Iloperidone (By mouth)

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant, or if you have liver disease, diabetes, breast cancer, trouble swallowing, or a history of seizures or neuroleptic malignant syndrome (NMS). Tell your doctor if you have any kind of blood vessel or heart problems, including low blood pressure, heart failure, a low amount of blood, low potassium or magnesium in the blood, heart rhythm problems (such as a prolonged QT interval), or a history of a heart attack or stroke.
• Do not breastfeed while you are using this medicine.
• This medicine is not approved to treat behavior disorders in older people who have dementia. Using this medicine to treat this problem could increase the risk of death. This risk has not been shown for the approved uses of this medicine.
• Some side effects are more likely to happen in elderly people with dementia or other memory problems. Make sure the doctor knows if the person who will be using this medicine has forgetfulness or confusion related to aging (such as Alzheimer's disease or dementia).
• Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.
• Stop taking this medicine and check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
• This medicine may increase the amount of sugar in your blood. Check with your doctor right away if you have increased thirst or increased urination. If you have diabetes, you may notice a change in the results of your urine or blood sugar tests. If you have any questions, check with your doctor.
• This medicine may increase your weight. Your doctor may need to check your weight regularly during treatment with this medicine.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert. You may also feel lightheaded when getting up suddenly from a lying or sitting position, so stand up slowly.
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often.
• You might get overheated while using this medicine. Drink plenty of water during hot weather, while exercising, or while using a hot tub or sauna. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Call your doctor if drinking cool water and moving away from the heat does not cool you down.
• This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Introduction

Iloperidone (eye-loe-PER-i-done)

Treats a mental disorder called schizophrenia.

Brand Name(s)

Fanapt, Fanapt Titration Pack

When This Medicine Should Not Be Used

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are using levomethadyl acetate, methadone (Dolophine®), pentamidine (Pentam 300®, Nebupent®), medicine for heart rhythm problems (such as amiodarone, procainamide, quinidine, sotalol, Betapace®, Cordarone®, or Pronestyl®), medicine to treat an infection (such as gatifloxacin, moxifloxacin, Avelox®, or Tequin®), or a phenothiazine medicine (such as chlorpromazine, thioridazine, or Thorazine®). Tell your doctor if you are also using clarithromycin (Biaxin®), ketoconazole (Nizoral®), fluoxetine (Prozac®), or paroxetine (Paxil®).
• Make sure your doctor knows if you are also using medicine to lower blood pressure (such as atenolol, hydrochlorothiazide [HCTZ], lisinopril, metoprolol, quinapril, Accupril®, Cozaar®, Diovan®, Lotrel®, Norvasc®, Toprol®, or Zestril®).
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.
• Do not drink alcohol while you are using this medicine.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chills, cough, sore throat, and body aches.
• Decrease in how much or how often you urinate.
• Dry mouth, increased hunger or thirst, or muscle cramps.
• Fast, pounding or uneven heartbeat.
• Fever, sweating, confusion, or muscle stiffness.
• Jerky muscle movement you cannot control (often in your face, tongue, or jaw).
• Lightheadedness, dizziness, or fainting.
• Mood or behavioral changes, or thoughts of hurting yourself or others.
• Painful, prolonged erection of your penis (in males).
• Problems with balance or walking.
• Seizures or tremors.
• Shortness of breath or troubled breathing.
• Swelling in your hands, ankles, or feet.
• Trouble with speaking or swallowing.
• Unusual tiredness or weakness.

If you notice these less serious side effects, talk with your doctor:

• Blurred vision.
• Diarrhea, nausea, vomiting, or stomach pain or upset.
• Problems with sex.
• Rash.
• Sleepiness or unusual drowsiness.
• Sores or white patches on your lips, mouth, or throat.
• Stuffy or runny nose.
• Weight gain.