ziprasidone (Rx)

Brand and Other Names:Geodon
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 20mg
  • 40mg
  • 60mg
  • 80mg

powder for injection

  • 20mg

Schizophrenia

20 mg PO q12hr with food initially; may be increased every other day PRN; not to exceed 80 mg q12hr

Periodically assess need for maintenance; clinical trials have documented no added benefit with doses above 20 mg q12hr

Acute Agitation With Schizophrenia

IM: 10 mg q2hr or 20 mg q4hr; not to exceed 40 mg/day; use IM for up to 3 days, and switch to PO if continuing past this time

Bipolar I Disorder

Acute treatment of manic or mixed episodes; maintenance therapy as adjunct to lithium or valproate

Acute treatment: 40 mg PO q12hr with food initially; on day 2, may be increased if necessary to 60-80 mg PO q12hr; adjust dose according to tolerance and efficacy within range of 40-80 mg q12hr

Maintenance: Continue at same dose at which patient was initially stabilized; periodically reassess need for maintenance therapy

Dosing Modifications

Renal impairment: Dose adjustment not necessary with PO administration; caution required with IM administration

Hepatic impairment: Use caution; drug undergoes extensive hepatic metabolism, which can increase systemic exposure

Dosage Forms & Strengths

capsule

  • 20mg
  • 40mg
  • 60mg
  • 80mg

powder for injection

  • 20mg

Tourette Syndrome (Off-label)

Days 1-3: 5 mg/day

Days 4-28: Titrate to 40 mg/day divided q12hr

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Interactions

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            Adverse Effects

            >10%

            Somnolence (11-15%)

            Headache (11%)

            Nausea (4-12%)

            Extrapyramidal symptoms (2-31%)

            Dizziness (3-16%)

            1-10%

            Respiratory disorders (1-8%)

            Constipation (2-9%)

            Dyspepsia (1-8%)

            Rash (4-5%)

            Tachycardia (2%)

            Hypoesthesia (2%)

            Priapism (1%)

            Orthostatic hypotension (5%)

            Xerostomia (1-5%)

            Anorexia (2%)

            Myalgia (2%)

            Rhinitis (1-4%)

            Cough (3%)

            <1%

            Syncope

            Seizures

            Frequency Not Defined

            Prolongation of QT interval

            Neuroleptic malignant syndrome (NMS)

            Hyperprolactinemia

            Drug reaction with eosinophilia and systemic syntoms

            Postmarketing reports

            Stevens-Johnson syndrome

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            Warnings

            Black Box Warnings

            Not approved for dementia-related psychosis; patients with dementia-related psychosis who are treated with antipsychotic drugs are at increased risk of death, as shown in short-term controlled trials; deaths in these trials appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature

            Not approved for the treatment of dementia-related psychosis

            Contraindications

            Documented hypersensitivity

            Any drugs or conditions that prolong QT interval

            Recent acute myocardial infarction

            Uncompensated heart failure

            Cautions

            Seizure disorders; may cause hypotension, EPS, somnolence, 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

            Atypical antipsychotics have been associated with metabolic changes (eg, hyperglycemia, dyslipidemia, and body weight gain) that may increase cardiovascular/cerebrovascular risk

            Hyperglycemia may occur and in some cases may be extreme, resulting in ketoacidosis, hyperosmolar coma, or death; monitor blood glucose of high-risk patients

            Neuroleptic malignant syndrome reported with antipsychotic drugs

            Tardive dyskinesia, acute dystonic reactions, pseudoparkinsonism, or akathisia may develop acutely or chronically

            Discontinue if rash develops without an identified cause

            Drug reaction with eosinophilia and systemic symptoms (DRESS) reported; DRESS consists of 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 therapy if DRESS suspected

            Cutaneous adverse reactions, such as Stevens-Johnson syndrome, reported; severe cutaneous adverse reactions are sometimes fatal; discontinue therapy if suspected

            Rare cases of priapism reported

            FDA warning regarding off-label use for dementia in elderly (see Black Box Warnings)

            May cause orthostatic hypotension

            Suicide attempt is inherent in psychotic illness or bipolar disorder, close supervision of high-risk patients should accompany drug therapy

            Dopamine2 antagonists may elevate prolactin levels; long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density

            Leukopenia/neutropenia and agranulocytosis reported; possible risk factors for leukopenia/neutropenia include preexisting low white blood cell (WBC) count and history of drug-induced leukopenia/neutropenia

            If patient has history of clinically significant low WBC count or drug-induced leukopenia/neutropenia, monitor complete blood count (CBC) frequently during first few months of therapy; discontinue drug at first sign of clinically significant WBC decline <1000/μL in absence of other causative factors, and continue monitoring WBC count until recovery

            Antipsychotic agents have been associated with esophageal dysmotility and aspiration; use caution in patients at risk of pneumonia

            May cause QTc prolongation, which has been associated with development of malignant ventricular arrhythmias (torsade de pointes) and sudden death; discontinue therapy in patients with persistent QTc intervals >500 msec; avoid hypokalemia or hypomagnesemia

            Moderate to highly sedative; use caution when required to operate heavy machinery

            May cause core body temperature regulation impairment; use caution with heat exposure, strenuous exercise, dehydration, or taking medications with anticholinergic effects

            Make electrolyte imbalance corrections, especially hypomagnesemia or hypokalemia before and throughout therapy

            Use with caution in hepatic impairment

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            Pregnancy & Lactation

            Pregnancy

            There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, during pregnancy; healthcare providers are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry

            Neonates exposed to antipsychotic drugs, during third trimester are at risk for extrapyramidal and/or withdrawal symptoms, following delivery; overall available data from published epidemiologic studies of pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; there are risks to mother associated with untreated schizophrenia or bipolar I disorder and with exposure to antipsychotics, during pregnancy

            There is risk to the mother from untreated schizophrenia or bipolar I disorder, including increased risk of relapse, hospitalization, and suicide

            Schizophrenia and bipolar I disorder are associated with increased adverse perinatal outcomes, including preterm birth; it is not known if this is a direct result of illness or other comorbid factors

            Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates exposed to drug, during third trimester of pregnancy; these symptoms have varied in severity; monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately; some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization

            Animal data

            • In animal studies, drug administration to pregnant rats and rabbits during organogenesis caused developmental toxicity at doses similar to recommended human doses, and was teratogenic in rabbits at 3 times maximum recommended human dose (MRHD); rats exposed to drug during gestation and lactation exhibited increased perinatal pup mortality and delayed neurobehavioral and functional development of offspring at doses less than or similar to human therapeutic doses

            Reproductive potential

            • Females: Based on pharmacologic action of ziprasidone (D2 antagonism), treatment may result in an increase in serum prolactin levels, which may lead to a reversible reduction in fertility in females of reproductive potential

            Lactation

            Limited data from a published case report indicate the presence of drug in human milk; although there are no reports of adverse effects on a breastfed infant exposed to drug via breast milk, there are reports of excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements) in infants exposed to other atypical antipsychotics through breast milk

            There is no information on effects of drug on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from mother’s underlying condition

            Infants exposed to drug should be monitored for excess sedation, irritability, poor feeding, and extrapyramidal symptoms (tremors and abnormal muscle movements)

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Acts as antagonist at dopamine D2 and serotonin type 1 and 2 (5HT1D, 5HT2A) receptors; acts as agonist at serotonin 5HT1A receptor; moderately inhibits reuptake of norepinephrine and serotonin; has alpha-blocking and antihistaminic activity

            Absorption

            Bioavailability: 60% (PO); 100% (IM)

            Peak plasma time: 6-8 hr (PO); ≤60 min (IM)

            Distribution

            Protein bound: 99%

            Vd: 1.5 L/kg

            Metabolism

            Metabolized in liver by CYP3A4 (major) and CYP1A2 (minor)

            Elimination

            Half-life: 7 hr (PO); 2-5 hr (IM)

            Total body clearance: 7.5 mL/min/kg

            Excretion: Feces (66%), urine (20%)

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            Administration

            Oral Administration

            Take capsules whole; do not open, crush, or chew the capsules

            Take with food for optimal absorption; in the presence of food, absorption increases twofold

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            ziprasidone oral
            -
            40 mg capsule
            ziprasidone oral
            -
            20 mg capsule
            ziprasidone oral
            -
            80 mg capsule
            ziprasidone oral
            -
            60 mg capsule
            ziprasidone oral
            -
            40 mg capsule
            ziprasidone oral
            -
            80 mg capsule
            ziprasidone oral
            -
            40 mg capsule
            ziprasidone oral
            -
            20 mg capsule
            ziprasidone oral
            -
            60 mg capsule
            ziprasidone oral
            -
            20 mg capsule
            ziprasidone oral
            -
            60 mg capsule
            ziprasidone oral
            -
            80 mg capsule
            ziprasidone oral
            -
            60 mg capsule
            ziprasidone oral
            -
            80 mg capsule
            ziprasidone oral
            -
            40 mg capsule
            ziprasidone oral
            -
            20 mg capsule
            ziprasidone oral
            -
            80 mg capsule
            ziprasidone oral
            -
            20 mg capsule
            ziprasidone oral
            -
            60 mg capsule
            ziprasidone oral
            -
            40 mg capsule
            ziprasidone oral
            -
            60 mg capsule
            ziprasidone oral
            -
            80 mg capsule
            ziprasidone oral
            -
            40 mg capsule
            ziprasidone oral
            -
            20 mg capsule
            Geodon oral
            -
            80 mg capsule
            Geodon oral
            -
            60 mg capsule
            Geodon oral
            -
            20 mg capsule
            Geodon oral
            -
            40 mg capsule

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            ziprasidone oral

            ZIPRASIDONE - ORAL

            (zi-PRAS-i-done)

            COMMON BRAND NAME(S): Geodon

            WARNING: There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.If you are using ziprasidone in combination with other medication to treat depression, also carefully read the drug information for the other medication.

            USES: This medication is used to treat certain mental/mood disorders (schizophrenia, bipolar disorder). This medication can decrease hallucinations and help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life.Ziprasidone belongs to a class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

            HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking ziprasidone and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with food as directed by your doctor, usually twice daily. Swallow the capsules whole. Do not open, crush, or chew the capsules.The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor.Tell your doctor if your condition lasts or gets worse.

            SIDE EFFECTS: Drowsiness, dizziness, lightheadedness, weakness, nausea, vomiting, runny nose, and cough may occur. If any of these effects last or get worse, tell your doctor promptly.Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: difficulty swallowing, muscle spasms, shaking (tremor), mental/mood changes (such as restlessness), vision changes, interrupted breathing during sleep.This drug may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.This drug may also rarely cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor.This drug may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual/uncontrolled movements (especially of the face, mouth, tongue, arms, or legs).This medication may increase a certain natural substance (prolactin) made by your body. For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.Get medical help right away if you have any very serious side effects, including: severe dizziness, fainting, seizures, signs of liver damage (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin).This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, signs of kidney problems (such as change in the amount of urine).Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking ziprasidone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: dementia, seizures, low white blood cell count, difficulty swallowing, heart disease (such as coronary artery disease, irregular heartbeat), diabetes (including family history), obesity, breathing trouble during sleep (sleep apnea).Ziprasidone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using ziprasidone, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, recent heart attack, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using ziprasidone safely.This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, lightheadedness, uncontrolled movements, and QT prolongation (see above). Drowsiness, dizziness, and lightheadedness can increase the risk of falling.During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away.Since untreated mental/mood problems (such as schizophrenia, bipolar disorder, depression) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: dolasetron, metoclopramide, saquinavir.Many drugs besides ziprasidone may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, moxifloxacin, pimozide, procainamide, quinidine, sotalol, tacrolimus, thioridazine, among others.Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, unusual/uncontrolled movements.

            NOTES: Do not share this medication with others.Lab and/or medical tests (such as blood mineral levels, blood sugar, EKG) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            Information last revised December 2022. Copyright(c) 2022 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.