Products

Rispadex

Risperidone 2 mg
Risperidone 3 mg 

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Active ingredient

Risperidone 2 mg
Risperidone 3 mg
 

Indications

Schizophrenia
• Adults
Rispadex (risperidone) is indicated for the acute and maintenance treatment of schizophrenia.
• Adolescents
Rispadex is indicated for the treatment of schizophrenia in adolescents aged 13–17 years. 
Bipolar Mania
• 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
• Pediatrics
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.

Dosage and Administration

Schizophrenia
• 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.
• Adults
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.
• 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.
• Children
Experience in schizophrenia is lacking in children less than 15 years of age.
Bipolar disorder
• Adults
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.
• Children
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.

Contraindication

In patients with a known hypersensitivity to the product.

Side effects

  • Increased mortality in elderly patients with dementia-related psychosis.  
  • Cerebrovascular adverse events, including stroke, in elderly patients with dementia-related psychosis. 
  • Neuroleptic malignant syndrome.
  • Tardive dyskinesia.  
  • Hyperglycemia and diabetes mellitus. 
  • Hyperprolactinemia. 
  • Orthostatic hypotension. 
  • Leukopenia,neutropenia, and agranulocytosis.
  • Potential for cognitive and motor impairment. 
  • Seizures. 
  • Dysphagia. 
  • Priapism. 
  • Disruption of body temperature regulation.
  • Antiemetic effect.

Drug Interaction

  • Given the primary CNS effects of Rispadex it should be used with caution in combination with other centrally acting drugs.
  • Rispadex may antagonize the effect of levodopa and other dopamine agonists.
  • Clinically significant hypotension has been observed postmarketing with concomitant use of risperidone and antihypertensive treatment. 
  • Caution is advised when prescribing Rispadex with drugs known to prolong the QT interval.
  • Carbamazepine has been shown to decrease the plasma level of the active antipsychotic fraction of risperidone. Similar effects may be observed with other CYP 3A4 hepatic enzyme inducers. When carbamazepine or other CYP 3A4 hepatic enzyme inducers are initiated or discontinued, the physician should re-evaluate the dosing of Rispadex. 
  • Fluoxetine and Paroxetine, CYP 2D6 inhibitors, increase the plasma concentration of risperidone, but less so of the active antipsychotic fraction. When concomitant fluoxetine or paroxetine is initiated or discontinued, the physician should re-evaluate the dosing of Rispadex. 
  • Topiramate modestly reduced the bioavailability of risperidone, but not that of the active antipsychotic fraction. Therefore, this interaction is unlikely to be of clinical significance.
  • Phenothiazines, tricyclic antidepressants, and some beta-blockers may increase the plasma concentrations of risperidone but not those of the active antipsychotic fraction. Amitriptyline does not affect the pharmacokinetics of risperidone or the active antipsychotic fraction. 
  • Cimetidine and ranitidine increased the bioavailability of risperidone, but only marginally that of the active antipsychotic fraction. Erythromycin, a CYP 3A4 inhibitor, does not change the pharmacokinetics of risperidone and the active antipsychotic fraction. The cholinesterase inhibitors, galantamine and donepezil, do not show a clinically relevant effect on the pharmacokinetics of risperidone and the active antipsychotic fraction.
  • When Rispadex is taken together with other highly protein-bound drugs, there is no clinically relevant displacement of either drug from the plasma proteins.
    Rispadex does not show a clinically relevant effect on the pharmacokinetics of lithium, valproate, or digoxin.

Pregnancy and Lactation

  • The safety of Rispadex for use during human pregnancy has not been established. Reversible extrapyramidal symptoms in
    the neonate were observed following postmarketing use of risperidone during the last trimester of pregnancy. Although, in experimental animals, risperidone did not show direct reproductive toxicity, some indirect, prolactin- and CNS-medicated effects were observed. No teratogenic effect of risperidone was noted in any study. Therefore, Rispadex should only be used during pregnancy if the benefits outweigh the risks.
  • In animal studies, risperidone and 9-hydroxy-risperidone are excreted in the milk. It has been demonstrated that risperidone and 9-hydroxy-risperidone are also excreted in human breast milk. Therefore, women receiving Rispadex should not breast feed.

Warning and Precaution

  • Increased mortality in Elderly Patients with Dementia-Related Psychosis.
  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Rispadex (risperidone) is not approved for the treatment of dementia-related psychosis.

Package and Storage

  • Package: A carton box containing 1, 2, & 3 strips each of 10 film coated Tablets & Insert Leaflet.
  • Storage: Store at temperature not exceeding 30°C in dry place.

Mother Company

Manufactured by Marcyrl