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Risperidon

Risperidone
Film-coated tablets 1 mg
Film-coated tablets 2 mg
Film-coated tablets 3 mg
Film-coated tablets 4 mg
ATC N05A X08
Prescription-only medicine
Reimburse by Health Insurance Fund

POSOLOGY AND METHOD OF ADMINISTRATION

Schizophrenia

Adults

Risperidon 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 individualized, 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 an 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 disorder

Adults

Risperidon should be administered on a once-daily schedule, starting with 2 mg risperidone. 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. As with all symptomatic treatments, the continued use of Risperidon must be evaluated and justified on an ongoing basis.

Adults

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. Since clinical experience in the elderly is limited, caution should be exercised.

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. Risperidon should not be used for more than 6 weeks in patients with persistent aggression in Alzheimer’s dementia. During treatment, patients must be evaluated frequently and regularly, and the need for continuing treatment reassessed.

Conduct disorder
Children and adolescents from 5 to 18 years of age

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. As with all symptomatic treatments, the continued use of Risperidon must be evaluated and justified on an ongoing basis. Risperidon 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 increased 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. Risperidon should be used with caution in these groups of patients.

Method of administration

Risperidon is for oral use. Food does not affect the absorption of the medicine. 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. 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 revaluated periodically.


Medicine’s information on this web page is only a short description of its characteristics. Do not take them as recommendations for self-treatment of your health condition.

You must inform your physician and pharmacist and follow their recommendations before you use the medicine for treatment. Always read carefully the patient information leaflet.

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COMPOSITION

Each film-coated tablet contains 1 mg risperidone.
Each film-coated tablet contains 2 mg risperidone.
Each film-coated tablet contains 3 mg risperidone.
Each film-coated tablet contains 4 mg risperidone.

THERAPEUTIC INDICATIONS

Risperidon is indicated for the treatment of schizophrenia.
Risperidon is indicated for the treatment of moderate to severe manic episodes associated with bipolar disorders.
Risperidon is indicated for the short-term treatment (up to 6 weeks) of persistent aggression in patients with moderate to severe Alzheimer's dementia unresponsive to non-pharmacological approaches and when there is a risk of harm to self or others.
Risperidon is indicated for the short-term symptomatic treatment (up to 6 weeks) of persistent aggression in conduct disorder in children from the age of 5 years and adolescents with subaverage intellectual functioning or mental retardation diagnosed according to DSM-IV criteria, in whom the severity of aggressive or other disruptive behaviours require pharmacologic treatment. Pharmacological treatment should be an integral part of a more comprehensive treatment programme, including psychosocial and educational intervention. It is recommended that risperidone be prescribed by a specialist in child neurology and child and adolescent psychiatry or physicians well familiar with the treatment of conduct disorder of children and adolescents.

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the excipients.


PACKAGING

Box of 20 tablets of 1 mg in a blister package.
Box of 20 tablets of 2 mg in a blister package.
Box of 20 tablets of 3 mg in a blister package.
Box of 20 tablets of 4 mg in a blister package.