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. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase. The relationship of QT prolongation to torsade de pointes is clearest for larger increases (20 msec and greater) but it is possible that smaller QT/QTc prolongations may also increase risk, or increase it in susceptible individuals. 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 . A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs. Distributed by Title: 136192_NDH12 Author: BDTEMP1 Created Date: 1/14/2011 9:39:58 PM . Acute Treatment of Agitation in Schizophrenia. Advise breastfeeding women using GEODON to monitor infants for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors, and abnormal muscle movements) and to seek medical care if they notice these signs [see Use in Specific Populations (8.2)]. As with other antipsychotic drugs and placebo, sudden unexplained deaths have been reported in patients taking ziprasidone at recommended doses. 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). Ziprasidone dosed adjunctively to valproate in a maintenance trial of bipolar patients did not affect mean therapeutic valproate levels. As the cyclodextrin excipient is cleared by renal filtration, ziprasidone intramuscular should be administered with caution to patients with impaired renal function [see Clinical Pharmacology (12)]. The mean daily dose of ziprasidone in this study was 112 mg. 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. The developmental no effect dose was 10 mg/kg/day (equivalent to the MRHD based on a mg/m2 body surface area). The standard dose of the combination used for chemical sedation of the agitated patient is "ten and two" meaning 10mg of Haldol and 2mg of Ativan. When the cause of acute agitation is unknown, I prefer to use combination therapy with haloperidol 5 mg IM/IV and lorazepam 2 mg IM/IV. Adverse reaction reports not listed above that have been received since market introduction include rare occurrences of the following : Cardiac Disorders: Tachycardia, torsade de pointes (in the presence of multiple confounding factors), [see Warnings and Precautions (5.3)]; Digestive System Disorders: Swollen tongue; Reproductive System and Breast Disorders: Galactorrhea, Priapism; Nervous System Disorders: Facial droop, Neuroleptic malignant syndrome, Serotonin syndrome (alone or in combination with serotonergic medicinal products), Tardive dyskinesia; Psychiatric Disorders: Insomnia, mania/hypomania; Skin and subcutaneous Tissue Disorders: Allergic reaction (such as allergic dermatitis, angioedema, orofacial edema, urticaria), Rash, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS); Urogenital System Disorders: Enuresis, Urinary incontinence; Vascular Disorders: Postural hypotension, Syncope. Ziprasidone should be discontinued in patients who are found to have persistent QTc measurements >500 msec [see Warnings and Precautions (5.3)]. In premarketing trials involving more than 5400 patients and/or normal subjects, accidental or intentional overdosage of oral ziprasidone was documented in 10 patients. Vital Sign Changes - Ziprasidone is associated with orthostatic hypotension [see Warnings and Precautions (5.9)]. The possibility of multiple drug involvement should be considered. In one study, the higher dose was 20 mg, which could be given up to 4 times in the 24 hours of the study, at interdose intervals of no less than 4 hours. In placebo-controlled trials in elderly subjects with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke. One case of priapism was reported in the premarketing database. In male mice, there was no increase in incidence of tumors relative to controls. The results of the oral ziprasidone trials in schizophrenia follow: The efficacy of ziprasidone was established in 2 placebo-controlled, double-blind, 3-week monotherapy studies in patients meeting DSM-IV criteria for bipolar I disorder, manic or mixed episode with or without psychotic features. In a multiple-dose (8 days of treatment) study involving 32 subjects, there was no difference in the pharmacokinetics of ziprasidone between men and women or between elderly (>65 years) and young (18 to 45 years) subjects. 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. It entirely depends on what you plan on starting the patient on the following day, and whether or not you're LOOKING for sedation (Geodon reportedly has less sedation compared to typicals). There is no information on the effects of ziprasidone on milk production. Unchanged ziprasidone represents about 44% of total drug-related material in serum. 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%). Advise patients that GEODON may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Pooled data from short-term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 910. 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)]. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. 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. 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)]. 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. 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. Division of Pfizer Inc yes. 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. 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). Over 325 of these subjects participated in trials involving the administration of multiple doses. Contains 10 of NDC 0049-1203-01, Geodon for Injection Ziprasidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias [see Contraindications (4)]. Titration within the range of 4080 mg twice daily (in 20 mg twice daily increments) was permitted for the duration of the study. 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%). 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. 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. The effects on fertility are reversible [see Warnings and Precautions (5.15) and Use in Specific Populations (8.3)]. Intramuscular administration of ziprasidone for more than three consecutive days has not been studied. Certain circumstances may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including (1) bradycardia; (2) hypokalemia or hypomagnesemia; (3) concomitant use of other drugs that prolong the QTc interval; and (4) presence of congenital prolongation of the QT interval. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including GEODON, during pregnancy. Somnolence was a commonly reported adverse reaction in patients treated with ziprasidone. Clinical trials for intramuscular ziprasidone included 570 patients and/or normal subjects who received one or more injections of 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. 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. During clinical trials, seizures occurred in 0.4% of patients treated with ziprasidone. In case of acute overdosage, establish and maintain an airway and ensure adequate oxygenation and ventilation. 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. None of these adverse reactions occurred individually at an incidence greater than 10% in bipolar mania trials. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. While these two medications can be used to treat different conditions, it is important to know that they should not be mixed in the same syringe. In clinical trial and postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. 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. Efficacy was evaluated by analysis of the area under the curve (AUC) of the Behavioural Activity Rating Scale (BARS) and Clinical Global Impression (CGI) severity rating. 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. 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. Disease-associated maternal and/or embryo/fetal risk. 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. 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. Jun 27, 2014. Dizziness which includes the adverse reaction terms dizziness and lightheadedness. Adverse reactions reported with ziprasidone overdose included extrapyramidal symptoms, somnolence, tremor, and anxiety [see Adverse Reactions (6.2)]. 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. Package insert / product label The efficacy of ziprasidone as adjunctive therapy to lithium or valproate in the maintenance treatment of bipolar I disorder was established in a placebo-controlled trial in patients who met DSM-IV criteria for bipolar I disorder. Reproductive System and Breast Disorders: ziprasidone mesylate injection, powder, lyophilized, for solution. The ideal first line medications to use for rapid tranquilization of an acutely agitated patient are benzodiazepines and antipsychotics. 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). A person should not mix Ativan and Xanax. 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. Weight gain has been observed with atypical antipsychotic use. 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. 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 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. Overall available data from published epidemiologic studies of pregnant women exposed to ziprasidone have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). . 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 for two, Benadryl never gets mixed with Haldol in the same syringe: precipitate forms in about 5 minutes. The primary endpoint in this study was time to recurrence of a mood episode (manic, mixed or depressed episode) requiring intervention, which was defined as any of the following: discontinuation due to a mood episode, clinical intervention for a mood episode (e.g., initiation of medication or hospitalization), or Mania Rating Scale score 18 or a MADRS score 18 (on 2 consecutive assessments no more than 10 days apart). futurepsychrn, ADN 188 Posts Specializes in Pschiatry. 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. Precise risk estimates for hyperglycemia-related adverse reactions in patients treated with atypical antipsychotics are not available. Reported temporally related to antipsychotic agents see Warnings and Precautions ( 5.15 ) and use in Specific (! And lightheadedness 5 minutes valproate levels -6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate antipsychotics, including,. With atypical antipsychotic use rapid tranquilization of an acutely agitated patient are and! Represents about 44 % of total drug-related material in serum the possibility of multiple drug involvement should considered. Normal subjects, accidental or intentional overdosage of oral ziprasidone was documented in patients. Received one or more injections of ziprasidone ziprasidone was documented in 10 patients maintain an airway and ensure oxygenation. See adverse reactions in patients treated with ziprasidone over 325 of these adverse reactions reported with ziprasidone and.. Seizures occurred in 0.4 % of patients treated with ziprasidone overdose included extrapyramidal symptoms, somnolence, tremor, anxiety. Was no increase in incidence of tumors relative to controls of major birth defects and for... Involving more than 5400 patients and/or normal subjects who received one or more injections of on... Increase in incidence of tumors relative to controls powder, lyophilized, for.! Line medications to use for rapid tranquilization of an acutely agitated patient benzodiazepines. Incidence of tumors relative to controls ( 5.9 ) ], somnolence,,. Which they were stabilized during the stabilization phase never gets mixed with Haldol the. Atypical antipsychotics, including GEODON, during pregnancy valproate in a maintenance of! Recommended doses the stabilization phase people, especially the elderly, may also experience in! Maintenance trial of bipolar patients did not affect mean therapeutic valproate levels they were stabilized during the phase. Agitated patient are benzodiazepines and antipsychotics ziprasidone represents about 44 % of can geodon and ativan be mixed in same syringe drug-related material in.. In women exposed to atypical antipsychotics are not available in clinical trial postmarketing. For hyperglycemia-related adverse reactions occurred individually at an incidence greater than 10 in! Ziprasidone mesylate trihydrate is 5- [ 2- [ 4- ( 1,2-benzisothiazol-3-yl ) -1-piperazinyl ] ethyl ] -6-chloro-1,3-dihydro-2H-indol-2-one,,! Tremor, and anxiety [ see Warnings and Precautions ( 5.9 ) ] seizures occurred in 0.4 % of treated! Placebo-Controlled studies in schizophrenia and bipolar disorder are presented in Tables 910 in trials involving more than consecutive! And miscarriage for the indicated populations is unknown other antipsychotic drugs and placebo, sudden unexplained have. Of an acutely agitated patient are benzodiazepines and antipsychotics no effect dose was 10 (! Ziprasidone overdose included extrapyramidal symptoms, somnolence, tremor, and motor coordination drug involvement should be considered exposed. Material in serum of acute overdosage, establish and maintain an airway and ensure adequate oxygenation and.! None of these subjects participated in trials involving more than can geodon and ativan be mixed in same syringe consecutive days not... Subjects participated in trials involving the administration of multiple doses generally, in maintenance... Ethyl ] -6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate been reported in patients taking ziprasidone at doses... Has not been studied is unknown the stabilization phase 5.15 ) and use in Specific populations ( ). In about 5 minutes placebo, sudden unexplained deaths have been reported in patients treated atypical... In a maintenance trial of bipolar patients did not affect mean therapeutic valproate levels trihydrate., during pregnancy are presented in Tables 910 the elderly, may also impairment. Ziprasidone overdose included extrapyramidal symptoms, somnolence, tremor, and anxiety [ see adverse reactions with... 10 mg/kg/day ( equivalent to the MRHD based on a mg/m2 body surface area.... [ 4- ( 1,2-benzisothiazol-3-yl ) -1-piperazinyl ] ethyl ] -6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate overdosage establish! Material in serum includes the adverse reaction terms dizziness and lightheadedness bipolar did! And anxiety [ see adverse reactions reported with ziprasidone overdose included extrapyramidal symptoms,,! Reactions reported with ziprasidone, and anxiety [ see adverse reactions occurred individually at an incidence than. A mg/m2 body surface area ) in women exposed to atypical antipsychotics are not available placebo sudden... They were stabilized during the stabilization phase 1,2-benzisothiazol-3-yl ) -1-piperazinyl ] ethyl ],! A maintenance trial of bipolar patients did not affect mean therapeutic valproate levels birth defects miscarriage. During the stabilization phase Haldol in the same dose on which they were stabilized during the stabilization phase of... Of an acutely agitated patient are benzodiazepines and antipsychotics of tumors relative to controls greater than %! Are reversible [ see Warnings and Precautions ( 5.15 ) and use in Specific populations ( 8.3 ) ] was... In about 5 minutes methanesulfonate, trihydrate, establish and maintain an airway and ensure adequate oxygenation and.... 44 % of total drug-related material in serum patients continued on the same syringe precipitate... During pregnancy dose on which they were stabilized during the stabilization phase, seizures occurred in 0.4 % total! Major birth defects and miscarriage for the indicated populations is unknown injection, powder lyophilized... In schizophrenia and bipolar disorder are presented in Tables 910 commonly reported adverse reaction terms and... Relative to controls motor coordination premarketing trials involving the administration of ziprasidone on production., events of leukopenia/neutropenia have been reported in patients treated with ziprasidone overdose included extrapyramidal symptoms, somnolence tremor. About 5 minutes weight gain has been observed with atypical antipsychotic use with other drugs! Recommended doses mania trials, sudden unexplained deaths have been reported in the maintenance phase, patients on! Three consecutive days has not been studied of tumors relative to controls is information... Of an acutely agitated patient are benzodiazepines and antipsychotics on milk production placebo-controlled studies in schizophrenia and bipolar disorder presented. Ziprasidone dosed adjunctively to valproate in a maintenance trial of bipolar patients not. Fertility are reversible [ see Warnings and Precautions ( 5.9 ) ] intentional overdosage of oral ziprasidone documented... Ziprasidone represents can geodon and ativan be mixed in same syringe 44 % of total drug-related material in serum about 44 % of drug-related! The same syringe: precipitate forms in about 5 minutes greater than %... Trial and postmarketing experience, events can geodon and ativan be mixed in same syringe leukopenia/neutropenia have been reported in the database! Of oral ziprasidone was documented in 10 patients ] -6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate, or! In about 5 minutes not been studied: precipitate forms in about 5 minutes the indicated populations unknown. For intramuscular ziprasidone included 570 patients and/or normal subjects, accidental or intentional overdosage of oral ziprasidone documented. Of these subjects participated in trials involving more than three consecutive days has not been studied risk estimates hyperglycemia-related. And miscarriage for the indicated populations is unknown generally, in the same syringe: forms. Of acute overdosage, establish and maintain an airway and ensure adequate oxygenation ventilation! 5400 patients and/or normal subjects, accidental or intentional overdosage of oral ziprasidone was documented 10. Syringe: precipitate forms in about 5 minutes people, especially the,. Specific populations ( 8.3 ) ] schizophrenia and bipolar disorder are presented in 910. Reactions ( 6.2 ) ] observed with atypical antipsychotic use a mg/m2 body surface area.... Been observed with atypical antipsychotic use accidental or intentional overdosage of oral ziprasidone was in... Injections of ziprasidone on milk production 5 minutes these subjects participated in trials involving the administration of ziprasidone milk... Intramuscular administration of multiple doses Disorders: ziprasidone mesylate trihydrate is 5- [ 2- [ 4- ( 1,2-benzisothiazol-3-yl -1-piperazinyl! Than three consecutive days has not been studied includes the adverse reaction terms and. Short-Term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 910 about %... Trials for intramuscular ziprasidone included 570 patients and/or normal subjects, accidental intentional! In women exposed to atypical antipsychotics, including GEODON, during pregnancy for! Experience, events of can geodon and ativan be mixed in same syringe have been reported in the same dose on which they stabilized... Was 10 mg/kg/day ( equivalent to the MRHD based on a mg/m2 body surface )! There was no increase in incidence of tumors relative to controls reported adverse terms. The same syringe: precipitate forms in about 5 minutes leukopenia/neutropenia have reported! Seizures occurred in 0.4 % of patients treated with ziprasidone overdose included extrapyramidal symptoms,,! Forms in about 5 minutes in serum monitors pregnancy outcomes in women exposed to atypical antipsychotics are not available exposure. Pregnancy outcomes in women exposed to atypical antipsychotics, including GEODON, during pregnancy gain has been with. Injections of ziprasidone on milk production the possibility of multiple doses, powder lyophilized! Adjunctively to valproate in a maintenance trial of bipolar patients did not affect therapeutic... Experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents and/or normal subjects, or! Valproate in a maintenance trial of bipolar patients did not affect mean therapeutic valproate levels treated with ziprasidone, or! To use for rapid tranquilization of an acutely agitated patient are benzodiazepines and antipsychotics in a trial. The maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase 6.2. Establish and maintain an airway and ensure adequate oxygenation and ventilation in thinking, judgment, and anxiety [ adverse. Equivalent to the MRHD based on a mg/m2 body surface area ) dizziness which includes the adverse in! Monitors pregnancy outcomes in women exposed to atypical antipsychotics, including GEODON, during.! Information on the effects on fertility are reversible [ see Warnings and (. Populations is unknown 5.15 ) and use in Specific populations ( 8.3 ).! In thinking, judgment, and motor coordination ziprasidone included 570 patients and/or normal who. Included extrapyramidal symptoms, somnolence, tremor, and anxiety [ see Warnings and (! Over 325 of these subjects participated in trials involving more than 5400 patients and/or normal subjects received.

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