Lurasidone is an antipsychotic medicine that is used to treat schizophrenia in adults and teenagers who are at least 13 years old.

Lurasidone is also used to treat episodes of depression related to bipolar disorder (manic depression) in adults and children who are at least 10 years old.

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

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

Some people have thoughts about suicide while taking lurasidone. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

Lurasidone comes as a tablet to take by mouth. It is usually taken with a meal (at least 350 calories) once a day. Take lurasidone at around the same time 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 lurasidone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Lurasidone controls schizophrenia and depression in people with bipolar disorder but it does not cure these conditions. It may take several weeks or longer before you feel the full benefit of lurasidone. Continue to take lurasidone even if you feel well. Do not stop taking lurasidone without talking to your doctor.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Lurasidone should be taken with food (at least 350 calories).

You may need frequent blood tests.

It may take several weeks before your symptoms improve. Keep using the medication as directed. Call your doctor if your symptoms do not improve, or if they get worse while using lurasidone.

You should not stop using lurasidone suddenly. Stopping suddenly may cause other problems.

It is easier to become dangerously overheated and dehydrated while you are taking lurasidone. Drink plenty of fluids, especially in hot weather and during exercise. You may also be more sensitive to temperature extremes (hot or cold).

Store at room temperature away from moisture and heat.

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

Many drugs can interact and cause dangerous effects. Some drugs should not be used together with lurasidone. Your doctor may change your treatment plan if you also use:

• antifungal medicine such as ketoconazole or voriconazole;

• an antibiotic such as clarithromycin or rifampin;

• an antiviral such as ritonavir;

• St. John's wort; or

• seizure medicine such as carbamazepine or phenytoin.

Lurasidone 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:

• heart disease or a stroke;

• high or low blood pressure;

• high cholesterol or triglycerides (a type of fat in the blood);

• diabetes or high blood sugar (in you or your family);

• a seizure;

• liver or kidney disease;

• low white blood cell (WBC) counts;

• abnormal hormone function tests (thyroid, pituitary gland);

• breast cancer; or

• suicidal thoughts or actions.

Some people have thoughts about suicide while taking lurasidone. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

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 lurasidone without your doctor's advice.

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

It may not be safe to breastfeed a baby while you are using lurasidone. Ask your doctor about any risks.

Lurasidone is not approved for schizophrenia in anyone younger than 13 years old. Lurasidone is not approved for depression in anyone younger than 10 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

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).

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

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.

Do not eat large amounts of grapefruit or drink grapefruit juice while taking this medication.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid driving or operating machinery until you know how lurasidone will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Grapefruit and grapefruit juice may interact with lurasidone and lead to unwanted side effects. Avoid the use of grapefruit products while taking lurasidone.

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

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

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

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

• any new or unusual muscle movements you cannot control;

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

• a seizure (convulsions);

• (in women) irregular menstrual periods, breast or vaginal changes, nipple discharge;

• (in men) breast swelling, impotence;

• trouble swallowing;

• manic episodes--racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative;

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

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

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

Common side effects of lurasidone may include:

• drowsiness;

• weight gain;

• tremors, muscle stiffness, slow muscle movement;

• feeling restless or being unable to sit still;

• nausea, vomiting;

• runny nose; or

• sleep problems (insomnia).

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.

Using lurasidone with other drugs that slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your current medicines. Many drugs can affect lurasidone, especially:

• depression or psychotic episodes;

• sleep problems (insomnia);

• high blood pressure or a heart rhythm disorder;

• swelling or inflammation;

• seizures; or

• Parkinson's disease.

This list is not complete and many other drugs may affect lurasidone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to lurasidone.

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.