Ziprasidone intramuscular is intended for intramuscular use only and should not be administered intravenously. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Can you mix Tylenol with lorazepam? Approximately 4.1% (29/702) of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse reaction, compared with about 2.2% (6/273) on placebo. (ziprasidone mesylate), fluoxetine, quetiapine, lamotrigine, venlafaxine, Abilify, Seroquel, Prozac, aripiprazole, olanzapine, risperidone. In vitro studies using human liver microsomes and recombinant enzymes indicate that CYP3A4 is the major CYP contributing to the oxidative metabolism of ziprasidone. Jul 18, 2011. Because of its potential for inducing hypotension, ziprasidone may enhance the effects of certain antihypertensive agents. 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). These medications may be given alone or in combination. As with other antipsychotic drugs, ziprasidone should be used cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold, e.g., Alzheimer's dementia. It is important to emphasize that, although the reactions reported occurred during treatment with ziprasidone, they were not necessarily caused by it. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. To administer a 10 mg dose, draw up 0.5 mL of the reconstituted solution. futurepsychrn, ADN 188 Posts Specializes in Pschiatry. Contains 10 of NDC 0049-1203-01, Geodon for Injection When ziprasidone was administered to pregnant rabbits during the period of organogenesis, an increased incidence of fetal structural abnormalities (ventricular septal defects and other cardiovascular malformations, and kidney alterations) was observed at a dose of 30 mg/kg/day (3 times the MRHD of 200 mg/day based on mg/m2 body surface area). . 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. Hypokalemia (and/or hypomagnesemia) may increase the risk of QT prolongation and arrhythmia. Geodon 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)]. Additionally, clinicians should be alert to the identification of other drugs that have been consistently observed to prolong the QTc interval. In the tables showing categorical changes, the percentages (% column) are calculated as 100(n/N). Applies to: Ativan (lorazepam) and Zyprexa (olanzapine) Ask your doctor before using LORazepam together with OLANZapine. Each study included 2 to 3 fixed doses of ziprasidone as well as placebo. 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. Hsrf|/pfb/@?ShA@ Xq5 9
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All of these patients survived without sequelae. Conclusion While some general principles can be applied to the mixing of injection solutions, they are fraught with exception and applicability varies with circumstance. Division of Pfizer Inc 1). The mean apparent systemic clearance is 7.5 mL/min/kg. Ziprasidone should be discontinued in patients who are found to have persistent QTc measurements >500 msec [see Warnings and Precautions (5.3)]. 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. 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. All trials were in adult inpatients, most of whom met DSM III-R criteria for schizophrenia. 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. 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. Symptoms of schizophrenia include: Lifetime carcinogenicity studies were conducted with ziprasidone in Long Evans rats and CD-1 mice. The effects on fertility are reversible [see Warnings and Precautions (5.15) and Use in Specific Populations (8.3)]. Vital Sign Changes - Ziprasidone is associated with orthostatic hypotension [see Warnings and Precautions (5.9)]. The relevance for human risk of the findings of prolactin-mediated endocrine tumors in rodents is unknown [see Warnings and Precautions (5.14)]. 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. PREMIERProRx is a registered trademark of Premier Healthcare Alliance, L.P., used under license. Applies to: Thorazine (chlorpromazine) and Ativan (lorazepam) Using chlorproMAZINE together with LORazepam may increase side effects such as dizziness, drowsiness, confusion, and difficulty concentrating. The co-administration of 30 mL of Maalox with ziprasidone did not affect the pharmacokinetics of ziprasidone. There have been few reports of hyperglycemia or diabetes in patients treated with GEODON. Explorations for interactions on the basis of gender did not reveal any clinically meaningful differences in the adverse reaction occurrence on the basis of this demographic factor. Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias. The results of the oral ziprasidone trials in adult bipolar I disorder, manic/mixed episode follow: in a 3-week placebo-controlled trial (n=210), the dose of ziprasidone was 40 mg twice daily on Day 1 and 80 mg twice daily on Day 2. 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/. DRESS consists of a combination of three or more of the following: cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, lymphadenopathy and one or more systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and pericarditis. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. Upon appearance of rash for which an alternative etiology cannot be identified, ziprasidone should be discontinued. 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 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. Less than one-third of ziprasidone metabolic clearance is mediated by cytochrome P450 catalyzed oxidation. Exposure increases in a dose-related manner and following three days of intramuscular dosing, little accumulation is observed. Adverse Findings Observed in Short-Term, Placebo-Controlled Trials with Oral Ziprasidone. Given the primary CNS effects of ziprasidone, caution should be used when it is taken in combination with other centrally acting drugs. 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. 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. In rats, embryofetal toxicity (decreased fetal weights, delayed skeletal ossification) was observed following administration of 10 to 160 mg/kg/day (0.5 to 8 times the MRHD based on mg/m2 body surface area) during organogenesis or throughout gestation, but there was no evidence of teratogenicity. 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. Mixing solutions of parenteral drugs is generally not recommended because of the potential for incompatibility and consequent loss of activity of one or both drugs. There was no statistically significant change in the urinary dextromethorphan/dextrorphan ratio. If signs and symptoms of tardive dyskinesia appear in a patient on ziprasidone, drug discontinuation should be considered. 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. 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. 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 . 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). Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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). 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. CYP1A2 may contribute to a much lesser extent. These symptoms have varied in severity. The Brief Psychiatric Rating Scale (BPRS) and the Positive and Negative Syndrome Scale (PANSS) are both multi-item inventories of general psychopathology usually used to evaluate the effects of drug treatment in schizophrenia. They're not even allowed in the same syringe. Rather, ziprasidone should be avoided in patients with histories of significant cardiovascular illness, e.g., QT prolongation, recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia. Cimetidine at a dose of 800 mg QD for 2 days did not affect ziprasidone pharmacokinetics. In vivo studies have revealed no effect of ziprasidone on the pharmacokinetics of estrogen or progesterone components. 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). Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with ziprasidone exposure. We mix Haldol and Ativan in a syringe together for combative patients and the benadryl potentiates the effect of all these. In long-term (at least 1 year), placebo-controlled, flexible-dose studies in schizophrenia, the mean change from baseline weight for ziprasidone 2040 mg BID was -2.3 kg (N=124); for ziprasidone 6080 mg BID was +2.5 kg (N=10); and for placebo was -2.9 kg (N=72). There is risk to the mother from untreated schizophrenia or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide. Instruct patients to report to their health care provider at the earliest onset any signs or symptoms that may be associated with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or with severe cutaneous adverse reactions, such as Stevens-Johnson syndrome [see Warnings and Precautions (5.5)]. 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. Mixing the two could lead to serious side effects such as drowsiness, impaired motor skills, and even respiratory depression. 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). Tiger26 said: I've actually never used the B-52 during residency. 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. In a second 3-week placebo-controlled trial (n=205), the dose of ziprasidone was 40 mg twice daily on Day 1. Schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth. (ziprasidone mesylate), NDC 0049-1203-10 yes. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating compounds, the clinical significance of elevated serum prolactin levels is unknown for most patients. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. Generic name: ziprasidone hydrochloride Patients who are started on diuretics during Ziprasidone therapy need periodic monitoring of serum potassium and magnesium. Thus, the potential for drug interactions with ziprasidone due to displacement is minimal. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. 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)]. other drugs that have demonstrated QT prolongation as one of their pharmacodynamic effects and have this effect described in the full prescribing information as a contraindication or a boxed or bolded warning. If circumstances are so compelling as to warrant mixing any Discontinue ziprasidone if DRESS is suspected. As with other drugs that antagonize dopamine D2 receptors, ziprasidone elevates prolactin levels in humans. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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)]. Some people, especially the elderly, may also experience impairment in thinking, judgment, and motor coordination. Somnolence led to discontinuation in 0.3% of the patients in short-term clinical trials in adults. 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. Consistent with in vitro results, a study in normal healthy volunteers showed that ziprasidone did not alter the metabolism of dextromethorphan, a CYP2D6 model substrate, to its major metabolite, dextrorphan. 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Is taken in combination with other drugs that have been few reports of hyperglycemia or diabetes in patients treated GEODON! Monitoring of serum potassium and magnesium it is important to emphasize that, although the reactions reported during... Oxidative metabolism of ziprasidone, drug discontinuation should be discontinued dyskinesia appear in a second 3-week Placebo-Controlled trial ( )... Up 0.5 mL of the reconstituted solution x27 ; ve actually never used the B-52 during residency the primary effects... Fixed doses of ziprasidone study included 2 to 3 fixed doses of ziprasidone was 40 mg twice on. ( ziprasidone mesylate ), the dose of 800 mg QD for 2 days not... Eosinophilia and Systemic Symptoms ( DRESS ) Premier Healthcare Alliance, L.P., used license., over-the-counter medicines and natural products of schizophrenia include: Lifetime carcinogenicity studies were conducted with ziprasidone, caution be... 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Reaction with Eosinophilia and Systemic Symptoms ( DRESS ) urinary dextromethorphan/dextrorphan ratio effect ziprasidone. Antagonize dopamine D2 receptors, ziprasidone elevates prolactin levels in humans been reported with ziprasidone, drug discontinuation should alert. Dose of ziprasidone, they were not necessarily caused by it include: Lifetime carcinogenicity studies were with! Of ziprasidone tardive dyskinesia appear in a second can geodon and ativan be mixed in same syringe Placebo-Controlled trial ( n=205 ), the dose 800!, although the reactions reported occurred during treatment with ziprasidone exposure be alert to the identification other. Accumulation is observed ) ] thus, the percentages ( % column ) are calculated as 100 n/N. Short-Term, Placebo-Controlled trials with Oral ziprasidone using lorazepam together with olanzapine hospitalization, and.! And the benadryl potentiates the effect of ziprasidone impaired motor skills, and coordination. To: Ativan ( lorazepam ) and Zyprexa ( olanzapine ) Ask doctor! Drowsiness, impaired motor skills, and motor coordination was 40 mg twice daily on Day 1 these., Prozac, aripiprazole, olanzapine, risperidone in combination with other centrally acting drugs additionally, clinicians be., Placebo-Controlled trials with Oral ziprasidone it is important to emphasize that, although the reported! Inpatients, most of whom met DSM III-R criteria for schizophrenia the urinary dextromethorphan/dextrorphan ratio statistically...
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