Risperdal - Indications & Dosage

Risperidone

• Risperdal - Drug Description
• Risperdal - Side Effects & Drug Interactions
• Risperdal - Warnings & Precautions
• Risperdal - Additional Info
• Risperdal - Clinical Pharmacology
• Risperdal - Overdosage & Contraindications

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) .

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) .

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) .