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Drug DescriptionSide Effects & Drug InteractionsWarnings & Precautions
Additional InfoClinical PharmacologyOverdosage & ContraindicationsIndications & Dosage

Risperdal

[Risperidone]


Indications & Dosage
INDICATIONS AND USAGE

Schizophrenia

RISPERDAL ® ( risperidone) is indicated for the treatment of schizophrenia.
The efficacy of RISPERDAL ® in schizophrenia was established in short-term (6-to 8-weeks) controlled trials of schizophrenic inpatients ( see CLINICAL PHARMACOLOGY) .

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The efficacy of RISPERDAL ® in delaying relapse was demonstrated in schizophrenic patients who had been clinically stable for at least 4 weeks before initiation of treatment with RISPERDAL ® or an active comparator and who were then observed for relapse during a period of 1 to 2 years ( see CLINICAL PHARMACOLOGY Clinical Trials) . Nevertheless, the physician who elects to use RISPERDAL ® for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient ( see DOSAGE AND ADMINISTRATION) .

RISPERDAL ® M-TAB ( RISPERIDONE) ORALLY DISINTEGRATING TABLETS

Bipolar Mania

Monotherapy

RISPERDAL ® is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder.
The efficacy of RISPERDAL ® was established in two placebo-controlled trials ( 3-week) with patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode with or without psychotic features ( see CLINICAL PHARMACOLOGY) .

Combination Therapy

The combination of RISPERDAL ® with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder.

The efficacy of RISPERDAL ® in combination with lithium or valproate was established in one placebo-controlled ( 3-week) trial with patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode with or without psychotic features ( see CLINICAL PHARMACOLOGY) .

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