Risperidone Dosage

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Usual Adult Dose for:

Usual Geriatric Dose for:

Usual Pediatric Dose for:

Additional dosage 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 Bipolar Disorder

Long-acting injection:
For monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder:

Recommended dose: 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 in this population.

Risperidone long-acting injection for extended periods should periodically reevaluate the long-term risks and benefits of the drug for the individual patient.

Oral:
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) antimanic 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.

Usual Geriatric Dose for Bipolar Disorder

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 0.125 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 at 2 week intervals.
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 at 2 week intervals.
Maximum recommended dose: 2.5 mg orally per day (3 mg/day in children over 45 Kg).

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 at 2 week intervals.
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.

Renal Dose Adjustments

Oral:
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/day should be done at greater than 1 week intervals.

Injection:
If a total daily dose of at least 2 mg orally is well tolerated, the long acting intramuscular formulation may be used.

Initial dose: 25 mg every 2 weeks by deep IM gluteal injection.

A starting dose of 12.5 mg IM may be considered when clinical factors warrant a dose adjustment; however, it should be noted that the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Liver Dose Adjustments

Oral:
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.

Injection:
If a total daily dose of at least 2 mg orally is well tolerated, the long acting intramuscular formulation may be used.

Initial dose: 25 mg every 2 weeks by deep IM gluteal injection.

A starting dose of 12.5 mg IM may be considered when clinical factors warrant a dose adjustment; however, it should be noted that the efficacy of the 12.5 mg dose has not been studied in clinical trials.

Dose Adjustments

A reduction in the initial dosage and a slower titration may be necessary in patients who are debilitated, predisposed to hypotension, or hypotension would pose a risk.

Precautions

Risperidone is not approved by the FDA for use in the treatment of behavioral disorders in elderly patients with dementia. Collective data from 17 placebo-controlled clinical studies (n=5106) involving the use of atypical antipsychotic agents, including risperidone, for the treatment of behavioral disorders in the elderly patient with dementia showed a risk of death 1.6 to 1.7 times greater in the drug- treated patient than in the placebo- treated patient. The average length of duration for the trials was 10 weeks with the cause of death in the majority of cases, though not all, reported as either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.

In addition, based on data from four placebo controlled trials conducted in elderly patients (n=1230), cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, have been reported in elderly patients with dementia- related psychosis. In placebo controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with risperidone compared to patients treated with placebo. Risperidone has not been shown to be safe or effective in the treatment of patients with dementia- related psychosis. Additional information on these and other clinical trials conducted in elderly patients can be obtained by calling 1-800- JANSSEN (800-526-7736).

The risperidone long acting intramuscular formulation should be administered into the gluteal muscle with careful avoidance of inadvertent injection into the vasculature.

Safety and effectiveness of the risperidone long acting intramuscular formulation have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

Doses greater than 6 mg per day are associated with more adverse effects and are generally not recommended, but may be necessary in some patients.

Risperidone induced hyperprolactinemia may be especially detrimental to pediatric patients as it may possibly result in irreversible hypogonadism and osteoporosis.

The therapeutically effective risperidone plasma concentration range is 20 to 60 ng/mL. Plasma concentrations above 74 ng/mL appear to be associated with parkinsonian adverse effects.

Development of hyperglycemia and/or diabetes mellitus is common in patients treated with atypical antipsychotics. Periodic monitoring of fasting plasma glucose is recommended in patients receiving risperidone.

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