Risperidone

Risperidone is a prescription medication used to treat schizophrenia. It is also used to treat manic or mixed episodes associated with Bipolar I Disorder. Risperidone also is used to treat behavioral symptoms associated with autism. Risperidone belongs to a group of drugs called atypical antipsychotics. It is not fully known how it works, but it is believed to work by changing the activity of natural substances in the brain.

Risperidone comes as a tablet, an oral solution, and an orally disintegrating tablet. It is usually taken once or twice a day with or without food. 

This medication also comes as a long-acting injectable allowing it to be given once every two weeks. It is injected into the upper arm or buttock by a healthcare provider.

Common side effects of risperidone are headache, increased appetite, and tremors.

Risperidone can cause dizziness. Do not drive or operate heavy machinery until you know how risperidone affects you.

CYP2D6 is a protein in your body that is involved in the elimination of risperidone and other drugs from your body. Some patients have less of this protein in their bodies, affecting how much of the drug gets eliminated. Levels of CYP2D6 can vary greatly between individuals, and those having less of this protein are known as "poor metabolizers." 

CYP2D6 testing is done to determine whether you are a poor metabolizer. If you are a poor metabolizer, the levels of risperidone in your blood can become too high. As a result you may be at an increased risk of having more side effects from risperidone. 

Your doctor may adjust your dose of risperidone if you are a poor metabolizer.

Oral:

• Risperidone is a prescription medication used to treat schizophrenia. It is also used to treat manic or mixed episodes associated with Bipolar I Disorder. Risperidone also is used to treat behavioral symptoms associated with autism.
• This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Injectable:

• Risperidone injectable is a prescription medication used to manage symptoms of schizophrenia and bipolar disorder.
• This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Risperidone may be found in some form under the following brand names:

• Perseris

• Risperdal

• Risperdal Consta

• Risperdal M-TAB

Oral:

Common side effects include the following:

• drowsiness
• dizziness
• nausea
• vomiting
• diarrhea
• constipation
• heartburn
• dry mouth
• increased saliva
• increased appetite
• weight gain
• stomach pain
• anxiety
• agitation
• restlessness
• dreaming more than usual
• difficulty falling asleep or staying asleep
• decreased sexual interest or ability
• breastmilk production
• vision problems
• muscle or joint pain
• dry or discolored skin
• difficulty urinating

Injectable:

• In a study of people taking risperidone injectable, the most common side effects in the treatment of schizophrenia were headache, tremors, dizziness, restlessness, tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth.
• In a study of people taking risperidone injectable , the most common side effects in the treatment of bipolar disorder were weight gain (when used alone) and tremors (when used with lithium or valproate).
• If you are taking risperidone injectable and think you are having any side effects, talk to your doctor immediately.

Tell your doctor about the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take: 

• antidepressants
• carbamazepine (Tegretol)
• cimetidine (Tagamet)
• clozapine (Clozaril)
• dopamine agonists such as bromocriptine (Parlodel), cabergoline (Dostinex), levodopa (Dopar, Larodopa), pergolide (Permax), and ropinirole (Requip)
• medications for anxiety, high blood pressure, or seizures
• other medications for mental illness
• paroxetine (Paxil)
• phenobarbital (Luminal, Solfoton)
• phenytoin (Dilantin)
• quinidine (Quinaglute, Quinidex)
• ranitidine (Zantac)
• rifampin (Rifadin, Rimactane)
• sedatives
• sleeping pills
• tranquilizers
• valproic acid (Depakote, Depakene)

This is not a complete list of risperidone drug interactions. Ask your doctor or pharmacist for more information.

Oral:

• Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as risperidone have an increased risk of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or mini-stroke during treatment. Tell your doctor and pharmacist if you are taking furosemide (Lasix).
• Risperidone is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking risperidone.
• Other serious side effects that require medical attention include the following:
  • fever
  • muscle stiffness
  • confusion
  • fast or irregular pulse
  • sweating
  • unusual movements of your face or body that you cannot control
  • faintness
  • seizures
  • slow movements or shuffling walk
  • rash
  • hives
  • itching
  • difficulty breathing or swallowing
  • painful erection of the penis that lasts for hours

• Risperidone may cause children to gain more weight than expected and for boys and male teenagers to have an increase in the size of their breasts. Talk to your doctor about the risks of giving this medication to your child.

Injectable:

• Risperidone injectable may make you drowsy. Do not drive a car or operate machinery until you know how it will affect you.
• Do not drink alcohol while taking this medicine. Alcohol can add to the drowsiness caused by risperidone injectable.
• Risperidone injectable may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position (orthostatic hypotension). This is more common when you first start taking it. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• Tell your doctor if you are pregnant or plan to become pregnant while taking risperidone injectable and for at least 12 weeks after the last injection of risperidone injectable.
• You should not breastfeed during treatment and for at least 12 weeks after the last risperidone injection.
• Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with risperidone injectable and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.
• Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with risperidone injectable and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.
• High blood sugar and diabetes have been reported with risperidone injectable and similar medications. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment with risperidone injectable. Complications of diabetes can be serious and even life-threatening. If signs of high blood sugar or diabetes develop, such as being thirsty all the time, going to the bathroom a lot, or feeling weak or hungry, contact your doctor.
• Risperidone injectable and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection.
• Some people taking risperidone injectable may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional’s dosing instructions, this side effect can be reduced or it may go away over time.
• Blood problems such as low numbers of white blood cells have been reported in patients taking risperidone and similar medications. In some cases it has been serious and life-threatening. Depending upon your medical condition, your doctor may choose to test your blood as you start therapy with risperidone injectable.
• Risperidone injectable should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.
• Painful, long-lasting erections have been reported with the use of risperidone injectable. Call your doctor immediately if you think you are having this problem.
• Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.
• Risperidone injectable may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of risperidone there are no specific foods that you must exclude from your diet when receiving risperidone.

Before receiving risperidone, tell your doctor about all of your medical conditions including if you have:

• Parkinson's Disease
• breast cancer
• heart disease (angina, irregular heartbeat, heart failure, heart attack, stroke)
• high blood pressure
• low blood pressure
• a history of seizures
• kidney disease
• liver disease
• diabetes

Tell your doctor if you are allergic to any ingredient in risperidone.

Be sure to tell your doctor if you are pregnant or breastfeeding.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. Risperidone can cross into human breast milk. It may harm your baby.

If your doctor has decided that risperidone is right for you, and you have never taken risperidone, he or she may give you a test dose of an oral version to ensure that you can tolerate the medicine.

Oral:

• Risperidone comes as a tablet, a solution (liquid), and an orally disintegrating tablet (tablet that dissolves quickly in the mouth) to take by mouth.
• It is usually taken once or twice a day with or without food. Take risperidone at around the same time(s) every day.
• Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.
• Take risperidone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Injectable:

• If you have taken risperidone before, and you can tolerate it, you may get your first injection right away. After the first injection, you will keep taking the oral medicine you're already on for 3 weeks to give risperidone a chance to start working. After that, you will come back to your healthcare professional every 2 weeks for your next dose.
• Once your doctor has prescribed risperidone, he or she may offer you a choice of where you want to get the medicine. Risperidone can be given as an injection in the upper arm or the upper buttock.
• Risperidone is given by a doctor or nurse every 2 weeks. In most cases, you may only have to expose a small area of skin.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Oral:

• Schizophrenia in Adults - The recommended dose range is 2 to 16 mg. 
• Schizophrenia in Adolescents - The recommended dose range is 0.5 to 6 mg. 
• Bipolar Mania in Adults - The recommended dose range is 2 to 6 mg. 
• Bipolar Mania in Children and Adolescents - The recommended dose range is 0.5 to 6 mg.
• Irritability associated with autistic disorder - The recommended dose range is 0.25 to 3 mg (if you weigh less than 20 kg) OR 0.5 to 3 mg (if you weight 20 kg or greater).

Injectable:

• Schizophrenia
  • The recommended dose for the treatment of schizophrenia is 25 mg IM (injected into muscle) every 2 weeks. 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 Risperdal Consta every 2 weeks. 
• Bipolar Disorder
  • The recommended dose for monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder is 25 mg IM every 2 weeks. Some patients may benefit from a higher dose of 37.5 mg or 50 mg. Dosages above 50 mg have not been studied.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Oral:

• Risperidone Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and moisture.
• Risperidone Oral Solution should be stored at controlled room temperature 15°–25°C (59°–77°F). Protect from light and freezing.
• Risperidone Orally Disintegrating Tablets should be stored at controlled room temperature 15°–25°C (59°–77°F).
• Keep out of reach of children.

Injectable:

• The entire dose pack should be stored in the refrigerator (36°– 46°F; 2°– 8°C) and protected from light.
• If refrigeration is unavailable, Risperdal Consta can be stored at temperatures not exceeding 77°F (25°C) for no more than 7 days prior to administration. Do not expose unrefrigerated product to temperatures above 77°F (25°C).
• Keep out of reach of children.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Risperidone is not approved for the treatment of patients with dementia-related psychosis.