Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Psychiatry/Psychology
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Risperdal Oral Formulation
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Janssen Pharmaceuticals
Approval Status: Approved July 1996
Treatment Area: schizophrenia
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 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.