What is the most important information I should know about lurasidone?
Lurasidone is not approved for use in psychotic conditions related to dementia. Lurasidone may increase the risk of death in older adults with dementia-related conditions.
Some young people have thoughts about suicide when first taking medicine to treat depression. 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 with lurasidone, and some drugs should not be used together.
What is lurasidone?
Lurasidone is an antipsychotic medicine. It works by changing the effects of chemicals in the brain.
Lurasidone 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 in adults with bipolar disorder (manic depression).
Lurasidone may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking lurasidone?
You should not use lurasidone if you are allergic to it.
Some medicines can interact with lurasidone and should not be used at the same time. Your doctor may need to change your treatment plan if you use certain other medicines, including:
- 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 is not approved for use in psychotic conditions related to dementia. Lurasidone may increase the risk of death in older adults with dementia-related conditions.
To make sure lurasidone is safe for you, tell your doctor if you have ever had:
- heart disease, 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 young people have thoughts about suicide when first taking medicine to treat depression. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking lurasidone, do not stop taking it without your doctor's advice.
If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of lurasidone on the baby.
It is not known whether lurasidone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding.
Lurasidone is not approved for schizophrenia in anyone younger than 13 years old. Lurasidone is not approved for depression in anyone younger than 18 years old.
How should I take lurasidone?
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Use lurasidone regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Lurasidone should be taken with food (at least 350 calories).
While using lurasidone, 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.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking lurasidone?
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).
Grapefruit and grapefruit juice may interact with lurasidone and lead to unwanted side effects. Avoid the use of grapefruit products while taking lurasidone.
Lurasidone may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you. 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.
Avoid drinking alcohol. Dangerous side effects could occur.
What are the possible side effects of 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. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take lurasidone, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women and older adults.
Call your doctor at once if you have:
- irregular menstrual periods, breast or vaginal changes, nipple discharge;
- dizziness, fainting, fast or slow heartbeats;
- trouble swallowing;
- seizure (convulsions);
-
blood cell disorders --sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, swollen gums, pain when swallowing, skin sores, cold or flu symptoms, 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 may include:
- weight gain;
- drowsiness;
- nausea, vomiting;
- feeling restless or being unable to sit still; or
- tremors, muscle stiffness, problems with muscle movement.
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.
What other drugs will affect lurasidone?
Taking lurasidone with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.
Many drugs can interact with lurasidone. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially medicines to treat:
- 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 can interact with lurasidone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.
Where can I get more information?
Your pharmacist can provide more information about lurasidone.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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