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Risperidone is an atypical antipsychotic used to treat schizophrenia (including adolescent schizophrenia), the mixed and manic states associated with bipolar disorder, and irritability in children with autism. The drug was developed by Janssen-Cilag and is sold under the trade name Risperdal in the Netherlands, United States, Canada, the United Kingdom, Portugal, Spain, Turkey and several other countries, Risperdal or Ridal in New Zealand, Sizodon or Riscalin in India, Rispolept in Eastern Europe, and Belivon, or Rispen elsewhere.
Indications and Uses
- treatment of schizophrenia in adults
- treatment of schizophrenia in adolescents aged 13-17 years
- alone or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults
- alone the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in children and adolescents aged 10-17 years
- reatment of irritability associated with autistic disorder in children and adolescents aged 5-16 years
Risperidone was approved by the United States Food and Drug Administration (FDA) in 1993 for the treatment of schizophrenia.
On August 22, 2007, Risperdal was approved as the only drug agent available for treatment of schizophrenia in youth ages 13???17; it was also approved that same day for treatment of bipolar disorder in youth and children ages 10???17, joining lithium. Risperidone contains the functional groups of benzisoxazole and piperidine as part of its molecular structure. In 2003 the FDA approved risperidone for the short-term treatment of the mixed and manic states associated with bipolar disorder. In 2006 the FDA approved risperidone for the treatment of irritability in children and adolescents with autism. The FDA`s decision was based in part on a study of autistic children with severe and enduring problems of violent meltdowns, aggression, and self-injury; risperidone is not recommended for autistic children with mild aggression and explosive behavior without an enduring pattern. Like other atypical antipsychotics, risperidone has also been used off-label for the treatment of anxiety disorders, such as obsessive-compulsive disorder; severe, treatment-resistant depression with or without psychotic features; Tourette syndrome; disruptive behavior disorders in children; and eating disorders, among others. In two small studies risperidone was reported to successfully treat the symptoms of phencyclidine psychosis due to acute intoxication and chronic use.
A 2009 Cochrane Library review found no evidence from randomized controlled trials that risperidone is effective for the treatment of attention-deficit hyperactivity disorder (ADHD) in people with intellectual disabilities. A multi-year UK study by the Alzheimer`s Research Trust suggested that this and other neuroleptic anti-psychotic drugs commonly given to Alzheimer`s patients with mild behavioural problems often made their condition worse. The study concluded that:
For most patients with AD, withdrawal of neuroleptics had no overall detrimental effect on functional and cognitive status and by some measures improved functional and cognitive status. Neuroleptics may have some value in the maintenance treatment of more severe neuropsychiatric symptoms, but this possibility must be weighed against the unwanted effects of therapy.
Common side effects include severe anxiety, akathisia, sedation, dysphoria, insomnia, sexual dysfunction, low blood pressure, muscle stiffness, muscle pain, tremors, increased salivation, and stuffy nose. Risperidone has been associated with minimal to moderate weight gain, with one study finding that 26 to 38 percent of participants on the drug experienced weight gain.
Occasionally breast tenderness and eventually lactation in both sexes may occur. Many antipsychotics are known to increase prolactin because they inhibit dopamine. However, risperidone is known to increase prolactin to a greater extent than most other antipsychotics, such as quetiapine. Over 40 pituitary neoplasm cases have been reported worldwide. It is thought that once risperidone raises prolactin, it may cause prolactinoma, a benign tumor of the pituitary gland. Tumors, in general, aren`t considered reversible. Medical therapy (dopamine agonists) may help reduce tumor size and restore normal reproduction and pituitary function, but if unsuccessful, surgery or radiation treatment may be required. This condition may recur if the patient is switched to a different antipsychotic. Risperidone has been known to cause increased thoughts of suicide.
Risperidone can potentially cause tardive dyskinesia (TD), extrapyramidal symptoms (EPS), and neuroleptic malignant syndrome (NMS). Risperidone may also trigger diabetes and more serious conditions of glucose metabolism, including ketoacidosis and hyperosmolar coma.
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