Basic Information
RISPERIDEX TABLET 2MG
TABLET, FILM COATED
Regulatory Information
SIN14417P
October 22, 2013
Prescription Only
Therapeutic
ORAL
August 10, 2023
June 3, 2025
XN05AX08
Company Information
Active Ingredients
Strength: 2.0MG
Detailed Information
Contraindications
**Contraindications** Risperidex Tablets are contraindicated in patients with a known hypersensitivity to the product.
Indication Information
**Indications** Risperidex Tablets are indicated for the treatment of a broad range of patients with schizophrenia, including first episode psychoses, acute schizophrenic exacerbations, chronic schizophrenia, and other psychotic conditions, in which positive symptoms (such as hallucinations, delusions, thought disturbances, hostility, suspiciousness), and/or negative symptoms (such as blunted affect, emotional and social withdrawal, poverty of speech) are prominent. Risperidex Tablets alleviate affective symptoms (such as depression, guilt feelings, anxiety) associated with schizophrenia. Risperidex Tablets are also effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response. Risperidex Tablets are indicated for the short-term treatment of persistent aggression in patients with moderate to severe dementia of the Alzheimer’s type unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others. Risperidex Tablets are indicated for the treatment of behavioural disorders associated with autism (eg irritability, social withdrawal, stereotypic behaviour, hyperactivity and inappropriate speech) in children and adolescents. Risperidex Tablets are also indicated for bipolar mania. _**Adjunctive therapy:**_ Risperidex Tablets are indicated as adjunctive therapy to mood stabilizers in the treatment of manic episodes associated with bipolar disorders. These episodes are characterized by symptoms such as elevated, expansive or irritable mood, inflated self-esteem, decreased need for sleep, pressured speech, racing thoughts, distractibility, or poor judgment, including disruptive or aggressive behaviours. _**Monotherapy:**_ Risperidex Tablets are indicated in the treatment of acute manic episodes associated with bipolar I disorder. The effectiveness of Risperidex Tablets for more than 12 weeks of treatment of an acute episode, and for the prevention of new manic episodes has not been established. Risperidex Tablets are indicated in the treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with subaverage intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent. As with all symptomatic treatments, the continued use of Risperidex Tablets must be evaluated and justified on an ongoing basis.