Risperdal

[Risperidone]

The effectiveness of RISPERDAL ® for longer-term use, that is, for more than 3 weeks of treatment of an acute episode, and for prophylactic use in mania, has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use RISPERDAL ® for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient ( see DOSAGE AND ADMINISTRATION) .

DOSAGE AND ADMINISTRATION

Schizophrenia

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Usual Initial Dose

RISPERDAL ® ( risperidone) can be administered on either a BID or a QD schedule. In early clinical trials, RISPERDAL ® was generally administered at 1 mg BID initially, with ncreases n increments of 1 mg BID on the second and third day, as tolerated, to a target dose of 3 mg BID by the third day. Subsequent controlled trials have indicated that total daily risperidone doses of up to 8 mg on a QD regimen are also safe and effective. However, regardless of which regimen is employed, in some patients a slower titration may be medically appropriate. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week, since steady state for the active metabolite would not be achieved for approximately 1 week in the typical patient. When dosage adjustments are necessary, small dose increments/ decrements of 1-2 mg are recommended.

Efficacy in schizophrenia was demonstrated in a dose range of 4 to 16 mg/ day in the clinical trials supporting effectiveness of RISPERDAL ® ; however, maximal effect was generally seen in a range of 4 to 8 mg/ day. Doses above 6 mg/ day for BID dosing were not demonstrated to be more efficacious than lower doses, were associated with more extrapyramidal symptoms and other adverse effects, and are not generally recommended. In a single study supporting QD dosing, the efficacy results were generally stronger for 8 mg than for 4 mg. The safety of doses above 16 mg/ day has not been evaluated in clinical trials.

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