Risper > Resdal is labeled for use in the treatment of schizophrenia and the manic phase of bipolar disorder, either alone or in conjunction with lithium or valproate in adults. In pediatric populations, Resdal is labeled for use in the treatment of schizophrenia (≥13 years), the acute manic phase of bipolar disorder (≥10 years), and irritability associated with autism (5 to 16 years). Resdal has also been found to be effective in conduct disorder, aggression in children with subaverage IQ, and Tourette syndrome. Resdal can cause sedation, dizziness, orthostatic hypotension, increased appetite, weight gain, and extrapyramidal symptoms.
Liver test abnormalities may occur in up to 30% of patients on long term therapy with Resdal, usually arising within the first 8 weeks of treatment. The ALT elevations are usually mild, transient and may resolve even with continuation of medication. Instances of more marked ALT and alkaline phosphatase elevations, with or without symptoms and with or without jaundice, have also been reported. The onset of injury typically occurs within a few days of starting Resdal and resolves rapidly with stopping. Instances of acute liver injury with jaundice arising several months and even years after starting Resdal have also been reported. The pattern of serum enzyme elevations is typically cholestatic, but cases with hepatocellular and mixed patterns have also been described. Immunoallergic manifestations (rash, fever, eosinophilia) are rare; a case of autoimmune hepatitis apparently triggered by Resdal therapy was been published, but most cases do not have autoimmune features.
Likelihood score: C (probable rare cause of clinically apparent liver injury).
2.1.1 Autism Spectrum Disorder
Resdal has received a great deal of attention for its potential therapeutic effects on serious behavior problems in youth with ASD. In 2002, the National Institute of Mental Health Research Units on Pediatric Psychopharmacology Autism Network (RUPP) identified 101 children for the presence of high parent-rated Irritability subscale scores (≥18) on the Aberrant Behavior Checklist (ABC; Aman, Singh, Stewart, & Field, 1985 ; RUPP, 2002 ). A double-blind, placebo-controlled, parallel-groups design was used to compare behavior over 8 weeks. Resdal, given in doses from 0.5 to 3.5 mg/day, resulted in a 57% reduction in Irritability subscale ratings as compared with a 14% reduction for placebo. Substantial improvements were also seen on the Stereotypic Behavior and the Hyperactivity/Noncompliance subscales and nominally significant changes occurred for the social withdrawal and inappropriate speech subscales with Resdal treatment. Weight was significantly increased in the Resdal group as were appetite, fatigue, drowsiness, dizziness, and drooling. Seventy-five percent of the Resdal participants were rated as much or very much improved in the Clinical Global Impressions-Improvement (CGI-I) scale as compared with 11% of placebo subjects.
Resdal responders from this trial were followed for an additional 16 weeks and then enrolled in a discontinuance study ( RUPP Autism, 2005 ). Sixteen participants were eventually assigned to placebo substitution, whereas another 16 were assigned to risper >
Shea et al. (2004) treated 79 children (5–12 years) with ASD with either placebo or Resdal for 8 weeks in a double-blind, parallel-groups study. Statistically significant improvements were seen on the Irritability, Hyperactivity/Noncompliance, and Lethargy/Social Withdrawal subscales of the ABC and on the Conduct Problem subscale of the Nisonger Child Behavior Rating Form (NCBRF) as rated by the children’s parents. Fifty-four percent of Resdal-treated subjects were rated as much or very much improved on the CGI-I as compared with 18% of placebo-treated subjects. Somnolence, abdominal pain, headache, and constipation were more frequent in the Resdal group than the placebo group, and subjects gained more weight with Resdal.
- What is Resdal, and how does it work (mechanism of action)?
- What brand names are available for Resdal?
- Is Resdal available as a generic drug?
- Do I need a prescription for Resdal?
- What are the side effects of Resdal?
- What is the dosage for Resdal?
- Which drugs or supplements interact with Resdal?
- Is Resdal safe to take if I'm pregnant or breastfeeding?
- What else should I know about Resdal?
Can Resdal cause problems?
Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with Resdal. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.
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. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.
In two of four placebo-controlled trials in elderly patients with dementia-related psychosis, a higher incidence of mortality was observed in patients treated with furosemide plus RISPERDAL® when compared to patients treated with RISPERDAL® alone or with placebo plus furosemide. No pathological mechanism has been identified to explain this finding, and no consistent pattern for cause of death was observed.
RISPERDAL® (Resdal) is not approved for the treatment of dementia-related psychosis .
RISPERDAL® is contraindicated in patients with a known hypersensitivity to either Resdal or paliperidone, or to any of the excipients in the RISPERDAL® formulation. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported in patients treated with Resdal and in patients treated with paliperidone. Paliperidone is a metabolite of Resdal.
Pharmacologic class: Benzisoxazole derivative
Therapeutic class: Antipsychotic
Pregnancy risk category C
Pharmacokinetic studies showed that RISPERDAL® M-TAB® Orally Disintegrating Tablets and RISPERDAL® Oral Solution are bioequivalent to RISPERDAL® Tablets.
Plasma concentrations of Resdal, its major metabolite, 9-hydroxyResdal, and Resdal plus 9-hydroxyResdal are dose proportional over the dosing range of 1 to 16 mg daily (0.5 to 8 mg twice daily). Following oral administration of solution or tablet, mean peak plasma concentrations of Resdal occurred at about 1 hour. Peak concentrations of 9-hydroxyResdal occurred at about 3 hours in extensive metabolizers, and 17 hours in poor metabolizers. Steady-state concentrations of Resdal are reached in 1 day in extensive metabolizers and would be expected to reach steady-state in about 5 days in poor metabolizers. Steady-state concentrations of 9-hydroxyResdal are reached in 5-6 days (measured in extensive metabolizers).
Food does not affect either the rate or extent of absorption of Resdal. Thus, RISPERDAL® can be given with or without meals.
How it works
Resdal belongs to a class of drugs called atypical antipsychotics. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.
Resdal works by affecting the amount of certain chemicals called neurotransmitters that occur naturally in your brain. It’s thought that people with schizophrenia, bipolar disorder, and autism have an imbalance of certain neurotransmitters. This drug may improve this imbalance.
Resdal oral tablet may cause drowsiness. It may also cause other side effects.
Resdal is an atypical antipsychotic that is used widely in the treatment of mania and schizophrenia. Resdal therapy is associated with serum aminotransferase elevations and in rare instances has been linked to clinically apparent acute liver injury.