Upon appearance of rash for which an alternative etiology cannot be identified, ziprasidone should be discontinued. Midazolam or lorazepam are the most studied . Acute Treatment of Manic or Mixed Episodes in Adults, Adverse Reactions Associated with Discontinuation of Treatment in Short Term, Placebo-Controlled Trials. 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). Each study included 2 to 3 fixed doses of ziprasidone as well as placebo. 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)]. 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. 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. To administer a 20 mg dose, draw up 1.0 mL of the reconstituted solution. Can you mix Tylenol with lorazepam? 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). 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)]. 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. Patients with low serum potassium and/or magnesium should be repleted with those electrolytes before proceeding with treatment. The risks of using ziprasidone in combination with other drugs have been evaluated as described below. Available for Android and iOS devices. In the double-blind randomization period, 127 subjects were treated with ziprasidone, and 112 subjects were treated with placebo. Geodon and Benadryl can interact with each other, which can cause serious side effects. Although there are no reports of adverse effects on a breastfed infant exposed to ziprasidone via breast milk, there are reports of excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements) in infants exposed to other atypical antipsychotics through breast milk (see Clinical Considerations). Patients with neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. 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. The mean increase in QTc from baseline for haloperidol was 6.0 msec following the first injection and 14.7 msec following the second injection. Disease-associated maternal and/or embryo/fetal risk. Hypokalemia (and/or hypomagnesemia) may increase the risk of QT prolongation and arrhythmia. 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). 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. Ziprasidone was significantly more effective than placebo in reduction of the MRS total score and the CGI-S score. Ziprasidone and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia. Rare adverse reactions occurring in fewer than 1/1000 patients (<0.1% of patients). Protect from light. 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)]. 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. Intramuscular ziprasidone has not been systematically evaluated in elderly patients or in patients with hepatic or renal impairment. 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. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density. 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). Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with GEODON. All interactions studies have been conducted with oral ziprasidone. Proliferative changes in the pituitary and mammary glands of rodents have been observed following chronic administration of other antipsychotic agents and are considered to be prolactin-mediated. In addition, instruct patients to report symptoms such as dizziness, palpitations, or syncope to the prescriber [see Warnings and Precautions (5.3)]. In vivo studies have revealed no effect of ziprasidone on the pharmacokinetics of estrogen or progesterone components. 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. futurepsychrn, ADN 188 Posts Specializes in Pschiatry. Unchanged ziprasidone represents about 44% of total drug-related material in serum. PREMIERProRx is a registered trademark of Premier Healthcare Alliance, L.P., used under license. 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. This product's label may have been updated. 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. Following reconstitution, GEODON for Injection can be stored, when protected from light, for up to 24 hours at 15C to 30C (59F to 86F) or up to 7 days refrigerated, 2C to 8C (36F to 46F). 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. 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. 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. Steady-state concentrations are achieved within one to three days of dosing. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. Ziprasidone dosed adjunctively to valproate in a maintenance trial of bipolar patients did not affect mean therapeutic valproate levels. 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. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology. Syncope was reported in 0.6% of the patients treated with ziprasidone. Cimetidine at a dose of 800 mg QD for 2 days did not affect ziprasidone pharmacokinetics. A total of 584 subjects were treated in the open-label stabilization period. Some people, especially the elderly, may also experience impairment in thinking, judgment, and motor coordination. There is little potential for drug interactions with ziprasidone due to displacement [see Clinical Pharmacology (12.3)]. Elimination of ziprasidone is mainly via hepatic metabolism with a mean terminal half-life of about 7 hours within the proposed clinical dose range. There were insufficient data to examine population subsets based on age and race. Depressive, manic, and mixed episodes accounted for 53%, 34%, and 13%, respectively, of the total number of relapse events in the study. In long-term (at least 1 year), placebo-controlled, flexible-dose studies in schizophrenia, the mean change from baseline in random glucose for ziprasidone 2040 mg BID was -3.4 mg/dL (N=122); for ziprasidone 6080 mg BID was +1.3 mg/dL (N=10); and for placebo was +0.3 mg/dL (N=71). While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile. . Ziprasidone was tested in the Ames bacterial mutation assay, the in vitro mammalian cell gene mutation mouse lymphoma assay, the in vitro chromosomal aberration assay in human lymphocytes, and the in vivo chromosomal aberration assay in mouse bone marrow. 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 most common reaction associated with dropout was rash, including 7 dropouts for rash among ziprasidone patients (1%) compared to no placebo patients [see Warnings and Precautions (5.8)]. ATIVAN Injection must be diluted with an equal volume of compatible solution. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. 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. Only the 100 mg twice daily dose group was superior to placebo on the PANSS negative subscale score. There is no information on the effects of ziprasidone on milk production. These symptoms have varied in severity. 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). 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%). Low serum potassium and magnesium should be replaced before proceeding with treatment. Therefore, ziprasidone should not be given with: Ziprasidone is contraindicated in individuals with a known hypersensitivity to the product. COMPATIBILITY OF DRUGS COMBINED IN A SYRINGE. Some drugs that prolong the QT/QTc interval have been associated with the occurrence of torsade de pointes and with sudden unexplained 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. 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). This medicinal product must not be mixed with other medicinal products or solvents other than Sterile Water for Injection. In premarketing trials involving more than 5400 patients and/or normal subjects, accidental or intentional overdosage of oral ziprasidone was documented in 10 patients. dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol or tacrolimus. Ziprasidone injection requires reconstitution prior to administration. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Severe priapism may require surgical intervention. One patient had a history of prolonged QTc and a screening measurement of 489 msec; QTc was 503 msec during ziprasidone treatment. This higher dose group was not superior to placebo on the BPRS psychosis cluster or on the SANS. Pooled data from short-term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 14. 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. Severe cutaneous adverse reactions are sometimes fatal. Tiger26 said: I've actually never used the B-52 during residency. A no-effect level was not established for these effects. 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. Positive results were obtained in both the in vitro mammalian cell gene mutation assay and the in vitro chromosomal aberration assay in human lymphocytes. Two meds that are Y site compatible may not necessarily be compatible mixed in an IM syringe. 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. Can you mix geodon and lorazepam in the same syringe? 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)]. If signs and symptoms of tardive dyskinesia appear in a patient on ziprasidone, drug discontinuation should be considered. 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. 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. When taking any two medications, consider this in addition to the fact that they have different mechanisms of action. And for two, Benadryl never gets mixed with Haldol in the same syringe: precipitate forms in about 5 minutes. 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. 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. 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. In vitro studies using human liver subcellular fractions indicate that S-methyldihydroziprasidone is generated in two steps. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. During clinical trials, seizures occurred in 0.4% of patients treated with ziprasidone. Absorption: Ziprasidone is well absorbed after oral administration, reaching peak plasma concentrations in 6 to 8 hours. Mar 27, 2013. Dopamine Epinephrine (Adrenalin) Esmolol (Brevibloc) Furosemide (Lasix) Heparin Insulin (regular) Lidocaine (Xylocaine) Lorazepam (Ativan) Magnesium . The empirical formula of C21H21ClN4OS (free base of ziprasidone) represents the following structural formula: GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. The possibility of obtundation, seizure, or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis. 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. 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. 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. The mean daily dose of ziprasidone in this study was 112 mg. Yes, you can mix both in the same syringe Can you mix xanax and Ativan? 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. 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. Other inhibitors of CYP3A4 would be expected to have similar effects. There was a reproducible mutagenic response in the Ames assay in one strain of S. typhimurium in the absence of metabolic activation. Medically reviewed by Drugs.com. Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final solution. This effect may be greater when higher doses of carbamazepine are administered. 2) Undifferentiated but routine drunk agitation: 5-10 mg Versed, also . 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. Each mL of reconstituted solution contains 20 mg ziprasidone. The mean increase in QTc from baseline for ziprasidone was 4.6 msec following the first injection and 12.8 msec following the second injection. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. 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. Adverse Findings Observed in Short-Term, Placebo-Controlled Trials with Oral Ziprasidone. The diagnostic evaluation of patients with this syndrome is complicated. 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. Ziprasidone has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence. Complications may result. A half-life of 7.1 hours was observed in subjects with cirrhosis compared to 4.8 hours in the control group. Adverse reactions are further categorized by body system and listed in order of decreasing frequency according to the following definitions: Frequent - adverse reactions occurring in at least 1/100 patients (1.0% of patients) (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); Infrequent - adverse reactions occurring in 1/100 to 1/1000 patients (in 0.11.0% of patients). Hsrf|/pfb/@?ShA@ Xq5 9
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