Risperidone (Oral route)
- Risperdal M-Tab
- RisperiDONE M-Tab
- Tablet, Disintegrating
Warnings:Oral route(Tablet;Tablet, Disintegrating;Solution)
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. RisperiDONE is not approved for the treatment of patients with dementia-related psychosis .
Uses of This Medicine:
Risperidone is used to treat schizophrenia, bipolar disorder, or irritability associated with autistic disorder. This medicine should not be used to treat behavioral problems in older adults who have dementia.
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 risperidone in children younger than 13 years of age with schizophrenia, in children younger than 10 years of age with bipolar disorder, or in children younger than 5 years of age with autistic disorder. Safety and efficacy have not been established.
Although appropriate studies on the relationship of age to the effects of risperidone have not been performed in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of risperidone in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving risperidone.
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.
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.
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Chloral Hydrate
- Ginkgo Biloba
- Inotuzumab Ozogamicin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- St John's Wort
- Valproic Acid
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:
- Allergic reaction to paliperidone (Invega®), history of—Should not be used in patients with this condition.
- Alzheimer disease or
- Dehydration or
- Heart attack, recent or history of or
- Heart or blood vessel disease or
- Heart failure, history of or
- Heart rhythm problem, or a history of or
- Hypotension (low blood pressure) or
- Hypovolemia (low amount of blood) or
- Stroke, history of or
- Trouble with swallowing—May cause side effects to become worse.
- Blood or bone marrow problems or
- Breast cancer, prolactin-dependent or
- Diabetes or
- Hyperglycemia (high blood sugar) or
- Hyperprolactinemia (high prolactin in the blood) or
- Neuroleptic malignant syndrome (NMS), history of or
- Parkinson disease or
- Priapism (painful or prolonged erection of the penis) or
- Seizures, history of—Use with caution. May make these conditions worse.
- Kidney disease, moderate to severe or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
- Phenylketonuria (PKU)—The oral disintegrating tablets may contain aspartame, which can make this condition worse.
Proper Use of This Medicine:
Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
You may take this medicine with or without food.
When using the oral liquid:
- Measure the dose with the measuring device provided with the container.
- Take the medicine directly from the measuring device or mix the liquid with a beverage (eg, water, coffee, orange juice, or low-fat milk). Do not mix the liquid with cola or tea. Drink all of the mixture.
- Rinse the empty measuring device with water. Place it back in its storage case. Put the plastic cap back on the bottle of medicine.
When using the orally disintegrating tablet:
- Do not open the package until you are ready to take the medicine. To remove one tablet, separate one of the 4 tablets by tearing it apart on the perforations.
- Bend the corner as shown on the package. Peel back the foil. Do not push the tablet through the foil because that could damage the tablet.
- With dry hands, take the tablet out of the package. Place it immediately on your tongue. Do not store the tablet once it is removed from the package.
- The tablet will disintegrate in seconds after it is placed on the tongue.
- You may swallow the tablet with or without liquid. Do not split or chew the tablet.
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 forms (solution, tablets, or orally disintegrating tablets):
- For bipolar disorder:
- Adults—At first, 2 to 3 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 mg per day.
- Older adults—At first, 0.5 mg 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 mg per day.
- Children 10 to 17 years of age—At first, 0.5 mg once a day, in the morning or evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 mg per day.
- Children younger than 10 years of age—Use and dose must be determined by your doctor.
- For irritability associated with autistic disorder:
- Children 5 to 16 years of age weighing 20 kilograms (kg) or greater—At first, 0.5 milligrams (mg) per day. Your doctor may adjust your dose as needed.
- Children 5 to 16 years weighing less than 20 kg—At first, 0.25 mg per day. Your doctor may adjust your dose as needed.
- Children younger than 5 years of age—Use and dose must be determined by your doctor.
- For schizophrenia:
- Adults—At first, 2 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 16 mg per day.
- Older adults—At first, 0.5 mg 2 times a day. Your doctor may adjust your dose as needed.
- Children 13 to 17 years of age—At first, 0.5 mg once a day, in the morning or evening. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 mg per day.
- Children younger than 13 years of age—Use and dose must be determined by your doctor.
- For bipolar disorder:
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 or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Check with your doctor right away if you or your child 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 or your child have any of the following symptoms while using this medicine: 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 or your child 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.
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.
Risperidone 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 cause drowsiness, trouble with thinking, or trouble with controlling body movements, which may lead to falls, fractures or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
This medicine may make it more difficult for your body to cool itself down. Use care not to become overheated during exercise or hot weather since overheating may result in heat stroke. Also, use extra care not to become too cold while you are taking risperidone. If you become too cold, you may feel drowsy, confused, or clumsy.
This medicine may increase your or your child's weight. Your doctor may need to check your or your child's weight on a regular basis while using this medicine.
Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This is to prevent side effects and to keep your condition from becoming worse.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with risperidone may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
This medicine may increase prolactin blood levels 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.
If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).
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
- Aggressive behavior
- changes in vision, including blurred vision
- difficulty concentrating
- difficulty speaking or swallowing
- inability to move the eyes
- increase in amount of urine
- loss of balance control
- mask-like face
- memory problems
- muscle spasms of the face, neck, and back
- problems with urination
- restlessness or need to keep moving (severe)
- shuffling walk
- skin rash or itching
- stiffness or weakness of the arms or legs
- tic-like or twitching movements
- trembling and shaking of the fingers and hands
- trouble sleeping
- twisting body movements
- Less common
- Back pain
- chest pain
- speech or vision problems
- sudden weakness or numbness in the face, arms, or legs
- extreme thirst
- fast, shallow breathing
- fast, weak heartbeat
- increased thirst
- lip smacking or puckering
- loss of appetite
- muscle cramps
- pale, clammy skin
- poor coordination
- prolonged, painful, inappropriate erection of the penis
- puffing of the cheeks
- rapid or worm-like movements of the tongue
- talking, feeling, and acting with excitement and activity that cannot be controlled
- uncontrolled chewing movements
- uncontrolled twisting movements of neck, trunk, arms, or legs
- unusual bleeding or bruising
- unusual facial expressions or body positions
- Incidence not known
- Actions that are out of control
- bleeding gums
- blood in the urine or stools
- bluish lips or skin
- change in mental status
- clay-colored stools
- cold sweats
- cool, pale skin
- dark or bloody urine
- decrease in the frequency of urination
- decrease in urine volume
- decreased awareness or responsiveness
- difficulty in passing urine (dribbling)
- dry mouth
- fast or irregular heartbeat
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased urination
- irregular heartbeat, recurrent
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss of consciousness
- low body temperature muscle ache, twitching, or weakness
- painful urination
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- severe constipation
- severe sleepiness
- slurred speech
- stomach pain
- swelling of the face, ankles, or hands
- tightness in the chest
- troubled breathing
- unexplained weight loss
- unpleasant breath odor
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- vomiting of blood
- weak or feeble pulse
- yellow eyes or skin
- More common
- increased dream activity
- increased length of sleep
- sore throat
- stuffy or runny nose
- Less common
- Absent, missed, or irregular menstrual periods
- body aches or pain
- breast swelling or soreness
- darkening of skin color
- decreased interest in sexual intercourse
- dry skin
- ear congestion
- inability to have or keep an erection
- increase in body movements
- increased watering of the mouth
- joint pain
- loss in sexual ability, desire, drive, or performance
- loss of voice
- oily skin
- pain or tenderness around the eyes and cheekbones
- stopping of menstrual bleeding
- unusual breast milk production
- weight loss
- Incidence not known
- change in taste
- enlargement of the penis or testes
- growth of pubic hair
- loss of taste
- rapid increase in height
- thinning or loss of hair
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: 6/18/2019