All of these patients survived without sequelae. 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. Patients who are started on diuretics during Ziprasidone therapy need periodic monitoring of serum potassium and magnesium. 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. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. 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). Antipsychotic drugs (which include GEODON) may cause somnolence, postural hypotension, and motor and sensory instability, which could lead to falls and, consequently, fractures or other injuries. 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)]. Titration within the range of 4080 mg twice daily (in 20 mg twice daily increments) was permitted for the duration of the study. To administer a 10 mg dose, draw up 0.5 mL of the reconstituted solution. 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. One patient had a history of prolonged QTc and a screening measurement of 489 msec; QTc was 503 msec during ziprasidone treatment. It is important to emphasize that, although the reactions reported occurred during treatment with ziprasidone, they were not necessarily caused by it. Mar 27, 2013. #13. Intramuscular ziprasidone has not been systematically evaluated in elderly patients or in patients with hepatic or renal impairment. Ziprasidone has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Agranulocytosis (including fatal cases) has also been reported. 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%). 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. Ziprasidone and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. Symptoms of schizophrenia include: Ziprasidone intramuscular has not been systematically evaluated in elderly patients (65 years and over). Ziprasidone inhibited synaptic reuptake of serotonin and norepinephrine. PREMIERProRx is a registered trademark of Premier Healthcare Alliance, L.P., used under license. 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). Ziprasidone is primarily cleared via three metabolic routes to yield four major circulating metabolites, benzisothiazole (BITP) sulphoxide, BITP-sulphone, ziprasidone sulphoxide, and S-methyldihydroziprasidone. 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). Distributed by Tiger26 said: I've actually never used the B-52 during residency. Title: 136192_NDH12 Author: BDTEMP1 Created Date: 1/14/2011 9:39:58 PM . Ziprasidone was superior to placebo in increasing the time to recurrence of a mood episode. Ziprasidone is an antagonist at the D2, 5HT2A, and 5HT1D receptors, and an agonist at the 5HT1A receptor. In clinical trial and postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents. In this study, no patients had a QTc interval exceeding 500 msec. Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. The conditions and duration of treatment with ziprasidone included open-label and double-blind studies, inpatient and outpatient studies, and short-term and longer-term exposure. There was an increase in the number of pups born dead and a decrease in postnatal survival through the first 4 days of lactation among the offspring of female rats treated during gestation and lactation with doses of 10 mg/kg/day (0.5 times the MRHD based on mg/m2 body surface area) or greater. Can You Mix Geodon And Benadryl In The Same Syringe. Contents should be mixed thoroughly by gently inverting the . Neither clinical studies nor epidemiologic studies conducted to date have shown an association between chronic administration of this class of drugs and tumorigenesis in humans; the available evidence is considered too limited to be conclusive at this time. 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. Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Clinical trials in adults for oral ziprasidone included approximately 5700 patients and/or normal subjects exposed to one or more doses of ziprasidone. Only the 100 mg twice daily dose group was superior to placebo on the PANSS negative subscale score. In the rat study, there was no evidence of an increased incidence of tumors compared to controls. If you are prescribed both medications, it is important to take them as directed by your healthcare provider. 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. Severe cutaneous adverse reactions are sometimes fatal. Ziprasidone should be discontinued in patients who are found to have persistent QTc measurements >500 msec [see Warnings and Precautions (5.3)]. This product's label may have been updated. These two drugs are compatible in syringe and should be mixed so that only one injection is needed. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer's dementia. Clinical experience with ziprasidone in patients with certain concomitant systemic illnesses is limited [see Use in Specific Populations (8.6), (8.7)]. 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. It is not known if this is a direct result of the illness or other comorbid factors. Note that a 30 mg dose of intramuscular ziprasidone is 50% higher than the recommended therapeutic dose. 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 were confounding factors that may have contributed to the occurrence of seizures in many of these cases. Consistent with these in vitro results, population pharmacokinetic evaluation has not revealed any significant pharmacokinetic differences between smokers and nonsmokers. 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)]. The pharmacokinetics of ziprasidone following 8 days of 20 mg twice daily dosing were similar among subjects with varying degrees of renal impairment (n=27), and subjects with normal renal function, indicating that dosage adjustment based upon the degree of renal impairment is not required. Several instruments were used for assessing psychiatric signs and symptoms in these studies. 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). 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. 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). The patient should be carefully monitored, since recurrences of NMS have been reported. There is no specific antidote to ziprasidone, and it is not dialyzable. And for two, Benadryl never gets mixed with Haldol in the same syringe: precipitate forms in about 5 minutes. If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. Of the total number of subjects in clinical studies of ziprasidone, 2.4 percent were 65 and over. An elevated risk of acute dystonia is observed in males and younger age groups. Geodon We mix Haldol and Ativan in a syringe together for combative patients and the benadryl potentiates the effect of all these. When ziprasidone was administered to pregnant rabbits during the period of organogenesis, an increased incidence of fetal structural abnormalities (ventricular septal defects and other cardiovascular malformations, and kidney alterations) was observed at a dose of 30 mg/kg/day (3 times the MRHD of 200 mg/day based on mg/m2 body surface area). In vitro studies using human liver microsomes and recombinant enzymes indicate that CYP3A4 is the major CYP contributing to the oxidative metabolism of ziprasidone. The premarketing experience for ziprasidone did not reveal an excess risk of mortality for ziprasidone compared to other antipsychotic drugs or placebo, but the extent of exposure was limited, especially for the drugs used as active controls and placebo. Last updated on Mar 1, 2022. . Adverse Findings Observed in Short-Term, Placebo-Controlled Trials with Oral Ziprasidone. For one, we typically use 10, 2, and 50 mg, which is 4 mL and too much for one muscle. 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. A pharmacokinetic interaction of ziprasidone with valproate is unlikely due to the lack of common metabolic pathways for the two drugs. There was no effect on fertility at 40 mg/kg/day (2 times the MRHD based on mg/m2 body surface area). Generic name: ziprasidone hydrochloride 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. 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. 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. Over 325 of these subjects participated in trials involving the administration of multiple doses. 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. 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. Common interactions include weight increased among females and dyspnoea among males. No appreciable affinity was exhibited for other receptor/binding sites tested, including the cholinergic muscarinic receptor (IC50 >1 M). 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. Ziprasidone has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence. 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. 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. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. This can cause low blood pressure, shallow breathing, weak pulse, muscle weakness, drowsiness, dizziness and slurred speech. In the second phase of the study, the effect of ziprasidone on QTc length was not augmented by the presence of a metabolic inhibitor (ketoconazole 200 mg twice daily). Steady-state concentrations are achieved within one to three days of dosing. 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. 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. Ativan is oily and hard to draw up by itself but by instilling the Haldol it causes it to draw up much easier! Although 80 mg twice daily had a numerically greater effect than 40 mg twice daily, the difference was not statistically significant. The co-administration of 30 mL of Maalox with ziprasidone did not affect the pharmacokinetics of ziprasidone. 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