Uses of Ziprasidone Injection:

• It is used to treat schizophrenia.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Ziprasidone Injection?

• If you are allergic to ziprasidone injection; any part of ziprasidone injection; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have ever had a long QT on ECG or other heartbeat that is not normal.
• If you have had a recent heart attack.
• If you have heart failure (weak heart).
• If you have any of these health problems: Low potassium or magnesium levels.
• If you are taking any of these drugs: Amiodarone, arsenic, chlorpromazine, disopyramide, dofetilide, dolasetron, dronedarone, droperidol, gatifloxacin, halofantrine, ibutilide, levomethadyl, mefloquine, mesoridazine, moxifloxacin, pentamidine, pimozide, probucol, procainamide, quinidine, sotalol, sparfloxacin, tacrolimus, or thioridazine.
• If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.

This is not a list of all drugs or health problems that interact with ziprasidone injection.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take ziprasidone injection with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Ziprasidone Injection?

• Tell all of your health care providers that you take ziprasidone injection. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how ziprasidone injection affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
• Dizziness, sleepiness, and feeling less stable may happen with ziprasidone injection. These may lead to falling, which can cause broken bones or other health problems.
• Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of infection. Rarely, infections have been deadly. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.
• A severe and sometimes deadly reaction has happened. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have questions, talk with the doctor.
• Some people may get a severe muscle problem called tardive dyskinesia. This problem may lessen or go away after stopping ziprasidone injection, but it may not go away. The risk is greater with diabetes and in older adults, especially older women. The risk is greater with longer use or higher doses, but it may also occur after short-term use with low doses. Call your doctor right away if you have trouble controlling body movements or problems with your tongue, face, mouth, or jaw like tongue sticking out, puffing cheeks, mouth puckering, or chewing.
• Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.
• An unsafe heartbeat that is not normal (long QT on ECG) has happened with ziprasidone injection. This may raise the chance of sudden death. Talk with the doctor.
• If you are 65 or older, use ziprasidone injection with care. You could have more side effects.
• Older adults with dementia taking drugs like this one have had a higher number of strokes. Sometimes these have been deadly. This medicine is not approved to treat mental problems caused by dementia.
• This medicine may affect being able to get pregnant. This effect goes back to normal when the drug is stopped. If you have questions, talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
• Taking ziprasidone injection in the third trimester of pregnancy may lead to uncontrolled muscle movements and withdrawal in the newborn.

How is this medicine (Ziprasidone Injection) best taken?

Use ziprasidone injection as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle.
• Drink lots of noncaffeine liquids unless told to drink less liquid by your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Avoid drinking alcohol while taking ziprasidone injection.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These may raise the chance of heart and brain blood vessel disease.
• Check your blood sugar as you have been told by your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Mental, mood, or behavior changes that are new or worse.
• If you are planning to harm yourself or the want to harm yourself gets worse.
• Very bad dizziness or passing out.
• Fast, slow, or abnormal heartbeat.
• Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
• Seizures.
• Change in eyesight.
• Enlarged breasts, nipple discharge, not able to get or keep an erection (in males), or period (menstrual) changes (in females).
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• A very bad and sometimes deadly health problem called neuroleptic malignant syndrome (NMS) may happen. Call your doctor right away if you have any fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, heartbeat that does not feel normal, or are sweating a lot.

What are some other side effects of Ziprasidone Injection?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Restlessness.
• Upset stomach or throwing up.
• Anxiety.
• Diarrhea or constipation.
• Dry mouth.
• Headache.
• Cough.
• Runny nose.
• Weight gain.
• Irritation where ziprasidone injection is given.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Ziprasidone Injection?

• If you need to store ziprasidone injection at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about ziprasidone injection, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.