Risperdal Oral Formulation

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved July 1996

Specific Treatments:

schizophrenia

Therapeutic Areas

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General Information

An oral formulation of Risperdal has been approved for the treatment of schizophrenia. Due to its ease of administration, Risperdal oral solution will provide treatment benefits to a wider range of subjects, particularly the elderly for whom liquid formulations are frequently prescribed, and for subjects treated in an acute care setting. The tablet form of Risperdal has been available since 1984.

Risperdal is indicated for the management of the manifestations of psychotic disorders, including both the positive symptoms (delusions, hallucinations, and hearing voices) and negative symptoms (diminished emotional expressions) of schizophrenia, schizoaffective disorder, and the psychotic features associated with bipolar disorder.

Clinical Results

Clinical studies have shown that extrapyramidal symptoms (EPS) with Risperdal, while dose dependent, is comparable to placebo at recommended doses. The most common side effects reported in clinical trials were insomnia, agitation, EPS, headache, anxiety and rhinitis; less common were somnolence, dizziness, constipation, nausea, and tachycardia. Risperdal may also cause orthostatic hypotension, a form of low blood pressure, especially during the initial dosing period.