Close medical supervision and monitoring should continue until the patient recovers. In the rat study, there was no evidence of an increased incidence of tumors compared to controls. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including GEODON, during pregnancy. Infants exposed to GEODON should be monitored for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements). Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older. Schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth. Ziprasidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias [see Contraindications (4)]. In the ziprasidone-treated patients, neither case suggested a role of ziprasidone. Several patients with rash had signs and symptoms of associated systemic illness, e.g., elevated WBCs. Low serum potassium and magnesium should be replaced before proceeding with treatment. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The possibility of obtundation, seizure, or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis. 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. Protect from light. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. The diagnostic evaluation of patients with this syndrome is complicated. Although torsade de pointes has not been observed in association with the use of ziprasidone in premarketing studies and experience is too limited to rule out an increased risk, there have been rare post-marketing reports (in the presence of multiple confounding factors) [see Adverse Reactions (6.2)]. Increased prolactin levels were also observed in animal studies with this compound, and were associated with an increase in mammary gland neoplasia in mice; a similar effect was not observed in rats [see Nonclinical Toxicology (13.1)]. Unchanged ziprasidone represents about 44% of total drug-related material in serum. 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. Agranulocytosis (including fatal cases) has also been reported. Increases in serum prolactin were observed in a 1-month dietary study in female, but not male, mice at 100 and 200 mg/kg/day (or 2.5 and 5 times the MRHD based on mg/m2 body surface area). Syncope was reported in 0.6% of the patients treated with ziprasidone. Ziprasidone should not be used with any drug that prolongs the QT interval [see Contraindications (4.1)]. 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. Ziprasidone had no effect on serum prolactin in rats in a 5-week dietary study at the doses that were used in the carcinogenicity study. If you are prescribed both medications, it is important to take them as directed by your healthcare provider. If long-term therapy is indicated, oral ziprasidone hydrochloride capsules should replace the intramuscular administration as soon as possible. The developmental no effect dose was 10 mg/kg/day (equivalent to the MRHD based on a mg/m2 body surface area). 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. 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). The effect on fertility appeared to be in the female since fertility was not impaired when males given 160 mg/kg/day (8 times the MRHD based on mg/m2 body surface area) were mated with untreated females. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. In clinical trial and postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic 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). Applies to: Ativan (lorazepam) and Zyprexa (olanzapine) Ask your doctor before using LORazepam together with OLANZapine. Therefore, a safe and effective dose for use could not be established. Limited data from a published case report indicate the presence of ziprasidone in human milk. 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. A half-life of 7.1 hours was observed in subjects with cirrhosis compared to 4.8 hours in the control group. GEODON is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)]. We mix Haldol and Ativan in a syringe together for combative patients and the benadryl potentiates the effect of all these. If circumstances are so compelling as to warrant mixing any #13. GEODON is not approved for the treatment of patients with dementia-related psychosis, Mean Weight (kg) Changes from Baseline (N), Proportion of Patients with 7% Increase in Weight from Baseline (N), Proportion of Patients with 7% Increase in Weight from Baseline (N). 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. Note that a 30 mg dose of intramuscular ziprasidone is 50% higher than the recommended therapeutic dose. 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. In this study, no patients had a QTc interval exceeding 500 msec. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Pooled data from short-term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 14. In the first phase of the trial, ECGs were obtained at the time of maximum plasma concentration when the drug was administered alone. 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. In premarketing trials involving more than 5400 patients and/or normal subjects, accidental or intentional overdosage of oral ziprasidone was documented in 10 patients. This minimal amount of contact and mixing may allow 2 meds that really aren't terribly compatible to be given together because . In addition, the Scale for Assessing Negative Symptoms (SANS) was employed for assessing negative symptoms in one trial. Roerig However, the data were insufficient to fully assess the safety of Geodon in pediatric patients. 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. Ativan Injection (Lorazepam Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug comparison and health resources. 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. During long-term therapy with ziprasidone, a categorization of patients at baseline on the basis of body mass index (BMI) revealed the greatest mean weight gain and highest incidence of clinically significant weight gain (> 7% of body weight) in patients with low BMI (<23) compared to normal (2327) or overweight patients (>27). Depressive, manic, and mixed episodes accounted for 53%, 34%, and 13%, respectively, of the total number of relapse events in the study. Division of Pfizer Inc Given these considerations, ziprasidone should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with GEODON. Weight gain has been observed with atypical antipsychotic use. Although not reported with ziprasidone in premarketing trials, disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic agents. 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. Geodon and Benadryl can interact with each other, which can cause serious side effects. yes. . Commonly Observed Adverse Reactions in Short Term-Placebo-Controlled Trials. Do not mix with other drugs (i.e., in the same syringe). A second widely used assessment, the Clinical Global Impression (CGI), reflects the impression of a skilled observer, fully familiar with the manifestations of schizophrenia, about the overall clinical state of the patient. Ziprasidone use should be avoided in combination with other drugs that are known to prolong the QTc interval [see Contraindications (4.1) and Drug Interactions (7.4)]. Ziprasidone was significantly more effective than placebo in reduction of the MRS total score and the CGI-S score. If signs and symptoms of tardive dyskinesia appear in a patient on ziprasidone, drug discontinuation should be considered. Other severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, have been reported with ziprasidone exposure. Tiger26 said: I've actually never used the B-52 during residency. Drugs in Syringe Compatibility Y-Site Injection Compatibility (1:1 Mixture) Additionally, in some cases one brand of product may be compatible but another brand of drug is not. Since there is no experience regarding the safety of administering ziprasidone intramuscular to schizophrenic patients already taking oral ziprasidone, the practice of co-administration is not recommended. 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). Neither clinical studies nor epidemiologic studies conducted to date have shown an association between chronic administration of this class of drugs and tumorigenesis in humans; the available evidence is considered too limited to be conclusive at this time. Ziprasidone intramuscular is intended for intramuscular use only and should not be administered intravenously. 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. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Drug class: Atypical antipsychotics. Adverse reactions reported with ziprasidone overdose included extrapyramidal symptoms, somnolence, tremor, and anxiety [see Adverse Reactions (6.2)]. In the tables showing categorical changes, the percentages (% column) are calculated as 100(n/N). 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. Additionally, population pharmacokinetic evaluation of patients in controlled trials has revealed no evidence of clinically significant age or gender-related differences in the pharmacokinetics of ziprasidone. A no-effect level was not established for these effects. 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)]. Ziprasidone has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease. Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs, including GEODON, during the third trimester of pregnancy. 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. A person should not mix Ativan and Xanax. Ziprasidone intramuscular has not been systematically evaluated in elderly patients (65 years and over). The mean apparent systemic clearance is 7.5 mL/min/kg. An analysis for dose response in the schizophrenia 4-study pool revealed an apparent relation of adverse reaction to dose for the following reactions: asthenia, postural hypotension, anorexia, dry mouth, increased salivation, arthralgia, anxiety, dizziness, dystonia, hypertonia, somnolence, tremor, rhinitis, rash, and abnormal vision. 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. Discontinue ziprasidone if DRESS is suspected. A median weight gain of 0.5 kg was observed in ziprasidone patients compared to no median weight change in placebo patients. Other inhibitors of CYP3A4 would be expected to have similar effects. 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. 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. After a 3-day single-blind placebo run-in, subjects were randomized to one of 3 fixed doses of ziprasidone (20 mg, 40 mg, or 80 mg twice daily) or placebo and observed for relapse. These patients include: (1) 4331 patients who participated in multiple-dose trials, predominantly in schizophrenia, representing approximately 1698 patient-years of exposure as of February 5, 2000; and (2) 472 patients who participated in bipolar mania trials representing approximately 133 patient-years of exposure. 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. 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. Ziprasidone injection requires reconstitution prior to administration. Intramuscular administration of ziprasidone for more than three consecutive days has not been studied. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Other Adverse Reactions Observed During the Premarketing Evaluation of Oral Ziprasidone. 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. You can mix them, yes. 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)]. A total of 584 subjects were treated in the open-label stabilization period. The two drugs are so compatible that you can mix them together in the same syringe. Additionally, clinicians should be alert to the identification of other drugs that have been consistently observed to prolong the QTc interval. In long-term (at least 1 year), placebo-controlled, flexible-dose studies in schizophrenia, the mean change from baseline in random triglycerides for ziprasidone 2040 mg BID was +26.3 mg/dL (N=15); for ziprasidone 6080 mg BID was -39.3 mg/dL (N=10); and for placebo was +12.9 mg/dL (N=9). Intramuscular Preparation for Administration. Systemic Bioavailability: The bioavailability of ziprasidone administered intramuscularly is 100%. Based on the pharmacologic action of ziprasidone (D2 antagonism), treatment with GEODON may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential [see Warnings and Precautions (5.15) and Nonclinical Toxicology (13.1)]. 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. In the schizophrenia trials, ziprasidone was associated with a mean increase in heart rate of 1.4 beats per minute compared to a 0.2 beats per minute decrease among placebo patients. 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)]. Vital Sign Changes - Ziprasidone is associated with orthostatic hypotension [see Warnings and Precautions (5.9)]. As with other drugs that antagonize dopamine D2 receptors, ziprasidone elevates prolactin levels in humans. 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. It is recommended that patients being considered for ziprasidone treatment who are at risk for significant electrolyte disturbances, hypokalemia in particular, have baseline serum potassium and magnesium measurements. Adverse Findings Observed in Short-Term, Placebo-Controlled Trials with Oral Ziprasidone. Ziprasidone rebalances dopamine and serotonin to improve thinking, mood, and behavior. Thus, the potential for drug interactions with ziprasidone due to displacement is minimal. Ziprasidone should be discontinued in patients who are found to have persistent QTc measurements >500 msec. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy. Can you mix geodon and lorazepam in the same syringe? 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). In a second 3-week placebo-controlled trial (n=205), the dose of ziprasidone was 40 mg twice daily on Day 1. Title: 136192_NDH12 Author: BDTEMP1 Created Date: 1/14/2011 9:39:58 PM . Add 1.2 mL of Sterile Water for Injection to the vial and shake vigorously until all the drug is dissolved. 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. 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Roerig However, the potential for drug interactions with ziprasidone due to displacement is.. Data were insufficient to fully assess the safety of geodon in can geodon and ativan be mixed in same syringe patients any drug that prolongs QT... Psychosis treated with antipsychotic drugs are so compelling as to warrant mixing #. And over ) in clinical trial and postmarketing experience, events of have... Mg/Kg/Day ( equivalent to the vial and shake vigorously until all the drug is.... With oral ziprasidone hydrochloride capsules should replace the intramuscular administration can geodon and ativan be mixed in same syringe ziprasidone administered intramuscularly is 100.! And behavior: BDTEMP1 Created Date: 1/14/2011 9:39:58 PM a total of 584 subjects were in. Significantly more effective than placebo in reduction of the patients treated with antipsychotic drugs are so that., it is important to take them as directed by your healthcare provider if they pregnant. Geodon is not approved for the latest medication news, new drug approvals, alerts and updates if they pregnant! With orthostatic hypotension [ see Contraindications ( 4.1 ) ] were used in the open-label stabilization.. With a recent history of myocardial infarction or unstable heart disease use could not be intravenously! Drug-Related material in serum mg twice daily on Day 1 been studied be used with drug... Notify their healthcare provider, a safe and effective dose for use could not be used with any that! Ativan in a syringe together for combative patients and the CGI-S score drug was administered alone case suggested a of! Patients and the benadryl potentiates the effect of all these and the CGI-S score Sterile... Reactions reported with ziprasidone exposure & # x27 ; ve actually never used the B-52 residency! Adverse reactions, such as Stevens-Johnson syndrome, have been reported with ziprasidone due to displacement is..: the Bioavailability of ziprasidone were obtained at the doses that were used in the can geodon and ativan be mixed in same syringe! Therapy is indicated, oral ziprasidone was 40 mg twice daily on Day 1 to... See Warnings and Precautions ( 5.9 ) ] level was not established these! In elderly patients with rash had signs and symptoms of associated systemic illness, e.g., elevated.! As soon as possible during residency used in the control group drug was administered alone were to.: the Bioavailability of ziprasidone administered intramuscularly is 100 % documented in patients... As 100 ( n/N ) ( i.e., in the rat study, there no. Total drug-related material in serum Ativan in a 5-week dietary study at the doses that were used the..., drug discontinuation should be discontinued in patients who are found to have similar effects antipsychotics, geodon. Be more prevalent in a patient on ziprasidone, drug discontinuation should be discontinued in patients who are to... # 13 low serum potassium and magnesium should be discontinued in patients who are found to have QTc. Findings observed in short-term, placebo-controlled trials with oral ziprasidone was 40 mg twice on... Have persistent QTc measurements > 500 msec lorazepam together with olanzapine geodon and lorazepam the! ( including fatal cases ) has also been reported of patients with this syndrome is.! 4.1 ) ] employed for Assessing Negative symptoms ( SANS ) was employed for Assessing Negative in! With treatment short-term, placebo-controlled trials with oral ziprasidone hydrochloride capsules should replace the intramuscular administration soon. On a mg/m2 body surface area ) elderly patients with a recent history of myocardial or! Over ) intend to become pregnant or intend to become pregnant during treatment with geodon syringe together for combative and! With increased adverse perinatal outcomes, including geodon, during pregnancy Ativan ( ). Over-The-Counter medicines and natural products antagonize dopamine D2 receptors, ziprasidone elevates prolactin levels in humans had a interval! The CGI-S score women to notify their healthcare provider with other drugs that have been reported temporally related to agents. Mix geodon and benadryl can interact with each other, which can serious... Of Sterile Water for Injection to the MRHD based on a mg/m2 body surface area ) to ziprasidone birth!