No appreciable affinity was exhibited for other receptor/binding sites tested, including the cholinergic muscarinic receptor (IC 50 >1 M). Last updated on Feb 1, 2022. have had any problem with the way your heart beats or any heart related illness or disease, any family history of heart disease, including recent heart attack, have had any problem with fainting or dizziness, are taking or have recently taken any prescription medicines, are taking any over-the-counter medicines you can buy without a prescription, including natural/herbal remedies, are pregnant, might be pregnant, or plan to get pregnant, have ever had an allergic reaction to Ziprasidone or any of the other ingredients of Ziprasidone capsules. Clinical trials in adults for oral Ziprasidone included approximately 5,700 patients and/or normal subjects exposed to one or more doses of Ziprasidone. In a 4-week, placebo-controlled trial (n=200) comparing 3 fixed doses of Ziprasidone (5 mg, 20 mg, and 40 mg twice daily), none of the dose groups was statistically superior to placebo on any outcome of interest. Little has been published regarding the pharmacokinetics of the intramuscular (IM) formulation of Ziprasidone. 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. Ziprasidone binds with relatively high affinity to the dopamine D 2 and D 3, serotonin 5HT 2A, 5HT 2C, 5HT 1A, 5HT 1D, and 1-adrenergic receptors (Ki s of 4.8, 7.2, 0.4, 1.3, 3.4, 2, and 10 nM, respectively), and with moderate affinity to the histamine H 1 receptor (K i=47 nM). 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. Of these 5,700, over 4,800 were patients who participated in multiple-dose effectiveness trials, and their experience corresponded to approximately 1,831 patient-years. These symptoms have varied in severity. Ziprasidone, sold under the brand name Geodon among others, is an atypical antipsychotic used to treat schizophrenia and bipolar disorder. Additionally, clinicians should be alert to the identification of other drugs that have been consistently observed to prolong the QTc interval. 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/m 2 body surface area). Prescribing Information. *"Random" glucose measurementsfasting/non-fasting status unknown, *"Random" glucose measurements fasting/non-fasting status unknown. US Brand Name. On This Page Boxed Warning Indications and Usage Dosage and Administration Dosage Forms and Strengths Contraindications Last updated on May 1, 2023. Certain circumstances may increase the risk of the occurrence of torsade de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including (1) bradycardia; (2) hypokalemia or hypomagnesemia; (3) concomitant use of other drugs that prolong the QTc interval; and (4) presence of congenital prolongation of the QT interval. Limited data from a published case report indicate the presence of Ziprasidone in human milk. There were trends toward dose response within the range of 20 mg to 80 mg twice daily, but results were not consistent. All reported reactions are included except those already listed in Table 11 or elsewhere in labeling, those reaction terms that were so general as to be uninformative, reactions reported only once and that did not have a substantial probability of being acutely life-threatening, reactions that are part of the illness being treated or are otherwise common as background reactions, and reactions considered unlikely to be drug-related. Disease-associated maternal and/or embryo/fetal risk. Delayed-onset drug reaction called drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with Ziprasidone. 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. Thus, the potential for drug interactions with Ziprasidone due to displacement is minimal. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Prescribing Information. The types of relapse events observed included depressive, manic, and mixed episodes. However, due to Viatris Specialty LLC's marketing exclusivity rights, this drug product is not labeled with that information. Ziprasidone capsules is a prescription medicine and only your doctor can decide if it is right for you. Ziprasidone capsules can also be used as maintenance treatment of bipolar disorder when added to lithium or valproate. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older. 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. High prolactin levelunexpected breast tissue growth, discharge from the nipple, change in sex drive or performance, irregular menstrual cycle. MISOPROSTOL DELAYED-RELEASE TABLETS, FOR ORAL USE. The patient should be carefully monitored, since recurrences of NMS have been reported. Geodon (ziprasidone) is a prescription medication used to treat schizophrenia and bipolar disorder. The effi cacy of oral ziprasidone was established in four short-term (4- and 6-week) controlled trials What is the most important safety information I should know about Ziprasidone capsules? Therefore, it is important to tell your doctor about any other medicines that you take, including non-prescription medicines, supplements, and herbal medicines. Ziprasidone capsules are not approved for the treatment of these patients. In order to ensure use of the lowest effective dose, patients should ordinarily be observed for improvement for several weeks before upward dosage adjustment. Less than one-third of Ziprasidone metabolic clearance is mediated by cytochrome P450 catalyzed oxidation. It is important to emphasize that, although the reactions reported occurred during treatment with Ziprasidone, they were not necessarily caused by it. 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 Ziprasidone at the first sign of decline in WBC in the absence of other causative factors. 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) . Additional signs may include elevated creatinine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Interpretation of these findings should take into consideration that only patients who adequately tolerated Ziprasidone entered the double-blind phase of the study, and there were substantial dropouts during the open label phase. Other inhibitors of CYP3A4 would be expected to have similar effects. The conditions and duration of treatment with Ziprasidone included open-label and double-blind studies, inpatient and outpatient studies, and short-term and longer-term exposure. Written by Cerner Multum. In the tables showing categorical changes, the percentages (% column) are calculated as 100x(n/N). The empirical formula is C 21H 21ClN 4OS HCl H 2O and its molecular weight is 467.42. None of these adverse reactions occurred individually at an incidence greater than 10% in bipolar mania trials. For the most recent prescribing information, please visit www. Close medical supervision and monitoring should continue until the patient recovers. Patients with these diagnoses were excluded from premarketing clinical studies. Add 1.2 mL of Sterile Water for Injection to the vial and shake vigorously until all the drug is dissolved. ECG Changes - Ziprasidone is associated with an increase in the QTc interval [see Warnings and Precautions ( 5.3)] . None of these adverse reactions occurred individually at an incidence greater than 5% in schizophrenia trials. No additional benefit was demonstrated for doses above 20 mg twice daily. In a 6-week, placebo-controlled trial (n=302) comparing 2 fixed doses of Ziprasidone (40 mg 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. Advise patients that Ziprasidone may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. There was no effect on fertility at 40 mg/kg/day (2 times the MRHD based on mg/m 2 body surface area). Since medications of the same drug class as Ziprasidone capsules may interfere with the ability of the body to adjust to heat, it is best to avoid situations involving high temperature or humidity. Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology. All trials were in adult inpatients, most of whom met DSM III-R criteria for schizophrenia. 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 . 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. Medication Guide. 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/m 2 body surface area). Ziprasidone is primarily cleared via three metabolic routes to yield four major circulating metabolites, benzisothiazole (BITP) sulphoxide, BITP-sulphone, Ziprasidone sulphoxide, and S-methyldihydroZiprasidone. 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. A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients undergoing treatment with antipsychotic drugs. 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. This effect may be greater when higher doses of carbamazepine are administered. 1 INDICATIONS AND USAGE Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. Adverse Findings Observed in Short-Term, Placebo-Controlled Trials with Oral Ziprasidone. It may be used by mouth and by injection into a muscle (IM). Geodon is available as a lower-cost generic. 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. In the double-blind randomization period, 127 subjects were treated with Ziprasidone, and 112 subjects were treated with placebo. Ziprasidone may antagonize the effects of levodopa and dopamine agonists. Ziprasidone inhibited synaptic reuptake of serotonin and norepinephrine. Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Ziprasidone works by changing some of the chemicals in the brain that cause psychotic disorders. Ziprasidone capsules has not been shown to be safe or effective in the treatment of children and teenagers under the age of 18 years old. 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. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In long-term (at least 1 year), placebo-controlled, flexible-dose studies in schizophrenia, the mean change from baseline in random triglycerides for Ziprasidone 20 to 40 mg BID was +26.3 mg/dL (N=15); for Ziprasidone 60 to 80 mg BID was -39.3 mg/dL (N=10); and for placebo was +12.9 mg/dL (N=9). Precise risk estimates for hyperglycemia-related adverse reactions in patients treated with atypical antipsychotics are not available. Four of the 5 trials were able to distinguish Ziprasidone from placebo; one short-term study did not. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Ziprasidone and any potential adverse effects on the breastfed child from Ziprasidone or from the mother's underlying condition. 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)]. chartwellpharma.com. Table 11 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy (up to 6 weeks) in predominantly patients with schizophrenia, 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. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized during the stabilization phase. Therefore, tell your doctor if you experience any of these signs. 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) . There was a reproducible mutagenic response in the Ames assay in one strain of S. typhimurium in the absence of metabolic activation. Normal to High (<100 mg/dL to 126 mg/dL), Borderline to High (100 mg/dL and <126 mg/dL to 126 mg/dL), Normal to High (<150 mg/dL to 200 mg/dL), Borderline to High (150 mg/dL and <200 mg/dL to 200 mg/dL), Normal to High (<200 mg/dL to 240 mg/dL), Borderline to High (200 mg/dL and <240 mg/dL to 240 mg/dL), Normal to High (<100 mg/dL to 160 mg/dL), Borderline to High (100 mg/dL and <160 mg/dL to 160 mg/dL), Ziprasidone is indicated for the treatment of schizophrenia in adults, Ziprasidone is indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder, Ziprasidone is indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults, in patients with a known history of QT prolongation (including congenital long QT syndrome), in patients with recent acute myocardial infarction, in patients with uncompensated heart failure. Talk to your healthcare provider about the best way to feed your baby if you receive Ziprasidone capsules. 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. 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). In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The effects on fertility are reversible [see Warnings and Precautions ( 5.15) and Use in Specific Populations ( 8.3)] . In the first phase of the trial, ECGs were obtained at the time of maximum plasma concentration when the drug was administered alone. Ziprasidone capsules should be administered at an initial daily dose of 20 mg twice daily with food. 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. The possibility of obtundation, seizure, or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis. fruity breath odor, very stiff (rigid) muscles, high fever, sweating , confusion, and. Ziprasidone is a prescription medication used to treat schizophrenia and bipolar disorder. If you become pregnant while receiving Ziprasidone capsules, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids. If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine carry a theoretical hazard of additive QT-prolonging effects that might be additive to those of Ziprasidone. Population pharmacokinetic analysis of schizophrenic patients enrolled in controlled clinical trials has not revealed evidence of any clinically significant pharmacokinetic interactions with benztropine, propranolol, or lorazepam. 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. 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)] . Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization. It is also important to remember that Ziprasidone capsules should be taken with food. Offspring developmental delays (decreased pup weights) and neurobehavioral functional impairment (eye opening air righting) were observed at doses of 5 mg/kg/day (0.2 times the MRHD based on mg/m 2 body surface area) or greater. Single-dose vials require reconstitution prior to administration. ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether -cyclodextrin sodium (SBECD). 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. It is particularly important to tell your doctor if you have diarrhea, vomiting, or another illness that can cause you to lose fluids. Antipsychotic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome, and thereby may possibly mask the underlying process. Syncope was reported in 0.6% of the patients treated with Ziprasidone. Advise the patient to read the FDA-approved patient labeling (Patient Information). Before you start Ziprasidone capsules, be sure to tell your doctor if you: Your doctor may want you to get additional laboratory tests to see if Ziprasidone capsules is an appropriate treatment for you. Dystonia - Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Hypokalemia may result from diuretic therapy, diarrhea, and other causes. Primary rating instruments used for assessing manic symptoms in these trials were: (1) the Mania Rating Scale (MRS), which is derived from the Schedule for Affective Disorders and Schizophrenia-Change Version (SADS-CB) with items grouped as the Manic Syndrome subscale (elevated mood, less need for sleep, excessive energy, excessive activity, grandiosity), the Behavior and Ideation subscale (irritability, motor hyperactivity, accelerated speech, racing thoughts, poor judgment) and impaired insight; and (2) the Clinical Global Impression-Severity of Illness Scale (CGI-S), which was used to assess the clinical significance of treatment response. Ziprasidone dosed adjunctively to lithium in a maintenance trial of bipolar patients did not affect mean therapeutic lithium levels. The mechanism of action of Ziprasidone in the treatment of the listed indications could be mediated through a combination of dopamine type 2 (D 2) and serotonin type 2 (5HT 2) antagonism. 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