Ziprasidone is an active pharmaceutical ingredient in the Indole Derivatives group (N05AE). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· revised March 22, 2025[1]
Schizophrenia ZELDOX (ziprasidone) is indicated for the treatment of schizophrenia and related psychotic disorders. The prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to other antipsychotic drugs (see
How to take
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USUnited States· FDA
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Uses
USOfficial regulatory label· revised April 5, 2025[2]
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.
3 ) ]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first.
1 ) ]. 2 )]. 2 ) ]. Ziprasidone capsule is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone capsule to prolong the QT interval and may consider the use of other drugs first.
(1) Ziprasidone capsules are indicated for the: • treatment of schizophrenia in adults. ( 1 ) • acute treatment of adults as monotherapy of manic or mixed episodes associated with bipolar I disorder. ( 1 ) • maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults.
Drug interactions
Known interactions involving Ziprasidone. Select one for details. This list is informational and not a complete interaction checker.
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Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]Health Canada (DPD) · 02298597 · revised March 22, 2025
[2]FDA DailyMed · 0071a228-21cc-56… · revised April 5, 2025 [PDF]
[3]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
). 2 CONTRAINDICATIONS QT Prolongation: 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, ZELDOX is contraindicated in patients with: • known history of QT prolongation (including congenital long QT syndrome); • recent acute myocardial infarction; or • uncompensated heart failure (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
Pharmacokinetic/pharmacodynamic studies between ziprasidone and other drugs that prolong the QT interval have not been performed. An additive effect of ziprasidone and other drugs that prolong the QT interval cannot be excluded. Therefore, ziprasidone should not be given with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmias, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol or tacrolimus.
Ziprasidone is also contraindicated with drugs that have demonstrated QT prolongation as one of their pharmacodynamic effects and have this effect described in their respective Product Monograph as a contraindication or a warning (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
Hypersensitivity: ZELDOX is contraindicated in patients who are hypersensitive to ziprasidone or to any ingredient in the formulation or component of the container. For a complete listing see
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[1]
). 4% of patients treated with ziprasidone. There were confounding factors that may have contributed to the occurrence of seizures in many of these cases. , Alzheimer’s dementia. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older.
ZELDOX (ziprasidone capsules) – Product Monograph Page 18 of 56 Serotonin toxicity / Serotonin syndrome: Serotonin toxicity, also known as serotonin syndrome, is a potentially life-threatening condition in patients taking multiple serotonergic agents or who have had considerable exposure to a single serotonin-augmenting drug.
5 Post-Market Adverse Reactions). g. g. anxiety, agitation, hypomania). In accordance with the Hunter Criteria, serotonin toxicity diagnosis is likely when, in the presence of at least one serotonergic agent, one of the following is observed: • spontaneous clonus • inducible clonus or ocular clonus with agitation or diaphoresis • tremor and hyperreflexia • hypertonia and body temperature >38°C and ocular clonus or inducible clonus.
If concomitant treatment with ZELDOX and serotonergic agents is clinically warranted, careful observation of the patient is advised. If serotonin toxicity is suspected, discontinuation of the serotonergic agents should be considered.
Psychiatric Suicide:
The possibility of a suicide attempt is inherent in psychotic illness; thus, close supervision and appropriate clinical management of high-risk patients should accompany drug therapy. Prescriptions for ZELDOX should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose.
3 Pharmacokinetics, Renal Insufficiency).
Reproductive Health:
Female and Male Potential There are no adequate and well-controlled studies in women and men exposed to ziprasidone.
Skin Severe Cutaneous Adverse Reactions:
Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) are potentially life threatening adverse drug reactions that have been reported with atypical antipsychotic exposure.
SCARs commonly present as a combination ZELDOX (ziprasidone capsules) – Product Monograph Page 19 of 56 of the following symptoms: malaise, mucosal ulceration, extensive cutaneous rash or exfoliative dermatitis, fever, lymphadenopathy and possible eosinophilia.
5 Post-Market Adverse Reactions). Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported with ziprasidone exposure. DRESS consists of a combination of three or more of the following: cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, lymphadenopathy and one or more systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and pericarditis.
5 Post Market Adverse Reactions). Severe cutaneous adverse reactions are sometimes fatal. Discontinue ziprasidone if severe cutaneous adverse reactions occur. Rash: In pre-marketing trials with ziprasidone, about 5% of patients developed rash (173/3834) and/or urticaria (12/3834), with discontinuation in about one-sixth of these cases.
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. , elevated white blood cells (WBC). Most patients improved promptly with adjunctive treatment with antihistamines or steroids and/or upon discontinuation of ziprasidone, and all patients experiencing these events were reported to recover completely.
Upon appearance of rash for which an alternative etiology cannot be identified, ziprasidone should be discontinued. 1 Pregnant Women There are no adequate and well-controlled studies in pregnant women. Women of childbearing potential receiving ziprasidone should therefore be counselled on the need to use an effective method of contraception during treatment with ZELDOX.
Patients should be advised to notify their health professional if they become pregnant or intend to become pregnant. ZELDOX should not be used during pregnancy unless the expected benefits to the mother markedly outweigh the potential risks to the fetus.
Teratogenic effects:
In animal studies, ziprasidone demonstrated developmental toxicity, including possible teratogenic effects at doses similar to human therapeutic doses. 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 maximum recommended human dose (MRHD) of 200 mg/day on a mg/m2 basis).
There was ZELDOX (ziprasidone capsules) – Product Monograph Page 20 of 56 no evidence to suggest that these developmental effects were secondary to maternal toxicity. The developmental no-effect dose was 10 mg/kg/day (equivalent to […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[1]
). The efficacy of ziprasidone was established in short-term (4- and 6-week) controlled trials of schizophrenic inpatients (see 14 CLINICAL TRIALS). ZELDOX has been shown to be effective in maintaining clinical improvement during long- term therapy (1-year).
The health professional who elects to use ZELDOX for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Bipolar Disorder ZELDOX is indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder.
The prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to other antipsychotic drugs (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS). The efficacy of ziprasidone in acute mania was established in 2 placebo-controlled, double- blind, 3-week studies which compared ziprasidone with placebo and 1 double-blind, 12- week (3-week placebo-controlled, active comparator acute phase and 9-week active comparator phase) study which compared ziprasidone to haloperidol and placebo, in patients meeting DSM-IV criteria for Bipolar I Disorder (see 14 CLINICAL TRIALS).
The effectiveness of ZELDOX for longer-term use and for prophylactic use in mania has not been systematically evaluated in controlled clinical trials. Therefore, health professionals who elect to use ziprasidone for extended periods should periodically re-evaluate the long- term risks and benefits of the drug for the individual patient.
1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of ZELDOX in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
3 Pediatrics). 3 Pharmacokinetics, Special Populations and Conditions). The greater frequency of decreased hepatic, renal, or cardiac function, characteristic of the elderly, as well as concomitant disease and use of other drugs may impact the ZELDOX (ziprasidone capsules) – Product Monograph Page 5 of 56 pharmacokinetics of ZELDOX in this population.
3 Pharmacokinetics, Special Populations and Conditions, and 4 DOSAGE AND ADMINISTRATION). 2 CONTRAINDICATIONS QT Prolongation: 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, ZELDOX is contraindicated in patients with: • known history of QT prolongation (including congenital long QT syndrome); • recent acute myocardial infarction; or • uncompensated heart failure (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[1]
, 7 WARNINGS AND PRECAUTIONS). The efficacy of ziprasidone was established in short-term (4- and 6-week) controlled trials of schizophrenic inpatients (see 14 CLINICAL TRIALS). ZELDOX has been shown to be effective in maintaining clinical improvement during long- term therapy (1-year).
The health professional who elects to use ZELDOX for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient. Bipolar Disorder ZELDOX is indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder.
The prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to other antipsychotic drugs (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS). The efficacy of ziprasidone in acute mania was established in 2 placebo-controlled, double- blind, 3-week studies which compared ziprasidone with placebo and 1 double-blind, 12- week (3-week placebo-controlled, active comparator acute phase and 9-week active comparator phase) study which compared ziprasidone to haloperidol and placebo, in patients meeting DSM-IV criteria for Bipolar I Disorder (see 14 CLINICAL TRIALS).
The effectiveness of ZELDOX for longer-term use and for prophylactic use in mania has not been systematically evaluated in controlled clinical trials. Therefore, health professionals who elect to use ziprasidone for extended periods should periodically re-evaluate the long- term risks and benefits of the drug for the individual patient.
1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of ZELDOX in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
3 Pediatrics). 2 Geriatrics ZELDOX is not indicated for use in elderly patients with dementia (see
This is not medical advice. Consult a qualified healthcare professional.
USOfficial regulatory label· revised April 5, 2025[2]
2 DOSAGE AND ADMINISTRATION Administer capsules orally with food. Do not open, crush, or chew. 1 ) Schizophrenia: Initiate at 20 mg twice daily. Daily dosage may be adjusted up to 80 mg twice daily. Dose adjustments should occur at intervals of not less than 2 days.
Safety and efficacy has been demonstrated in doses up to 100 mg twice daily. The lowest effective dose should be used. 2 ) Acute treatment of manic/mixed episodes of bipolar I disorder: Initiate at 40 mg twice daily. Increase to 60 mg or 80 mg twice daily on day 2 of treatment.
Subsequent dose adjustments should be based on tolerability and efficacy within the range of 40 to 80 mg twice daily. 3 ) Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate: Continue treatment at the same dose on which the patient was initially stabilized, within the range of 40 to 80 mg twice daily.
1 Administration Information for Ziprasidone Capsules Administer ziprasidone capsules orally with food. Swallow capsules whole, do not open, crush, or chew the capsules. 2 Schizophrenia Dose Selection Ziprasidone capsules should be administered at an initial daily dose of 20 mg twice daily with food.
In some patients, daily dosage may subsequently be adjusted on the basis of individual clinical status up to 80 mg twice daily. Dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state is achieved within 1 to 3 days.
In order to ensure use of the lowest effective dose, patients should ordinarily be observed for improvement for several weeks before upward dosage adjustment. 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. 1) ]. 1) ]. No additional benefit was demonstrated for doses above 20 mg twice daily.
Patients should be periodically reassessed to determine the need for maintenance treatment. 3 Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate) Acute Treatment of Manic or Mixed Episodes In adults oral ziprasidone should be administered at an initial daily dose of 40 mg twice daily with food.
The dose may then be increased to 60 mg or 80 mg twice daily on the second day of treatment and subsequently adjusted on the basis of tolerance and efficacy within the range 40 mg to 80 mg twice daily. 2 ) ]. Maintenance Treatment (as an adjunct to lithium or valproate) Continue treatment at the same dose on which the patient was initially stabilized, within the range of 40 mg to 80 mg twice daily with food.
2 )] . 5 Switching Patients to or from a Monoamine Oxidase Inhibitor (MAOI) Antidepressant At least 14 days must elapse between discontinuation of an MAOI (intended to treat psychiatric disorders) and initiation of therapy with ziprasidone capsules.
1) ].
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 309 reports total. [3]
Drug Ineffective 38
Off Label Use 30
Drug Interaction 24
Acute Kidney Injury 21
Weight Increased 20
Toxicity To Various Agents 18
Electrocardiogram Qt Prolonged 16
Neuroleptic Malignant Syndrome 15
Depression 13
Nausea 13
Product Use In Unapproved Indication 13
Fatigue 12
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised April 5, 2025[2]
19) ] Commonly observed adverse reactions (incidence ≥5% and at least twice the incidence for placebo) were : • Schizophrenia: Somnolence, respiratory tract infection. gov/medwatch. 1 Clinical Trials Experience 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.
Clinical trials in adults for oral ziprasidone included approximately 5700 patients and/or normal subjects exposed to one or more doses of 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 as of February 5, 2000; and (2) 472 patients who participated in bipolar mania trials representing approximately 133 patient-years of exposure.
7 patient-years of exposure to ziprasidone. 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. 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.
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.
Adverse Findings Observed in Short-Term, Placebo-Controlled Trials with Oral Ziprasidone The following findings are based on the short-term placebo-controlled premarketing trials for schizophrenia (a pool of two 6-week, and two 4-week fixed-dose trials) and bipolar mania (a pool of two 3-week flexible-dose trials) in which ziprasidone was administered in doses ranging from 10 to 200 mg/day.
Commonly Observed Adverse Reactions in Short Term-Placebo-Controlled Trials 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): Schizophrenia trials (see Table 11) • Somnolence • Respiratory Tract Infection Bipolar trials (see Table 12) • Somnolence • Extrapyramidal Symptoms which includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching.
None of these adverse reactions occurred individually at an incidence greater than 10% in bipolar mania trials. • Dizziness which includes the adverse reaction terms dizziness and lightheadedness. 2% (6/273) on placebo. 9) ]. Adverse Reactions Occurring at an Incidence of 2% or More Among Ziprasidone-Treated Patients in Short-Term, Oral, Placebo-Controlled Trials 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.
None of these adverse reactions occurred individually at an incidence greater than 5% in schizophrenia trials. ** Dizziness includes the adverse reaction terms dizziness and lightheadedness. Dose Dependency of Adverse Reactions in Short-Term, Fixed-Dose, Placebo-Controlled Trials 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.
Extrapyramidal Symptoms (EPS) The incidence of reported EPS (which included the adverse reaction terms extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching) for ziprasidone-treated patients in the short-term, placebo-controlled schizophrenia trials was 14% vs.
8% for placebo. Objectively collected data from those trials on the Simpson-Angus Rating Scale (for EPS) and the Barnes Akathisia Scale (for akathisia) did not generally show a difference between ziprasidone and placebo.
Dystonia Class Effect:
Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. 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.
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. An elevated risk of acute dystonia is observed in males and younger age groups.
3) ]. 2 beats per minute decrease among placebo patients. Other Adverse Reactions Observed During the Premarketing Evaluation of Oral Ziprasidone 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.
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.
It is important to emphasize that, although the reactions reported occurred during treatment with ziprasidone, they were not necessarily caused by it. 1% of patients). 7% (5/136) on placebo. The most common reactions associated with dropout in the ziprasidone-treated patients were akathisia, anxiety, depression, dizziness, dystonia, rash and vomiting, with 2 dropouts for each of these reactions among ziprasidone patients (1%) compared to one placebo patient each for dystonia and rash (1%) and no placebo patients for the remaining adverse reactions.
Adverse Reactions Occurring at an Incidence of 2% or More Among Ziprasidone-Treated Patients in Short-Term, Oral, Placebo-Controlled Trials 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.
Table 12:
Treatment-Emergent Adverse Reactions Incidence in Short-Term Oral Placebo-Controlled Trials – Manic and Mixed Episodes Associated with Bipolar Disorder Percentage of Patients Reporting Reaction Body System/Adverse Reaction Ziprasidone (N=279) Placebo (N=136) Body as a Whole Headache 18 17 Asthenia 6 2 Accidental Injury 4 1 Cardiovascular Hypertension 3 2 Digestive Nausea 10 7 Diarrhea 5 4 Dry Mouth 5 4 Vomiting 5 2 Increased Salivation 4 0 Tongue Edema 3 1 Dysphagia 2 0 Musculoskeletal Myalgia 2 0 Nervous Somnolence 31 12 Extrapyramidal Symptoms* 31 12 Dizziness** 16 7 Akathisia 10 5 Anxiety 5 4 Hypesthesia 2 1 Speech Disorder 2 0 Respiratory Pharyngitis 3 1 Dyspnea 2 1 Skin and Appendages Fungal Dermatitis 2 1 Special Senses Abnormal Vision 6 3 * Extrapyramidal Symptoms includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching.
None of these adverse reactions occurred individually at an incidence greater than 10% in bipolar mania trials. ** Dizziness includes the adverse reaction terms dizziness and lightheadedness. Explorations for interactions on the basis of gender did not reveal any clinically meaningful differences in the adverse reaction occurrence on the basis of this demographic factor.
2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of ziprasidone. 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.
3) ]; Digestive System Disorders: Swollen Tongue; Reproductive System and Breast Disorders: Galactorrhea, priapism; Nervous System Disorders: Facial Droop, neuroleptic malignant syndrome, serotonin syndrome (alone or in combination with serotonergic medicinal products), tardive dyskinesia; Psychiatric Disorders: Insomnia, mania/hypomania; somnambulism; Skin and subcutaneous Tissue Disorders: Allergic reaction (such as allergic dermatitis, angioedema, orofacial edema, urticaria), rash, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS); Urogenital System Disorders: Enuresis, urinary incontinence; Vascular Disorders: Postural hypotension, syncope.
USOfficial regulatory label· Warnings and precautions· revised April 5, 2025[2]
, stroke, transient ischemic attack). 2) QT Interval Prolongation : Ziprasidone use should be avoided in patients with bradycardia, hypokalemia or hypomagnesemia, congenital prolongation of the QT interval, or in combination with other drugs that have demonstrated QT prolongation.
3) Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue ziprasidone and serotonergic agents and initiate supportive treatment. 4) Neuroleptic Malignant Syndrome (NMS) : Potentially fatal symptom complex has been reported with antipsychotic drugs.
Manage with immediate discontinuation of drug and close monitoring. 5) Severe Cutaneous Adverse Reactions, su ch as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and Stevens-Johnson syndrome has been reported with ziprasidone exposure.
DRESS and other Severe Cutaneous Adverse Reactions (SCAR) are sometimes fatal. Discontinue ziprasidone if DRESS or SCAR are suspected . 7) Metabolic Changes : Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/ cerebrovascular risk.
These metabolic changes include hyperglycemia, dyslipidemia, and weight gain. 8) Hyperglycemia and Diabetes Mellitus (DM) : Monitor all patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness.
Patients with DM risk factors should undergo blood glucose testing before and during treatment. 8) Dyslipidemia : Undesirable alterations have been observed in patients treated with atypical antipsychotics. 8) Weight Gain : Weight gain has been reported.
Monitor weight gain. 8) Rash : Discontinue in patients who develop a rash without an identified cause. 9) Orthostatic Hypotension : Use with caution in patients with known cardiovascular or cerebrovascular disease. 10) Leukopenia, Neutropenia, and Agranulocytosis has been reported with antipsychotics.
Patients with a pre-existing low white blood cell count (WBC) or a history of 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 a decline in WBC in the absence of other causative factors.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised April 5, 2025[2]
2) Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs. 1 QT Prolongation 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: 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 Pharmacokinetic/pharmacodynamic studies between ziprasidone and other drugs that prolong the QT interval have not been performed.
An additive effect of ziprasidone and other drugs that prolong the QT interval cannot be excluded. Therefore, ziprasidone should not be given with: 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.
3) ] . 2 Hypersensitivity Ziprasidone is contraindicated in individuals with a known hypersensitivity to the product. 3) ].
This is not medical advice. Consult a qualified healthcare professional.
Pharmacokinetic/pharmacodynamic studies between ziprasidone and other drugs that prolong the QT interval have not been performed. An additive effect of ziprasidone and other drugs that prolong the QT interval cannot be excluded. Therefore, ziprasidone should not be given with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmias, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol or tacrolimus.
Ziprasidone is also contraindicated with drugs that have demonstrated QT prolongation as one of their pharmacodynamic effects and have this effect described in their respective Product Monograph as a contraindication or a warning (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular).
Hypersensitivity: ZELDOX is contraindicated in patients who are hypersensitive to ziprasidone or to any ingredient in the formulation or component of the container. For a complete listing see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
ZELDOX (ziprasidone capsules) – Product Monograph Page 6 of 56 3 SERIOUS WARNINGS AND PRECAUTIONS Serious Warnings and Precautions Increased Mortality in Elderly Patients with Dementia Elderly patients with dementia treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo.
6-fold increase in the death rate in the drug-treated patients. 4 Geriatrics, Use in Geriatric Patients with Dementia). 1 Dosing Considerations Dosage adjustments are generally not required on the basis of age, gender, race, or renal impairment.
The absorption of ziprasidone is increased up to two-fold in the presence of a meal. Concomitant treatment with other drugs that have been consistently observed to prolong the QT/QTc interval should be avoided. See also: 7 WARNINGS and PRECAUTIONS, Recommendations Regarding Risk Factors for QT Prolongation.
3 Pediatrics) Adults: • Schizophrenia Initial Treatment: ZELDOX may be administered at an initial daily dose of 40 mg BID with a meal. However, individual patients may benefit from an initial dose of 20 mg BID. Daily dosage may subsequently be adjusted on the basis of clinical status up to 80 mg BID.
Dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, since steady-state is achieved within 1 to 3 days. Efficacy in schizophrenia was studied in a dose range of 20 to 100 mg BID in short-term, placebo-controlled clinical trials.
There were trends toward dose response within the range of 20 to 80 mg BID, but results […]
12) Seizures : Use cautiously in patients with a history of seizures or with conditions that lower seizure threshold. 13) Potential for Cognitive and Motor Impairment : Patients should use caution when operating machinery. 16) Suicide : Closely supervise high-risk patients.
1 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. 7 times the risk of death in placebo-treated patients.
6% in the placebo group. , pneumonia) in nature. 2 Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis In placebo-controlled trials in elderly subjects with dementia, patients randomized to risperidone, aripiprazole, and olanzapine had a higher incidence of stroke and transient ischemic attack, including fatal stroke.
1) ]. 4) ]. Additionally, clinicians should be alert to the identification of other drugs that have been consistently observed to prolong the QTc interval. Such drugs should not be prescribed with ziprasidone. Ziprasidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias [see Contraindications (4) ].
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 first phase of the trial, ECGs were obtained at the time of maximum plasma concentration when the drug was administered alone.
In the second phase of the trial, ECGs were obtained at the time of maximum plasma concentration while the drug was co-administered with an inhibitor of the CYP4503A4 metabolism of the drug. In the first phase of the study, the mean change in QTc from baseline was calculated for each drug, using a sample-based correction that removes the effect of heart rate on the QT interval.
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.
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). In placebo-controlled trials in adults, oral ziprasidone increased the QTc interval compared to placebo by approximately 10 msec at the highest recommended daily dose of 160 mg.
23%) patients who received placebo revealed 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. Some drugs that prolong the QT/QTc interval have been associated with the occurrence of torsade de pointes and with sudden unexplained death.
The relationship of QT prolongation to torsade de pointes is clearest for larger increases (20 msec and greater) but it is possible that smaller QT/QTc prolongations may also increase risk, or increase it in susceptible individuals .
2) ]. As with other antipsychotic drugs and placebo, sudden unexplained deaths have been reported in patients taking ziprasidone at recommended doses. 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.
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.
This possibility needs to be considered in deciding among alternative drug products [see Indications and Usage (1) ]. 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.
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. Hypokalemia (and/or hypomagnesemia) may increase the risk of QT prolongation and arrhythmia.
Hypokalemia may result from diuretic therapy, diarrhea, and other causes. Patients with low serum potassium and/or magnesium should be repleted with those electrolytes before proceeding with treatment. 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. , QT prolongation, recent acute myocardial infarction, uncompensated heart failure, or cardiac arrhythmia.
Ziprasidone should be discontinued in patients who are found to have persistent QTc measurements >500 msec. , Holter monitoring may be useful. 4 Serotonin Syndrome Ziprasidone can precipitate serotonin syndrome, a potentially lifethreatening condition.
The risk is increased with concomitant use of other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, tramadol, meperidine, methadone, lithium, tryptophan, buspirone, amphetamines, and St.
3) ]. , nausea, vomiting, diarrhea). The concomitant use of ziprasidone with MAOIs is contraindicated. In addition, do not initiate ziprasidone in a patient being treated with MAOIs such as linezolid or intravenous methylene blue. 3) ].
Monitor all patients taking ziprasidone for the emergence of serotonin syndrome. Discontinue treatment with ziprasidone and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment.
If concomitant use of ziprasidone with other serotonergic drugs is clinically warranted, inform patients of the increased risk of serotonin syndrome and monitor for symptoms. 5 Neuroleptic Malignant Syndrome (NMS) A potentially fatal symptom complex sometimes referred to as 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.
The diagnostic evaluation of patients with this syndrome is complicated. ) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology.
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. If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered.
The patient should be carefully monitored, since recurrences of NMS have been reported. 6 Severe Cutaneous Adverse Reactions Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with Ziprasidone exposure.
DRESS consists of a combination of three or more of the following: cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, lymphadenopathy and one or more systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and pericarditis.
DRESS is sometimes fatal. Discontinue ziprasidone if DRESS is suspected. Other severe cutaneous adverse reactions 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. 7 Tardive Dyskinesia A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients undergoing treatment with antipsychotic drugs.
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. The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase.
However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn.
Antipsychotic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome, and thereby may possibly mask the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.
Given these considerations, ziprasidone should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. 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.
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 need for continued treatment should be reassessed periodically. If signs and symptoms of tardive dyskinesia appear in a patient on ziprasidone, drug discontinuation should be considered.
However, some patients may require treatment with ziprasidone despite the presence of the syndrome. 8 Metabolic Changes Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk.
These metabolic changes include hyperglycemia, dyslipidemia, and body weight gain. While all of the drugs in the class have been shown to produce some metabolic changes, each drug has its own specific risk profile. Hyperglycemia and Diabetes Mellitus 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.
There have been few reports of hyperglycemia or diabetes in patients treated with ziprasidone. Although fewer patients have been treated with ziprasidone, it is not known if this more limited experience is the sole reason for the paucity of such reports.
Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population.
Given these confounders, the relationship between atypical antipsychotic use and hyperglycemia-related adverse reactions is not completely understood. Precise risk estimates for hyperglycemia-related adverse reactions in patients treated with atypical antipsychotics are not available.
Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. , obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment.
Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing.
In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of the suspect drug. Pooled data from short-term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 1-4.
Note that for the flexible dose studies in both schizophrenia and bipolar disorder, each subject is categorized as having received either low (20 to 40 mg BID) or high (60 to 80 mg BID) dose based on the subject’s modal daily dose.
In the tables showing categorical changes, the percentages (% column) are calculated as 100x (n/N). 3 mg/dL (N=71). 9%) *Fasting Dyslipidemia Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
Pooled data from short-term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 5-8. 9 mg/dL (N=9). 7 mg/dL (N=10); and for placebo was -28 mg/dL (N=9). 9%) *Fasting Weight Gain Weight gain has been observed with atypical antipsychotic use.
Monitoring of weight is recommended. Pooled data from short-term, placebo-controlled studies in schizophrenia and bipolar disorder are presented in Tables 9-10. 9 kg (N=72). 6% (N=72). 8 kg (N=70). 9% (N=70). 8% (N=451) * Note that in the High Dose group, there were 2 subjects with modal 200 mg total daily dose and 1 subject with modal 100 mg total daily dose.
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%).
5 kg was observed in ziprasidone patients compared to no median weight change in placebo patients. 4% of ziprasidone and placebo patients, respectively. 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 (23 to 27) or overweight patients (>27).
3 kg mean weight loss for patients who entered the program with a “high” BMI. 6% for both ziprasidone and placebo treatment groups who completed the 6 months of observation for relapse. 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.
9 Rash In premarketing trials with ziprasidone, about 5% of patients developed rash and/or urticaria, with discontinuation of treatment in about one-sixth of these cases. 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.
, elevated WBCs. 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.
Upon appearance of rash for which an alternative etiology cannot be identified, ziprasidone should be discontinued. 10 Orthostatic Hypotension 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.
6% of the patients treated with ziprasidone. 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).
11 Falls Antipsychotic drugs (which include ziprasidone) may cause somnolence, postural hypotension, and motor and sensory instability, which could lead to falls and, consequently, fractures or other injuries. 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.
12 Leukopenia, Neutropenia, and Agranulocytosis In clinical trial and postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents. Agranulocytosis (including fatal cases) has also been reported.
Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug induced leukopenia/neutropenia. 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.
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. Patients with severe neutropenia (absolute neutrophil count <1000/mm3) should discontinue ziprasidone and have their WBC followed until recovery.
4% of patients treated with ziprasidone. There were confounding factors that may have contributed to the occurrence of seizures in many of these cases. , Alzheimer’s dementia. Conditions that lower the seizure threshold may be more prevalent in a population of 65 years or older.
14 Dysphagia 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.
Ziprasidone and other antipsychotic drugs should be used cautiously in patients at risk for aspiration pneumonia [see Boxed Warning ]. 15 Hyperprolactinemia As with other drugs that antagonize dopamine D 2 receptors, ziprasidone elevates prolactin levels in humans.
1) ]. 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.
Published epidemiologic studies have shown inconsistent results when exploring the potential association between hyperprolactinemia and breast cancer. 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. 16 Potential for Cognitive and Motor Impairment Somnolence was a commonly reported adverse reaction in patients treated with ziprasidone.
In the 4- and 6-week placebo-controlled trials in adults, somnolence was reported in 14% of patients on ziprasidone compared to 7% of placebo patients. 3% of the patients in short-term clinical trials in adults. 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.
17 Priapism 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. 18 Body Temperature Regulation 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.
, exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration. 19 Suicide 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.
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. 7) ] Ziprasidone has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease.
Patients with these diagnoses were excluded from premarketing clinical studies. 21 Laboratory Tests 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. 3)]