Lurasidone (Oral route)
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Lurasidone is not approved for the treatment of patients with dementia-related psychosis. An increased risk of suicidal thoughts and behavior was found in pediatric and young adult patients taking antidepressants. Monitor for clinical worsening and emergence of suicidal thoughts and behaviors .
Uses of This Medicine:
Lurasidone is used to treat symptoms of psychotic (mental) disorders, such as schizophrenia. This medicine should not be used to treat behavioral problems in elderly patients who have dementia. It may be used alone or with other medicines (eg, lithium, valproate) to treat depression caused by bipolar disorder.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of lurasidone to treat schizophrenia in the children younger than 13 years of age, and to treat depression in children. Safety and efficacy have not been established in these age groups.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lurasidone in the elderly. However, this medicine should not be used for behavioral problems in older adults with dementia.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- St John's Wort
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alzheimer's disease or dementia or
- Dehydration or
- Heart attack, history of or
- Heart failure or
- Heart or blood vessel disease or
- Heart rhythm problems or
- Hypotension (low blood pressure) or
- Hypovolemia (low amount of blood) or
- Parkinson's disease or
- Stroke, history of or
- Trouble swallowing—May cause side effects to become worse.
- Blood or bone marrow problems (eg, agranulocytosis, leukopenia, neutropenia) or
- Diabetes, or risk factors for diabetes or
- Dyslipidemia (high cholesterol or fats in the blood) or
- Hyperglycemia (high blood sugar) or
- Hyperprolactinemia (high prolactin in the blood) or
- Mania, or history of or
- Seizures, history of—Use with caution. May make these conditions worse.
- Kidney disease, moderate to severe or
- Liver disease, moderate to severe—You may need a dose adjustment. Talk with your doctor if you have concerns about this.
Proper Use of This Medicine:
Take this medicine only as directed by your doctor even if you feel well. Do not take more of this medicine and do not take it more often than your doctor ordered. This medicine works best if there is a constant amount in the blood. To keep blood levels constant, take this medicine at the same time each day and do not miss any doses.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
You must take this medicine with food (containing at least 350 calories).
Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For schizophrenia:
- Adults—At first, 40 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 160 mg per day.
- Children 13 to 17 years of age—At first, 40 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mg per day.
- Children younger than 13 years of age—Use and dose must be determined by your doctor.
- For depression:
- Adults—At first, 20 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 120 mg per day.
- Children—Use and dose must be determined by your doctor.
- For schizophrenia:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Lurasidone should not be used with certain medicines such as carbamazepine (Tegretol®), clarithromycin (Biaxin®), ketoconazole (Nizoral®), phenytoin (Dilantin®), rifampin (Rifadin®, Rimactane®), ritonavir (Norvir®), St. John's wort, or voriconazole (Vfend®). Using these medicines together may cause serious unwanted effects. Make sure your doctor knows all of the medicines you are taking.
Lurasidone 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. If you or your caregiver notice any of these side effects, tell your doctor right away.
This medicine may increase risk of transient ischemic attack or stroke in elderly patients. Tell your doctor right away if you have confusion, double vision, headache, inability to move the arms, legs, or facial muscles, slow speech, or trouble speaking, thinking, or walking while using this medicine.
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 cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have 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 while you are using this medicine.
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 on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.
Lurasidone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, a cough or hoarseness, lower back or side pain, or painful or difficult urination.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.
This medicine may cause some people to become drowsy or dizzy, or to have trouble with thinking or controlling body movements, which may lead to falls, fractures or other injuries. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that requires you to be alert, well-coordinated, or able to think well.
Avoid activities involving high temperature or humidity. This medicine may reduce your body's ability to adjust to the heat.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicines including other narcotics, medicine for seizures (eg, barbiturates), muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.
Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- More common
- Absence of or decrease in body movement
- difficulty with swallowing
- inability to sit still
- incremental or ratchet-like movement of the muscle
- loss of balance control
- mask-like face
- muscle discomfort
- muscle trembling, jerking, or stiffness
- need to keep moving
- rigid or stiff muscles
- shakiness in the legs, arms, hands, or feet
- shuffling walk
- slow movements
- slow reflexes
- slurred speech
- stiffness of the arms and legs
- tic-like (jerky) movements of the head, face, mouth, and neck
- trembling or shaking of the hands or feet
- twisting movements of the body
- uncontrolled movements, especially of the face, neck, and back
- Less common
- Arm, back, or jaw pain
- blurred vision
- burning while urinating
- changes in patterns and rhythms of speech
- chest pain or discomfort
- cold sweats
- difficult or painful urination
- difficulty opening the mouth
- difficulty with breathing
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- fixed position of the eye
- high fever
- inability to move the eyes
- inability to speak
- increased blinking or spasms of the eyelid
- increased sweating
- loss of bladder control
- muscle spasm, especially of the neck and back
- pale skin
- pounding in the ears
- severe muscle stiffness
- severe or sudden headache
- slow or fast heartbeat
- slurred speech
- sticking out of the tongue
- temporary blindness
- trouble with breathing, speaking, or swallowing
- troubled breathing with exertion
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- unusual bleeding or bruising
- unusual facial expressions
- unusual tiredness or weakness
- unusually pale skin
- weakness in the arm or leg on one side of the body, sudden and severe
- Black, tarry stools
- bloody urine
- breast pain or swelling
- dark-colored urine
- decreased frequency or amount of urine
- increased thirst
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- lower back or side pain
- muscle cramps or spasms
- muscle pain or stiffness
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swelling of the face, fingers, or lower legs
- swollen glands
- troubled breathing
- weight gain
- More common
- Acid or sour stomach
- dry mouth
- relaxed and calm
- sleepiness or unusual drowsiness
- stomach discomfort, upset, or pain
- trouble sleeping
- unusually deep sleep
- unusually long duration of sleep
- Less common
- Abnormal dreams
- back pain
- blurred vision
- burning feeling in the chest or stomach
- decreased appetite
- feeling of constant movement of self or surroundings
- itching or skin rash
- sensation of spinning
- tenderness in the stomach area
- watering of mouth and drooling
- Decreased interest in sexual intercourse
- inability to have or keep an erection
- loss in sexual ability, desire, drive, or performance
- unexpected or excess milk flow from the breasts
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/4/2017