Iloperidone 

(eye'' loe per' i done)

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 take antipsychotics (medications for mental illness) such as iloperidone 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.

Iloperidone 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 iloperidone. For more information visit the FDA website: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm149578.htm .

WHY is this medicine prescribed?

Iloperidone 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). Iloperidone 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?

Iloperidone comes as a tablet to take by mouth. It is usually taken with or without food twice a day. Take iloperidone 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 iloperidone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of iloperidone and gradually increase your dose, not more often than once every day for the first 7 days. Your doctor will also need to start you on a low dose of iloperidone and gradually increase your dose if you do not take iloperidone for 3 days or longer at any time during your treatment.

Iloperidone may help control your symptoms but will not cure your condition. It may take up to 2 weeks or longer before iloperidone begins to control your symptoms. Continue to take iloperidone even if you feel well. Do not stop taking iloperidone 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 iloperidone,

  • tell your doctor and pharmacist if you are allergic to iloperidone, or any other medications, or any of the ingredients in iloperidone tablets. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what 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: amiodarone (Cordarone, Pacerone); antidepressants; antifungal medications such as itraconazole (Sporanox) and ketoconazole (Nizoral); bupropion (Aplenzin, Wellbutrin, Zyban); chlorpromazine; clarithromycin (Biaxin); fluoxetine (Prozac, Sarafem); gatifloxacin (Tequin) (not available in the U.S.); certain HIV protease inhibitors such as indinavir (Crixivan), nelfinavir (Viracept), and ritonavir (Norvir, in Kaletra); levo-alpha-acetylmethadol (ORLAAM) (not available in the U.S.); medications for high blood pressure, mental illness, or seizures; methadone (Dolophine, Methadose); moxifloxacin (Avelox); nefazodone; paroxetine (Paxil, Pexeva); pentamidine (Nebupent, Pentam); procainamide; quinidine; sedatives; sleeping pills; sotalol (Betapace); thioridazine 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 use or have ever used street drugs or have overused prescription medications or if you have difficulty swallowing. Also tell your doctor if you or anyone in your family has or has ever had diabetes and if you have or have ever had prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), a slow or irregular heartbeat, a recent heart attack, a low level of potassium or magnesium in your blood, seizures, breast cancer, or heart or liver disease. Also tell your doctor if you have a low level of white blood cells or if you have ever developed a low level of blood cells as a side effect of a medication that you took. Also tell your doctor if you have severe vomiting or diarrhea or become dehydrated at any time during your treatment.
  • 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 iloperidone, call your doctor. Iloperidone may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
  • you should know that iloperidone may affect your thinking, judgment, and ability to move. 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 iloperidone. Alcohol can make the side effects from iloperidone 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 iloperidone or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking iloperidone: 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 iloperidone may cause dizziness, lightheadedness, fast heartbeat, and fainting when you get up too quickly from a lying position. This is more common when you first start taking iloperidone or when your dose is increased. 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 taking iloperidone may make it harder for your body to cool down if 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?

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

  • weight gain

• nausea

  • diarrhea
  • stomach pain
  • dry mouth
  • sleepiness
  • breast enlargement or discharge
  • missed menstrual periods
  • decreased sexual ability in men
  • joint pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• rash

• hives

• itching

  • dizziness
  • fast, pounding, or irregular heartbeat
  • fainting
  • difficulty breathing or swallowing
  • unusual movements of the face or body that you cannot control
  • seizures
  • sore throat, fever, chills, and other signs of infection
  • unexplained fever without other signs of infection
  • muscle stiffness
  • confusion
  • sweating
  • painful erection that lasts for hours

Iloperidone may cause other side effects. Call your doctor if you have any unusual problems while you are 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 http://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 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:

  • drowsiness
  • fast or irregular heartbeat
  • slow or abnormal movements

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 iloperidone.

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.

Brand Names
  • Fanapt®

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