Iloperidone is an antipsychotic medication that is used to treat schizophrenia in adults.

Iloperidone may also be used for purposes not listed in this medication guide.

Iloperidone is not approved for use in older adults with dementia-related psychosis.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Your doctor will need to check your progress on a regular basis.

If you have stopped taking iloperidone for more than 3 days in a row, talk with your doctor before you start taking it again. You may need to restart the medicine at a lower dose.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Schizophrenia:

Initial dose: 1 mg orally twice a day
Maintenance dose: 6 to 12 mg twice a day
Maximum dose: 24 mg/day

Comments:
-This drug must be titrated slowly to avoid orthostatic hypotension.
-Control of symptoms may be delayed during the first 1 to 2 weeks of treatment because of the need to titrate slowly.
-Treatment should be increased in increments of not more than 2 mg twice daily as tolerated.
-Healthcare providers should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.

Use: Treatment of schizophrenia

You should not use iloperidone if you are allergic to it.

Iloperidone may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• trouble swallowing;

• long QT syndrome (in you or a family member);

• a seizure;

• diabetes, or risk factors such as being overweight or having a family history of diabetes;

• breast cancer;

• high cholesterol or triglycerides;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• low bone mineral density; or

• liver disease.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of iloperidone on the baby.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking iloperidone without your doctor's advice.

You should not breastfeed while you are taking iloperidone.

Iloperidone is not approved for use by anyone younger than 18 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

Avoid driving or hazardous activity until you know how iloperidone will affect you. Your reactions could be impaired.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

While you are taking iloperidone, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

Drinking alcohol with this medicine can cause side effects.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of iloperidone can cause a serious movement disorder that may not be reversible. The longer you use iloperidone, the more likely you are to develop this disorder, especially if you are an older adult.

Iloperidone may cause serious side effects. Call your doctor at once if you have:

• fast or pounding heartbeats, fluttering in your chest;

• a light-headed feeling, like you might pass out;

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• tremors, slow muscle movement, muscles pain or stiffness;

• confusion, agitation, thoughts of hurting yourself;

• loss of bladder control;

• penis erection that is painful or lasts 4 hours or longer;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;

• low white blood cell counts--fever, chills, sore throat, mouth sores, skin sores, cough, trouble breathing; or

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

Older adults may be more likely to have side effects from iloperidone.

Common side effects of iloperidone may include:

• weight gain;

• dizziness, drowsiness, tired feeling;

• dry mouth, stuffy nose; or

• fast heart rate.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Iloperidone can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using iloperidone with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can affect iloperidone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

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.