Posology : מינונים

4.2     Posology and method of administration
RISPERDAL may be given as oral tablets or oral solution.

RISPERDAL 0.5 mg tabs are not registered in Israel, therefore the RISPERDAL 1 mg/ml oral solution should be used for 0.5 mg dose adjustments.

Schizophrenia

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 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.

Adolescents (13-17 years)

A starting dose of 0.5 mg daily is recommended, administered as a single-daily dose either in the morning or evening. If indicated, this dosage can then be adjusted at intervals not less than 24 hours in increments of 0.5 or 1 mg/day, as tolerated, to a recommended dose of 3 mg/day. Efficacy has been demonstrated at doses between 1 and 6 mg/day. Doses higher than 6 mg/day have not been studied.

Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily.

Children

Experience in schizophrenia is lacking in children aged less than 13 years of age.
Bipolar mania

Adults
RISPERDAL 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. Efficacy was demonstrated in flexible doses over a range of 1 to 6 mg per day.
As with all symptomatic treatments, the continued use of RISPERDAL must be evaluated and justified on an ongoing basis.

Children and Adolescents (10-17 years of age)
A starting dose of 0.5mg once daily is recommended, administered as a single-daily dose in either the morning or evening. If indicated, this dosage can then be adjusted at intervals not less than 24 hours in increments of 0.5 or 1 mg/day, as tolerated, to a recommended dose of 2.5 mg/day. Although efficacy has been demonstrated at doses between 0.5 and 6 mg/day. No additional benefit was seen above 2.5 mg/day, and higher doses were associated with more adverse events. Doses higher than 6 mg/day have not been studied.

Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily.

As with all symptomatic treatments, the continued use of RISPERDAL® must be evaluated and justified on an ongoing basis.
Experience is lacking in bipolar mania in children less than 10 years of age.


Psychotic manifestations of 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.
RISPERDAL should not be used more than 6 weeks in patients with persistent aggression in Alzheimer's dementia. During treatment, patients must be evaluated frequently and regularly, and the need for continuing treatment reassessed.

Conduct and other disruptive behavior disorders (5-18 years of age)
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.

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 RISPERDAL must be evaluated and justified on an ongoing basis.

Experience is lacking in children aged less than 5 years of age.

Renal and Hepatic Impairment
Patients with renal impairment have less ability to eliminate the active antipsychotic fraction than in adults with normal renal fraction. 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.

Method of administration
RISPERDAL is for oral use. Food does not affect the absorption of RISPERDAL.

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 section 4.8). 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 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.