Rispadex (risperidone) is indicated for the acute and maintenance treatment of schizophrenia.
Rispadex is indicated for the treatment of schizophrenia in adolescents aged 13–17 years.
• Monotherapy - Adults and Pediatrics
Rispadex is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults and in children and adolescents aged 10-17 years.
• Combination Therapy – Adults
The combination of Rispadex with lithium or valproate is indicated for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder.
Irritability Associated with Autistic Disorder
Rispadex is indicated for the treatment of irritability associated with autistic disorder in children and adolescents aged 5–16 years, including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.
• Switching from other Antipsychotics.
When medically appropriate gradual discontinuation of the previous treatment while Rispadex therapy is indicated is recommended. Also if medically appropriate, when switching patients from depot antipsychotics, initiate Rispadex therapy in place of the next scheduled injection. The need for continuing existing anti-parkinson medications should be re-evaluated periodically.
Rispadex may be given once daily or twice daily.
Patients should start with 2 mg/day Rispadex. The dosage may be increased on the second day to 4 mg. from then on the dosage can be maintained unchanged, or further individualised, if needed. Most patients will benefit from daily doses between 4 and 6 mg. In some patients, a slower titration phase and a lower starting and maintenance dose may be appropriate.
Doses above 10 mg/day have not been shown to be superior in efficacy to lower doses and may cause extrapyramidal symptoms. Since the safety of doses above 16 mg/day has not been evaluated, doses above this level should not be used.
A benzodiazepine may be added to Rispadex when additional sedation is required.
A starting dose of 0.5 mg twice daily is recommended. This dosage can be individually adjusted with 0.5 mg twice daily increments to 1 to 2 mg twice daily.
Experience in schizophrenia is lacking in children less than 15 years of age.
Rispadex should be administered on a once daily schedule, starting with 2 mg to 3 mg. Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments of 1 mg per day. Efficacy was demonstrated in flexible doses over a range of 1 to 6 mg per day.
As with all symptomatic treatments, the continued use of Rispadex must be evaluated and justified on an on-going basis.
Experience is lacking in bipolar mania in children and adolescents less than 18 years of age,
Behavioural Disturbances in Patients with Dementia
A starting dose of 0.25 mg twice daily is recommended. This dosage can be individually adjusted by increments of 0.25 mg twice daily, not more frequently than every other day, if needed. The optimum dose is 0.5 mg twice daily for most patients. Some patients, however, may benefit from doses up to 1 mg twice daily.
Once patients have reached their target dose, a once daily dosing regimen can be considered. As with all symptomatic treatment, the continued use of Rispadex must be evaluated and justified on an on-going basis.
Conduct and other Disruptive Behaviour Disorders
For subjects >50 kg, a starting dose of 0.5 mg once daily is recommended. This dosage can be individually adjusted by increments of 0.5 mg once daily not more frequently than every other day, if needed. The optimum dose is 1 mg once daily for most patients. Some patients, however, may benefit from 0.5 mg once daily while others may require 1.5 mg once daily. For subjects <50 kg, a starting dose of 0.25 mg once daily is recommended. This dosage can be individually adjusted by increments of 0.25 mg once daily not more frequently than every other day, if needed. The optimum dose is 0.5 mg once daily for most patients. Some patients, however, may benefit from 0.25 mg once daily while others may require 0.75 mg once daily.
Experience is lacking in children less than 5 years of age.
Renal and hepatic impairment
Patients with renal impairment have less ability to eliminate the active antipsychotic fraction than in normal adults. Patients with impaired hepatic function have increases in plasma concentration of the free fraction of risperidone.
Irrespective of the indication, starting and consecutive dosing should be halved, and dose titration should be slower for patients with renal or hepatic impairment.
Rispadex should be used with caution in these groups of patients.
In patients with a known hypersensitivity to the product.
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