Brand Name
Geodon
Generic Name
Ziprasidone
View Brand Information FDA approval date: December 23, 2003
Classification: Atypical Antipsychotic
Form: Injection, Capsule
What is Geodon (Ziprasidone)?
Ziprasidone is 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. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions.
Save this treatment for later
Not sure about your diagnosis?
Tired of the same old research?
Related Clinical Trials
Proposal To Develop A Rapid And Cost-Effective Diagnostic Test For Schizophrenia
Summary: Schizophrenia is a severe psychotic illness of unknown cause that affects 1% of the population worldwide. Currently, there is no diagnostic test for schizophrenia. Instead, the diagnosis is typically established through a psychiatric interview of the patient, who is evaluated against a set of established criteria of signs and symptoms. It can take many months to years to establish a diagnosis of s...
An Observational Study on Atypical Antipsychotics Long-term Treatment Patients With Schizophrenia
Summary: This multi-centre study will evaluate the safety and related factors study of atypical antipsychotics long-term treatment in Chinese Patients with Schizophrenia. The atypical antipsychotics include quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, paliperidone , amisulpride , perospirone and clozapine. This is an open, cohort, multi-center observational clinical study. The main purpo...
Related Latest Advances
Brand Information
Geodon (ziprasidone hydrochloride)
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. GEODON is not approved for the treatment of patients with dementia-related psychosis
1INDICATIONS AND USAGE
GEODON is 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. GEODON intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs
Schizophrenia
- GEODON is indicated for the treatment of schizophrenia in adults
Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate)
- GEODON is indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder
- GEODON is indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults
Acute Treatment of Agitation in Schizophrenia
- GEODON intramuscular is indicated for the treatment of acute agitation in schizophrenic adult patients for whom treatment with ziprasidone is appropriate and who need intramuscular antipsychotic medication for rapid control of agitation
2DOSAGE FORMS AND STRENGTHS
GEODON capsules are differentiated by capsule color/size and are imprinted in black ink with “Pfizer and ZDX [dosage strength]” or “Pfizer” and a unique number. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. They are supplied in the following strengths and package configurations:
GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions)
3ADVERSE REACTIONS
The following adverse reactions are described in more detail in other sections of the prescribing information:
- Increased Mortality in Elderly Patients with Dementia-Related Psychosis
- Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis
- QT Prolongation and Risk of Sudden Death
- Serotonin Syndrome
- Neuroleptic Malignant Syndrome (NMS)
- Severe Cutaneous Adverse Reactions
- Tardive Dyskinesia
- Metabolic Changes
- Rash
- Orthostatic Hypotension
- Falls
- Leukopenia, Neutropenia, and Agranulocytosis
- Seizures
- Dysphagia
- Hyperprolactinemia
- Potential for Cognitive and Motor Impairment
- Priapism
- Body Temperature Regulation
- Suicide
3.1Clinical 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. An additional 127 patients with bipolar disorder participated in a long-term maintenance treatment study representing approximately 74.7 patient-years of exposure to ziprasidone. 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.
Clinical trials for intramuscular ziprasidone included 570 patients and/or normal subjects who received one or more injections of ziprasidone. Over 325 of these subjects participated in trials involving the administration of multiple doses.
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
- Somnolence
- Respiratory Tract Infection
Bipolar trials
- 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.
- Akathisia
- Abnormal Vision
- Asthenia
- Vomiting
SCHIZOPHRENIA
Adverse Reactions Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials of Oral Ziprasidone
Approximately 4.1% (29/702) of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse reaction, compared with about 2.2% (6/273) on placebo. The most common reaction associated with dropout was rash, including 7 dropouts for rash among ziprasidone patients (1%) compared to no placebo patients
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.
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.
Vital Sign Changes
Ziprasidone is associated with orthostatic hypotension
ECG Changes
Ziprasidone is associated with an increase in the QTc interval
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 are further categorized by body system and listed in order of decreasing frequency according to the following definitions:
Frequent - adverse reactions occurring in at least 1/100 patients (≥1.0% of patients) (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing);
Infrequent - adverse reactions occurring in 1/100 to 1/1000 patients (in 0.1-1.0% of patients)
Rare - adverse reactions occurring in fewer than 1/1000 patients (<0.1% of patients).
Body as a Whole
Frequent abdominal pain, flu syndrome, fever, accidental fall, face edema, chills, photosensitivity reaction, flank pain, hypothermia, motor vehicle accident
Cardiovascular System
Frequent tachycardia, hypertension, postural hypotension
Infrequent bradycardia, angina pectoris, atrial fibrillation
Rare first degree AV block, bundle branch block, phlebitis, pulmonary embolus, cardiomegaly, cerebral infarct, cerebrovascular accident, deep thrombophlebitis, myocarditis, thrombophlebitis
Digestive System
Frequent anorexia, vomiting
Infrequent rectal hemorrhage, dysphagia, tongue edema
Rare gum hemorrhage, jaundice, fecal impaction, gamma glutamyl transpeptidase increased, hematemesis, cholestatic jaundice, hepatitis, hepatomegaly, leukoplakia of mouth, fatty liver deposit, melena
Endocrine
Rare hypothyroidism, hyperthyroidism, thyroiditis
Hemic and Lymphatic System
Infrequent anemia, ecchymosis, leukocytosis, leukopenia, eosinophilia, lymphadenopathy
Rare thrombocytopenia, hypochromic anemia, lymphocytosis, monocytosis, basophilia, lymphedema, polycythemia, thrombocythemia
Metabolic and Nutritional Disorders
Infrequent thirst, transaminase increased, peripheral edema, hyperglycemia, creatine phosphokinase increased, alkaline phosphatase increased, hypercholesteremia, dehydration, lactic dehydrogenase increased, albuminuria, hypokalemia
Rare BUN increased, creatinine increased, hyperlipemia, hypocholesteremia, hyperkalemia, hypochloremia, hypoglycemia, hyponatremia, hypoproteinemia, glucose tolerance decreased, gout, hyperchloremia, hyperuricemia, hypocalcemia, hypoglycemic reaction, hypomagnesemia, ketosis, respiratory alkalosis
Musculoskeletal System
Frequent myalgia
Infrequent tenosynovitis
Rare myopathy
Nervous System
Frequent agitation, extrapyramidal syndrome, tremor, dystonia, hypertonia, dyskinesia, hostility, twitching, paresthesia, confusion, vertigo, hypokinesia, hyperkinesia, abnormal gait, oculogyric crisis, hypesthesia, ataxia, amnesia, cogwheel rigidity, delirium, hypotonia, akinesia, dysarthria, withdrawal syndrome, buccoglossal syndrome, choreoathetosis, diplopia, incoordination, neuropathy
Infrequent paralysis
Rare myoclonus, nystagmus, torticollis, circumoral paresthesia, opisthotonos, reflexes increased, trismus
Respiratory System
Frequent dyspnea
Infrequent pneumonia, epistaxis
Rare hemoptysis, laryngismus
Skin and Appendages
Infrequent maculopapular rash, urticaria, alopecia, eczema, exfoliative dermatitis, contact dermatitis, vesiculobullous rash
Special Senses
Frequent fungal dermatitis
Infrequent conjunctivitis, dry eyes, tinnitus, blepharitis, cataract, photophobia
Rare eye hemorrhage, visual field defect, keratitis, keratoconjunctivitis
Urogenital System
Infrequent impotence, abnormal ejaculation, amenorrhea, hematuria, menorrhagia, female lactation, polyuria, urinary retention metrorrhagia, male sexual dysfunction, anorgasmia, glycosuria
Rare gynecomastia, vaginal hemorrhage, nocturia, oliguria, female sexual dysfunction, uterine hemorrhage
BIPOLAR DISORDER
Acute Treatment of Manic or Mixed Episodes in Adults
Adverse Reactions Associated with Discontinuation of Treatment in Short Term, Placebo-Controlled Trials
Approximately 6.5% (18/279) of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse reaction, compared with about 3.7% (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.
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.
INTRAMUSCULAR ZIPRASIDONE
Adverse Reactions Occurring at an Incidence of 1% or More Among Ziprasidone-Treated Patients in Short-Term Trials of Intramuscular Ziprasidone
Table 13 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy with intramuscular ziprasidone in 1% or more of patients.
In these studies, the most commonly observed adverse reactions associated with the use of intramuscular ziprasidone (incidence of 5% or greater) and observed at a rate on intramuscular ziprasidone (in the higher dose groups) at least twice that of the lowest intramuscular ziprasidone group were headache (13%), nausea (12%), and somnolence (20%).
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of GEODON. 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.
Adverse reaction reports not listed above that have been received since market introduction include rare occurrences of the following : Cardiac Disorders: Tachycardia, torsade de pointes (in the presence of multiple confounding factors),
4DRUG INTERACTIONS
Drug-drug interactions can be pharmacodynamic (combined pharmacologic effects) or pharmacokinetic (alteration of plasma levels). The risks of using ziprasidone in combination with other drugs have been evaluated as described below. All interactions studies have been conducted with oral ziprasidone. Based upon the pharmacodynamic and pharmacokinetic profile of ziprasidone, possible interactions could be anticipated:
4.1Metabolic Pathway
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.
4.2In Vitro Studies
An
4.3Pharmacodynamic Interactions
- Ziprasidone should not be used with any drug that prolongs the QT interval
- Given the primary CNS effects of ziprasidone, caution should be used when it is taken in combination with other centrally acting drugs.
- Because of its potential for inducing hypotension, ziprasidone may enhance the effects of certain antihypertensive agents.
- Ziprasidone may antagonize the effects of levodopa and dopamine agonists.
- Risk of serotonin syndrome with concomitant therapy with other serotonergic drugs such as SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort
4.4Lithium
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. Ziprasidone dosed adjunctively to lithium in a maintenance trial of bipolar patients did not affect mean therapeutic lithium levels.
4.5Oral Contraceptives
In vivo studies have revealed no effect of ziprasidone on the pharmacokinetics of estrogen or progesterone components. Ziprasidone at a dose of 20 mg twice daily did not affect the pharmacokinetics of concomitantly administered oral contraceptives, ethinyl estradiol (0.03 mg) and levonorgestrel (0.15 mg).
4.6Dextromethorphan
Consistent with
4.7Valproate
A pharmacokinetic interaction of ziprasidone with valproate is unlikely due to the lack of common metabolic pathways for the two drugs. Ziprasidone dosed adjunctively to valproate in a maintenance trial of bipolar patients did not affect mean therapeutic valproate levels.
4.8Other Concomitant Drug Therapy
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.
4.9Food Interaction
The absolute bioavailability of a 20 mg dose under fed conditions is approximately 60%. The absorption of ziprasidone is increased up to two-fold in the presence of food
5DESCRIPTION
GEODON contains the active moiety, ziprasidone, in either the form of ziprasidone hydrochloride salt for capsules and in the form of ziprasidone mesylate salt for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2
GEODON capsules contain a monohydrochloride, monohydrate salt of ziprasidone. Chemically, ziprasidone hydrochloride monohydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2
GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. GEODON capsules contain ziprasidone hydrochloride monohydrate, lactose, magnesium stearate and pregelatinized starch. Each capsule for oral use contains ziprasidone hydrochloride monohydrate equivalent to either 20 mg, 40 mg, 60 mg, or 80 mg of ziprasidone.
GEODON for Injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2
GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions)
6HOW SUPPLIED/STORAGE AND HANDLING
GEODON capsules are differentiated by capsule color/size and are imprinted in black ink with “Pfizer and ZDX [dosage strength]” or with “Pfizer” and a unique number. GEODON capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. They are supplied in the following strengths and package configurations:
or
GEODON capsules should be stored at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions)
GEODON for Injection should be stored at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in dry form. Protect from light. Following reconstitution, GEODON for Injection can be stored, when protected from light, for up to 24 hours at 15°C to 30°C (59°F to 86°F) or up to 7 days refrigerated, 2°C to 8°C (36°F to 46°F).
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Administration Information for Capsules
Advise patients to take GEODON capsules whole. Do not open, crush, or chew the capsules. Instruct patients to take GEODON capsules with food for optimal absorption. The absorption of ziprasidone is increased up to two-fold in the presence of food
QTc Prolongation
Advise patients to inform their health care providers of the following: History of QT prolongation; recent acute myocardial infarction; uncompensated heart failure; prescription of other drugs that have demonstrated QT prolongation; risk for significant electrolyte abnormalities; and history of cardiac arrhythmia
Instruct patients 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. In addition, instruct patients to report symptoms such as dizziness, palpitations, or syncope to the prescriber
Serotonin Syndrome
Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of GEODON with other serotonergic drugs including SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair the metabolism of serotonin (in particular, MAOIs, which include those intended to treat psychiatric disorders and also others, such as linezolid). Instruct patients to contact their health care provider, or report to the emergency room, should they experience signs or symptoms of serotonin syndrome
Severe Cutaneous Adverse Reactions
Instruct patients to report to their health care provider at the earliest onset any signs or symptoms that may be associated with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) or with severe cutaneous adverse reactions, such as Stevens-Johnson syndrome
Pregnancy
Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with GEODON. Advise patients that GEODON may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to GEODON during pregnancy
Lactation
Advise breastfeeding women using GEODON to monitor infants for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors, and abnormal muscle movements) and to seek medical care if they notice these signs
Infertility
Advise females of reproductive potential that GEODON may impair fertility due to an increase in serum prolactin levels. The effects on fertility are reversible
Distributed by:
© 2024 Viatris Inc.
GEODON is a registered trademark of Viatris Specialty LLC, a Viatris Company.
The brands listed are trademarks of their respective owners.
UPJ:GDNCI:RX
8PATIENT SUMMARY OF INFORMATION ABOUT
GEODON
Information for patients taking GEODON or their caregivers
This summary contains important information about GEODON. It is not meant to take the place of your doctor’s instructions. Read this information carefully before you take GEODON. Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about GEODON.
What Is GEODON?
GEODON is a type of prescription medicine called a psychotropic, also known as an atypical antipsychotic. GEODON can be used to treat symptoms of schizophrenia and acute manic or mixed episodes associated with bipolar disorder. GEODON can also be used as maintenance treatment of bipolar disorder when added to lithium or valproate.
Who Should Take GEODON?
Only your doctor can know if GEODON is right for you. GEODON may be prescribed for you if you are an adult with schizophrenia or bipolar disorder.
Symptoms of schizophrenia may include:
- hearing voices, seeing things, or sensing things that are not there (hallucinations)
- beliefs that are not true (delusions)
- unusual suspiciousness (paranoia)
- becoming withdrawn from family and friends
Symptoms of manic or mixed episodes of bipolar disorder may include:
- extremely high or irritable mood
- increased energy, activity, and restlessness
- racing thoughts or talking very fast
- easily distracted
- little need for sleep
If you show a response to GEODON, your symptoms may improve. If you continue to take GEODON there is less chance of your symptoms returning. Do not stop taking the capsules even when you feel better without first discussing it with your doctor.
It is also important to remember that GEODON capsules should be taken with food.
What is the most important safety information I should know about GEODON?
GEODON is not approved for the treatment of patients with dementia-related psychosis. Elderly patients with a diagnosis of psychosis related to dementia treated with antipsychotics are at an increased risk of death when compared to patients who are treated with placebo (a sugar pill).
GEODON is an effective drug to treat the symptoms of schizophrenia and the manic or mixed episodes of bipolar disorder. However, one potential side effect is that it may change the way the electrical current in your heart works more than some other drugs. The change is small and it is not known whether this will be harmful, but some other drugs that cause this kind of change have in rare cases caused dangerous heart rhythm abnormalities. Because of this, GEODON should be used only after your doctor has considered this risk for GEODON against the risks and benefits of other medications available for treating schizophrenia or bipolar manic and mixed episodes.
Your risk of dangerous changes in heart rhythm can be increased if you are taking certain other medicines and if you already have certain abnormal heart conditions. Therefore, it is important to tell your doctor about any other medicines that you take, including non-prescription medicines, supplements, and herbal medicines. You must also tell your doctor about any heart problems you have or have had.
Who should NOT take GEODON?
Elderly patients with a diagnosis of psychosis related to dementia. GEODON is not approved for the treatment of these patients.
Do not take GEODON if you:
- take anything that can increase the chance of a heart rhythm abnormality.
- have certain heart diseases, for example, long QT syndrome, a recent heart attack, severe heart failure, or certain irregularities of heart rhythm (discuss the specifics with your doctor).
- 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.
- are taking a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including linezolid or intravenous methylene blue.
- have stopped taking an MAOI in the last 14 days.
- are allergic to ziprasidone or any of the ingredients in GEODON.
What To Tell Your Doctor Before You Start GEODON
Only your doctor can decide if GEODON is right for you. Before you start GEODON, be sure to tell your doctor if you:
- 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
- have had any problems with your liver
- are pregnant, might be pregnant, or plan to get pregnant
- are breastfeeding or plan to breastfeed
- are allergic to any medicines
- have ever had an allergic reaction to ziprasidone or any of the other ingredients of GEODON capsules. Ask your doctor or pharmacist for a list of these ingredients
- have low levels of potassium or magnesium in your blood
Your doctor may want you to get additional laboratory tests to see if GEODON is an appropriate treatment for you.
GEODON And Other Medicines
There are some medications that may be unsafe to use when taking GEODON, and there are some medicines that can affect how well GEODON works. While you are on GEODON, check with your doctor before starting any new prescription or over-the-counter medications, including natural/herbal remedies.
How To Take GEODON
- Take GEODON only as directed by your doctor.
- Swallow GEODON capsules whole. Do not chew, crush, or open the capsules.
- Take GEODON capsules with food.
- It is best to take GEODON at the same time each day.
- GEODON may take a few weeks to work. It is important to be patient.
- Do not change your dose or stop taking your medicine without your doctor’s approval.
- Remember to keep taking your capsules, even when you feel better.
Possible Side Effects
Because these problems could mean you’re having a heart rhythm abnormality, contact your doctor
- Faint or lose consciousness
- Feel a change in the way that your heart beats (palpitations)
Common side effects of GEODON include the following and should also be discussed with your doctor if they occur:
Adults:
- Feeling unusually tired or sleepy
- Nausea or upset stomach
- Constipation
- Dizziness
- Restlessness
- Abnormal muscle movements, including tremor, shuffling, and uncontrolled involuntary movements
- Diarrhea
- Rash
- Increased cough / runny nose
If you develop any side effects that concern you, talk with your doctor. It is particularly important to tell your doctor if you have diarrhea, vomiting, or another illness that can cause you to lose fluids. Your doctor may want to check your blood to make sure that you have the right amount of important salts after such illnesses.
For a list of all side effects that have been reported, ask your doctor or pharmacist for the GEODON Professional Package Insert.
What To Do For An Overdose
In case of an overdose, call your doctor or poison control center right away or go to the nearest emergency room.
Other Important Safety Information
A potentially life-threatening problem called serotonin syndrome can happen when you take GEODON with certain other medicines.
- Call your healthcare provider if you have any of the following signs and symptoms of serotonin syndrome: agitation, hallucinations, coma, or other changes in mental status; racing heartbeat, high or low blood pressure; coordination problems or muscle twitching; nausea, vomiting, or diarrhea; sweating or fever; muscle rigidity.
A serious condition called neuroleptic malignant syndrome (NMS) can occur with all antipsychotic medications including GEODON. Signs of NMS include very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. NMS is a rare but serious side effect that could be fatal. Therefore, tell your doctor if you experience any of these signs.
Delayed-onset drug reaction called drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with ziprasidone. Signs of DRESS may include rash, fever, and swollen lymph nodes. Other severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome can occur with ziprasidone. Signs of Stevens-Johnson syndrome may include rash with blisters which could include ulcers in mouth, skin shedding, fever and target-like spots in the skin. DRESS and other SCAR are sometimes fatal; therefore, tell your doctor immediately if you experience any of these signs.
Adverse reactions related to high blood sugar (hyperglycemia), sometimes serious, have been reported in patients treated with atypical antipsychotics. There have been few reports of hyperglycemia or diabetes in patients treated with GEODON, and it is not known if GEODON is associated with these reactions. Patients treated with an atypical antipsychotic should be monitored for symptoms of hyperglycemia.
Dizziness caused by a drop in your blood pressure may occur with GEODON, especially when you first start taking this medication or when the dose is increased. If this happens, be careful not to stand up too quickly, and talk to your doctor about the problem.
Before taking GEODON, tell your doctor if you
- are pregnant or plan on becoming pregnant.
- are breastfeeding or plan to breastfeed. GEODON can pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you receive GEODON.
Because GEODON can cause sleepiness, be careful when operating machinery or driving a motor vehicle.
Since medications of the same drug class as GEODON may interfere with the ability of the body to adjust to heat, it is best to avoid situations involving high temperature or humidity.
It is best to avoid consuming alcoholic beverages while taking GEODON.
Call your doctor
GEODON has not been shown to be safe or effective in the treatment of children and teenagers under the age of 18 years old.
Keep GEODON and all medicines out of the reach of children.
How To Store GEODON
Store GEODON capsules at room temperature (59°F to 86°F or 15°C to 30°C).
For More Information About GEODON
This sheet is only a summary. GEODON is a prescription medicine and only your doctor can decide if it is right for you. If you have any questions or want more information about GEODON, talk with your doctor or pharmacist.
Distributed by:
© 2024 Viatris Inc.
GEODON is a registered trademark of Viatris Specialty LLC, a Viatris Company.
The brands listed are trademarks of their respective owners.
UPJ:PL:GDNCI:RX
Revised: 1/2025
9PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Label
NDC 0049-3960-60
Pfizer
Geodon®
ziprasidone HCl
ziprasidone HCl
20 mg*
60 Capsules
10PRINCIPAL DISPLAY PANEL - 60 mg Capsule Bottle Label
NDC 0049-3980-60
Pfizer
Geodon®
ziprasidone HCl
ziprasidone HCl
60 mg*
60 Capsules
11PRINCIPAL DISPLAY PANEL - 80 mg Capsule Bottle Label
NDC 0049-3990-60
Pfizer
Geodon®
ziprasidone HCl
ziprasidone HCl
80 mg*
60 Capsules
12PRINCIPAL DISPLAY PANEL - 20 mg/mL Single Dose Vial Label
Single Dose Vial
Geodon®
for Injection
(ziprasidone mesylate)
for Injection
(ziprasidone mesylate)
equivalent to
Sterile
13PRINCIPAL DISPLAY PANEL – 20 mg/mL Vial Carton
NDC 0049-3920-20
Single Dose Vial
Geodon
for Injection
for Injection
(ziprasidone mesylate)
equivalent to
Sterile
Pfizer Injectables
Rx only
14PRINCIPAL DISPLAY PANEL - 10 Vial Carton
NDC 0049-3920-83
10 Single Dose Vials
Geodon
(ziprasidone mesylate)
(ziprasidone mesylate)
equivalent to
Sterile
Pfizer Injectables
Rx only
15PRINCIPAL DISPLAY PANEL - 20 mg/mL Vial Label - 0049-3920-01
NDC 0049-3920-01
Geodon
(ziprasidone mesylate)
equivalent to
20 mg/mL*
of ziprasidone
(ziprasidone mesylate)
equivalent to
20 mg/mL*
of ziprasidone
PROTECT FROM LIGHT.
Sterile
16PRINCIPAL DISPLAY PANEL - 20 mg/mL Vial Carton - 0049-3920-10
10 Single Dose Vials
Geodon
equivalent to
PROTECT FROM LIGHT.
Sterile
Pfizer Injectables
17PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Label - 0052
NDC 0049-0052-60
Pfizer
Geodon®
(ziprasidone HCl)
capsules
(ziprasidone HCl)
capsules
20 mg*
60 Capsules
18PRINCIPAL DISPLAY PANEL - 40 mg Capsule Bottle Label - 0054
NDC 0049-0054-60
Pfizer
Geodon®
(ziprasidone HCl)
capsules
(ziprasidone HCl)
capsules
40 mg*
60 Capsules
19PRINCIPAL DISPLAY PANEL - 60 mg Capsule Bottle Label - 0056
NDC 0049-0056-60
Pfizer
Geodon®
(ziprasidone HCl)
capsules
(ziprasidone HCl)
capsules
60 mg*
60 Capsules
20PRINCIPAL DISPLAY PANEL - 80 mg Capsule Bottle Label - 0058
NDC 0049-0058-60
Pfizer
Geodon®
(ziprasidone HCl)
capsules
(ziprasidone HCl)
capsules
80 mg*
60 Capsules
21PRINCIPAL DISPLAY PANEL - 20 mg Capsule Bottle Label - 0352
NDC 0049-0352-60
Pfizer
Geodon
(ziprasidone)
capsules
(ziprasidone)
capsules
20 mg*
60 Capsules
22PRINCIPAL DISPLAY PANEL - 40 mg Capsule Bottle Label - 0354
NDC 0049-0354-60
Pfizer
Geodon
(ziprasidone)
capsules
(ziprasidone)
capsules
40 mg*
60 Capsules
23PRINCIPAL DISPLAY PANEL - 60 mg Capsule Bottle Label - 0356
NDC 0049-0356-60
Pfizer
Geodon
(ziprasidone)
capsules
(ziprasidone)
capsules
60 mg*
60 Capsules
24PRINCIPAL DISPLAY PANEL - 80 mg Capsule Bottle Label - 0358
NDC 0049-0358-60
Pfizer
Geodon
(ziprasidone)
capsules
(ziprasidone)
capsules
80 mg*
60 Capsules
