Aspidon/Aspidon OS

Aspidon/Aspidon OS Dosage/Direction for Use

risperidone

Manufacturer:

Torrent

Distributor:

Torrent
Full Prescribing Info
Dosage/Direction for Use
Aspidon: 1 mg: Schizophrenia: When switching from other antipsychotics, where medically appropriate, gradual discontinuation of the previous treatment while Risperidone therapy is initiated is recommended.
Adults: Risperidone may be given once or twice daily. Treatment should be started with 2 mg/day, whether for acute or chronic condition. The dosage may be increased to 4 mg/day on the second day.
Some patients, such as first episode patients, may benefit from a slower rate of titration. From then on, the dosage can be maintained unchanged, or further individualized, if needed. Most patients will benefit from daily doses between 4 and 6 mg/day although in some, an optimal response may be obtained at lower doses.
Doses above 10 mg/day generally have not been shown to provide additional efficacy to lower doses and may increase the risk of extrapyramidal symptoms. Doses above 10 mg/day should only be used in individual patients if the benefit is considered to outweigh the risk. Doses above 16 mg/day have not been extensively evaluated for safety and therefore should not be used.
Elderly & Patients with renal and liver disease: A starting dose of 0.5 mg b.d. is recommended. This dosage can be individually adjusted with 0.5 mg b.d. increments to 1 to 2 mg b.d. Risperidone should be used with caution in this group of patients until further experience is gained.
Children: Use of Risperidone for schizophrenia in children aged less than 15 years has not been formally evaluated.
Bipolar Mania: Adults: Risperidone should be administered on a once daily schedule, 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. A dosing range between 1 and 6 mg per day is recommended.
As with all symptomatic treatments, the continued use of Risperidone must be evaluated and justified on an ongoing basis.
Elderly & Patients with renal and liver disease: A starting dose of 0.5 mg b.d. is recommended. This dosage can be individually adjusted with 0.5 mg b.d. increments to 1 to 2 mg b.d. Risperidone should be used with caution in this group of patients until further experience is gained.
Combined use with mood stabilisers: There is limited information on the combined use of Risperidone with carbamazepine in bipolar mania. Carbamazepine has been shown to induce the metabolism of risperidone producing lower plasma levels of the antipsychotic fraction of Risperidone. It is therefore not recommended to co-administer Risperidone with carbamazepine in bipolar mania patients until further experience is gained. The combined use with lithium or valproate does not require any adjustment of the dose of Risperidone.
2 mg: Schizophrenia: Adults: Usual Initial Dose: Risperidone (Aspidon) tablets can be administered once or twice daily. Initial dosing is 2 mg per day. May increase the dose at intervals of 24 hours or greater, in increments of 1 to 2 mg per day, as tolerated, to a recommended dose of 4 to 6 mg per day. In some patients, slower titration may be appropriate. Efficacy has been demonstrated in a range of 4 mg to 16 mg per day. However, doses above 10 mg/day have not been shown to be more efficacious than lower doses, and may cause extrapyramidal symptoms and other adverse effects, and are generally not recommended. The safety of doses above 16 mg/day has not been evaluated, doses above this level should not be used.
Adolescents: The initial dose is 0.5 mg once daily, administered as a single-daily dose in the morning or evening. The dose may be adjusted at intervals of 24 hours or greater, in increments of 0.5 mg or 1 mg/day, as tolerated, to a recommended dose of 3 mg/day.
Doses higher than 6 mg per day have not been studied.
Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily.
Experience in schizophrenia is lacking in children less than 13 years of age.
Switching From Other Antipsychotics: When switching from other antipsychotics, where medically appropriate, gradual discontinuation of the previous treatment while Risperidone (Aspidon) therapy is initiated is recommended.
Bipolar Mania: Usual Dose: Adults: The initial dose range is 2 mg to 3 mg/ day. The dose may be adjusted at intervals of 24 hours or greater, in increments of 1 mg/day.
A dosing range between 1 to 6 mg/day is recommended.
As with all symptomatic treatments, the continued use of Risperidone (Aspidon) must be evaluated and justified on an ongoing basis.
Pediatrics: The initial dose is 0.5 mg once daily, administered as a single-daily dose in the morning or evening. The dose may be adjusted at intervals of 24 hours or greater, in increments of 0.5 or 1 mg/day, as tolerated, to the recommended target dose of 1 to 2.5 mg/day. Although efficacy has been demonstrated in studies of pediatric patients with bipolar mania at doses between 0.5 and 6 mg/day. Doses higher than 6 mg per day have not been studied.
Patients experiencing persistent somnolence may benefit from administering half the daily dose twice daily.
As with all symptomatic treatments, the continued use of Risperidone (Aspidon) must be evaluated and justified on an ongoing basis.
Experience is lacking in bipolar mania in children less than 10 years of age.
Dosing in Patients with Severe Renal or Hepatic Impairment: For patients with severe renal impairment (CLcr < 30 mL/min) or hepatic impairment (10-15 points on Child Pugh System), the initial starting dose is 0.5 mg twice daily. The dose may be increased in increments of 0.5 mg or less, administered twice daily. For doses above 1.5 mg twice daily, increase in intervals of one week or greater. Risperidone (Aspidon) should be used with caution in this group of patients.
Dose Adjustments for Specific Drug Interactions: When Risperidone (Aspidon) tablets are co-administered with enzyme inducers (e.g., carbamazepine), the dose of Risperidone (Aspidon) tablets should be increased up to double the patient's usual dose. It may be necessary to decrease the Risperidone (Aspidon) tablets dose when enzyme inducers such as carbamazepine are discontinued. Similar effect may be expected with co-administration of Risperidone (Aspidon) tablets with other enzyme inducers (e.g., phenytoin, rifampin, and phenobarbital).
When fluoxetine or paroxetine is co-administered with Risperidone (Aspidon) tablets, the dose of Risperidone (Aspidon) tablets should be reduced. The Risperidone (Aspidon) tablets dose should not exceed 8 mg per day in adults when co-administered with these drugs. When initiating therapy, Risperidone (Aspidon) tablets should be titrated slowly.
It may be necessary to increase the Risperidone (Aspidon) tablets dose when enzyme inhibitors such as fluoxetine or paroxetine are discontinued.
Aspidon OS: Risperidone (Aspidon OS) is for oral use. Food does not affect the absorption of Risperidone (Aspidon OS).
Adult patients with schizophrenia may be given Risperidone (Aspidon OS) once daily or twice daily.
Patients should start with 2 mg/day Risperidone (Aspidon OS). The dosage may be increased on the second day to 4 mg.
In elderly patients with schizophrenia and bipolar disorder, 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.
Risperidone (Aspidon OS) is not recommended for use in children below age 18 with schizophrenia and bipolar mania due to a lack of data on efficacy.
Adult patients with bipolar disorder should be administered with Risperidone (Aspidon OS) on a once daily schedule, starting with 2 mg Risperidone (Aspidon OS). Dosage adjustments, if indicated, should occur at intervals of not less than 24 hours and in dosage increments of 1 mg per day. Risperidone (Aspidon OS) 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 (Aspidon OS) have not been investigated in patients with manic episodes.
A starting dose of 0.25 mg twice daily is recommended in patients with Alzheimer's dementia. 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. Risperidone (Aspidon OS) should not be used more than 6 weeks in patients with persistent aggression in Alzheimer's dementia.
Risperidone (Aspidon OS) 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.
Patients with impaired hepatic function have increases in plasma concentration of the free fraction of Risperidone (Aspidon OS). Irrespective of the indication, starting and consecutive dosing should be halved, and dose titration should be slower for patients with renal or hepatic impairment.
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 re-evaluated periodically.
During treatment, patients must be evaluated frequently and regularly, and the need for continuing treatment reassessed.
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