Risperidone-Chanelle

Risperidone-Chanelle Dosage/Direction for Use

risperidone

Manufacturer:

Chanelle

Distributor:

Medicell Pharma
Full Prescribing Info
Dosage/Direction for Use
1 ml of Risperidone Oral Solution contains 1 mg risperidone. The liquid may be diluted with mineral water, orange juice or black coffee (see Cautions for Usage).
Schizophrenia: Adults: Risperidone may be given once daily or twice daily.
Patients should start with 2 mg/day risperidone. The dosage may be increased on the second day to 4 mg. Subsequently, 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 demonstrated superior efficacy to lower doses and may cause increased incidence of extrapyramidal symptoms. Safety of doses above 16 mg/day has not been evaluated, and are therefore not recommended.
Elderly: 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.
Paediatric population: Risperidone is not recommended for use in children below age 18 with schizophrenia due to a lack of data on efficacy.
Manic episodes in bipolar mania: Adults: Risperidone should be administered once daily, starting with 2 mg. Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments of 1 mg per day. Risperidone can be administered in flexible doses over a range of 1 to 6 mg per day to optimize each patient's level of efficacy and tolerability. Daily doses over 6 mg risperidone have not been investigated in patients with manic episodes. The physician who elects to use risperidone for periods extending beyond 12 weeks should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
As with all symptomatic treatments, the continued use of risperidone must be evaluated and justified on an ongoing basis.
Paediatric population: Risperidone is not recommended for use in children below age 18 with bipolar mania due to a lack of data on efficacy.
Persistent aggression in patients with moderate to severe Alzheimer's 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.
There is no data to support treatment beyond 12 weeks in patients with moderate to severe dementia of the Alzheimer type with agitation, aggression or psychotic symptoms. During treatment, patients must be evaluated frequently and regularly, and the need for continuing treatment reassessed.
Conduct disorders: Children and adolescents from 5 to 18 years of age: Patients weighing more than 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.
Patients weighing less than 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, although some patients may benefit from 0.25 mg once daily while others may require 0.75 mg once daily.
As with all symptomatic treatments, the continued use of risperidone must be evaluated and justified on an on-going basis.
Risperidone is not recommended in children less than 5 years of age, as there is no experience in children less than 5 years of age with this disorder.
Renal and hepatic impairment: Patients with renal impairment have less ability to eliminate the active antipsychotic fraction than in adults with normal renal function. 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.
Risperidone should be used with caution in these groups of patients.
Method of administration: Risperidone is for oral use. Food does not affect the absorption of risperidone.
Upon discontinuation, gradual withdrawal is advised. Acute withdrawal symptoms, including nausea, vomiting, sweating, and insomnia have very rarely been described after abrupt cessation of high doses of antipsychotic medicines (see Adverse Reactions). Recurrence of psychotic symptoms may also occur, and the emergence of involuntary movement disorders (such as akathisia, dystonia and dyskinesia) has been reported.
Switching from other antipsychotics: When medically appropriate, gradual discontinuation of the previous treatment while risperidone therapy is initiated is recommended. Also, if medically appropriate, when switching patients from depot antipsychotics, initiate risperidone therapy in place of the next scheduled injection. The need for continuing existing anti-Parkinson medicines should be re-evaluated periodically.
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