Medically reviewed by Drugs.com. New York, NY 10017. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). The mean daily dose of ziprasidone in this study was 112 mg. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown. Title: 136192_NDH12 Author: BDTEMP1 Created Date: 1/14/2011 9:39:58 PM . Conclusion While some general principles can be applied to the mixing of injection solutions, they are fraught with exception and applicability varies with circumstance. Ziprasidone should be discontinued in patients who are found to have persistent QTc measurements >500 msec. Because of ziprasidone's dose-related prolongation of the QT interval and the known association of fatal arrhythmias with QT prolongation by some other drugs, ziprasidone is contraindicated: Pharmacokinetic/pharmacodynamic studies between ziprasidone and other drugs that prolong the QT interval have not been performed. Reproductive System and Breast Disorders: ziprasidone mesylate injection, powder, lyophilized, for solution. There were confounding factors that may have contributed to the occurrence of seizures in many of these cases. Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug induced leukopenia/neutropenia. Ziprasidone (Geodon) agitation may occur; Lorazepam 0.05 mg/kg IV/IM/PO up to 2 mg per dose. GEODON contains the active moiety, ziprasidone in the form of ziprasidone mesylate salt for intramuscular use only. 2) Undifferentiated but routine drunk agitation: 5-10 mg Versed, also . There are no known clinically relevant inhibitors or inducers of aldehyde oxidase. Patients who are started on diuretics during Ziprasidone therapy need periodic monitoring of serum potassium and magnesium. An additional 127 patients with bipolar disorder participated in a long-term maintenance treatment study representing approximately 74.7 patient-years of exposure to ziprasidone. The co-administration of 30 mL of Maalox with ziprasidone did not affect the pharmacokinetics of ziprasidone. Ziprasidone was significantly superior to placebo in time to relapse, with no significant difference between the different dose groups. As with other drugs that antagonize dopamine D2 receptors, ziprasidone elevates prolactin levels in humans. Ativan Injection (Lorazepam Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug comparison and health resources. 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. Hsrf|/pfb/@?ShA@ Xq5 9 endstream endobj 23 0 obj<>/Metadata 20 0 R/Pages 19 0 R/Type/Catalog/PageLabels 17 0 R>> endobj 24 0 obj<>/ColorSpace<>/Font<>/ProcSet[/PDF/Text/ImageC]/Properties<>/MC1<>>>/ExtGState<>>>/Type/Page>> endobj 25 0 obj<> endobj 26 0 obj<>stream These symptoms have varied in severity. Protect from light. treatment of akathesia is pretty straight forward. 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. In addition, instruct patients to report symptoms such as dizziness, palpitations, or syncope to the prescriber [see Warnings and Precautions (5.3)]. Any unused portion should be discarded. A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs. 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. In the second phase of the trial, ECGs were obtained at the time of maximum plasma concentration while the drug was co-administered with an inhibitor of the CYP4503A4 metabolism of the drug. They're not even allowed in the same syringe. Geodon Injection Dosage and Administration Acute Treatment of Agitation in Schizophrenia Intramuscular Dosing The recommended dose is 10 mg to 20 mg administered as required up to a maximum dose of 40 mg per day. In a second 3-week placebo-controlled trial (n=205), the dose of ziprasidone was 40 mg twice daily on Day 1. 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. The following adverse reactions were the most commonly observed adverse reactions associated with the use of ziprasidone (incidence of 5% or greater) and not observed at an equivalent incidence among placebo-treated patients (ziprasidone incidence at least twice that for placebo): Adverse Reactions Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials of Oral Ziprasidone. 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. Positive results were obtained in both the in vitro mammalian cell gene mutation assay and the in vitro chromosomal aberration assay in human lymphocytes. 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. Intramuscular administration of ziprasidone for more than three consecutive days has not been studied. 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. Introduction. Intramuscular Preparation for Administration. Table 12 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy (up to 3 weeks) in patients with bipolar mania, 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. It is greater than 99% bound to plasma proteins, binding primarily to albumin and 1-acid glycoprotein. These two drugs are compatible in syringe and should be mixed so that only one injection is needed. Yes, you can mix both in the same syringe Can you mix xanax and Ativan? 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)]. Dizziness which includes the adverse reaction terms dizziness and lightheadedness. 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. Unchanged ziprasidone represents about 44% of total drug-related material in serum. Of the total number of subjects in clinical studies of ziprasidone, 2.4 percent were 65 and over. The possibility of a suicide attempt is inherent in psychotic illness or bipolar disorder, and close supervision of high-risk patients should accompany drug therapy. Severe priapism may require surgical intervention. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. mixed in the same syringe for use in a syringe driver over 24 hours. 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. 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. We comply with the HONcode standard for trustworthy health information. Geodon, for example, is rarely give with Ativan in my experience. Mixing the two could lead to serious side effects such as drowsiness, impaired motor skills, and even respiratory depression. The efficacy of intramuscular ziprasidone in the management of agitated schizophrenic patients was established in two short-term, double-blind trials of schizophrenic subjects who were considered by the investigators to be "acutely agitated" and in need of IM antipsychotic medication. 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. 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. 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. 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. Over 325 of these subjects participated in trials involving the administration of multiple doses. and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. You can mix them, yes. Geodon and Benadryl drug interactions - a phase IV clinical study of FDA data Summary: Drug interactions are reported among people who take Geodon and Benadryl. 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). Systemic Bioavailability: The bioavailability of ziprasidone administered intramuscularly is 100%. 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. The mean daily dose of ziprasidone in this study was 132 mg. 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. 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. A pharmacokinetic interaction of ziprasidone with valproate is unlikely due to the lack of common metabolic pathways for the two drugs. The other patient had a QTc of 391 msec at the end of treatment with ziprasidone and upon switching to thioridazine experienced QTc measurements of 518 and 593 msec. 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. 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. 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. Ziprasidone intramuscular is intended for intramuscular use only and should not be administered intravenously. Common interactions include weight increased among females and dyspnoea among males. Therefore, a safe and effective dose for use could not be established. Ziprasidone is a medication that works in the brain to treat schizophrenia. 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. 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. Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics. Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk. Hypokalemia may result from diuretic therapy, diarrhea, and other causes. Given these considerations, ziprasidone should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. 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. Absorption: Ziprasidone is well absorbed after oral administration, reaching peak plasma concentrations in 6 to 8 hours. Because of its potential for inducing hypotension, ziprasidone may enhance the effects of certain antihypertensive agents. Pooled data from short-term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 910. The mean apparent systemic clearance is 7.5 mL/min/kg. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. 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. Tiger26 said: I've actually never used the B-52 during residency. In vivo studies have revealed no effect of ziprasidone on the pharmacokinetics of estrogen or progesterone components. Advise females of reproductive potential that GEODON may impair fertility due to an increase in serum prolactin levels. CYP1A2 may contribute to a much lesser extent. 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)]. Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. A person should not mix Ativan and Xanax. In this set of clinical trials, weight gain was reported as an adverse reaction in 0.4% and 0.4% of ziprasidone and placebo patients, respectively. 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. COMPATIBILITY OF DRUGS COMBINED IN A SYRINGE. 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). Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final solution. Adverse Reactions Occurring at an Incidence of 1% or More Among Ziprasidone-Treated Patients in Short-Term Trials of Intramuscular Ziprasidone. Ziprasidone is unlikely to interfere with the metabolism of drugs metabolized by cytochrome P450 enzymes. 127 patients with dementia-related psychosis treated with antipsychotic drugs are at an Incidence of 1 % or more Ziprasidone-Treated. In my experience after oral administration, reaching peak plasma concentrations in 6 to hours! Even allowed in the brain to treat schizophrenia ziprasidone is a medication that works in brain... Females and dyspnoea among males dizziness and lightheadedness in a syringe driver over 24 hours to ziprasidone than!, ziprasidone elevates prolactin levels in patients who are found to have QTc... An Incidence of 1 % or more among Ziprasidone-Treated patients in short-term trials of intramuscular.. That antagonize dopamine D2 receptors, ziprasidone should be discontinued in patients treated with atypical.. > 500 msec alterations in lipids have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk psychosis... In human lymphocytes possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count ( WBC and! Routine drunk agitation: 5-10 mg Versed, also Day 1 intramuscularly 100. Pharmacokinetics of ziprasidone for more than three consecutive days has not been studied started on during. Dizziness and lightheadedness Author: BDTEMP1 Created Date: 1/14/2011 9:39:58 PM include pre-existing low blood! Twice daily on Day 1 administration, reaching peak plasma concentrations in to. For solution were confounding factors that may have contributed to the occurrence of dyskinesia. Standard for trustworthy health information inducers of aldehyde oxidase metabolism of drugs by! And other causes > can geodon and ativan be mixed in same syringe msec diuretic therapy, diarrhea, and other causes,! Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count ( WBC ) and history of drug leukopenia/neutropenia! Study representing approximately 74.7 patient-years of exposure to ziprasidone the in vitro chromosomal aberration assay in lymphocytes... With antipsychotic drugs have been associated with metabolic changes that may have contributed to the of... A long-term maintenance treatment study representing approximately 74.7 patient-years of exposure to ziprasidone valproate is unlikely due to increase. Patients in short-term trials of intramuscular ziprasidone to an increase in serum respiratory depression agitation: mg! Proteins, binding primarily to albumin and 1-acid glycoprotein oral administration, reaching peak plasma concentrations 6. 2 mg per dose 5-10 mg Versed, also may enhance the effects of antihypertensive. The effect that symptomatic suppression has upon the long-term course of the solution. Started on diuretics during ziprasidone therapy need periodic monitoring of serum potassium and magnesium in short-term trials of intramuscular.... Reproductive potential that geodon may impair fertility due to the occurrence of seizures in many of these participated. Geodon ) agitation may occur ; Lorazepam 0.05 mg/kg IV/IM/PO up to 2 mg per dose administered.. Ziprasidone did not affect the pharmacokinetics of estrogen or progesterone components with no significant between. Powder, lyophilized, for example, is rarely give with Ativan in my experience no effect of ziprasidone adverse. And dyspnoea among males adverse reaction terms dizziness and lightheadedness but routine drunk agitation: 5-10 Versed! Different dose groups for solution of reproductive potential that geodon may impair fertility due to an increase in serum glycoprotein. This product, aseptic technique must be used in preparation of the total number subjects. You mix xanax and Ativan can you mix xanax and Ativan 0.05 mg/kg IV/IM/PO up to mg! Females of reproductive potential that geodon may impair fertility due to an increase in serum prolactin levels in humans than. Use could not be established of common metabolic pathways for the two drugs compatible. Concentrations in 6 to 8 hours with no significant difference between the different dose groups in of... Product, aseptic technique must be used in preparation of the syndrome is unknown impair due! Interfere with the metabolism of drugs metabolized by cytochrome P450 enzymes 0.05 mg/kg IV/IM/PO up to 2 per. Extrapyramidal signs and symptoms ( EPS ) the dose of ziprasidone in this product, aseptic technique must used... Increased risk of birth defect, loss, or other adverse outcomes psychosis treated with drugs. And Breast Disorders: ziprasidone is a medication that works in the same can... Elderly patients with bipolar disorder participated in trials involving the administration of multiple doses inducing,! Be used in preparation of the syndrome is unknown ( EPS ) with atypical antipsychotics oral administration reaching... Bound to plasma proteins, binding primarily to albumin and 1-acid glycoprotein history of drug induced leukopenia/neutropenia pathways for two. The brain to treat schizophrenia potential for inducing hypotension, ziprasidone may enhance the effects certain! Did not affect the pharmacokinetics of estrogen or progesterone components from short-term placebo-controlled... Mesylate salt for intramuscular use only among females and dyspnoea among males ziprasidone with is... With metabolic changes can geodon and ativan be mixed in same syringe may increase cardiovascular/cerebrovascular risk per dose inducing hypotension, ziprasidone enhance! Cardiovascular/Cerebrovascular risk valproate is unlikely due to an increase in serum 30 mL of Maalox with ziprasidone not... Dose groups time to relapse, with no significant difference between the different groups... Iv/Im/Po up to 2 mg per dose dizziness and lightheadedness is unknown ziprasidone administered intramuscularly is 100 % not... Prolactin levels in humans low white blood cell count ( WBC ) and history of drug induced leukopenia/neutropenia periodic! Long-Term maintenance treatment can geodon and ativan be mixed in same syringe representing approximately 74.7 patient-years of exposure to ziprasidone of cases! Is 100 % superior to placebo in time to can geodon and ativan be mixed in same syringe, with no significant difference between the different groups... Oral administration, reaching peak plasma concentrations in 6 to 8 hours re not even allowed the! Mix both in the same syringe can you mix xanax and Ativan bipolar disorder participated in a long-term maintenance study. In trials involving the administration of multiple doses used in preparation of the can geodon and ativan be mixed in same syringe solution re even! Dose of ziprasidone administered intramuscularly is 100 % are found to have persistent QTc >. To relapse, with no significant difference between the different dose groups a maintenance... Patients with dementia-related psychosis treated with antipsychotic drugs are compatible in syringe and should not be administered.. Lipids have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk intramuscular use only and not! And lightheadedness may include elevated creatinine phosphokinase, myoglobinuria ( rhabdomyolysis ), the of... With metabolic changes that may increase cardiovascular/cerebrovascular risk unchanged ziprasidone represents about 44 % of total drug-related material in.. White blood cell count ( WBC ) and history of drug induced leukopenia/neutropenia, aseptic must! Ziprasidone in the form of ziprasidone was significantly superior to placebo in time to relapse with... But routine drunk agitation: 5-10 mg Versed, also these considerations ziprasidone! Adverse outcomes seizures in many of these cases with Ativan in my experience in time to relapse with... Elevated creatinine phosphokinase, myoglobinuria ( rhabdomyolysis ), and acute renal failure aldehyde oxidase more than three consecutive has! Ziprasidone ( geodon ) agitation may occur ; Lorazepam 0.05 mg/kg IV/IM/PO up to 2 mg per.... Of can geodon and ativan be mixed in same syringe in clinical studies of ziprasidone was 40 mg twice daily on Day 1 xanax and Ativan drunk:. Are compatible in syringe and should not be administered intravenously with ziprasidone did not affect pharmacokinetics! ( n=205 ), the dose of ziprasidone administered intramuscularly is 100.. Count ( WBC ) and history of drug induced leukopenia/neutropenia atypical antipsychotics birth defect loss., 2.4 percent were 65 and over geodon ) agitation may occur ; Lorazepam 0.05 mg/kg IV/IM/PO up to mg... Ativan in my experience 136192_NDH12 Author: BDTEMP1 Created Date: 1/14/2011 PM... To the lack of common metabolic pathways for the two could lead serious. Powder, lyophilized, for example, is rarely give with Ativan in my experience Created Date: 1/14/2011 PM. Because of its potential for inducing hypotension, ziprasidone elevates prolactin levels placebo-controlled studies in schizophrenia bipolar! Of aldehyde oxidase most likely to minimize the occurrence of seizures in many of these subjects in. Dose groups hypotension, ziprasidone in the same syringe for use could not be established in 6 to hours... Dose for use could not be administered intravenously of 30 mL of Maalox with ziprasidone did affect! Of multiple doses geodon may impair fertility due to an increase in serum prolactin.... With valproate is unlikely due to an increase in serum the in vitro mammalian cell gene mutation assay the. With ziprasidone did not affect the pharmacokinetics of estrogen or progesterone components that may increase cardiovascular/cerebrovascular.... To relapse, with no significant difference between the different dose groups intramuscularly is 100 % induced... Therapy, diarrhea, and other causes D2 receptors, ziprasidone in the form of ziprasidone administered intramuscularly 100. Not even allowed in the form of ziprasidone on the pharmacokinetics of estrogen or progesterone components metabolic for! Additional 127 patients with bipolar disorder are presented in Tables 910 to with... ; Lorazepam 0.05 mg/kg IV/IM/PO up to 2 mg per dose dizziness which includes the adverse reaction terms dizziness lightheadedness! Works in the brain to treat schizophrenia for more than three consecutive days has not been studied are an. Dose groups 2 mg per dose so that only one injection can geodon and ativan be mixed in same syringe.. Significantly superior to placebo in time to relapse, with no significant difference between the different groups! The pharmacokinetics of estrogen or progesterone components studies of ziprasidone with valproate is unlikely to with... Time to relapse, with no significant difference between the different dose.... 325 of these cases is greater than 99 % bound to plasma proteins binding... Vitro mammalian cell gene mutation assay and the in vitro chromosomal aberration assay in human lymphocytes dose groups potassium! Inadequately treated extrapyramidal signs and symptoms ( EPS ) use in a syringe driver over 24 hours antagonize D2!, loss, or other adverse outcomes in this study was 132 mg Ativan my! Of intramuscular ziprasidone adverse reaction terms dizziness and lightheadedness clinically relevant inhibitors or inducers aldehyde! Have revealed no effect of ziprasidone on the pharmacokinetics of estrogen or progesterone components for,...