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risperidone (injection)

Pronunciation

Generic Name: risperidone (injection) (ris PER i done)
Brand Name: 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 may also be used for purposes not listed in this medication guide.

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

Risperidone is not approved for use in psychotic conditions related to dementia. Risperidone may increase the risk of death in older adults with dementia-related conditions.

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

You should not use risperidone if you are allergic to it.

Risperidone is not approved for use in psychotic conditions related to dementia. Risperidone may increase the risk of death in older adults with dementia-related conditions.

To make sure risperidone is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure, heart rhythm problems;

  • coronary artery disease or recent heart attack;

  • diabetes (or risk factors such as obesity or family history of diabetes);

  • a history of low white blood cell (WBC) counts;

  • liver or kidney disease;

  • high cholesterol or triglycerides (a type of fat in the blood);

  • a history of seizures;

  • a history of breast cancer;

  • low bone mineral density;

  • trouble swallowing;

  • Parkinson's disease;

  • if you are dehydrated; or

  • if you also take blood pressure medicine.

Some people with mental illness have thoughts about suicide. Your doctor will need to check your progress at regular visits while you are using risperidone. Your family or other caregivers should also be alert to changes in your mood or symptoms.

It is not known whether risperidone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while receiving risperidone injections or within 12 weeks after you stop using this medicine.

Using antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop using your medicine during pregnancy. Tell your doctor if you become pregnant while receiving risperidone injections.

Risperidone can pass into breast milk and may harm a nursing baby. Do not breast-feed while using this medicine and for at least 12 weeks after your treatment ends.

How is risperidone given?

Risperidone is injected into a muscle. A healthcare provider will give you this injection.

Risperidone is usually given once every 2 weeks. You may also need to take risperidone by mouth in pill or liquid form during the first 3 weeks of your treatment with risperidone injections. Follow your doctor's instructions.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your risperidone injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking risperidone?

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It may increase certain side effects of risperidone.

While you are receiving 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.

Risperidone side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

  • breast swelling or tenderness (in men or women), nipple discharge, impotence, lack of interest in sex, missed menstrual periods;

  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

  • low white blood cells--sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

  • low levels of platelets in your blood--easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or

  • penis erection that is painful or lasts 4 hours or longer.

Common side effects may include:

  • headache;

  • dizziness, drowsiness, tired feeling;

  • feeling hot or cold;

  • tremors, twitching or uncontrollable muscle movements;

  • agitation, anxiety, restless feeling;

  • depressed mood;

  • dry mouth, upset stomach, constipation;

  • weight gain; or

  • pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Risperidone dosing information

Usual Adult Dose for Schizophrenia:

Oral Formulations:
Initial dose: 2 mg orally per day
Titration dose: May increase in increments of 1 to 2 mg per day at interval of 24 hours or more, as tolerated.
Target dose: 4 to 8 mg orally per day
Maximum dose: 16 mg orally per day

Comments:
-May be administered orally once a day or in divided doses twice a day.
-Doses above 12 mg per day were not demonstrated to be more efficacious and were associated with more extrapyramidal symptoms and other adverse effects.

Long-acting IM Injection:

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

Initial dose: 25 mg IM every 2 weeks
Titration dose: May increase to 37.5 mg or 50 mg if needed; dose titration should occur no more frequently than every 4 weeks as expected drug release starts 3 weeks after injection.
Maximum dose: 50 mg IM every 2 weeks

Comments:
-Should be administered by a health care professional as deep IM deltoid or gluteal injection; do not administer IV.
-To ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of drug from the injection, oral risperidone (or another antipsychotic drug) should be given for 3 weeks following the first injection.
-Some patients not responding to the 25 mg dose may benefit from a 37.5 mg or 50 mg dose, and some patients who have a history of poor tolerability to psychotropic medications may benefit from a lower initial dose of 12.5 mg, however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Use: Treatment of schizophrenia

Usual Adult Dose for Bipolar Disorder:

Oral formulations:
Initial dose: 2 to 3 mg orally per day
Titration dose: May increase in increments of 1 mg per day at interval of 24 hours or more, as tolerated.
Effective dose range: 1 to 6 mg orally per day
Maximum dose: 6 mg orally per day

Comments: May be administered orally once a day or in divided doses twice a day; patients experiencing somnolence may benefit from twice a day dosing.

Long-acting IM Injection:

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

Initial dose: 25 mg IM every 2 weeks
Titration dose: May increase to 37.5 mg or 50 mg if needed; dose titration should occur no more frequently than every 4 weeks as expected drug release starts 3 weeks after injection.
Maximum dose: 50 mg IM every 2 weeks


Comments:
-Should be administered by a health care professional as deep IM deltoid or gluteal injection; do not administer IV.
-To ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of drug from the injection, oral risperidone (or another antipsychotic drug) should be given for 3 weeks following the first injection.
-Some patients not responding to the 25 mg dose may benefit from a 37.5 mg or 50 mg dose, and some patients who have a history of poor tolerability to psychotropic medications may benefit from a lower initial dose of 12.5 mg, however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Uses: As monotherapy or as adjunctive therapy with lithium or valproate for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.

Usual Geriatric Dose for Schizophrenia:

Oral formulations:
Initial dose: 0.5 mg orally twice a day
Titration dose: May increase in increments of 1 to 2 mg per day at interval of 24 hours or more, as tolerated.
Target dose: 4 to 8 mg orally per day
Maximum dose: 16 mg orally per day

Comments:
-May be administered orally once a day or in divided doses twice a day.
-Elderly patients exhibit a greater tendency to orthostatic hypotension, careful titration with monitoring of orthostatic vital signs should be considered.
-Doses above 12 mg per day were not demonstrated to be more efficacious and were associated with more extrapyramidal symptoms and other adverse effects.

Long-acting IM Injection:

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

Initial dose: 25 mg IM every 2 weeks
Titration dose: May increase to 37.5 mg or 50 mg if needed; dose titration should occur no more frequently than every 4 weeks as expected drug release starts 3 weeks after injection.
Maximum dose: 50 mg IM every 2 weeks

Comments:
-Should be administered by a health care professional as deep IM deltoid or gluteal injection; do not administer IV.
-Elderly patients exhibit a greater tendency to orthostatic hypotension, careful titration with monitoring of orthostatic vital signs should be considered.
-To ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of drug from the injection, oral risperidone (or another antipsychotic drug) should be given for 3 weeks following the first injection.
-Some patients not responding to the 25 mg dose may benefit from a 37.5 mg or 50 mg dose, and some patients who have a history of poor tolerability to psychotropic medications may benefit from a lower initial dose of 12.5 mg, however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Use: Treatment of schizophrenia

Usual Geriatric Dose for Bipolar Disorder:

Oral formulations:
Initial dose: 0.5 mg orally twice a day
Titration dose: May increase in increments of 1 mg per day at interval of 24 hours or more, as tolerated.
Effective dose range: 1 to 6 mg orally per day
Maximum dose: 6 mg orally per day

Comments:
-May be administered orally once a day or in divided doses twice a day; patients experiencing somnolence may benefit from twice a day dosing.
-Elderly patients exhibit a greater tendency to orthostatic hypotension, careful titration with monitoring of orthostatic vital signs should be considered.

Long-acting IM Injection:

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

Initial dose: 25 mg IM every 2 weeks
Titration dose: May increase to 37.5 mg or 50 mg if needed; dose titration should occur no more frequently than every 4 weeks as expected drug release starts 3 weeks after injection.
Maximum dose: 50 mg IM every 2 weeks

Comments:
-Should be administered by a health care professional as deep IM deltoid or gluteal injection; do not administer IV.
-Elderly patients exhibit a greater tendency to orthostatic hypotension, careful titration with monitoring of orthostatic vital signs should be considered.
-To ensure adequate therapeutic plasma concentrations are maintained prior to the main release phase of drug from the injection, oral risperidone (or another antipsychotic drug) should be given for 3 weeks following the first injection.
-Some patients not responding to the 25 mg dose may benefit from a 37.5 mg or 50 mg dose, and some patients who have a history of poor tolerability to psychotropic medications may benefit from a lower initial dose of 12.5 mg, however, the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Uses: As monotherapy or as adjunctive therapy with lithium or valproate for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.

Usual Pediatric Dose for Schizophrenia:

13 years or older:
Initial dose: 0.5 mg orally once a day
Titration dose: May increase in increments of 0.5 mg to 1 mg per day at interval of 24 hours or more, as tolerated.
Target dose: 3 mg orally per day
Maximum dose: 6 mg orally per day

Comments:
-May be administered orally once a day or in divided doses twice a day; patients experiencing somnolence may benefit from twice a day dosing.
-Doses greater than 6 mg per day have not been studied

Use: Treatment of schizophrenia

Usual Pediatric Dose for Bipolar Disorder:

10 years or older:
Initial dose: 0.5 mg orally once a day
Titration dose: May increase in increments of 0.5 mg to 1 mg per day at interval of 24 hours or more, as tolerated.
Target dose: 1 to 2.5 mg orally per day
Maximum dose: 6 mg orally per day

Comments: May be administered orally once a day or in divided doses twice a day; patients experiencing somnolence may benefit from twice a day dosing.

Use: As monotherapy or as adjunctive therapy with lithium or valproate for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder.

Usual Pediatric Dose for Autism:

Ages 5 to 17 years:
-Weight greater than 15 kg and less than 20 kg:
Initial dose: 0.25 mg orally once a day
Titration: after a minimum of 4 days, may increase to 0.5 mg per day; maintain this dose for a minimum of 14 days; subsequent dose increases may be made in increments of 0.25 mg at intervals of 2 weeks or more, as tolerated
Recommended dose: 0.5 mg orally per day
-Weight 20 kg or greater:
Initial dose: 0.5 mg orally once a day
Titration: After a minimum of 4 days, may increase to 1 mg per day; maintain this dose for a minimum of 14 days; subsequent dose increases in increments of 0.5 mg at intervals of 2 weeks or more, as tolerated.
Recommended dose: 1 mg orally per day

Effective dose range: 0.5 mg to 3 mg orally per day; individualize dose according to response and tolerability.
Maximum dose: 3 mg orally per day
Maintenance dose: Once sufficient clinical response has been achieved and maintained, consider gradually reducing the dose to achieve the optimal balance of safety and efficacy.

Comments:
-Dosing data is not available for children weighing less than 15 kg.
-May be administered orally once a day or in divided doses twice a day; patients experiencing somnolence may benefit from twice a day dosing.

Use: For the treatment of irritability associated with autistic disorder, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

What other drugs will affect risperidone?

Using this medicine with other drugs that make you sleepy can worsen these effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with risperidone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or 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.
  • Disclaimer: 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.05. Revision Date: 2016-04-18, 8:46:05 AM.

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