Ziprasidone

Ziprasidone is a prescription medication used to treat symptoms of schizophrenia and bipolar disorder. Ziprasidone belongs to a group of drugs called atypical antipsychotics. It is believed to work by lessening the effects of certain chemicals in the brain involved with schizophrenia and bipolar disorder.

This medication comes in a capsule and suspension form and is usually taken twice daily with food.

This medication is available in an injectable form to be given directly into the muscle (IM) by a healthcare professional.

Common side effects of ziprasidone include nausea, constipation, and drowsiness.  Do not drive or operate machinery until you know how this medication affects you.

Oral/Injectable:

Ziprasidone is a prescription medication used to treat schizophrenia and bipolar disorder.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Ziprasidone may be found in some form under the following brand names:

• Geodon

Oral/Injectable:

Ziprasidone, like any medication can cause side effects, some of which can be serious or life-threatening. See "Ziprasidone Precautions".

Because these problems could mean you're having a heart rhythm abnormality, contact your doctor IMMEDIATELY if you: 

• Faint or lose consciousness
• Feel a change in the way that your heart beats (palpitations)

Common side effects of ziprasidone include the following and should also be discussed with your doctor if they occur:

• 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 Ziprasidone package insert.

There are some medications that may be unsafe to use when taking ziprasidone, and there are some medicines that can affect how well ziprasidone works. While you are on ziprasidone, check with your doctor before starting any new prescription or over-the-counter medications, including natural/herbal remedies.

Especially tell your doctor if you take:

• amiodarone and other anti-arrhythmics
• mesoridazine
• thioridazine
• chlorpromazine
• disopyramide
• sparfloxacin
• gatifloxacin
• halofantrine
• arsenic trioxide
• levomethadyl acetate
• dofetilide
• dolasetron mesylate
• probucol
• droperidol
• erythromycin
• mefloquine
• moxifloxacin
• pentamidine
• pimozide
• procainamide
• quinidine
• sotalol
• tacrolimus
• antidepressants
• antifungals
• aprepitant
• carbamazepine
• clarithromycin
• cyclosporine
• delavirdine
• diltiazem
• diuretics
• dopamine agonists
• fluoxetine
• fluvoxamine
• HIV protease inhibitors
• hormonal contraceptives
• lovastatin
• medicines for anxiety
• medicines high blood pressure
• medicines for seizures
• verapamil

This is not a complete list of ziprasidone drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported including a rare but serious, potentially fatal skin reaction known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Tell your doctor right away if you develop a fever with a rash and/or swollen lymph glands.

Oral/Injectable:

Ziprasidone 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).

Ziprasidone 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, ziprasidone should be used only after your doctor has considered this risk for ziprasidone 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 ziprasidone?

Elderly patients with a diagnosis of psychosis related to dementia. Ziprasidone is not approved for the treatment of these patients.

Anything that can increase the chance of a heart rhythm abnormality should be avoided. Therefore, do not take ziprasidone if:

• You 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)
• You are currently taking medications that should not be taken in combination with ziprasidone, for example, dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol or tacrolimus.

A serious condition called neuroleptic malignant syndrome (NMS) can occur with all antipsychotic medications including ziprasidone. 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.

Atypical antipsychotic drugs, including ziprasidone, have been linked to changes in overall body metabolism, including high blood sugar, poor cholesterol control, and weight gain.

• High blood sugar and Diabetes Mellitus (DM): Watch for symptoms of high blood sugar including excessive thirst, excessive urination, excessive hunger, and weakness. Those at risk for DM should have blood sugar testing done before and during treatment.
• Poor cholesterol control: Undesirable changes have been seen in patients treated with atypical antipsychotics.
• Weight Gain: Weight gain has been reported. Monitor weight gain.

Dizziness caused by a drop in your blood pressure may occur with ziprasidone, 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 ziprasidone, tell your doctor if you are pregnant or plan on becoming pregnant. It is advised that you don't breast feed an infant if you are taking ziprasidone.

Because ziprasidone can cause sleepiness, be careful when operating machinery or driving a motor vehicle. Since medications of the same drug class as ziprasidone 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 ziprasidone.

Call your doctor immediately if you take more than the amount of ziprasidone prescribed by your doctor.

Ziprasidone has not been shown to be safe or effective in the treatment of children and teenagers under the age of 18 years old.

Grapefruit and grapefruit juice may interact with ziprasidone and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
 

Before you start ziprasidone, 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 breast feeding
• are allergic to any medicines
• have ever had an allergic reaction to ziprasidone or any of the other ingredients of ziprasidone capsules. Ask your doctor or pharmacist for a list of these ingredients
• have low levels of potassium or magnesium in your blood

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if ziprasidone is excreted in human breast milk or if it will harm your nursing baby.

Oral: (Capsules/ Suspension)

• Take ziprasidone only as directed by your doctor.
• Swallow the capsules whole.
• You should only use the oral dispenser and bottle adapter provided in the package to administer the oral suspension.
• Take ziprasidone with food.
• It is best to take ziprasidone at the same time each day.
• Remember to keep taking ziprasidone, even when you feel better.

Injectable:

• This medication is available in an injectable form to be given directly into the muscle (IM) by a healthcare professional.

Ziprasidone 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.

Oral/Injectable:

The following is a list of recommended dosages:

• 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. 
• 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 40–80 mg twice daily. 
• 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 40–80 mg twice daily. 
• Acute treatment of agitation associated with schizophrenia (intramuscular administration): 10 mg–20 mg up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every 2 hours. Doses of 10 mg may be administered every 2 hours. Doses of 20 mg may be administered every 4 hours 

Your doctor will determine the best dose for you. Take ziprasidone exactly as prescribed. Follow the directions on your prescription label carefully.

If you take too much ziprasidone, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If ziprasidone is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Keep ziprasidone and all medicines out of the reach of children.
• Store ziprasidone at room temperature (59°–86°F or 15°–30°C).

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. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Ziprasidone is not approved for the treatment of patients with Dementia-Related Psychosis.