Risperidone

RISPERIDONE- risperidone tablet, film coated
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WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIARELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. RISPERIDONE (risperidone) is not approved for the treatment of patients with dementia-related psychosis. [see Warnings and Precautions ( 5.1)]

1 INDICATIONS AND USAGE

1.1 Schizophrenia

RISPERIDONE (risperidone) is indicated for the treatment of schizophrenia. Efficacy was established in 4 short-term trials in adults, 2 short-term trials in adolescents (ages 13 to 17 years), and one long-term maintenance trial in adults [see Clinical Studies ( 14.1) ].

1.2 Bipolar Mania

Monotherapy

RISPERIDONE is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in 2 short-term trials in adults and one short-term trial in children and adolescents (ages 10 to 17 years) [see Clinical Studies ( 14.2) ].

Adjunctive Therapy

RISPERIDONE adjunctive therapy with lithium or valproate is indicated for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder. Efficacy was established in one short-term trial in adults [see Clinical Studies ( 14.3) ].

1.3 Irritability Associated with Autistic Disorder

Pediatrics

RISPERIDONE is indicated for the treatment of irritability associated with autistic disorder, 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) ].

2 DOSAGE AND ADMINISTRATION

Table 1Recommended Daily Dosage by Indication

Initial Dose

Titration (Increments)

Target Dose

Effective Dose Range

Schizophrenia: adults (2.1)

2 mg

1 to 2 mg

4 to 8 mg

4 to 16 mg

Schizophrenia: adolescents (2.2)

0.5 mg

0.5 to 1 mg

3 mg

1 to 6 mg

Bipolar mania: adults (2.2)

2 to 3 mg

1mg

1 to 6mg

1 to 6 mg

Bipolar mania: children and adolescents (2.2)

0.5 mg

0.5 to 1mg

1 to 2.5 mg

1 to 6 mg

Irritability in autistic disorder (2.3)

0.25 mg Can increase to 0.5 mg by Day 4: (body weight less than 20 kg) 0.5 mg Can increase to 1 mg by Day 4: (body weight greater than or equal to 20 kg)

After Day 4, at intervals of > 2 weeks: 0.25 mg (body weight less than 20 kg) 0.5 mg (body weight greater than or equal to 20 kg)

0.5 mg: (body weight less than 20 kg) 1 mg: (body weight greater than or equal to 20 kg)

0.5 to 3 mg

Severe Renal and Hepatic Impairment in Adults: use a lower starting dose of 0.5 mg twice daily.

May increase to dosages above 1.5 mg twice daily at intervals of one week or longer

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