It is greater than 99% bound to plasma proteins, binding primarily to albumin and 1-acid glycoprotein. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. The mechanism of action of ziprasidone in the treatment of the listed indications could be mediated through a combination of dopamine type 2 (D2) and serotonin type 2 (5HT2) antagonism. A person should not mix Ativan and Xanax. 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. Pooled data from short-term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 58. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. GEODON contains the active moiety, ziprasidone in the form of ziprasidone mesylate salt for intramuscular use only. 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. Dizziness which includes the adverse reaction terms dizziness and lightheadedness. GEODON is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)]. This can cause low blood pressure, shallow breathing, weak pulse, muscle weakness, drowsiness, dizziness and slurred speech. GEODON is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions (5.1)]. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Ziprasidone should not be used with any drug that prolongs the QT interval [see Contraindications (4.1)]. Dose Dependency of Adverse Reactions in Short-Term, Fixed-Dose, Placebo-Controlled Trials. 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 . Ziprasidone is unlikely to interfere with the metabolism of drugs metabolized by cytochrome P450 enzymes. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. chlorproMAZINE LORazepam. Adverse reactions are further categorized by body system and listed in order of decreasing frequency according to the following definitions: Frequent - adverse reactions occurring in at least 1/100 patients (1.0% of patients) (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); Infrequent - adverse reactions occurring in 1/100 to 1/1000 patients (in 0.11.0% of patients). A study directly comparing the QT/QTc prolonging effect of oral ziprasidone with several other drugs effective in the treatment of schizophrenia was conducted in patient volunteers. The management of NMS should include: (1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; (2) intensive symptomatic treatment and medical monitoring; and (3) treatment of any concomitant serious medical problems for which specific treatments are available. CYP1A2 may contribute to a much lesser extent. mixed in the same syringe for use in a syringe driver over 24 hours. Primary rating instruments used for assessing manic symptoms in these trials were: (1) the Mania Rating Scale (MRS), which is derived from the Schedule for Affective Disorders and Schizophrenia-Change Version (SADS-CB) with items grouped as the Manic Syndrome subscale (elevated mood, less need for sleep, excessive energy, excessive activity, grandiosity), the Behavior and Ideation subscale (irritability, motor hyperactivity, accelerated speech, racing thoughts, poor judgment) and impaired insight; and (2) the Clinical Global Impression-Severity of Illness Scale (CGI-S), which was used to assess the clinical significance of treatment response. Intravenous access should be established, and gastric lavage (after intubation, if patient is unconscious) and administration of activated charcoal together with a laxative should be considered. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. Can you put Ativan and Haldol in the same syringe? 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. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with previously detected breast cancer. Ziprasidone dosed adjunctively to valproate in a maintenance trial of bipolar patients did not affect mean therapeutic valproate levels. The patient should be carefully monitored, since recurrences of NMS have been reported. Introduction. None of these adverse reactions occurred individually at an incidence greater than 10% in bipolar mania trials. 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. Ziprasidone intramuscular has not been systematically evaluated in elderly patients (65 years and over). Monitoring of weight is recommended. If sympathomimetic agents are used for vascular support, epinephrine and dopamine should not be used, since beta stimulation combined with 1 antagonism associated with ziprasidone may worsen hypotension. Other inhibitors of CYP3A4 would be expected to have similar effects. One case of priapism was reported in the premarketing database. A median weight gain of 0.5 kg was observed in ziprasidone patients compared to no median weight change in placebo patients. The possibility of multiple drug involvement should be considered. 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. In clinical trials with oral ziprasidone, the electrocardiograms of 2/2988 (0.06%) patients who received GEODON and 1/440 (0.23%) patients who received placebo revealed QTc intervals exceeding the potentially clinically relevant threshold of 500 msec. When agitation presents as an acute risk, these medications can be given as an intramuscular (IM) dose for even more rapid onset of action, and when time is of essence. Ziprasidone should be discontinued in patients who are found to have persistent QTc measurements >500 msec. An additive effect of ziprasidone and other drugs that prolong the QT interval cannot be excluded. 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%). Contents should be mixed thoroughly by gently inverting the . Patients with low serum potassium and/or magnesium should be repleted with those electrolytes before proceeding with treatment. When meds are run together at a Y site, there is actually very little surface area of mixture between the two. Discontinue ziprasidone if severe cutaneous adverse reactions are suspected. Do not mix with other drugs (i.e., in the same syringe). There's just seldom a decent reason to do so. The occurrence of rash was related to dose of ziprasidone, although the finding might also be explained by the longer exposure time in the higher dose 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. Additionally, clinicians should be alert to the identification of other drugs that have been consistently observed to prolong the QTc interval. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. If you must take both medications, it is recommended to do so at least an hour apart to avoid any . There were insufficient data to examine population subsets based on age and race. The BARS is a seven point scale with scores ranging from 1 (difficult or unable to rouse) to 7 (violent, requires restraint). Clinical experience with ziprasidone in patients with certain concomitant systemic illnesses is limited [see Use in Specific Populations (8.6), (8.7)]. This minimal amount of contact and mixing may allow 2 meds that really aren't terribly compatible to be given together because . All interactions studies have been conducted with oral ziprasidone. 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. This higher dose group was not superior to placebo on the BPRS psychosis cluster or on the SANS. Ziprasidone was significantly superior to placebo in time to relapse, with no significant difference between the different dose groups. 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). Ziprasidone and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia. The following adverse reactions have been identified during post-approval use of GEODON. Yes, you can mix both in the same syringe Can you mix xanax and Ativan? In a second 3-week placebo-controlled trial (n=205), the dose of ziprasidone was 40 mg twice daily on Day 1. This combination works faster than using either drug alone. 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)]. 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. 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). 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. The Brief Psychiatric Rating Scale (BPRS) and the Positive and Negative Syndrome Scale (PANSS) are both multi-item inventories of general psychopathology usually used to evaluate the effects of drug treatment in schizophrenia. Drug class: Atypical antipsychotics. 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 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. . A no-effect level was not established for these effects. Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. Advise patients to inform their health care providers of the following: History of QT prolongation; recent acute myocardial infarction; uncompensated heart failure; prescription of other drugs that have demonstrated QT prolongation; risk for significant electrolyte abnormalities; and history of cardiac arrhythmia [see Contraindications (4.1) and Warnings and Precautions (5.3)]. When taking any two medications, consider this in addition to the fact that they have different mechanisms of action. The BPRS psychosis cluster (conceptual disorganization, hallucinatory behavior, suspiciousness, and unusual thought content) is considered a particularly useful subset for assessing actively psychotic schizophrenic patients. Some drugs that prolong the QT/QTc interval have been associated with the occurrence of torsade de pointes and with sudden unexplained death. The multiple-dose pharmacokinetics of ziprasidone are dose-proportional within the proposed clinical dose range, and ziprasidone accumulation is predictable with multiple dosing. This product's label may have been updated. During long-term therapy with ziprasidone, a categorization of patients at baseline on the basis of body mass index (BMI) revealed the greatest mean weight gain and highest incidence of clinically significant weight gain (> 7% of body weight) in patients with low BMI (<23) compared to normal (2327) or overweight patients (>27). The two drugs are so compatible that you can mix them together in the same syringe. 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. Package insert / product label 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 4-week, placebo-controlled trial (n=139) comparing 2 fixed doses of ziprasidone (20 and 60 mg twice daily) with placebo, only the 60 mg dose was superior to placebo on the BPRS total score and the CGI severity score. DRESS consists of a combination of three or more of the following: cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, lymphadenopathy and one or more systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and pericarditis. futurepsychrn, ADN 188 Posts Specializes in Pschiatry. Somnolence led to discontinuation in 0.3% of the patients in short-term clinical trials in adults. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile. 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%. As with other antipsychotic drugs and placebo, sudden unexplained deaths have been reported in patients taking ziprasidone at recommended doses. The mean daily dose of ziprasidone in this study was 132 mg. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for GEODON and any potential adverse effects on the breastfed child from GEODON or from the mother's underlying condition. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. Feb 15, 2021 A grizzled LPN veteran taught me a nice little trick, pull up your haldol first in the syringe and inject it into your Ativan vial, then draw both of them up. All trials were in adult inpatients, most of whom met DSM III-R criteria for schizophrenia. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with ziprasidone exposure. Medically reviewed by Drugs.com. Reproductive System and Breast Disorders: ziprasidone mesylate injection, powder, lyophilized, for solution. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older. If circumstances are so compelling as to warrant mixing any Commonly Observed Adverse Reactions in Short Term-Placebo-Controlled Trials. Both studies compared higher doses of ziprasidone intramuscular with a 2 mg control dose. Advise patients that GEODON may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Infants exposed to GEODON should be monitored for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements). In vitro studies using human liver microsomes and recombinant enzymes indicate that CYP3A4 is the major CYP contributing to the oxidative metabolism of ziprasidone. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. 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. All of these patients survived without sequelae. We mix Haldol and Ativan in a syringe together for combative patients and the benadryl potentiates the effect of all these. Dosage form: injection, powder, lyophilized, for solution 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). 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). 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. Advise females of reproductive potential that GEODON may impair fertility due to an increase in serum prolactin levels. The absorption of ziprasidone is increased up to two-fold in the presence of food. other drugs that have demonstrated QT prolongation as one of their pharmacodynamic effects and have this effect described in the full prescribing information as a contraindication or a boxed or bolded warning. 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. Intramuscular Preparation for Administration. The in vitro plasma protein binding of ziprasidone was not altered by warfarin or propranolol, two highly protein-bound drugs, nor did ziprasidone alter the binding of these drugs in human plasma. Limited data from a published case report indicate the presence of ziprasidone in human milk. Tiger26 said: I've actually never used the B-52 during residency. It is not known if this is a direct result of the illness or other comorbid factors. Instruct patients to report the onset of any conditions that put them at risk for significant electrolyte disturbances, hypokalemia in particular, including but not limited to the initiation of diuretic therapy or prolonged diarrhea. 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. 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. Ziprasidone rebalances dopamine and serotonin to improve thinking, mood, and behavior. 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. However, in some circumstances there may be compelling reasons for mixing two or more parenteral drug solutions in the same infusion bag, in the same syringe or at a Y . The results of the oral ziprasidone trials in adult bipolar I disorder, manic/mixed episode follow: in a 3-week placebo-controlled trial (n=210), the dose of ziprasidone was 40 mg twice daily on Day 1 and 80 mg twice daily on Day 2. Of these 5700, over 4800 were patients who participated in multiple-dose effectiveness trials, and their experience corresponded to approximately 1831 patient-years. The mean daily dose of ziprasidone in this study was 112 mg. It is essential to periodically monitor serum electrolytes in patients for whom diuretic therapy is introduced during ziprasidone treatment. Syncope was reported in 0.6% of the patients treated with ziprasidone. Absorption: Ziprasidone is well absorbed after oral administration, reaching peak plasma concentrations in 6 to 8 hours. Adverse Reactions Occurring at an Incidence of 2% or More Among Ziprasidone-Treated Patients in Short-Term, Oral, Placebo-Controlled Trials. Approximately 6.5% (18/279) of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse reaction, compared with about 3.7% (5/136) on placebo. Hypokalemia (and/or hypomagnesemia) may increase the risk of QT prolongation and arrhythmia. Titration within the range of 4080 mg twice daily (in 20 mg twice daily increments) was permitted for the duration of the study. 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. Patients who are started on diuretics during Ziprasidone therapy need periodic monitoring of serum potassium and magnesium. Can you mix Tylenol with lorazepam? treatment of akathesia is pretty straight forward. Ziprasidone inhibited synaptic reuptake of serotonin and norepinephrine. 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. There is risk to the mother from untreated schizophrenia or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide. There were few patients with a rating higher than 5 on the BARS, as the most severely agitated patients were generally unable to provide informed consent for participation in premarketing clinical trials. 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. Mixing is best avoided. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Close medical supervision and monitoring should continue until the patient recovers. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. Lifetime carcinogenicity studies were conducted with ziprasidone in Long Evans rats and CD-1 mice. 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. Depressive, manic, and mixed episodes accounted for 53%, 34%, and 13%, respectively, of the total number of relapse events in the study. 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)]. Several patients with rash had signs and symptoms of associated systemic illness, e.g., elevated WBCs. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Ziprasidone at a dose of 40 mg twice daily administered concomitantly with lithium at a dose of 450 mg twice daily for 7 days did not affect the steady-state level or renal clearance of lithium. 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. The co-administration of 30 mL of Maalox with ziprasidone did not affect the pharmacokinetics of ziprasidone. Each study included 2 to 3 fixed doses of ziprasidone as well as placebo. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias. In premarketing trials involving more than 5400 patients and/or normal subjects, accidental or intentional overdosage of oral ziprasidone was documented in 10 patients. 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. Based on in vitro studies utilizing human liver enzymes, ziprasidone is not a substrate for CYP1A2; smoking should therefore not have an effect on the pharmacokinetics of ziprasidone. Ziprasidone is an antagonist at the D2, 5HT2A, and 5HT1D receptors, and an agonist at the 5HT1A receptor. Ziprasidone has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Instruct patients to report to their health care provider at the earliest onset any signs or symptoms that may be associated with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or with severe cutaneous adverse reactions, such as Stevens-Johnson syndrome [see Warnings and Precautions (5.5)]. The safety and effectiveness of Geodon have not been established in pediatric patients. 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%). 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. Alert to the fact that they have different mechanisms of action carefully monitored, since recurrences of NMS been! Hour apart to avoid any the benadryl potentiates the effect of all these accumulation is predictable with dosing. Relapse, hospitalization, and suicide way to lookup drug information, identify pills, check interactions and up! Eosinophilia and Systemic Symptoms ( DRESS ) has been reported in vitro studies human. 112 mg used the B-52 during residency of serum potassium and magnesium control!, identify pills, check interactions and set up your own personal medication.. 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