RisperiDONE M-Tab (Oral)Pronunciation
Generic Name: risperidone (Oral route)
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 .
Commonly used brand name(s)
In the U.S.
- Risperdal M-Tab
- RisperiDONE M-Tab
Available Dosage Forms:
- Tablet, Disintegrating
Therapeutic Class: Antipsychotic
Chemical Class: Benzisoxazole
Uses For RisperiDONE M-Tab
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.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, risperidone is used in certain patients with the following medical conditions:
- Tourette syndrome (inherited nerve, motor, and vocal disorder).
Before Using RisperiDONE M-Tab
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 be sensitive to the effects of risperidone, and have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving risperidone. This medicine should not be used for behavioral problems in older adults with dementia.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
Interactions with Medicines
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.
- Arsenic Trioxide
- Chloral Hydrate
- Ginkgo Biloba
- Insulin Aspart, Recombinant
- Insulin Bovine
- Insulin Degludec
- Insulin Detemir
- Insulin Glulisine
- Insulin Lispro, Recombinant
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.
- Valproic Acid
Interactions with Food/Tobacco/Alcohol
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:
- Aspiration pneumonia, risk or history of or
- Blood circulation problems or
- Dehydration or
- Dementia, such as decreasing mental ability or
- Difficulty swallowing—May cause side effects to become worse.
- Breast cancer, prolactin-dependent or
- Diabetes or
- Epilepsy or other seizure disorders or
- Heart or blood vessel problems, including stroke and unusual heartbeats or
- Hyperglycemia (high blood sugar) or
- Hyperprolactinemia (high prolactin in the blood) or
- Parkinson disease—May make these conditions worse.
- Kidney disease 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 risperidone
This section provides information on the proper use of a number of products that contain risperidone. It may not be specific to RisperiDONE M-Tab. Please read with care.
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 two 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 of age 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 two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 6 mg per day.
- 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 RisperiDONE M-Tab
Your doctor will want to check your progress at regular visits, especially during the first few months of treatment with this medicine. This will allow for dose changes if necessary.
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.
This medicine may add to the effects of alcohol and other CNS depressants (medicine that makes you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.
Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Taking risperidone together with medicines that are used during surgery, dental, or emergency treatments may increase the CNS depressant effects.
This medicine may cause blurred vision, dizziness, or drowsiness. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see clearly.
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 make it more difficult for your body to keep a constant temperature. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heatstroke. Hot baths or saunas may make you feel dizzy or faint while you are taking this medicine. 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.
Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Signs of tardive dyskinesia include fine, worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks, jaw, or arms and legs. Other serious but rare side effects may also occur. These include neuroleptic malignant syndrome (NMS), which may cause severe muscle stiffness, fever, severe tiredness or weakness, fast heartbeat, difficult breathing, increased sweating, loss of bladder control, or seizures. You should discuss the good this medicine will do as well as the risks of taking it with your doctor.
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.
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.
RisperiDONE M-Tab 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
- 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
- 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
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
- dry mouth
- increased dream activity
- increased length of sleep
- sleepiness or unusual drowsiness
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
- weight gain
- 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
- shortness of breath or troubled breathing
- stomach pain
- stopping of menstrual bleeding
- tightness of the chest or wheezing
- unusual breast milk production
- weight loss
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.
See also: Side effects (in more detail)
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