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ziprasidone

Pronunciation

Generic Name: ziprasidone (zi PRAY si done)
Brand Name: Geodon

What is ziprasidone?

Ziprasidone is an antipsychotic medication. It works by changing the effects of chemicals in the brain.

Ziprasidone is used to treat schizophrenia and the manic symptoms of bipolar disorder (manic depression) in adults and children who are at least 10 years old.

Ziprasidone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about ziprasidone?

You should not use this medicine if you have a personal or family history of Long QT syndrome, if you have recently had a heart attack, or if you have uncontrolled heart failure.

Some medicines can cause unwanted or dangerous effects when used with ziprasidone, and should not be used at the same time. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

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Stop taking ziprasidone and call your doctor right away if you have a headache with chest pain, severe dizziness, and a fast or pounding heartbeat. These could be signs of a serious heart rhythm problem.

Ziprasidone is not approved for use in psychotic conditions related to dementia. Ziprasidone may increase the risk of death in older adults with dementia-related conditions.

What should I discuss with my healthcare provider before taking ziprasidone?

You should not use this medicine if you are allergic to ziprasidone, or if you have:

  • a personal or family history of "Long QT syndrome";

  • history of recent heart attack; or

  • uncontrolled or untreated heart failure.

Ziprasidone is not approved for use in psychotic conditions related to dementia. Ziprasidone may increase the risk of death in older adults with dementia-related conditions.

Ziprasidone should never be taken together with any of the following drugs, or a life-threatening heart rhythm disorder could occur:

  • arsenic trioxide, fluconazole, methadone, tacrolimus, tizanidine;

  • an antibiotic--azithromycin, ciprofloxacin, clarithromycin, erythromycin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin, pentamidine, trazodone, trimipramine; HIV or AIDS medication--lopinavir, saquinavir;

  • anti-malaria medication--chloroquine, mefloquine, quinine; medicine to prevent or treat nausea and vomiting--dolasetron, droperidol, granisetron, ondansetron.

  • an antidepressant--amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, maprotiline, nortriptyline; medicine to treat a psychiatric disorder--chlorpromazine, clozapine, fluphenazine, haloperidol, perphenazine, pimozide, prochlorperazine, promethazine, quetiapine, risperidone, thioridazine, trazodone, trifluoperazine; or

  • cancer medicine--epirubicin, daunorubicin, doxorubicin, idarubicin, tamoxifen, toremifene; heart rhythm medicine--amiodarone, dofetilide, disopyramide, flecainide, ibutilide, procainamide, propafenone, quinidine, sotalol.

To make sure ziprasidone is safe for you, tell your doctor if you have:

  • a heart rhythm disorder;

  • a history of heart attack or stroke;

  • a history of bone marrow or blood cell disorder;

  • a history of breast cancer;

  • low blood levels of potassium or magnesium;

  • diabetes (ziprasidone may raise your blood sugar);

  • high cholesterol or triglycerides (a type of fat in the blood);

  • seizures or epilepsy;

  • a history of suicidal thoughts;

  • Parkinson's disease, Alzheimer's;

  • trouble swallowing;

  • liver disease; or

  • kidney disease.

Ziprasidone may cause you to have high blood sugar (hyperglycemia). Talk to your doctor if you have any signs of hyperglycemia such as increased thirst or urination, excessive hunger, or weakness. If you are diabetic, check your blood sugar levels on a regular basis while you are taking ziprasidone.

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking ziprasidone, do not stop taking it without your doctor's advice.

It is not known whether ziprasidone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Older adults may be more likely to have side effects from this medicine.

How should I take ziprasidone?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

While using ziprasidone, you may need frequent blood tests. Your kidney or liver function may also need to be checked.

Take this medicine with food.

Use ziprasidone regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture, light, and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking ziprasidone?

While you are taking ziprasidone, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking ziprasidone.

Ziprasidone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid drinking alcohol. It can increase some of the side effects of ziprasidone.

Ziprasidone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using ziprasidone and call your doctor at once if you have:

  • dizziness, feeling light-headed, fainting, fast or pounding heartbeat;

  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;

  • chills, body aches, flu symptoms;

  • white patches or sores inside your mouth or on your lips;

  • tremor (uncontrolled shaking), restless muscle movements in your eyes, tongue, jaw, or neck;

  • agitation, hostility, confusion;

  • increased thirst or urination, weakness, extreme hunger; or

  • penis erection that is painful or lasts 4 hours or longer.

Common side effects may include:

  • mild skin rash;

  • anxiety, headache, depressed mood;

  • dizziness, drowsiness;

  • muscle pain or twitching;

  • nausea, vomiting, loss of appetite;

  • runny or stuffy nose, cough, sore throat; or

  • weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Ziprasidone dosing information

Usual Adult Dose for Schizophrenia:

Injection:
10 mg IM every 2 hours or 20 mg every 4 hours as needed
Maximum dose: 40 mg per day
There are no data on the IM administration of ziprasidone for greater than 3 consecutive days.

Oral:
Initial dose: 20 mg twice a day with food. If clinically necessary, initial dosage may be adjusted at intervals of not less than 2 days up to 80 mg twice a day.
Maximum dose: 100 mg twice a day

One study has reported that oral ziprasidone should be taken with food and that a meal equal to or greater than 500 kcal, irrespective of fat content, is required for optimal and reproducible bioavailability of the administered dose.

Usual Adult Dose for Autism:

Injection:
10 mg IM every 2 hours or 20 mg every 4 hours as needed
Maximum dose: 40 mg per day
There are no data on the IM administration of ziprasidone for greater than 3 consecutive days.

Oral:
Initial dose: 20 mg twice a day with food. If clinically necessary, initial dosage may be adjusted at intervals of not less than 2 days up to 80 mg twice a day.
Maximum dose: 100 mg twice a day

One study has reported that oral ziprasidone should be taken with food and that a meal equal to or greater than 500 kcal, irrespective of fat content, is required for optimal and reproducible bioavailability of the administered dose.

Usual Adult Dose for Bipolar Disorder:

Oral:
Acute Treatment of Manic or Mixed Episodes:
Initial dose: 40 mg twice a day with food. The dose should then be increased to 60 mg or 80 mg twice a day on the second day of treatment. The dose should then be adjusted on the basis of toleration and efficacy within the 40 mg to 80 mg twice a day range.

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. Patients should be periodically reassessed to determine the need for maintenance treatment.

One study has reported that oral ziprasidone should be taken with food and that a meal equal to or greater than 500 kcal, irrespective of fat content, is required for optimal and reproducible bioavailability of the administered dose.

Usual Pediatric Dose for Tourette's Syndrome:

Not FDA approved:
Tourette's syndrome: 5 to 40 mg orally per day

Usual Pediatric Dose for Bipolar Disorder:

Not FDA Approved:
Note: In June 2009, an FDA advisory panel advised that ziprasidone is effective in patients 10 to 17 years of age for the treatment of mixed and manic episodes of bipolar disorder, but did not conclude that it was safe due to large number of subjects lost to follow-up and ambiguity within QTc prolongation data; limited data available.

Children and Adolescents 10 to 17 years:
Initial dose: 20 mg/day; titrate dose upwards as tolerated, using twice daily dosing over a 2 week period to the weight-based target range: 60 to 80 mg/day (45 kg or less) divided into twice daily doses or 120 to 160 mg/day (greater than 45 kg) divided into twice daily doses.
Alternate dosing: An open-label, 8 week study of 21 patients [6 to 17 years (mean: 10.3 years)] with bipolar disorder and comorbid conditions (ADHD, depression, conduct disorder) used the following weight-based dosing regimen:
Initial dose: 1 mg/kg/day divided twice daily; increase to 1.5 mg/kg/day divided twice daily by Week 2 and increase to 2 mg/kg/day divided twice daily by Week 3 if tolerated; maximum dose: 160 mg/day; Note: Only 14 of the 21 patients completed the study; five dropped out due to lack of efficacy; two dropped out due to adverse reactions; patients experienced a high incidence of sedation (46%) and headaches (38%).

Usual Pediatric Dose for Autism:

Not FDA Approved:
Autism and PDD-NOS (Pervasive Developmental Disorder Not Otherwise Specified) irritability: Children and Adolescents 8 to 20 years: Limited data available; dose not established. Reported final dose range: 20 to 160 mg/day divided twice daily
A prospective, open-labeled study of 12 patients (12 to 18 years) used the following individually titrated doses:
Patient weight 35 kg or less: Initial: 20 mg every other day given at bedtime for 2 doses; then increase dose in weekly increments based on clinical response and tolerability: Week 1: 10 mg twice daily (20 mg/day); Week 2: 20 mg twice daily (40 mg/day); Week 3: 40 mg twice daily (80 mg/day); Week 4: 80 mg twice daily (160 mg/day)
Patient weight greater than 35 kg: Initial: 20 mg/day at bedtime for 3 doses; then increase dose in weekly increments based on clinical response and tolerability: Week 1: 20 mg twice daily (40 mg/day); Week 2: 40 mg twice daily (80 mg/day); Week 4: 80 mg twice daily (160 mg/day)
A case series of 12 patients (8 to 20 years) initiated with 20 mg/day given at bedtime and then increased by 10 to 20 mg/week divided twice daily based on clinical response and tolerability; final ziprasidone dosage ranged between 20 to 120 mg/day (mean: 60 mg/day) divided twice daily.

Usual Pediatric Dose for Schizophrenia:

Not FDA Approved:
Acute agitation (schizophrenia): Children and Adolescents: Limited information available; dose not established
5 to 11 years: 10 mg intramuscularly once.
12 years or older : 10 to 20 mg intramuscularly once. Note: One study (n=59; age range: 5 to 19 years) reported that 69% of 20 mg doses surpassed the desired calming therapeutic effect and caused varying degrees of sedation (4% of patients were unable to be aroused).

What other drugs will affect ziprasidone?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking ziprasidone with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with ziprasidone. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with ziprasidone. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

Where can I get more information?

  • Your pharmacist can provide more information about ziprasidone.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 10.04. Revision Date: 2014-06-13, 12:50:40 PM.

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