Lurasidone

Lurasidone is a medicine that helps treat schizophrenia in adults and teenagers who are 13 years old or older.

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

Lurasidone may also be used for other reasons that are not mentioned in this medication guide.

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.

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

Some people may have thoughts about suicide while taking lurasidone. Be aware of changes in your mood or symptoms. Inform your doctor about any new or worsening symptoms.

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

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.

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.

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

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

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

Do not drink alcohol. Dangerous side effects could happen.

Do not drive or operate machinery until you understand how lurasidone will affect you. Do not get up too quickly from a sitting or lying position, or you may feel dizzy. Dizziness or drowsiness can lead to falls, accidents, or serious injuries.

Grapefruit and grapefruit juice may interact with lurasidone and cause unwanted side effects. Avoid using grapefruit products while taking lurasidone.

Using lurasidone with other medications that can slow your breathing may lead to serious side effects or death. Consult your doctor before taking opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Inform your doctor about all your current medications. Many drugs can impact 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 medications may affect lurasidone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.