| IMPORTANT WARNING:
| IMPORTANT WARNING
| WHY is this medicine prescribed?
| HOW should this medicine be used?
| Are there OTHER USES for this medicine?
| What SPECIAL DIETARY instructions should I follow?
| What should I do IF I FORGET to take a dose?
| What SIDE EFFECTS can this medicine cause?
| What should I know about STORAGE and DISPOSAL of this medication?
| What should I do in case of OVERDOSE?
| What OTHER INFORMATION should I know?
[Posted 12/11/2014]ISSUE:FDA is warning that the antipsychotic drug ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but serious skin reaction that can progress to affect other parts of the body. A new warning has been added to the ziprasidone drug label to describe the serious condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). See the FDA Drug Safety Communication at: Web Sitefor a Data Summary and additional information.
DRESS may start as a rash that can spread to all parts of the body. It can include fever, swollen lymph nodes, and inflammation of organs such as the liver, kidney, lungs, heart, or pancreas. DRESS also causes a higher-than-normal number of a particular type of white blood cell called eosinophils in the blood. DRESS can lead to death.
BACKGROUND:Ziprasidone is an atypical antipsychotic drug used to treat schizophrenia and bipolar I disorder.
FDA reviewed information from six patients in whom the signs and symptoms of DRESS appeared between 11 and 30 days after ziprasidone treatment was started. None of these patients died (see Data Summary in the Drug Safety Communication at: Web Site). Based on this information, FDA required the manufacturer of ziprasidone to add a new warning for DRESS to the Warnings and Precautions section of the drug labels for the capsule, oral suspension, and injection formulations.
RECOMMENDATION:Patients who have a fever with a rash and/or swollen lymph glands should seek urgent medical care. Health care professionals should immediately stop treatment with ziprasidone if DRESS is suspected. For more information visit the FDA website at: Web Siteand Web Site.
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 take antipsychotics (medications for mental illness) such as ziprasidone 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 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 the FDA website: Web Site
WHY is this medicine prescribed?
Ziprasidone is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). It is also used to treat episodes of mania (frenzied, abnormally excited or irritated mood) or mixed episodes (symptoms of mania and depression that happen together) in patients with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Ziprasidone is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
HOW should this medicine be used?
Ziprasidone comes as a capsule to take by mouth. It is usually taken twice a day with food. Take ziprasidone at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ziprasidone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
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. Continue to take ziprasidone even if you feel well. Do not stop taking ziprasidone without talking to your doctor.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking ziprasidone,
- tell your doctor and pharmacist if you are allergic to ziprasidone or any other medications.
- tell your doctor if you are taking amiodarone (Cordarone, Pacerone), chlorpromazine (Thorazine), cisapride (Propulsid) (no longer available in the U.S.), disopyramide (Norpace), dofetilide (Tikosyn), dolasetron (Anzemet), droperidol (Inapsine), erythromycin (E.E.S., E-Mycin, Erythrocin), gatifloxacin (Tequin)(no longer available in the U.S.), halofantrine (Halfan)(no longer available in the U.S.), levomethadyl (ORLAAM) (no longer available in the U.S.), mefloquine (Lariam), mesoridazine (Serentil; no longer available in the U.S.), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam 300), pimozide (Orap), procainamide (Procanbid, Promine, Pronestyl), quinidine (Quinidex), sotalol (Betapace), sparfloxacin (Zagam), tacrolimus (Prograf), or thioridazine (Mellaril). Your doctor may tell you not to take ziprasidone if you are taking one or more of these medications.
- 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; certain antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); aprepitant (Emend); carbamazepine (Tegretol); clarithromycin (Biaxin, in Prevpac); cyclosporine (Neoral, Sandimmune); delavirdine (Rescriptor); diltiazem (Cardizem, Dilacor, Tiazac, others); diuretics ('water pills');dopamine agonists such as bromocriptine (Parlodel), cabergoline (Dostinex), levodopa (Dopar, Larodopa), pergolide (Permax), and ropinirole (Requip); efavirenz (Sustiva); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors including atazanavir (Reyataz), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase); hormonal contraceptives (birth control pills, rings, patches, implants, and injections); lovastatin (Mevacor, in Advicor); medications for anxiety, high blood pressure or seizures; nefazodone; sertraline (Zoloft); sleeping pills; tranquilizers; troleandomycin (TAO; no longer available in the U.S.); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you use or have ever used street drugs or have overused prescription medications or if you have recently had a heart attack or have trouble swallowing. Also tell your doctor if you have or have ever had heart or liver disease, breast cancer, heart failure, an irregular heartbeat, a stroke or mini-stroke, or seizures, or if you or anyone in your family has or has ever had diabetes. Also tell your doctor if you have ever had to stop taking a medication for mental illness because of severe side effects.
- 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 breast-feeding. 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.
- 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.
- you should know that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while taking ziprasidone.
- 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.
Be sure to drink plenty of water every day while you are taking this medication.
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:
- loss of appetite
- muscle pain
- runny nose, sneezing
- weight gain
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:
- unusual movements of your face or body that you cannot control
- fast, irregular, or pounding heartbeat
- rash or hives
- muscle stiffness
- painful erection of the penis that lasts for hours
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 [at
] 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 and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- slurred speech
- sudden movements that you cannot control
- uncontrollable shaking of a part of the body
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.
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.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: December 11, 2014.