RISPERIDONE

Atypical Antipsychotic

Brand names: RISPERIDONE, Risperdal

Oral

Mechanism of Action

12.1 Mechanism of Action The mechanism of action of risperidone in schizophrenia is unclear. The drug's therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D 2 ) and serotonin Type 2 (5HT 2 ) receptor antagonism. The clinical effect from risperidone results from the combined concentrations of risperidone and its major metabolite, 9-hydroxyrisperidone (paliperidone) [see Clinical Pharmacology ( 12.3 )] . Antagonism at receptors other than D 2 and 5HT 2 may explain some of the other effects of risperidone [see Clinical Pharmacology ( 12.1 )] .

Indications

1 INDICATIONS AND USAGE Risperidone tablets are an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate

2 short-term trials in adolescents (ages 13 to 17 years)

including symptoms of aggression towards others

deliberate self-injuriousness

temper tantrums

and quickly changing moods. Efficacy was established in 3 short-term trials in children and adolescents (ages 5 to 17 years) [see Clinical Studies (14.4) ] .

Contraindications

• 4 CONTRAINDICATIONS Risperidone tablets are contraindicated in patients with a known hypersensitivity to either risperidone or paliperidone
• or to any of the excipients in the risperidone tablets formulation. Hypersensitivity reactions
• including anaphylactic reactions and angioedema
• have been reported in patients treated with risperidone and in patients treated with paliperidone. Paliperidone is a metabolite of risperidone. Known hypersensitivity to risperidone
• paliperidone

FDA Warnings

5 WARNINGS AND PRECAUTIONS Cerebrovascular events, including stroke, in elderly patients with dementia-related psychosis: Risperidone tablets are not approved for use in patients with dementia-related psychosis ( 5
4 ) Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that may increase cardiovascular / cerebrovascular risk
Monitor glucose regularly in patients with diabetes or at risk for diabetes
6 ) Orthostatic hypotension: For patients at risk, consider a lower starting dose and slower titration

Known Side Effects

3 documented side effects by frequency

Weight Gain

1-10%

Drug Not Working

1-10%

Drowsiness

0.1-1%

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Compare With

19 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral