Description
Milsaperidone is used to treat schizophrenia. It is also used to treat manic or mixed episodes associated with bipolar disorder (manic-depressive illness). This medicine should not be used to treat behavioral problems in older adult patients who have dementia.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet
Before Using
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:
Allergies
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.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of milsaperidone in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of milsaperidone in the elderly. However, elderly patients are more likely to have dementia and serious unwanted effects, which may require caution in patients receiving milsaperidone.
Breastfeeding
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.
Drug Interactions
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
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:
- Blood or bone marrow problems (eg, leukopenia, neutropenia) or
- Breast cancer, prolactin-dependent or
- Diabetes or
- Dyslipidemia (high cholesterol or fats in the blood) or
- Hyperglycemia (high blood sugar) or
- Hyperprolactinemia (high prolactin in the blood) or
- Neuroleptic malignant syndrome (NMS), history of or
- Priapism (painful and prolonged erection of the penis) or
- Seizures, history of—Use with caution. May make these conditions worse.
- Blood vessel disease or
- Dehydration or
- Heart attack, recent or history of, or
- Heart failure, history of or
- Heart rhythm problems (eg, prolonged QT interval), or a history of or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood) or
- Hypotension (low blood pressure) or
- Hypovolemia (low amount of blood) or
- Stroke, history of—May cause side effects to become worse.
- Cataract surgery—An eye problem called Intraoperative Floppy Iris Syndrome (IFIS) has occurred in patients who are taking or who have recently taken this medicine when they are having cataract surgery. You should tell your ophthalmologist (eye doctor) before your surgery if you are taking milsaperidone.
- Liver disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Liver disease, severe—Should not use in patients with this condition.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
You may take this medicine with or without food.
Dosing
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 treatment of schizophrenia and manic or mixed episodes with bipolar disorder:
- Adults—At first, 1 milligram (mg) 2 times a day. Your doctor may adjust your dose if needed and tolerated. However, the dose is usually not more than 12 mg 2 times a day.
- Children—Use and dose must be determined by your doctor.
- For treatment of schizophrenia and manic or mixed episodes with bipolar disorder:
Missed Dose
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.
Call your doctor for instructions if you must stop taking the medicine for more than 3 days.
Storage
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
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
This medicine can cause a change in heart rhythm called QT prolongation. This condition may change the way your heart beats (faster or slower) and can cause chest pain, dizziness, fainting, or trouble breathing. Call your doctor right away if you have any of these symptoms or any questions.
Check with your doctor right away if you have difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, seizures, 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.
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 the amount of cholesterol and fats in your blood. If this condition occurs, your doctor may give you medicines that can lower these.
This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.
This medicine 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 immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
This medicine may increase prolactin levels in the body if used for a long time. Check with your doctor if you have breast swelling or soreness, unusual breast milk production, absent, missed, or irregular menstrual periods, stopping of menstrual bleeding, loss in sexual ability, desire, drive, or performance, decreased interest in sexual intercourse, or an inability to have or keep an erection.
This medicine may make it more difficult for your body to cool down. It might reduce how much you sweat. Your body could get too hot if you do not sweat enough. If your body gets too hot, you might feel dizzy, weak, tired, or confused. You might vomit or have an upset stomach. Do not get too hot while you are exercising. Avoid places that are very hot. Call your doctor if you are too hot and can not cool down.
This medicine may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision, 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 other jobs that require you to be alert, well-coordinated, or able to think or see well.
Avoid drinking alcohol while you are using 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
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:
More common
- Chills
- cold sweats
- confusion
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
Less common
- Actions that are out of control
- anxiety
- attack, assault, force
- blurred vision
- body aches or pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain, discomfort, or tightness
- confusion as to time, place, or person
- constipation
- cough
- delusions of persecution, mistrust, suspiciousness, and/or combativeness
- depressed mood
- discouragement
- dry mouth
- dry skin and hair
- ear congestion
- false beliefs that cannot be changed by facts
- feeling cold
- feeling sad or empty
- fever
- frequent strong or increased urge to urinate
- gaseous abdominal pain
- hair loss
- hallucinations
- headache
- hoarseness or husky voice
- holding false beliefs that cannot be changed by fact
- inability to sit still
- increased thirst
- irritability
- loss of appetite
- loss of bladder control
- loss of interest or pleasure
- loss of memory
- loss of voice
- mood changes
- muscle aches, cramps, pains, and stiffness
- nausea or vomiting
- need to keep moving
- nervousness
- numbness or tingling in the hands, feet, or lips
- pale skin
- problems with memory
- restlessness
- seizures
- shakiness in the legs, arms, hands, or feet
- slowed heartbeat
- sore throat
- sore tongue
- stomach fullness
- stuffy or runny nose
- sweating
- talking, feeling, and acting with excitement
- trembling or shaking of the hands or feet
- trouble breathing
- trouble concentrating
- trouble sleeping
- twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- unusual bleeding or bruising
- unusual excitement, nervousness, or restlessness
- unusual tiredness or weakness
- weight gain
- yellow eyes or skin
Rare
- Aching or discomfort in the lower legs or sensation of crawling in the legs
- agitation
- black, tarry stools
- coma
- confusion
- decreased urine output
- dilated neck veins
- inability to move the eyes
- increased blinking or spasms of the eyelid
- lethargy
- loss of balance control
- mask-like face
- muscle twitching
- painful or difficult urination
- shuffling walk
- slow reflexes
- slurred speech
- sores, ulcers, or white spots on lips or in mouth
- sticking out of tongue
- stiffness of the arms and legs
- stupor
- swollen glands
- tic-like (jerky)movements of head, face, mouth, and neck
- trouble in speaking, or swallowing
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- unusual facial expressions
Incidence not known
- Blurred vision
- flushed, dry skin
- fruit-like breath odor
- hives, itching, skin rash
- increased hunger
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of consciousness
- painful or prolonged erection of the penis
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- unexplained weight loss
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:
More common
- Diarrhea
- sleepiness or unusual drowsiness
Less common
- Absent, missed, or irregular menstrual periods
- breast pain
- bloody nose
- burning, dry or itching eyes
- continuing ringing or buzzing or other unexplained noise in ears
- decreased interest in sexual intercourse
- decreased sexual performance or desire
- difficult ejaculating
- difficulty in moving
- discharge, excessive tearing
- dry eye
- feeling of constant movement of self or surroundings
- hearing loss
- inability to have or keep an erection
- irritation or soreness of the mouth
- joint pain
- loss in sexual ability, desire, drive, or performance
- redness, pain, swelling of eye, eyelid, or inner lining of the eyelid
- sensation of spinning
- stopping of menstrual bleeding
Rare
- Back pain
- dry throat
- extremely high fever or body temperature
- groin pain
- heartburn
- longer or heavier menstrual periods
- pain or burning in the throat
- swelling of the breasts or breast soreness in both females and males
- swelling or inflammation of the mouth
- swollen, tender prostate
- uncontrolled twisting movements of neck
Incidence not known
- Swelling of the mouth or throat
- throat tightness
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.
DRG-80010349
