Ziprasidone

IMPORTANT WARNING:

Older adults with dementia (loss of memory and brain function) may have an increased chanceof death if treated with antipsychotic medications such as ziprasidone. Older adults with dementia may also have a greater chance of having a stroke or mini-stroke during treatment with antipsychotics.

Ziprasidone is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking ziprasidone. For more information visit https://www.fda.gov/Drugs.

WHY is this medicine prescribed?

Ziprasidone is used to treat schizophrenia (a mental illness that affects how a person thinks, feels and behaves) and bipolar disorder (a disease that causes depression, mania, and other abnormalmoods). Ziprasidone is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Ziprasidone comes as a capsule to take by mouth. Take twice a day with food. Take ziprasidone at around the same times every day.

Take ziprasidone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not split, chew, or crush them.

Your doctor may start you on a low dose of ziprasidone and gradually increase your dose.

Ziprasidone may help control your symptoms but will not cure your condition. It may take a few weeks or longer before you feel the full benefit of ziprasidone. Continue to take ziprasidone even if you feel well. Do not stop taking ziprasidone without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking ziprasidone,

• tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• some medications should not be taken with ziprasidone. Other medications may cause dosing changes or extra monitoring when taken with ziprasidone. Make sure you have discussed any medications you are currently taking or plan to take before starting ziprasidone with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking ziprasidone, please get the advice of your doctor or pharmacist.

• the following nonprescription or herbal products may interact with ziprasidone: St. John's Wort and tryptophan. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking ziprasidone. Do not start these medications while taking ziprasidone without discussing with your healthcare provider.

• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: a monoamine oxidase (MAO) inhibitor such as isocarboxazid, linezolid, methylene blue, phenelzine, selegiline, and tranylcypromine.

• tell your doctor if you have heart failure, long QT syndrome (a heart condition that may cause dizziness, fainting, or irregular heartbeat), or if you have recently had a heart attack. Your doctor will probably tell you not to take ziprasidone.

• tell your doctor if you have or have had thoughts about harming or killing yourself, breast cancer, an irregular heartbeat, a stroke or ministroke, seizures, diabetes, dyslipidemia (high cholesterol levels), trouble keeping your balance, or heart or liver disease. Also, tell your doctor if you low levels of potassium or magnesium in your blood, if you use or have ever used street drugs or have overused prescription medications, or have trouble swallowing. Also tell your doctor if you have severe diarrhea or vomiting or you think you may be dehydrated.

• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant. If you become pregnant while taking ziprasidone, call your doctor. Ziprasidone may cause problems in newborns following delivery if it is taken during the last months of pregnancy.

• tell your doctor if you are breastfeeding or plan to breastfeed. Ziprasidone may cause sleepiness, irritation, and other problems in breastfed infants.

• you should know that this medication may cause infertility in women. Talk to your doctor aboutthe risks of taking ziprasidone.

• you should know that ziprasidone may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

• ask your doctor about the safe use of alcoholic beverages while you are taking ziprasidone. Alcohol can make the side effects from ziprasidone worse.

• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking ziprasidone or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking ziprasidone: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar that is not treated can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.

• you should know that ziprasidone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking ziprasidone. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• you should know that ziprasidone may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to do vigorous exercise or be exposed to extreme heat.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Ziprasidone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• restlessness
• anxiety
• lack of energy
• constipation
• diarrhea
• loss of appetite
• muscle pain
• stomach pain
• runny nose
• cough
• weight gain
• breast enlargement or discharge
• late or missed menstrual period
• decreased sexual ability
• dizziness, feeling unsteady, or having trouble keeping your balance

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section or the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

• unusual movements of your face or body that you cannot control
• fast, irregular, or pounding heartbeat; dizziness; or fainting
• rash, hives, or itching
• blisters or peeling of skin, mouth sores, swollen glands, or fever
• falling
• painful erection of the penis that lasts for hours
• agitation, fever, sweating, confusion, loss of consciousness, fast or irregular heartbeat, shivering or shaking, severe muscle stiffness or twitching, hallucinations, loss of coordination, nausea, vomiting, or diarrhea

Ziprasidone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature away from light and excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reachhttps://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• drowsiness
• slurred speech
• sudden movements that you cannot control
• uncontrollable shaking of a part of the body
• anxiety

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to ziprasidone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.