Risperdal/Risperdal Consta Dosage/Direction for Use

Risperdal: Schizophrenia: Switching from other antipsychotics: When medically appropriate, gradual discontinuation of the previous treatment while RISPERDAL therapy is initiated is recommended. Also, if medically appropriate, when switching patients from depot antipsychotics, initiate RISPERDAL therapy in place of the next scheduled injection. The need for continuing existing anti-Parkinson medications should be re-evaluated periodically.
Adults: RISPERDAL may be given once daily or twice daily.
Patients should start with 2 mg/day RISPERDAL. The dosage may be increased on the second day to 4 mg. From then on the dosage can be maintained unchanged, or further individualized, if needed. Most patients will benefit from daily doses between 4 and 6 mg. In some patients, a slower titration phase and a lower starting and maintenance dose may be appropriate.
Doses above 10 mg/day have not been shown to be superior in efficacy to lower doses and may cause extrapyramidal symptoms. Since the safety of doses above 16 mg/day has not been evaluated, doses above this level should not be used.
A benzodiazepine may be added to RISPERDAL when additional sedation is required.
Elderly (65 years of age and older): A starting dose of 0.5 mg twice daily is recommended. This dosage can be individually adjusted with 0.5 mg twice daily increments to 1 to 2 mg twice daily.
Children: Risperidone is not recommended for use in children below age 18 with schizophrenia due to a lack of data on efficacy.
Manic episodes in bipolar disorder: Adults: RISPERDAL should be administered on a once daily schedule, starting with 2 mg risperidone. Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments of 1 mg per day. Risperidone can be administered in flexible doses over a range of 1 to 6 mg per day to optimise each patient's level of efficacy and tolerability. Daily doses over 6 mg risperidone have not been investigated in patients with manic episodes.
As with all symptomatic treatments, the continued use of RISPERDAL must be evaluated and justified on an ongoing basis.
Elderly: A starting dose of 0.5 mg twice daily is recommended. This dosage can be individually adjusted with 0.5 mg twice daily increments to 1 to 2 mg twice daily. Since clinical experience in elderly is limited, caution should be exercised.
Paediatric population: Risperidone is not recommended for use in children below age 18 with bipolar mania due to a lack of data on efficacy.
Conduct disorder: Children and adolescents from 5 to 18 years of age: For subjects ≥ 50 kg, a starting dose of 0.5 mg of oral solution once daily is recommended. This dosage can be individually adjusted by increments of 0.5 mg once daily not more frequently than every other day, if needed. The oral solution is the recommended pharmaceutical form to administer 0.5 mg. The optimum dose is 1 mg once daily for most patients. Some patients, however, may benefit from 0.5 mg once daily while others may require 1.5 mg once daily. For subjects < 50 kg, a starting dose of 0.25 mg of oral solution once daily is recommended. The oral solution is the recommended pharmaceutical form to administer 0.25 mg. This dosage can be individually adjusted by increments of 0.25 mg once daily not more frequently than every other day, if needed. The optimum dose is 0.5 mg once daily for most patients. Some patients, however, may benefit from 0.25 mg once daily while others may require 0.75 mg of oral solution once daily. The oral solution is the recommended pharmaceutical form to administer 0.75 mg.
As with all symptomatic treatments, the continued use of RISPERDAL must be evaluated and justified on an ongoing basis.
RISPERDAL is not recommended in children less than 5 years of age, as there is no experience in children less than 5 years of age with this disorder.
Renal and hepatic impairment: Patients with renal impairment have less ability to eliminate the active antipsychotic fraction than normal adults. Patients with impaired hepatic function have increases in plasma concentration of the free fraction of risperidone.
Irrespective of the indication, starting and consecutive dosing should be halved, and dose titration should be slower for patients with renal or hepatic impairment.
RISPERDAL should be used with caution in these groups of patients.
Administration: RISPERDAL may be given as oral tablets or oral solution.
Risperdal Consta: For risperidone naive patients, it is recommended to establish tolerability with oral risperidone prior to initiating treatment with RISPERIDAL CONSTA.
Schizophrenia and Schizoaffective Disorders: Dosage - Adults (older than 18 years of age): The recommended dose is 25 mg intramuscular every two weeks. Some patients may benefit from a higher doses of 37.5 mg or 50 mg. No additional benefit was observed with 75 mg in clinical trials in patients with schizophrenia. Doses higher than 50 mg every 2 weeks are not recommended.
Sufficient antipsychotic coverage should be ensured during the three-week lag period following the first RISPERDAL CONSTA injection (see Pharmacology: Pharmacokinetics under Actions).
Upward dosage adjustment should not be made more frequently than every 4 weeks. The effect of this dose adjustment should not be anticipated earlier than 3 weeks after the first injection with the higher dose.
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 in this population. The physician who elects to use RISPERDAL CONSTA for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.
Special Populations: Pediatric (18 years of age and younger): RISPERDAL CONSTA has not been studied in children younger than 18 years.
Elderly (65 years of age and older): For elderly patients treated with RISPERDAL CONSTA, the recommended dosage is 25 mg IM every 2 weeks. Oral RISPERDAL (or another antipsychotic medication) should be given with the first injection of RISPERDAL CONSTA and should be continued for 3 weeks to ensure that adequate therapeutic plasma concentrations are maintained prior to the main release phase of risperidone from the injection site (see Pharmacology: Pharmacokinetics under Actions).
Hepatic and Renal Impairment: RISPERDAL CONSTA has not been studied in hepatically and renally impaired patients.
If hepatically or renally impaired patients require treatment with RISPERDAL CONSTA, a starting dose of 0.5 mg twice daily oral risperidone is recommended during the first week. The second week 1 mg twice daily or 2 mg once daily can be given. If an oral total daily dose of at least 2 mg is well tolerated, an injection of 25 mg RISPERDAL CONSTA can be administered every 2 weeks.
Administration: RISPERDAL CONSTA should be administered every two weeks by deep intramuscular deltoid or gluteal injection. Each injection should be administered by a health care professional using the appropriate enclosed safety needle. For deltoid administration, use the 1-inch needle alternating injections between the two arms. For gluteal administration, use the 2-inch needle alternating injections between the two buttocks. Do not administer intravenously (see Precautions and Administration and Instructions for Use and Handling and Disposal under Cautions for Usage).