Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase. Mixing is best avoided. 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 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. 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. New York, NY 10017. These studies indicate that the reduction reaction is mediated primarily by chemical reduction by glutathione as well as by enzymatic reduction by aldehyde oxidase and the subsequent methylation is mediated by thiol methyltransferase. 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. Complications may result. If you must take both medications, it is recommended to do so at least an hour apart to avoid any . When taking any two medications, consider this in addition to the fact that they have different mechanisms of action. Several instruments were used for assessing psychiatric signs and symptoms in these studies. Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse reactions is not completely understood. It is also known as a second generation antipsychotic (SGA) or atypical antipsychotic. 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)]. Both studies compared higher doses of ziprasidone intramuscular with a 2 mg control dose. A person should not mix Ativan and Xanax. In case of acute overdosage, establish and maintain an airway and ensure adequate oxygenation and ventilation. In a 4-week, placebo-controlled trial (n=139) comparing 2 fixed doses of ziprasidone (20 and 60 mg twice daily) with placebo, only the 60 mg dose was superior to placebo on the BPRS total score and the CGI severity score. But the LSD will likely not do anything on account of Geodon's high affinity blockade of the 5HT2a receptor. Ziprasidone intramuscular is intended for intramuscular use only and should not be administered intravenously. 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. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. usually we use a benzo, such as ativan, once in a rare while inderal. The multiple-dose pharmacokinetics of ziprasidone are dose-proportional within the proposed clinical dose range, and ziprasidone accumulation is predictable with multiple dosing. for Injection Intramuscular administration of ziprasidone for more than three consecutive days has not been studied. An additive effect of ziprasidone and other drugs that prolong the QT interval cannot be excluded. A retrospective cohort study from a Medicaid database of 9258 women exposed to antipsychotics during pregnancy did not indicate an overall increased risk for major birth defects. 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%). 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. Infants exposed to GEODON should be monitored for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements). When meds are run together at a Y site, there is actually very little surface area of mixture between the two. Ziprasidone was significantly more effective than placebo in reduction of the MRS total score and the CGI-S score. The possibility of multiple drug involvement should be considered. If long-term therapy is indicated, oral ziprasidone hydrochloride capsules should replace the intramuscular administration as soon as possible. GEODON is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions (5.1)]. Ziprasidone (Geodon) agitation may occur; Lorazepam 0.05 mg/kg IV/IM/PO up to 2 mg per dose. Last updated on Mar 1, 2022. In vitro studies using human liver microsomes and recombinant enzymes indicate that CYP3A4 is the major CYP contributing to the oxidative metabolism of ziprasidone. Of the total number of subjects in clinical studies of ziprasidone, 2.4 percent were 65 and over. 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. Patients with these diagnoses were excluded from premarketing clinical studies. Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. #13. In male mice, there was no increase in incidence of tumors relative to controls. . Ziprasidone may antagonize the effects of levodopa and dopamine agonists. Antipsychotic drugs (which include GEODON) may cause somnolence, postural hypotension, and motor and sensory instability, which could lead to falls and, consequently, fractures or other injuries. Applies to: Thorazine (chlorpromazine) and Ativan (lorazepam) Using chlorproMAZINE together with LORazepam may increase side effects such as dizziness, drowsiness, confusion, and difficulty concentrating. Ziprasidone rebalances dopamine and serotonin to improve thinking, mood, and behavior. Ativan Injection (Lorazepam Injection) may treat, side effects, dosage, drug interactions, warnings, patient labeling, reviews, and related medications including drug comparison and health resources. 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. No appreciable affinity was exhibited for other receptor/binding sites tested, including the cholinergic muscarinic receptor (IC50 >1 M). 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. 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/. 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 If signs and symptoms of tardive dyskinesia appear in a patient on ziprasidone, drug discontinuation should be considered. futurepsychrn, ADN 188 Posts Specializes in Pschiatry. There was no effect on fertility at 40 mg/kg/day (2 times the MRHD based on mg/m2 body surface area). In clinical trials with oral ziprasidone, the electrocardiograms of 2/2988 (0.06%) patients who received GEODON and 1/440 (0.23%) patients who received placebo revealed QTc intervals exceeding the potentially clinically relevant threshold of 500 msec. There was a mean weight gain of 1.4 kg for those patients with a "low" baseline BMI, no mean change for patients with a "normal" BMI, and a 1.3 kg mean weight loss for patients who entered the program with a "high" BMI. Depressive, manic, and mixed episodes accounted for 53%, 34%, and 13%, respectively, of the total number of relapse events in the study. If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. A half-life of 7.1 hours was observed in subjects with cirrhosis compared to 4.8 hours in the control group. In vitro studies using human liver subcellular fractions indicate that S-methyldihydroziprasidone is generated in two steps. Common interactions include weight increased among females and dyspnoea among males. 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. The safety and effectiveness of Geodon have not been established in pediatric patients. A pharmacokinetic interaction of ziprasidone with valproate is unlikely due to the lack of common metabolic pathways for the two drugs. Evidence for the use of chemical sedation is limited to small trials of at most a few hundred patients. Ziprasidone should be discontinued in patients who are found to have persistent QTc measurements >500 msec [see Warnings and Precautions (5.3)]. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. While the clinical trials did not reveal any tendency for drug-seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which ziprasidone will be misused, diverted, and/or abused once marketed. In the trial, ECGs were obtained at the time of maximum plasma concentration following two injections of ziprasidone (20 mg then 30 mg) or haloperidol (7.5 mg then 10 mg) given four hours apart. 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. 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. Rare adverse reactions occurring in fewer than 1/1000 patients (<0.1% of patients). 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). Intramuscular Preparation for Administration. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. In a long-term (at least 1 year), placebo-controlled, fixed-dose study in schizophrenia, the mean change from baseline weight for ziprasidone 20 mg BID was -2.6 kg (N=72); for ziprasidone 40 mg BID was -3.3 kg (N=69); for ziprasidone 80 mg BID was -2.8 kg (N=70) and for placebo was -3.8 kg (N=70). If circumstances are so compelling as to warrant mixing any 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. and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). 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 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. Nevertheless, ziprasidone's larger prolongation of QTc length compared to several other antipsychotic drugs raises the possibility that the risk of sudden death may be greater for ziprasidone than for other available drugs for treating schizophrenia. Pooled data from short-term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 58. Ziprasidone should be discontinued in patients who are found to have persistent QTc measurements >500 msec. Midazolam or lorazepam are the most studied . Ziprasidone inhibited synaptic reuptake of serotonin and norepinephrine. Dosage modifications for age or gender are, therefore, not recommended. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Unchanged ziprasidone represents about 44% of total drug-related material in serum. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology. Table 13 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy with intramuscular ziprasidone in 1% or more of patients. Ziprasidone dosed adjunctively to lithium in a maintenance trial of bipolar patients did not affect mean therapeutic lithium levels. A median weight gain of 0.5 kg was observed in ziprasidone patients compared to no median weight change in placebo patients. 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. 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. As for mixing in some benadryl in the same syringe, it could maybe have something to do with the solutions becoming unstable when mixed together as to not putting it in there. In the rat study, there was no evidence of an increased incidence of tumors compared to controls. It is important to emphasize that, although the reactions reported occurred during treatment with ziprasidone, they were not necessarily caused by it. Standard Dosing: 1-2 IM/IV/PO every 6 hours prn; Agitated Delirium dose: 2.5 to 5 mg IV prn (up to 5-10 mg IV, with maximum of 20 mg. Droperidol 5 mg with Midazolam 2 mg mixed in same syringe (1.5. You can mix them, yes. 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)]. Such drugs should not be prescribed with ziprasidone. Drug class: Atypical antipsychotics. Several patients with rash had signs and symptoms of associated systemic illness, e.g., elevated WBCs. Acute Treatment of Manic or Mixed Episodes in Adults, Adverse Reactions Associated with Discontinuation of Treatment in Short Term, Placebo-Controlled Trials. The efficacy of oral ziprasidone in the treatment of schizophrenia was evaluated in 5 placebo-controlled studies, 4 short-term (4- and 6-week) trials and one maintenance trial. Applies to: Ativan (lorazepam) and Zyprexa (olanzapine) Ask your doctor before using LORazepam together with OLANZapine. 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. 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). 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. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. treatment of akathesia is pretty straight forward. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. 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. Ziprasidone at a dose of 20 mg twice daily did not affect the pharmacokinetics of concomitantly administered oral contraceptives, ethinyl estradiol (0.03 mg) and levonorgestrel (0.15 mg). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Cimetidine at a dose of 800 mg QD for 2 days did not affect ziprasidone pharmacokinetics.