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risperidone

Generic Name: risperidone (oral) (ris PER i done)
Brand names: Risperdal, Risperdal M-Tab, Risperdal Consta

What is risperidone?

Risperidone is an antipsychotic medication. It works by changing the effects of chemicals in the brain.

Risperidone is used to treat schizophrenia and symptoms of bipolar disorder (manic depression). Risperidone is also used in autistic children to treat symptoms of irritability.

Risperidone may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about risperidone?

Risperidone is not for use in psychotic conditions related to dementia. Risperidone may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

Do not give this medication to a child without a doctor's advice.

While you are taking risperidone, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking risperidone. Risperidone can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of risperidone. Stop using risperidone and call your doctor at once if you have fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, restless muscle movements in your face or neck, tremor (uncontrolled shaking), trouble swallowing, feeling light-headed, or fainting.

There may be other drugs not listed that can affect risperidone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking risperidone?

Risperidone is not for use in psychotic conditions related to dementia. Risperidone may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. You should not use this medication if you are allergic to risperidone.

Before taking risperidone, tell your doctor if you are allergic to any drugs, or if you have:

liver disease;
kidney disease;
heart disease, high blood pressure, heart rhythm problems;
a history of heart attack or stroke;
a history of breast cancer;
seizures or epilepsy;
diabetes (risperidone may raise your blood sugar);
a history of suicidal thoughts;
Parkinson's disease; or
trouble swallowing.

Risperidone may cause you to have high blood sugar (hyperglycemia). Talk to your doctor if you have any signs of hyperglycemia such as increased thirst or urination, excessive hunger, or weakness. If you are diabetic, check your blood sugar levels on a regular basis while you are taking risperidone.

The risperidone orally disintegrating tablet may contain phenylalanine. Talk to your doctor before using this form of risperidone if you have phenylketonuria (PKU).

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether risperidone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to a child without a doctor's advice.

How should I take risperidone?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Risperidone can be taken with or without food.

To take risperidone orally disintegrating tablets (Risperdal M-Tabs):

Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.
Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.
Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
Swallow several times as the tablet dissolves. If desired, you may drink liquid after the tablet is completely dissolved.

It is important to take risperidone regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Measure the liquid form of risperidone with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not mix the liquid form of risperidone with cola or tea. It may take several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve. Store risperidone at room temperature away from moisture, light, and heat. Do not allow the liquid form of risperidone to freeze.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical treatment if you think you have used too much of this medicine.

Overdose symptoms may include drowsiness, fast heart rate, feeling light-headed, fainting, and restless muscle movements in your eyes, tongue, jaw, or neck.

What should I avoid while taking risperidone?

Risperidone side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using risperidone and call your doctor at once if you have any of these serious side effects:

fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
restless muscle movements in your eyes, tongue, jaw, or neck;
tremor (uncontrolled shaking);
trouble swallowing; or
feeling light-headed, fainting.

Less serious side effects may include:

mild restlessness, drowsiness, or tremor;
sleepiness, dreaming more than usual;
blurred vision;
dizziness or headache;
weight gain;
problems with urination;
nausea, dry mouth, constipation; or
decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Risperidone Dosing Information

Usual Adult Dose for Schizophrenia:

Initial dose: 1 mg orally twice a day
Titration dose: May increase in increments of 1 mg twice daily on the second and third day. Dosage adjustments after the third day should be done in one week intervals.
Maximum dose: 16 mg per day

Injection:
For patients who have never taken oral risperidone, it is recommended to establish tolerability with oral risperidone prior to initiating treatment with risperidone long acting injection.

25 mg every 2 weeks by deltoid or deep IM gluteal injection.

Although dose response for effectiveness has not been established for risperidone long acting injection, some patients not responding to 25 mg may benefit from a higher dose of 37.5 mg or 50 mg. The maximum dose should not exceed 50 mg every 2 weeks. When clinical factors warrant a dose adjustment, such as in patients with hepatic or renal dysfunction or a possible drug interaction, a lower initial dose of 12.5 mg may be appropriate; however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Oral risperidone (or another antipsychotic medication) should be given with the first injection and continued for 3 weeks to ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of risperidone from the injection.

Usual Adult Dose for Mania:

For use in the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder:

Initial Dose: 2 or 3 mg orally once a day.

If needed, dosage adjustments should occur at intervals of not less than 24 hours in dosage increments/decrements of 1 mg per day.

Clinical trials for short-term (3 week) anti- manic use have reported efficacy at a dosage range of 1 to 6 mg per day. Dosages above 6 mg per day have not been studied.

Note: Use of the long acting injectable form of risperidone is not recommended for this indication.

Usual Geriatric Dose for Mania:

For use in the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder:

Initial Dose: 0.5 mg twice a day

If needed, dosage adjustments should occur at intervals of not less than 24 hours in dosage increments/decrements of 1 mg per day.

Clinical trials for short-term (3 week) anti- manic use have reported efficacy at a dosage range of 1 to 6 mg per day. Dosages above 6 mg per day have not been studied.

Note: Use of the long acting injectable form of risperidone is not recommended for this indication.

Usual Geriatric Dose for Schizophrenia:

Initial dose: 0.5 mg orally twice a day.
Maintenance dose: May increase in 0.5 mg twice a day increments. Dosage increases greater than 1.5 mg per day should be done at greater than 1 week intervals.

Many clinicians recommend a daily dosage of 0.5 to 2 mg in elderly patients for the treatment of schizophrenia. The incidence of side effects, especially extrapyramidal symptoms, has been reported to be increased with doses of 2 mg or greater per day in this population.

Injection:
For patients who have never taken oral risperidone, it is recommended to establish tolerability with oral risperidone prior to initiating treatment with risperidone long acting injection.

25 mg every 2 weeks by deep IM gluteal injection.

Oral risperidone (or another antipsychotic medication) should be given with the first injection and continued for 3 weeks to ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of risperidone from the injection.

Usual Pediatric Dose for Autism:

Risperidone is approved by the FDA for use in pediatric patients for the treatment of irritability associated with autistic disorder in children and adolescents:

5 years to 18 years; 15 kg to 19 kg body weight:
Initial dose: 0.25 mg orally once a day (or 12.5 mg orally twice a day) for a minimum duration of 4 days
Maintenance dose: 0.5 mg orally once a day (or 0.25 mg orally twice a day) for a minimum duration of 14 days. Then, if necessary, the dose may be titrated upwards in increments of no more than 0.25 mg per day.
Maximum recommended dose: 1 mg orally per day

5 years to 18 years; 20 kg to 39 kg body weight:
Initial dose: 0.5 mg orally once a day (or 0.25 mg orally twice a day) for a minimum duration of 4 days
Maintenance dose: 1 mg orally once a day (or 0.5 mg orally twice a day) for a minimum duration of 14 days. Then, if necessary, the dose may be titrated upwards in increments of no more than 0.5 mg per day.
Maximum recommended dose: 2.5 mg orally per day

5 years to 18 years; at least 40 kg:
Initial dose: 0.5 mg orally once a day (or 0.25 mg orally twice a day) for a minimum duration of 4 days
Maintenance dose: 1 mg orally once a day (or 0.5 mg orally twice a day) for a minimum duration of 14 days. Then, if necessary, the dose may be titrated upwards in increments of no more than 0.5 mg per day.
Maximum recommended dose: 3 mg orally per day

Once sufficient clinical response is achieved, clinicians may want to consider a gradual reduction in dose keeping in mind the optimal balance of safety and efficacy.

Usual Pediatric Dose for Bipolar Disorder:

Risperidone is approved by the FDA for use in pediatric patients for the treatment of bipolar mania in children and adolescents:

10 to 17 years:
Initial dose: 0.5 mg once a day
Maintenance dose: Initial dose may be titrated upwards to a maximum recommended dose of 2.5 mg per day. If necessary, upward titration may occur in increments of 0.5 to 1 mg per day at intervals not less than 24 hours.

There are data from clinical studies supporting efficacy in doses up to 6 mg per day in pediatric patients with bipolar mania. However, no additional benefit was observed in doses greater than 2.5 mg per day. In addition, higher doses have been associated with more adverse effects.

Usual Pediatric Dose for Schizophrenia:

Risperidone is approved by the FDA for use in the treatment of schizophrenia in adolescents:

13 to 17 years:
Initial dose: 0.5 mg orally once a day
Titrated dose: Initial dose may be titrated upwards in increments of 0.5 to 1 mg per day at intervals not less than 24 hours
Maintenance dose: 3 mg per day
Doses up to 6 mg per day have been studied in the treatment of schizophrenia in adolescents. However, no additional benefit was observed at doses greater than 3 mg per day.

There are no clinical data regarding the use of risperidone in adolescents with schizophrenia for periods exceeding 8 weeks.

Usual Pediatric Dose for Other:

Pervasive Developmental Disorders:
6 to 12 years:
Initial dose: 0.5 mg orally per day
Maintenance: titrate up to 0.75 to 3 mg orally per day

Tourette's Syndrome:
6 to 18 years:
Initial dose: 0.5 mg orally per day
Maintenance dose: Titrate as needed up to 2 to 4 mg per day

What other drugs will affect risperidone?

Before you take risperidone, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by risperidone.

Also tell your doctor if you are taking any of the following medicines:

carbamazepine (Carbatrol, Tegretol);
phenytoin (Dilantin);
phenobarbital (Luminal, Solfoton);
clozapine (Clozaril);
fluoxetine (Prozac) or paroxetine (Paxil);
rifampin (Rifadin, Rimactane, Rifater); or
medicines used to treat Parkinson's Disease such as levodopa (Dopar, Larodopa, Sinemet, Atamet, others), bromocriptine (Parlodel, others), pergolide (Permax), pramipexole (Mirapex), or ropinirole (Requip).

This list is not complete and there may be other drugs that can interact with risperidone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about risperidone.

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.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.