There may be a slightly increased risk of serious, possibly fatal side effects (e.g., stroke, heart failure) when this medication is used in elderly patients with dementia. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with your doctor.

This medication is used to treat certain mental/mood disorders (schizophrenia or manic/mixed episodes associated with bipolar disorder). It may be used after other medications have not been effective. Ziprasidone is a psychiatric medication (anti-psychotic type) that works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain.

This medication can make you feel less nervous and improve your concentration. It helps you to think more clearly and take a more active part in everyday life.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug has also been used to treat dementia-related behavior problems (e.g., agitation, aggression) when standard treatments (e.g., behavioral therapy, cholinesterase inhibitors) have not been successful.

Read the Patient Information Leaflet available from your pharmacist. Consult your doctor or pharmacist if you have any questions.

Take this medication by mouth, usually twice daily or as directed by your doctor. Swallow the capsules whole with food. Your doctor may start you at a low dose and gradually increase your dose in order to lessen side effects such as drowsiness. Follow your doctor's instructions carefully. Your dosage is based on your medical condition and response to therapy.

Do not stop taking ziprasidone without consulting your doctor even if you start to feel better. Some conditions may worsen if the medication is suddenly stopped.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. It may take several weeks before you get the full benefit of this medication.

Inform your doctor if your condition persists or worsens.

Dizziness, drowsiness, weakness, nausea, vomiting, runny nose, and cough may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: severe/persistent dizziness, mental/mood changes (e.g., agitation, anxiety, depression, suicidal thoughts), feelings of restlessness, mask-like facial expression (pseudoparkinsonism), shakiness (tremors), muscle spasm/stiffness, numbness/tingling, trouble swallowing, vision problems, difficulty walking.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, fainting, jaw/left arm pain, slow/fast/irregular heartbeat, seizures.

This drug may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any unusual uncontrolled movements (especially of the face, mouth, tongue, arms or legs).

This medication may rarely cause a very serious condition called serotonin syndrome. The risk may increase when this medication is used with certain other drugs such as "triptans" used to treat migraine headaches (e.g., sumatriptan, eletriptan), certain antidepressants including SSRIs (e.g., citalopram, paroxetine) and SNRIs (e.g., duloxetine, venlafaxine), lithium, tramadol, tryptophan, or a certain drug to treat obesity (sibutramine). Before taking this drug, tell your doctor if you take any of these medications. Seek immediate medical attention if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitchy muscles.

Medications used for a similar purpose to ziprasidone may infrequently cause a serious (rarely fatal) nervous system disorder called neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you notice any of the following rare but very serious side effects: confusion, fever, fast heartbeat, muscle stiffness, increased sweating.

In rare instances, this medication may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missing/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 these symptoms, tell your doctor immediately.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking ziprasidone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain heart problems (e.g., recent heart attack, untreated heart failure).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: Alzheimer's disease, heart problems (e.g., coronary artery disease, irregular heartbeat, low blood pressure), severe dizziness/fainting, diabetes (including family history), liver disease, nervous system problems (e.g., stroke, seizures, NMS), obesity, swallowing problems, aspiration pneumonia.

Ziprasidone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using ziprasidone, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, 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. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may infrequently make your blood sugar level rise, causing or worsening diabetes. This high blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst or urination. If you already have diabetes, be sure to check your blood sugar regularly.

This drug may rarely cause weight gain and a rise in your blood cholesterol (or triglyceride) levels. These effects, (especially if you have diabetes), may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor.

This medication can make you prone to heat stroke. Avoid activities that might cause you to overheat (e.g., doing strenuous work, exercising in hot weather, or using a hot tub).

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially involuntary movements and dizziness.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because very serious interactions may occur: sibutramine.

If you are currently using the medication listed above, tell your doctor or pharmacist before starting ziprasidone.

Many drugs besides ziprasidone may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using ziprasidone, report all medications you are currently using to your doctor or pharmacist.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: antimuscarinics (e.g., scopolamine), drugs for high blood pressure (e.g., beta blockers, calcium channel blockers), dopamine agonists (e.g., amantadine, bromocriptine), levodopa, drugs affecting liver enzymes that remove ziprasidone from your body (such as azole antifungals including ketoconazole, macrolide antibiotics including erythromycin, rifamycins including rifampin, St. John's wort, certain anti-seizure medications such as carbamazepine).

Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with ziprasidone such as bupropion, isoniazid (INH), phenothiazines (e.g., chlorpromazine), theophylline, or tricyclic antidepressants (e.g., amoxapine) among others. Consult your doctor or pharmacist for details.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., phenytoin), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: slurred speech, fast/pounding heartbeat with headache, uncontrolled movements (tremor).

Do not share this medication with others. Keep all medical appointments so your doctor can monitor your progress closely and adjust or change your medication if needed.

Laboratory and/or medical tests (e.g., blood mineral levels, blood sugar, electrocardiograms) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

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 and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.