Ziprasidone Injection

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 injection. Older adults with dementia may also have a greater chance of having a stroke or mini stroke during treatment.

Ziprasidone injection 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 receiving ziprasidone. For more information visit https://www.fda.gov/Drugs.

Talk to your doctor about the risks of receiving ziprasidone injection.

WHY is this medicine prescribed?

Ziprasidone injection is used to treat episodes of agitation in people who have schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). 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 injection comes as a powder to be mixed with water and injected into a muscle by a healthcare provider. Ziprasidone injection is given as needed for agitation. If you are still agitated after you receive your first dose, you may be given one or more additional doses.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving ziprasidone injection,

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

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

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

• tell your doctor or pharmacist if you are taking the following medications or have stoppedtaking them within the past two weeks: a monoamine oxidase (MAO) inhibitor such asisocarboxazid (Marplan^®), linezolid (Zyvox^®), methylene blue, phenelzine (Nardil^®), selegiline(Emsam^®, Zelapar^®), and tranylcypromine (Parnate^®).

• tell your doctor if you have heart failure, QT prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death), or if you have recently had a heart attack. Your doctor will probably tell you not to receive ziprasidone injection.

• tell your doctor if you have or have had thoughts about harming or killing yourself, an irregular heartbeat, a stroke or ministroke, seizures, diabetes, dyslipidemia (high cholesterol levels), trouble keeping your balance, a low number of white blood cells, or heart, kidney, 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 receiving ziprasidone, call your doctor. Ziprasidone may cause problems in newborns following delivery if it is given during the last months of pregnancy.

• tell your doctor if you are breastfeeding. Ziprasidone injection 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 receiving ziprasidone injection.

• you should know that ziprasidone injection 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 receiving ziprasidone injection. Alcohol can make the side effects from ziprasidone injection worse.

• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are receiving 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 receiving ziprasidone or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are receiving 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 injection may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start receiving 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 injection 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 SIDE EFFECTS can this medicine cause?

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

• headache
• injection site pain
• nausea
• vomiting
• restlessness
• heartburn
• anxiety
• agitation
• lack of energy
• constipation
• diarrhea
• loss of appetite
• weight gain
• stomach pain
• pricking, or tingling feeling
• speech problems
• 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 or the SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

• unusual movements of your face or body that you cannot control
• rash, hives, or itching
• blisters or peeling of skin, mouth sores, swollen glands, or fever
• yellowing of the skin or eyes
• fast, irregular, or pounding heartbeat; dizziness; or fainting
• falling
• sweating
• 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 ofcoordination, nausea, vomiting, or diarrhea

Ziprasidone injection may cause other side effects. Call your doctor if you have any unusual problems while receiving 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 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 injection.

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.