended dose is 10 mg to 20 mg administered as required up to a maximum dose of 40 mg per day. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. but as this is a thread about the use of haldol and ativan together, one would hope the ativan would counteract the possiblity of akathesia . Other severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, have been reported with ziprasidone exposure. The trial included patients whose most recent episode was manic or mixed, with or without psychotic features. In long-term (at least 1 year), placebo-controlled, flexible-dose studies in schizophrenia, the mean change from baseline in random total cholesterol for ziprasidone 2040 mg BID was +2.5 mg/dL (N=14); for ziprasidone 6080 mg BID was -19.7 mg/dL (N=10); and for placebo was -28.0 mg/dL (N=9). A study was conducted in stable chronic or subchronic (CGI-S 5 at baseline) schizophrenic inpatients (n=294) who had been hospitalized for not less than two months. Ziprasidone injection requires reconstitution prior to administration. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase. In the tables showing categorical changes, the percentages (% column) are calculated as 100(n/N). 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. Of the total number of subjects in clinical studies of ziprasidone, 2.4 percent were 65 and over. 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. A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs. 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 Ziprasidone at a dose of 20 mg twice daily did not affect the pharmacokinetics of concomitantly administered oral contraceptives, ethinyl estradiol (0.03 mg) and levonorgestrel (0.15 mg). Typically lasts 1.5-3 hrs. 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 -cyclodextrin sodium (SBECD). Ziprasidone intramuscular is intended for intramuscular use only and should not be administered intravenously. Absorption: Ziprasidone is well absorbed after oral administration, reaching peak plasma concentrations in 6 to 8 hours. 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. The following adverse reactions have been identified during post-approval use of GEODON. Offspring developmental delays (decreased pup weights) and neurobehavioral functional impairment (eye opening air righting) were observed at doses of 5 mg/kg/day (0.2 times the MRHD based on mg/m2 body surface area) or greater. Patients with neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether -cyclodextrin sodium (SBECD). 1). mixed in the same syringe for use in a syringe driver over 24 hours. It is also known as a second generation antipsychotic (SGA) or atypical antipsychotic. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile. No appreciable affinity was exhibited for other receptor/binding sites tested, including the cholinergic muscarinic receptor (IC50 >1 M). Extrapyramidal Symptoms (EPS) - The incidence of reported EPS (which included the adverse reaction terms extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching) for ziprasidone-treated patients in the short-term, placebo-controlled schizophrenia trials was 14% vs. 8% for placebo. 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. 2) Undifferentiated but routine drunk agitation: 5-10 mg Versed, also . The relevance for human risk of the findings of prolactin-mediated endocrine tumors in rodents is unknown [see Warnings and Precautions (5.14)]. Mar 27, 2013. The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. It is not recommended to mix benadryl and ativan in the same syringe as they are both central nervous system depressants. In the 4- and 6-week placebo-controlled trials in adults, somnolence was reported in 14% of patients on ziprasidone compared to 7% of placebo patients. There was no effect on fertility at 40 mg/kg/day (2 times the MRHD based on mg/m2 body surface area). These studies indicate that the reduction reaction is mediated primarily by chemical reduction by glutathione as well as by enzymatic reduction by aldehyde oxidase and the subsequent methylation is mediated by thiol methyltransferase. 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). Ziprasidone may antagonize the effects of levodopa and dopamine agonists. In vitro studies using human liver subcellular fractions indicate that S-methyldihydroziprasidone is generated in two steps. Infants exposed to GEODON should be monitored for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements). Pooled data from short-term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 910. Applies to: Ativan (lorazepam) and Zyprexa (olanzapine) Ask your doctor before using LORazepam together with OLANZapine. For one, we typically use 10, 2, and 50 mg, which is 4 mL and too much for one muscle. Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. As with other antipsychotic drugs, ziprasidone should be used cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold, e.g., Alzheimer's dementia. 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. Limited data from a published case report indicate the presence of ziprasidone in human milk. Only the 100 mg twice daily dose group was superior to placebo on the PANSS negative subscale score. 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. We mix Haldol and Ativan in a syringe together for combative patients and the benadryl potentiates the effect of all these. Roerig Mixing is best avoided. The types of relapse events observed included depressive, manic, and mixed episodes. Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final solution. Somnolence was a commonly reported adverse reaction in patients treated with ziprasidone. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids. Titration within the range of 4080 mg twice daily (in 20 mg twice daily increments) was permitted for the duration of the study. Acute Treatment of Agitation in Schizophrenia. Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Ativan is oily and hard to draw up by itself but by instilling the Haldol it causes it to draw up much easier! Clinical trials in adults for oral ziprasidone included approximately 5700 patients and/or normal subjects exposed to one or more doses of ziprasidone. This medicinal product must not be mixed with other medicinal products or solvents other than Sterile Water for Injection. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. Ziprasidone should be discontinued in patients who are found to have persistent QTc measurements >500 msec [see Warnings and Precautions (5.3)]. There is no specific antidote to ziprasidone, and it is not dialyzable. 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. In the first phase of the study, the mean change in QTc from baseline was calculated for each drug, using a sample-based correction that removes the effect of heart rate on the QT interval. In rats, embryofetal toxicity (decreased fetal weights, delayed skeletal ossification) was observed following administration of 10 to 160 mg/kg/day (0.5 to 8 times the MRHD based on mg/m2 body surface area) during organogenesis or throughout gestation, but there was no evidence of teratogenicity. Increases in serum prolactin were observed in a 1-month dietary study in female, but not male, mice at 100 and 200 mg/kg/day (or 2.5 and 5 times the MRHD based on mg/m2 body surface area). 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 (2.1)]. Severe priapism may require surgical intervention. All interactions studies have been conducted with oral ziprasidone. 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). Note that for the flexible dose studies in both schizophrenia and bipolar disorder, each subject is categorized as having received either low (2040 mg BID) or high (6080 mg BID) dose based on the subject's modal daily dose. The risks of using ziprasidone in combination with other drugs have been evaluated as described below. futurepsychrn, ADN 188 Posts Specializes in Pschiatry. Do not mix haloperidol and LORazepam, consult with your pharmacist or doctor before doing so. In the double-blind randomization period, 127 subjects were treated with ziprasidone, and 112 subjects were treated with placebo. Drugs in Syringe Compatibility Y-Site Injection Compatibility (1:1 Mixture) Additionally, in some cases one brand of product may be compatible but another brand of drug is not. 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. If signs and symptoms of tardive dyskinesia appear in a patient on ziprasidone, drug discontinuation should be considered. no its not good to mix any drugs together in a syringe inless its in a IV bag mixed by a professional but deffinitly dont mix in a single syringe. and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Ziprasidone should not be used with any drug that prolongs the QT interval [see Contraindications (4.1)]. Can you mix Tylenol with lorazepam? The possibility of a suicide attempt is inherent in psychotic illness or bipolar disorder, and close supervision of high-risk patients should accompany drug therapy. Interpretation of these findings should take into consideration that only patients who adequately tolerated ziprasidone entered the double-blind phase of the study, and there were substantial dropouts during the open label phase. Consequently, patients should be evaluated carefully for a history of drug abuse, and such patients should be observed closely for signs of ziprasidone misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior). Conclusion While some general principles can be applied to the mixing of injection solutions, they are fraught with exception and applicability varies with circumstance. Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. The absorption of ziprasidone is increased up to two-fold in the presence of food. 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). 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. GEODON contains the active moiety, ziprasidone in the form of ziprasidone mesylate salt for intramuscular use only. Although 80 mg twice daily had a numerically greater effect than 40 mg twice daily, the difference was not statistically significant. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Jul 18, 2011. 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)].