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Ziprasidone Injection

(zi pray' si done)

Brand Name(s): Geodon®

IMPORTANT WARNING:

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who use antipsychotics (medications for mental illness) such as ziprasidone injection have an increased risk of death during treatment. 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 the FDA website: http://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 come as a powder to be mixed with water and injected into a muscle by a healthcare provider. Ziprasidone injection is usually 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 ziprasidone, any other medications, or any of the ingredients in ziprasidone injection. Ask your pharmacist for a list of the ingredients.

  • tell your doctor if you are taking amiodarone (Cordarone, Nexterone, Pacerone), arsenic trioxide (Trisenox), chlorpromazine, disopyramide (Norpace), dofetilide (Tikosyn), dolasetron (Anzemet), dronedarone (Multaq), droperidol (Inapsine), gatifloxacin (no longer available in the U.S.), ibutilide (Corvert), halofantrine (Halfan) (no longer available in the U.S.), levomethadyl (ORLAAM) (no longer available in the U.S.), mefloquine, mesoridazine (no longer available in the U.S.), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), pimozide (Orap), probucol (no longer available in the U.S.), procainamide, quinidine (in Nuedexta), sotalol (Betapace, Sorine, Sotylize), sparfloxacin (no longer available in the U.S.), tacrolimus (Astagraf, Prograf), or thioridazine. Your doctor may not prescribe ziprasidone if you are taking one or more of these medications. Other medications may also interact with ziprasidone, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants, carbamazepine (Carbatrol, Tegretol, Teril, others), certain antifungals such as ketoconazole (Extina, Nizoral), dopamine agonists such as bromocriptine (Cycloset, Parlodel), cabergoline, levodopa (in Sinemet), pergolide (Permax) (no longer available in the U.S.), and ropinirole (Requip), medications for high blood pressure, mental illness, seizures, or anxiety; and sedatives, sleeping pills, or tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

  • 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 or are breastfeeding. 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.

  • 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 alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while receiving ziprasidone.

  • 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
  • itching
  • blisters or peeling of skin
  • mouth sores
  • swollen glands
  • fever
  • chills
  • yellowing of the skin or eyes
  • shortness of breath
  • fast, irregular, or pounding heartbeat
  • shaking
  • muscle stiffness
  • falling
  • confusion
  • sweating
  • loss of consciousness
  • painful erection of the penis that lasts for hours

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 (http://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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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