Eperon Dosage/Direction for Use

Schizophrenia: Adults: Eperon may be given once daily or twice daily. Patients should start with 2 mg/day risperidone. The dosage may be increased on the second day to 4 mg. Subsequently, the dosage can be maintained unchanged, or further individualised, if needed. Most patients will benefit from daily doses between 4 and 6mg. In some patients, a slower titration phase and a lower starting and maintenance dose may be appropriate.
Doses above 10 mg/day have not demonstrated superior efficacy to lower doses and may cause increased incidence of extrapyramidal symptoms. Safety of doses above 16 mg/day has not been evaluated, and is therefore not recommended.
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.
Paediatric population: 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: Eperon should be administered on a once daily schedule, starting with 2 or 3 mg. Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments of 1 mg per day. A dosing range between 2-6 mg per day is recommended. The physician who elects to use Eperon for periods extending beyond 12 weeks should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
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 2mg 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.
Behavioral Disturbances in patients with Dementia: A starting dose of 0.25 mg twice daily is recommended.
This dosage can be individually adjusted by increments of 0.25 mg twice daily, not more frequently than every other day, if needed.
The optimum dose is 0.5 mg twice daily for most patients. Some patients, however, may benefit from doses up to 1 mg twice daily.
Conduct disorder: Children and adolescents from 5 to 18 years of age: For subjects ≥ 50 kg, a starting dose of 0.5 mg 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 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 once daily is recommended. 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 once daily.
As with all symptomatic treatments, the continued use of Eperon must be evaluated and justified on an ongoing basis.
Eperon 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.
Autism: Pediatrics (5-17 years of age): The dosage of risperidone should be individualized according to the needs and response of the patient. Dosing should be initiated at 0.25 mg per day for patients < 20 kg and 0.5 mg per day for patients ≥ 20 kg.
On Day 4, the dose may be increased by 0.25 mg for patients < 20 kg and 0.5 mg for patients ≥ 20 kg.
This dose should be maintained and response should be assessed at approximately Day 14. Only in patients not achieving sufficient clinical response should additional dose increases be considered. Dose increases may proceed at ≥ 2-week intervals in increments of 0.25 mg for patients < 20 kg or 0.5 mg for patients ≥ 20 kg.
In clinical studies, the maximum dose studied did not exceed a total daily dose of 1.5 mg in patients < 20 kg, 2.5 mg in patients ≥ 20 kg, or 3.5 mg in patients > 45 kg. Doses below 0.25mg/day were not effective in clinical studies. (See Table 1.)

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For prescribers preferring to dose on a mg/kg/day basis the following guidance is provided. (See Table 2.)

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Risperidone can be administered once daily or twice daily. Patients experiencing somnolence may benefit from a switch in dosing from once daily to either once daily at bedtime or twice daily. Once sufficient clinical response has been achieved and maintained, consideration may be given to gradually lowering the dose to achieve the optimal balance of efficacy and safety. Experience is lacking in children less than 5 years and limited in autistic adolescents. Effectiveness for more than 8 weeks has not been systematically evaluated in double-blind, parallel-controlled clinical trials. Therefore, the physician who elects to use risperidone for the treatment of behavioral disorders associated with autism (eg irritability, social withdrawal, stereotypic behaviour, hyperactivity and inappropriated speech) in children and adolescents for extended periods should periodically re-evaluate the long term risks and benefits of the drug for the individual patient.
Hepatic and renal impairment: Patients with renal impairment have less ability to eliminate the active antipsychotic fraction than in adults with normal renal function. 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.
Eperon should be used with caution in these groups of patients.
Method of administration: Eperon is for oral use. Food does not affect the absorption of Eperon.
Upon discontinuation, gradual withdrawal is advised. Acute withdrawal symptoms, including nausea, vomiting, sweating, and insomnia have very rarely been described after abrupt cessation of high doses of antipsychotic medicines (see Adverse Reactions). Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported.
Switching from other antipsychotic: When medically appropriate, gradual discontinuation of the previous treatment while Eperon therapy is initiated is recommended. Also, if medically appropriate, when switching patients from depot antipsychotics, initiate Eperon therapy in place of the next scheduled injection. The need for continuing existing anti-Parkinson medicines should be re-evaluated periodically.