Ziprasidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias [see Contraindications (4)]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS, Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Jun 27, 2014. Mixing is best avoided. Elimination of ziprasidone is mainly via hepatic metabolism with a mean terminal half-life of about 7 hours within the proposed clinical dose range. Ziprasidone has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Consistent with these in vitro results, population pharmacokinetic evaluation has not revealed any significant pharmacokinetic differences between smokers and nonsmokers. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older. Only the 100 mg twice daily dose group was superior to placebo on the PANSS negative subscale score. Dosage modifications for age or gender are, therefore, not recommended. 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). In many cases this would lead to the conclusion that other drugs should be tried first. 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). None of these adverse reactions occurred individually at an incidence greater than 10% in bipolar mania trials. 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. Patients' scores on the BARS at baseline were mostly 5 (signs of overt activity [physical or verbal], calms down with instructions) and as determined by investigators, exhibited a degree of agitation that warranted intramuscular therapy. Mar 27, 2013. 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. Contents should be mixed thoroughly by gently inverting the . GEODON contains the active moiety, ziprasidone in the form of ziprasidone mesylate salt for intramuscular use only. for Injection 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.) In a 4-week, placebo-controlled trial (n=200) comparing 3 fixed doses of ziprasidone (5, 20, and 40 mg twice daily), none of the dose groups was statistically superior to placebo on any outcome of interest. (ziprasidone mesylate), NDC 0049-1203-10 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). Ziprasidone is primarily cleared via three metabolic routes to yield four major circulating metabolites, benzisothiazole (BITP) sulphoxide, BITP-sulphone, ziprasidone sulphoxide, and S-methyldihydroziprasidone. 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)]. Such drugs should not be prescribed with ziprasidone. A no-effect level was not established for these effects. Answer (1 of 3): Generally, any two antipsychotics can be taken together. Upon appearance of rash for which an alternative etiology cannot be identified, ziprasidone should be discontinued. Patients being considered for ziprasidone treatment that are at risk of significant electrolyte disturbances should have baseline serum potassium and magnesium measurements. Yes, you can mix geodon and benadryl in the same syringe. Ziprasidone rebalances dopamine and serotonin to improve thinking, mood, and behavior. 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. 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. There was a reproducible mutagenic response in the Ames assay in one strain of S. typhimurium in the absence of metabolic activation. 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. 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. 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. Intramuscular ziprasidone has not been systematically evaluated in elderly patients or in patients with hepatic or renal impairment. COMPATIBILITY OF DRUGS COMBINED IN A SYRINGE. 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. A median weight gain of 0.5 kg was observed in ziprasidone patients compared to no median weight change in placebo patients. Low serum potassium and magnesium should be replaced before proceeding with treatment. 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. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase. Unchanged ziprasidone represents about 44% of total drug-related material in serum. Precise risk estimates for hyperglycemia-related adverse reactions in patients treated with atypical antipsychotics are not available. Nevertheless, the presence of multiple factors that might increase the pharmacodynamic response to ziprasidone, or cause poorer tolerance or orthostasis, should lead to consideration of a lower starting dose, slower titration, and careful monitoring during the initial dosing period for some elderly patients. Contains 10 of NDC 0049-1203-01, Geodon for Injection Ziprasidone should not be used with any drug that prolongs the QT interval [see Contraindications (4.1)]. Metabolism and Elimination: Although the metabolism and elimination of IM ziprasidone have not been systematically evaluated, the intramuscular route of administration would not be expected to alter the metabolic pathways. Other inhibitors of CYP3A4 would be expected to have similar effects. Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Absorption: Ziprasidone is well absorbed after oral administration, reaching peak plasma concentrations in 6 to 8 hours. Therefore, a safe and effective dose for use could not be established. If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine carry a theoretical hazard of additive QT-prolonging effects that might be additive to those of ziprasidone. Adverse Reactions Occurring at an Incidence of 1% or More Among Ziprasidone-Treated Patients in Short-Term Trials of Intramuscular Ziprasidone. In male mice, there was no increase in incidence of tumors relative to controls. Syncope was reported in 0.6% of the patients treated with ziprasidone. Applies to: Thorazine (chlorpromazine) and Ativan (lorazepam) Using chlorproMAZINE together with LORazepam may increase side effects such as dizziness, drowsiness, confusion, and difficulty concentrating. Objectively collected data from those trials on the Simpson-Angus Rating Scale (for EPS) and the Barnes Akathisia Scale (for akathisia) did not generally show a difference between ziprasidone and placebo. 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. Less than one-third of ziprasidone metabolic clearance is mediated by cytochrome P450 catalyzed oxidation. In vitro studies using human liver subcellular fractions indicate that S-methyldihydroziprasidone is generated in two steps. Pooled data from short-term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 14. Roerig Extrapyramidal Symptoms which includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. Do not mix with other drugs (i.e., in the same syringe). Healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. 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. 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. Metabolism and Elimination: Ziprasidone is extensively metabolized after oral administration with only a small amount excreted in the urine (<1%) or feces (<4%) as unchanged drug. Acute Treatment of Manic or Mixed Episodes in Adults, Adverse Reactions Associated with Discontinuation of Treatment in Short Term, Placebo-Controlled Trials. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. 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. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. There's just seldom a decent reason to do so. Weight gain has been observed with atypical antipsychotic use. Jul 18, 2011. This possibility needs to be considered in deciding among alternative drug products [see Indications and Usage (1)]. ECG Changes - Ziprasidone is associated with an increase in the QTc interval [see Warnings and Precautions (5.3)]. 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). For patients taking ziprasidone who experience symptoms that could indicate the occurrence of torsade de pointes, e.g., dizziness, palpitations, or syncope, the prescriber should initiate further evaluation, e.g., Holter monitoring may be useful. 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. 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. Severe priapism may require surgical intervention. 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