Sacher J, Mossaheb N, Spindelegger C, et al. June 2008. 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. Ziprasidone is primarily cleared via three metabolic routes to yield four major circulating metabolites, benzisothiazole BITP sulphoxide, BITP-sulphone, Ziprasidone sulphoxide, and S-methyldihydroZiprasidone. Approximately 20% of the dose is excreted in the urine, with approximately 66% being eliminated in the feces. Unchanged Ziprasidone represents about 44% of total drug-related material in serum. In vitro studies using human liver subcellular fractions indicate that S-methyldihydroZiprasidone is generated in two steps. 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. In vitro studies using human liver microsomes and recombinant enzymes indicate that CYP3A4 is the major CYP contributing to the oxidative metabolism of Ziprasidone. CYP1A2 may contribute to a much lesser extent. Based on in vivo abundance of excretory metabolites, less than one-third of Ziprasidone metabolic clearance is mediated by cytochrome P450 catalyzed oxidation and approximately two-thirds via reduction. There are no known clinically relevant inhibitors or inducers of aldehyde oxidase. kriki.info biaxin
If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy. Efficacy in schizophrenia was demonstrated in a dose range of 20 mg to 100 mg twice daily in short-term, placebo-controlled clinical trials. There were trends toward dose response within the range of 20 mg to 80 mg twice daily, but results were not consistent. An increase to a dose greater than 80 mg twice daily is not generally recommended. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.
Miceli JJ, Glue P, Alderman J, Wilner K 2007. "The effect of food on the absorption of oral ziprasidone". Psychopharmacology Bulletin. People with schizophrenia who get counseling are also more likely to stick with their medications. Recently, the FDA required the manufacturers of some atypical antipsychotics to include a warning about the risk of and with atypical antipsychotics.
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. There is no general agreement about specific pharmacological treatment regimens for NMS. For example, you may hear voices that make fun of you or insult you. They might also tell you to do harmful things. Ziprasidone hydrochloride capsules contain Ziprasidone hydrochloride monohydrate, lactose monohydrate, pregelatinized maize starch, and magnesium stearate.
Take this medication by mouth with food as directed by your doctor, usually twice daily. Swallow the capsules whole. Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. There is a slight risk 1 in 1500 patients that ziprasidone by itself could significantly increase the QT interval. There is an even smaller risk 1 in 4000 patients that it could cause a potentially serious change in the rhythm of the heart. Ziprasidone is not approved for use in psychotic conditions related to dementia. Ziprasidone may increase the risk of death in older adults with dementia-related conditions. Ziprasidone at a dose of 40 mg twice daily administered concomitantly with lithium at a dose of 450 mg twice daily for 7 days did not affect the steady-state level or renal clearance of lithium. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. CBC monitored frequently during the first few months of therapy and should discontinue Ziprasidone hydrochloride at the first sign of decline in WBC in the absence of other causative factors. Ziprasidone is unlikely to interfere with the metabolism of drugs metabolized by cytochrome P450 enzymes. Food and Drug Administration. WebMD does not endorse any specific product, service or treatment. Many people using this medication not have serious side effects. Ziprasidone did not affect the pharmacokinetics of Ziprasidone.
QTc interval have been associated with the occurrence of torsade de pointes and with sudden unexplained death. Anything that can increase the chance of a heart rhythm abnormality should be avoided. This list is not complete and there may be other drugs that should not be taken at the same time as ziprasidone. Tell your doctor about all medicines you use. Unlike many other antipsychotics, ziprasidone has no significant affinity for the mACh receptors, and as such lacks any side effects. Like most other antipsychotics, ziprasidone is sedating due primarily to serotonin and dopamine blockade. In the rat study, there was no evidence of an increased incidence of tumors compared to controls. In male mice, there was no increase in incidence of tumors relative to controls. Keating AM, Aoun SL, Dean CE 2005. United Kingdom: Royal Pharmaceutical Society of Great Britain. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Keep all drug products away from children and pets. naprosyn
Keep Ziprasidone hydrochloride capsules and all medicines out of the reach of children. 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. Every effort has been made to ensure that the information provided by Cerner Multum, Inc. 'Multum' is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Ziprasidone frequently causes 1 in 7 patients. Therefore, care should be exercised in any activity requiring mental alertness, such as operating a motor vehicle including automobiles or operating hazardous machinery. Less common side effects include 1 in 250 patients. You are currently taking medications that should not be taken in combination with Ziprasidone, for example, 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. This medicine may be harmful if swallowed. Requip; ketoconazole Nizoral; medications for high blood pressure, mental illness, seizures, or anxiety; and sedatives, sleeping pills, or tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. 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. There was a reproducible mutagenic response in the Ames assay in one strain of S. typhimurium in the absence of metabolic activation. Positive results were obtained in both the in vitro mammalian cell gene mutation assay and the in vitro chromosomal aberration assay in human lymphocytes. Other severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, have been reported with Ziprasidone exposure. Severe cutaneous adverse reactions are sometimes fatal. Discontinue Ziprasidone if severe cutaneous adverse reactions are suspected. The occurrence of rash was related to dose of Ziprasidone, although the finding might also be explained by the longer exposure time in the higher dose patients.
Ziprasidone may induce orthostatic hypotension associated with dizziness, tachycardia, and, in some patients, syncope, especially during the initial dose-titration period, probably reflecting its α 1-adrenergic antagonist properties. Sandson NB, Armstrong SC, Cozza KL 2005. "An overview of psychotropic drug-drug interactions". Psychosomatics. The diagnostic evaluation of patients with this syndrome is complicated. 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. All trials were in adult inpatients, most of whom met DSM III-R criteria for schizophrenia. Each study included 2 to 3 fixed doses of Ziprasidone as well as placebo. Four of the 5 trials were able to distinguish Ziprasidone from placebo; one short-term study did not. 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. Take this medication by mouth with food as directed by your doctor, usually twice daily. If you have any health problems, consult your doctor or pharmacist before using this product. It is best to take Ziprasidone hydrochloride capsules at the same time each day. Ziprasidone hydrochloride capsules have not been shown to be safe or effective in the treatment of children and teenagers under the age of 18 years old. Consult your healthcare professional before taking or discontinuing any drug or commencing any course of treatment. Ziprasidone hydrochloride capsules contain a monohydrochloride, monohydrate salt of Ziprasidone. Salmi P, Ahlenius S April 2000. "Sedative effects of the dopamine D1 receptor agonist A 68930 on rat open-field behavior. Your spouse or partner is cheating on you. Because of this, Ziprasidone hydrochloride should be used only after your doctor has considered this risk for Ziprasidone hydrochloride against the risks and benefits of other medications available for treating schizophrenia. tesco furadantin
Ziprasidone 5, 20, and 40 mg twice daily none of the dose groups was statistically superior to placebo on any outcome of interest. European Journal of Pharmacology. This medication is a mild corticosteroid. People with paranoid delusions are unreasonably suspicious of others. This can make it hard for them to hold a job, run errands, have friendships, and even go to the doctor. 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.
Ziprasidone is not removed by hemodialysis. 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. 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. Daniel DG, Zimbroff DL, Potkin SG, Reeves KR, Harrigan EP, Lakshminarayanan M May 1999. 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. If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Antipsychotic drugs which include Ziprasidone hydrochloride may cause somnolence, postural hypotension, and motor and sensory instability, which could lead to falls and, consequently, fractures or other injuries. Retrieved June 4, 2015. Stahl; Chiara Mattei; Maria Paola Rapagnani February 2011. Ziprasidone. Of these 5700, over 4800 were patients who participated in multiple-dose effectiveness trials, and their experience corresponded to approximately 1831 patient-years. These patients include 1 4331 patients who participated in multiple-dose trials, predominantly in schizophrenia, representing approximately 1698 patient-years of exposure. 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. Positive, encouraging support from family and friends really helps, too. The possibility of a suicide attempt is inherent in psychotic illness and close supervision of high-risk patients should accompany drug therapy. 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. It is also important to remember that Ziprasidone hydrochloride capsules should be taken with food. The safety and effectiveness of Ziprasidone in pediatric patients have not been established. purchase genuine metoprolol
Who should NOT take Ziprasidone Hydrochloride Capsules? If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking ziprasidone or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking ziprasidone: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar that is not treated can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness. About FAERS: The FDA Adverse Event Reporting System FAERS is used by FDA for activities such as looking for new safety concerns that might be related to a marketed product, evaluating a manufacturer's compliance to reporting regulations and responding to outside requests for information. Reporting of adverse events is a voluntary process, and not every report is sent to FDA and entered into FAERS. Neuroleptic Malignant Syndrome NMS has been reported in association with administration of antipsychotic drugs. 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. Additional signs may include elevated creatinine phosphokinase, myoglobinuria rhabdomyolysis and acute renal failure. Tatsumi M, Jansen K, Blakely RD, Richelson E March 1999. "Pharmacological profile of neuroleptics at human monoamine transporters". European Journal of Pharmacology. QTc intervals exceeding the potentially clinically relevant threshold of 500 msec. In the Ziprasidone-treated patients, neither case suggested a role of Ziprasidone. One patient had a history of prolonged QTc and a screening measurement of 489 msec; QTc was 503 msec during Ziprasidone treatment. 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. The recommends a gradual withdrawal when discontinuing antipsychotic treatment to avoid acute withdrawal syndrome or rapid relapse. This is more common when you first start taking ziprasidone. Patients being considered for Ziprasidone treatment that are at risk of significant electrolyte disturbances should have baseline serum potassium and magnesium measurements. Low serum potassium and magnesium should be replaced before proceeding with treatment. Patients who are started on diuretics during Ziprasidone therapy need periodic monitoring of serum potassium and magnesium. 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. One case of priapism was reported in the premarketing database. 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. Severe priapism may require surgical intervention. It is greater than 99% bound to plasma proteins, binding primarily to albumin and α 1-acid glycoprotein. 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. Thus, the potential for drug interactions with Ziprasidone due to displacement is minimal. Before having surgery, tell your doctor or dentist about all the products you use including prescription drugs, nonprescription drugs, and herbal products. If prescribed by your doctor, use this medication for your current condition only. Do not use it later for other unless told to do so by your doctor. A different medication may be necessary in those cases. After a single dose intramuscular administration, the peak serum concentration typically occurs at about 60 minutes after the dose is administered, or earlier. Steady state plasma concentrations are achieved within one to three days. Exposure increases in a dose-related manner and following three days of intramuscular dosing, little accumulation is observed. Do not change your dose or stop taking your medicine without your doctor's approval.
In animal studies Ziprasidone demonstrated developmental toxicity, including possible teratogenic effects at doses similar to human therapeutic doses. Ziprasidone is a psychotropic agent belonging to the chemical class of benzisoxazole derivatives and is indicated for the treatment of schizophrenia. Ziprasidone is a selective monoaminergic antagonist with high affinity for the serotonin Type 2 5HT2 dopamine Type 2 D2 1 and 2 adrenergic, and H1 histaminergic receptors. Ziprasidone acts as an antagonist at other receptors, but with lower potency. Antagonism at receptors other than dopamine and 5HT2 with similar receptor affinities may explain some of the other therapeutic and side effects of Ziprasidone. Ziprasidone's antagonism of muscarinic M1-5 receptors may explain its anticholinergic effects. Ziprasidone's antagonism of histamine H1 receptors may explain the somnolence observed with this drug. Ziprasidone's antagonism of adrenergic a1 receptors may explain the orthostatic hypotension observed with this drug. No additional benefit was demonstrated for doses above 20 mg twice daily. Patients should be periodically reassessed to determine the need for maintenance treatment. Some side effects can be serious. 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. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown. Lifetime carcinogenicity studies were conducted with Ziprasidone in Long Evans rats and CD-1 mice. atrovent
Ziprasidone hydrochloride capsules, 40 mg are size '4' capsules with dark blue opaque cap and dark blue opaque body, imprinted axially with "LU" on cap and "V52" on body in black ink, containing off-white to pinkish granular powder. Retrieved June 19, 2015. 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. This medication can decrease hallucinations and help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life. Nemeroff CB, Lieberman JA, Weiden PJ, et al. November 2005. The effect of Ziprasidone on labor and delivery in humans is unknown. Your doctor may prescribe an antipsychotic drug to make the delusions go away. It could be pills, a liquid, or shots. It can take a few weeks for these drugs to work fully, but you could start to feel a little calmer quickly. You might need to try more than one to find a or combination that's right for you. Ziprasidone also inhibits synaptic reuptake of serotonin and norepinephrine. Group, BMJ, ed. March 2009. Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer's dementia. As with other drugs that antagonize dopamine D 2 receptors, Ziprasidone elevates prolactin levels in humans.
Ziprasidone was documented in 10 patients. All of these patients survived without sequelae. Patients should be instructed to report the onset of any conditions that put them at risk for significant electrolyte disturbances, hypokalemia in particular, including but not limited to the initiation of diuretic therapy or prolonged diarrhea. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. 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. It is essential to periodically monitor serum electrolytes in patients for whom diuretic therapy is introduced during Ziprasidone treatment. 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. irbesartan to buy in uk
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Approximately two-thirds of Ziprasidone is metabolized via a combination of chemical reduction by glutathione and enzymatic reduction by aldehyde oxidase. There are no known clinically relevant inhibitors or inducers of aldehyde oxidase. Less than one-third of Ziprasidone metabolic clearance is mediated by cytochrome P450 catalyzed oxidation. Heinz Lüllmann; Klaus Mohr 2006. OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. warticon
All reported reactions are included except those already listed in Table 6 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. 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. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density.
Ziprasidone absorption is optimally achieved when administered with food. Without a meal preceding dose, the bioavailability of the drug is reduced by approximately 50%. PDF. FDA. July 19, 2000. As with other antipsychotics, long-term use of ziprasidone may lead to a potentially irreversible condition called tardive dyskinesia involuntary movements of the jaw, lips, and tongue. Any patient developing symptoms that suggest diabetes during treatment should be tested for diabetes. pramipexole manchester
Ziprasidone or any of the other ingredients of Ziprasidone hydrochloride capsules. Since Ziprasidone has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about performing activities requiring mental alertness, such as operating a motor vehicle including automobiles or operating hazardous machinery until they are reasonably certain that Ziprasidone therapy does not affect them adversely. 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. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.