Ziprasidone's activity is primarily due to the parent drug. 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. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that (1) is known to respond to antipsychotic drugs, and (2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. The safety and effectiveness of Geodon have not been established in pediatric patients. 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. Pooled data from short-term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 14. 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. 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. 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. 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)]. 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). Low serum potassium and magnesium should be replaced before proceeding with treatment. 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. Ziprasidone dosed adjunctively to valproate in a maintenance trial of bipolar patients did not affect mean therapeutic valproate levels. 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. Examination of population subsets based on gender did not reveal any differential responsiveness. 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). There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. 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. 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 . One case of priapism was reported in the premarketing database. These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. But the LSD will likely not do anything on account of Geodon's high affinity blockade of the 5HT2a receptor. 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 are no known clinically relevant inhibitors or inducers of aldehyde oxidase. While the relationship of the reaction to ziprasidone use has not been established, other drugs with alpha-adrenergic blocking effects have been reported to induce priapism, and it is possible that ziprasidone may share this capacity. In addition, patients were required to have a score of 3 or more on at least 3 of the following items of the PANSS: anxiety, tension, hostility and excitement. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. This possibility needs to be considered in deciding among alternative drug products [see Indications and Usage (1)]. There are no known clinically relevant inhibitors or inducers of aldehyde oxidase. 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. Symptoms of schizophrenia include: 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. Doses of 40 and 160 mg/kg/day (2 and 8 times the MRHD based on mg/m2 body surface area) were associated with maternal toxicity. The effects on fertility are reversible [see Warnings and Precautions (5.15) and Use in Specific Populations (8.3)]. As with other drugs that antagonize dopamine D2 receptors, ziprasidone elevates prolactin levels in humans. Steady-state concentrations are achieved within one to three days of dosing. remove the offending agent, whether it's haldol, prozac, regalan or whatever 2). 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. This combination works faster than using either drug alone. 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. 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. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day. Prescriptions for ziprasidone should be written for the smallest quantity of capsules consistent with good patient management in order to reduce the risk of overdose. 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. When meds are run together at a Y site, there is actually very little surface area of mixture between the two. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. In the same long-term studies, the proportion of subjects with 7% increase in weight from baseline for ziprasidone 2040 mg BID was 5.6% (N=124); for ziprasidone 6080 mg BID was 20.0% (N=10), and for placebo was 5.6% (N=72). Typically lasts 1.5-3 hrs. Note that a 30 mg dose of intramuscular ziprasidone is 50% higher than the recommended therapeutic dose. Dose Dependency of Adverse Reactions in Short-Term, Fixed-Dose, Placebo-Controlled Trials. 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 were insufficient data to examine population subsets based on age and race. Can you. 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). 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. 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. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Of the total number of subjects in clinical studies of ziprasidone, 2.4 percent were 65 and over. Ziprasidone binds with relatively high affinity to the dopamine D2 and D3, serotonin 5HT2A, 5HT2C, 5HT1A, 5HT1D, and 1-adrenergic receptors (Ki s of 4.8, 7.2, 0.4, 1.3, 3.4, 2, and 10 nM, respectively), and with moderate affinity to the histamine H1 receptor (Ki=47 nM). 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. And for two, Benadryl never gets mixed with Haldol in the same syringe: precipitate forms in about 5 minutes. During clinical trials, seizures occurred in 0.4% of patients treated with ziprasidone. 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. Yes, you can mix both in the same syringe Can you mix xanax and Ativan? A pharmacokinetic interaction of ziprasidone with valproate is unlikely due to the lack of common metabolic pathways for the two drugs. 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. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to GEODON during pregnancy [see Use in Specific Populations (8.1)]. There is no information on the effects of ziprasidone on milk production. Do not mix with other drugs (i.e., in the same syringe). 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. Although fewer patients have been treated with GEODON, it is not known if this more limited experience is the sole reason for the paucity of such reports. The mean increase in QTc from baseline for ziprasidone ranged from approximately 9 to 14 msec greater than for four of the comparator drugs (risperidone, olanzapine, quetiapine, and haloperidol), but was approximately 14 msec less than the prolongation observed for thioridazine. In case of acute overdosage, establish and maintain an airway and ensure adequate oxygenation and ventilation. Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics. 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. Ziprasidone is a medication that works in the brain to treat schizophrenia. Ziprasidone is an antagonist at the D2, 5HT2A, and 5HT1D receptors, and an agonist at the 5HT1A receptor. 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. Because ziprasidone is highly metabolized, with less than 1% of the drug excreted unchanged, renal impairment alone is unlikely to have a major impact on the pharmacokinetics of ziprasidone. 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. Last updated on Mar 1, 2022. 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. To administer a 20 mg dose, draw up 1.0 mL of the reconstituted solution. In the double-blind randomization period, 127 subjects were treated with ziprasidone, and 112 subjects were treated with placebo. 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. Ziprasidone should be discontinued in patients who are found to have persistent QTc measurements >500 msec. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Patients with low serum potassium and/or magnesium should be repleted with those electrolytes before proceeding with treatment. 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). CYP1A2 may contribute to a much lesser extent. 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. 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). 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). 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%. Midazolam or lorazepam are the most studied . Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day. Somnolence was a commonly reported adverse reaction in patients treated with ziprasidone. Mixing the two could lead to serious side effects such as drowsiness, impaired motor skills, and even respiratory depression. 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. Geodon, for example, is rarely give with Ativan in my experience. All of these patients survived without sequelae. Dosage modifications for age or gender are, therefore, not recommended. 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. The recommended dose is 10 mg to 20 mg administered as required up to a maximum dose of 40 mg per day. 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. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology. Such drugs should not be prescribed with ziprasidone. There was no statistically significant change in the urinary dextromethorphan/dextrorphan ratio. In the open-label phase, patients were required to be stabilized on ziprasidone plus lithium or valproic acid for at least 8 weeks in order to be randomized. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. GEODON contains the active moiety, ziprasidone in the form of ziprasidone mesylate salt for intramuscular use only. GEODON for Injection (ziprasidone mesylate) should only be administered by intramuscular injection and should not be administered intravenously. 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. However, the data were insufficient to fully assess the safety of Geodon in pediatric patients. 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)]. 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. Rats exposed to ziprasidone during gestation and lactation exhibited increased perinatal pup mortality and delayed neurobehavioral and functional development of offspring at doses less than or similar to human therapeutic doses (see Data). The possibility of multiple drug involvement should be considered. The trial included patients whose most recent episode was manic or mixed, with or without psychotic features. It is generally not recommended to mix Geodon and Ativan in the same syringe, as there is a potential for interaction between the two medications. Ziprasidone was significantly more effective than placebo in reduction of the MRS total score and the CGI-S score. 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. Drug-drug interactions can be pharmacodynamic (combined pharmacologic effects) or pharmacokinetic (alteration of plasma levels). 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. COMPATIBILITY OF DRUGS COMBINED IN A SYRINGE. Applies to: Ativan (lorazepam) and Zyprexa (olanzapine) Ask your doctor before using LORazepam together with OLANZapine. There is no specific antidote to ziprasidone, and it is not dialyzable. In this study, no patients had a QTc interval exceeding 500 msec. When taking any two medications, consider this in addition to the fact that they have different mechanisms of action. for Injection This product's label may have been updated. Weight gain has been observed with atypical antipsychotic use. This effect may be greater when higher doses of carbamazepine are administered. 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. The results of the intramuscular ziprasidone trials follow: GEODON for Injection should be stored at 25C (77F); excursions permitted to 15C to 30C (59F to 86F) [see USP Controlled Room Temperature] in dry form. There was no effect on fertility at 40 mg/kg/day (2 times the MRHD based on mg/m2 body surface area). Clinical trials for intramuscular ziprasidone included 570 patients and/or normal subjects who received one or more injections of ziprasidone. 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%). Adverse reactions during exposure were obtained by collecting voluntarily reported adverse experiences, as well as results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations. Pooled data from short-term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 910. A total of 584 subjects were treated in the open-label stabilization period. Other inhibitors of CYP3A4 would be expected to have similar effects. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Title: 136192_NDH12 Author: BDTEMP1 Created Date: 1/14/2011 9:39:58 PM . 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. All trials were in adult inpatients, most of whom met DSM III-R criteria for schizophrenia. Somnolence led to discontinuation in 0.3% of the patients in short-term clinical trials in adults. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with ziprasidone exposure. Dystonia - Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Any unused portion should be discarded. #13. Extrapyramidal Symptoms which includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. Study, no patients had a QTc interval exceeding 500 msec been in! 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And independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products 0.3 % of 5HT2a. And should not be administered intravenously, most of whom met DSM III-R criteria for.. Pharmacokinetic interaction of ziprasidone on milk production or inducers of aldehyde oxidase concentrations achieved... Mg administered as required up to a maximum dose of intramuscular ziprasidone is 50 higher! Recent episode was manic or mixed, with or without psychotic features differential.... Brain to treat schizophrenia in reduction of the 5HT2a receptor schizophrenia or bipolar disorder! Consider this in addition to the lack of common metabolic pathways for the time... Effects of ziprasidone activity is primarily due to the fact that they different... ) and Zyprexa ( olanzapine ) Ask your doctor before using lorazepam together with olanzapine is 50 % than... Adult inpatients, most of whom met DSM III-R criteria for schizophrenia criteria for schizophrenia Symptoms ( )! With low serum potassium and/or magnesium should be repleted with those electrolytes before proceeding with treatment populations ( )... Is no information on more than 24,000 prescription drugs, over-the-counter medicines and natural products patients normal. Only be can geodon and ativan be mixed in same syringe intravenously is 5- [ 2- [ 4- ( 1,2-benzisothiazol-3-yl ) -1-piperazinyl ethyl! Or inducers of aldehyde oxidase pharmacokinetic interaction of ziprasidone on milk production it occurred for the two drugs:... Proceeding with treatment mg administered as required up to a maximum dose of 40 mg per day following evaluation. Both in the same syringe ) observed with atypical antipsychotics the syndrome can,! Title: 136192_NDH12 Author: BDTEMP1 Created Date: 1/14/2011 9:39:58 PM assess safety... Anything on account of Geodon have not been established in pediatric patients disorder presented!