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The classical clinical picture of antiphospholipid antibody syndrome (APS) is characterized by venous and arterial thrombosis, fetal losses and thrombocytopenia in the presence of anticardiolipin antibodies and/or lupus anticoagulant. APS can occur either as a primary disorder or secondary to a connective tissue disease, most frequently systemic lupus erythematosus. Central nervous system involvement is one of the most prominent clinical manifestations of APS, and includes thrombotic events, psychiatric features and a variety of other non-thrombotic neurological syndromes. We present a 9-year-old Saudi girl who developed psychotic illness without thrombotic manifestations. Autoantibodies against cardiolipin were persistent and strongly positive while antinuclear antibodies and antibodies against double-stranded DNA was absent. Her brain computed tomography, magnetic resonance imaging, magnetic resonance arteriography and magnetic resonance venography all were normal. There was no evidence of infection, drug intake or connective tissue disorders, So a diagnosis of primary APS was likely. Starting on antipsychotics only was unsatisfactory and marked improvement occurred after combined treatment with antidepressants (imipramine 10 mg and risperdal 0.2 mg, both once daily), small-dose aspirin (100 mg) and hydroycloroquine (100 mg) both once daily. Unfortunately aspirin was stopped by the family and 5 months later she developed right axillary vein thrombosis. This case presented psychotic illness. Investigations revealed the presence of anticardiolipin antibodies without a thromboembolic picture, mimicking Hughes syndrome but not fulfilling the criteria needed for the diagnosis. Thus, psychosis should be appreciated as a presenting symptom for primary APS and combined treatment with antipsychotics, aspirin and antimalarials is recommended.
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Long-acting risperidone is effective and generally well tolerated in patients with schizophrenia, including those patients with stable symptoms. Long-acting risperidone is the first atypical antipsychotic available in a formulation which offers a sustained, steady release of drug and is thus an attractive, new option in the treatment of patients with schizophrenia.
RLAI (at a mean dose of 47 mg/2 weeks at six and up to 23.1+/-3.3 months) was associated with major improvements in all outcome measures (p<0.001). Initial BPRS scores fell by an average of 50% within six months; hospitalizations declined from 19.8% to 0%, and rates of adverse events were reduced by 2.5- to 7.4-fold. Such benefits were sustained during 18 months of follow-up with RLAI-treatment.
The 90% CI for the geometric means ratios (test/reference) of the log-trasformed Cmax, AUC0-t and AUC0-inf of risperidone and its major active metabolite were within the bioequivalence acceptance criteria of 80% - 125% of the US-FDA.
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Risperidone (Risperdal) is a recently released novel antipsychotic medication. It is different from the conventional neuroleptics, such as haloperidol, as it has both serotinergic and dopaminergic activity. It has a more tolerable side-effect profile compared with other antipsychotic medications. We review the literature regarding the side effects of risperidone use, describe a case of overdose with risperidone, and discuss the clinical sequelae and management of such an overdose.
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Polycaprolactones (PCL) were used as polymers to prepare microspheres. The research included screening and optimizing of suitable commercial polymers of variable molecular weights: PCL-14000, PCL-45000, PCL-80000 or the blends of these polymers to prepare microspheres with zero-order drug-releasing properties without the lag phase. In the present study, the sustained release risperidone microspheres were prepared by o/w emulsion solvent evaporation technique and the yield was determined. Microspheres were evaluated for their drug content and in vitro drug release. Microspheres prepared using a blend of PCL-45000 and PCL-80000 at a ratio of 1:1 resulted in the release of the drug in a time frame of 90 days, demonstrated zero-order drug release without lag time and burst release. This formulation was considered optimized formulation. Optimized formulation was characterized for solid state of the drug using differential scanning calorimetry, surface morphology using scanning electron microscopy and in vivo drug release in rats.
Two reviewers independently extracted data from trial reports. Janssen-Cilag was asked to provide missing information.
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Generic atypical antipsychotics in tablet form differ in name, appearance and packaging from the innovator brand antipsychotics. These differences might cause anxiety, confusion and misperceptions in some ambulant patients with psychoses/schizophrenia, especially if the brand atypical antipsychotic is substituted in the pharmacy without the acknowledgement of the patient and treating psychiatrist. Furthermore, generic substitution of branded oral atypical antipsychotics in the pharmacy might cause nonadherence and potentially lead to suboptimal treatment outcomes if patients perceive the medicines to be clinically different.
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Two reviewers extracted data from included trials. Data were pooled where possible, and analysed using appropriate statistical methods. Odds ratios of average differences were calculated. Only 'intention to treat' data were included. Analysis included haloperidol treated patients, compared with placebo.
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Aggression is a common symptom of many psychiatric disorders including attention deficit hyperactivity disorder, oppositional defiant disorder, conduct disorder, Tourette's disorder, mood disorders (including bipolar disorder), substance-related disorders, alcohol-related disorders, mental retardation, pervasive developmental disorders, intermittent explosive disorder and personality disorders (particularly antisocial personality disorder). Many forms of organic brain disorders may present with aggressive behavior. Aggression is common in some epileptic patients and some endocrinological diseases (e.g., diabetes and hyperthyroidism) may be associated with aggressive behavior. Physicians need to rule out many medical and psychiatric disorders before diagnosing aggressive behavior. A thorough diagnostic work up is the most important step in determining the nature of comorbid disorders associated with the behavioral problem. Structured interviews and rating scales completed by patients, parents, teachers and clinicians may aid the diagnosis and provide quantification for the change process related to treatment. The integration of medication, individual and family counseling, educational and psychosocial interventions including the school and community, may increase the effectiveness of interventions. Due to the common association of aggression and disruptive behaviors with attention deficit hyperactivity disorder, psychostimulants including new generation long-acting medications and other nonstimulant medications are considered the drug of choice for managing aggressive behavior and disruptive behavior disorders. Severe aggressive behavior not responding to these medications may require the single or combined use of mood regulators including lithium and/or antispychotic medications. Drugs such as risperidone (Risperdal, Janssen-Cilag) have documented effectiveness and safety in children and adolescents, and can be used in treatment.
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Risperidone (Risperdal, Janssen Pharmaceutica) is a second generation antipsychotic (SGA) for the treatment of schizophrenia and other psychotic disorders. It is a potent antagonist of serotonin-2 (5-HT2) and dopamine-2 (D2) receptors in the brain. In comparison to conventional antipsychotics, risperidone demonstrates superior efficacy against the positive and negative symptoms of schizophrenia and a decreased occurrence of extrapyramidal side effects (EPS). Risperidone causes less weight gain than other marketed SGAs, but can increase prolactin levels and cause EPS in a dose-related manner. In a variety of pharmacoeconomic analyses, it has proven to be a cost-effective addition to the antipsychotic armamentarium. As the first SGA available for front line use, risperidone has established a new standard of care for the treatment of individuals with psychotic disorders.
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Schizophrenia is a chronic disease characterized by psychotic symptoms as well as negative symptoms such as affective flattening, social withdrawal and occupational dysfunction. Anti-psychotic medications reduce the risk of psychotic exacerbations and hospitalization. Poor compliance is common among patients with schizophrenia. Long-acting medications have such advantages as stabilizing drug levels and improving compliance. Second generation anti-psychotic medications were found to be more effective and tolerable compared to first generation drugs. These medications cause less extra-pyramidal symptoms, and compliance with them was shown to be better. Until recently there were only first generation long-acting anti-psychotics in use. Recently a new second generation long-acting anti-psychotic drug was introduced in Israel. We present our experience with a first schizophrenic patient treated with long-acting Risperidone (Risperdal Consta). The patient was treated in the past with several first generation anti-psychotics and suffered severe extra-pyramidal symptoms. His compliance with treatment was poor. Under treatment with oral Risperidone a considerable improvement was recorded, however compliance remained poor. Under treatment with long-acting Risperidone, Intramuscularly 25 Mg every two week, both positive and negative symptoms improved substantially, as well as compliance with treatment. The results of this case study encourage us to believe that many more patients will benefit from the advantages of both a second-generation anti-psychotic and a long-acting preparation.
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Of the respondents, 73% stated that they would be unlikely to take a generic antipsychotic if their pharmacist were to substitute it. Providing patients with a short explanation had a significantly positive effect on their intention to take a generic version; however, overall, the patients' intention to take the generic antipsychotic lay well below a neutral midpoint.
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Most patients (24/25 MDD; 20/21 BP; 17/18 DE; 14/15 SZ) improved by 1 point on CGI-S from baseline or experienced no change at endpoint. Adverse events (AEs) occurring in any group at a > or =10% incidence included headache (19%) and pharyngolaryngeal pain (10%), reported in the BP group only.
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To compare the bioavailability of two risperidone orodispersible tablet products, Risperidone 1 mg Mouth dissolving tablet, Ranbaxy (Malaysia) Sdn. Bhd., Malaysia, as a test product and Risperdal 1 mg Quicklet, Janssen Ortho LLC, Gurabo, Puerto Rico, as a reference product, in healthy male volunteers under fasting condition.
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One-hundred sixty-four patients were enrolled at nine geographically diverse sites. The switch to Risperdal Consta was associated with a significant reduction in mean annual days in hospital from 39 to 21 days per year (45%), which was linked to a significant reduction in the number of hospitalizations from 0.86 to 0.63 per year (27%). The alternative "modelling-inspired" estimate of the reduction in mean annual days in hospital was also 27%.
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This open-label, multi-centre study enrolled 82 adults from four diagnostic groups (major depressive disorder (MDD), n = 25; bipolar disorder (BP), n = 21; dementia (DE), n = 20; schizophrenia (SZ), n = 16). Patients were switched from their previous dosage of compressed tablets (0.5, 1.0, 2.0, 3.0, or 4.0 mg/day) to an equivalent dosage of orally disintegrating risperidone and followed for 4 weeks. The primary effectiveness parameter evaluated was the Clinical Global Impression-Severity (CGI-S) scale.
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Atypical antipsychotic agents are widely used psychopharmacological interventions for autism spectrum disorders (ASDs). Among the atypical antipsychotic agents, risperidone has demonstrated considerable benefits in reducing several behavioral symptoms associated with ASDs. This meta-analysis examined research regarding the effectiveness of risperidone use among children with ASD using articles published since the year 2000.
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Patients with psychoses/schizophrenia using atypical antipsychotics in tablet form perceive generic versions of their antipsychotics as being significantly different. This perceived difference lowers their intention of continuing to take the medication, thus possibly jeopardizing treatment outcome. Caution with the generic substitution of atypical antipsychotics in the pharmacy is therefore recommended. Generic substitution should take place only with the knowledge and agreement of the psychiatrist and the patient.
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It has been suggested that atypical antipsychotic drugs (A-APDs) other than clozapine may be effective to improve positive symptoms in some patients with treatment resistant schizophrenia (TRS), if both the dose is higher, and the duration of the trial longer, than those which have been ineffective in non-TRS (NTRS) patients. This hypothesis was tested with long acting injectable risperidone (Risperdal Consta®, RLAI). One hundred sixty TRS patients selected for persistent moderate-severe delusions or hallucinations, or both, were randomized to RLAI, 50 or 100mg biweekly, in a six month, outpatient, double-blind, multicenter trial. We hypothesized that RLAI, 100mg, would be more effective than RLAI, 50mg. However, both doses produced clinically significant and equivalent improvement in PANSS Total, Positive, and Negative subscale scores, as well as key cognitive, global and functional measures, with increasing response during the course of the study, confirming the value of longer clinical trial duration for patients with TRS, but not superiority of the higher dose. The overall response rate was comparable to that previously reported for clozapine and high dose olanzapine, another A-APD, in TRS. Both doses of RLAI were equally well tolerated, producing minimal extrapyramidal side effects and few drop outs. Plasma levels of the active moiety, risperidone+9-hydroxyrisperidone, during treatment with RLAI 100mg, were comparable to those for 6-8 mg/day oral risperidone, which have not been effective in TRS. Further study of RLAI, ≥ 50-100mg biweekly, should compare it with clozapine and oral risperidone in TRS, with duration of treatment ≥ six months.
Risperidone (Risperdal) is an atypical antipsychotic with high affinity for 5-hydroxytryptamine (5-HT)2A, dopamine D2 and alpha1- and alpha2-adrenergic receptors. Risperidone is now approved in the UK and the US for use in bipolar mania. Risperidone < or =6 mg/day, as monotherapy or adjunctive therapy with first-line mood stabilisers, significantly improves moderate and severe bipolar mania and improves global functioning over 3 weeks. Improvements in Young Mania Rating Scale (YMRS) scores in double-blind trials were greater with risperidone than with placebo over 3 weeks, and similar to those with haloperidol over 3 and 12 weeks. Risperidone was reasonably well tolerated. Limited data are available on the combination of risperidone and carbamazepine. Risperidone, as monotherapy or combined therapy with lithium or valproate semisodium, is an effective treatment option in bipolar mania.
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To review the efficacy and tolerability of risperidone as treatment for mania.
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Suicide accounts for approximately 10% of patient deaths in schizophrenia. The atypical antipsychotic clozapine (Clozaril), successful in treatment-resistant patients with schizophrenia, may have an additional antisuicidal effect. Numerous published reports, including the collaborative International Suicide Prevention Trial, have compared mortality rates between clozapine recipients and patients receiving other forms of antipsychotic treatment and observed a significant reduction in patient risk for suicide with clozapine therapy. Preliminary reports indicate improvements in suicidality in schizophrenia patients treated with other modern atypical antipsychotics, for example olanzapine [Zyprexa], risperidone [Risperdal] and sertindole [Serdolect], but further investigation is required to clarify their role as antisuicidal drugs. It has been estimated that 53 suicides in treatment-resistant patients could have been prevented by clozapine, but the number of lives saved may be significantly higher if clozapine therapy was extended to treatment responders at a high risk for suicide.
Schizophrenia is a chronic disorder, usually necessitating lifelong treatment. Although atypical antipsychotic agents have improved outcomes in schizophrenia, their clinical potential remains limited by patients' nonadherence to medication. Long-acting antipsychotics were developed in the 1960s to enhance treatment adherence and simplify the medication process. However, although conventional long-acting agents assure medication delivery, they are associated with similar side effects to their oral equivalents. The need for an agent combining the advantages of a long-acting formulation with those of an atypical antipsychotic was highlighted in 1997 by the American Psychiatric Association's Practice Guideline for the Treatment of Patients with Schizophrenia. The first long-acting injectable atypical antipsychotic, long-acting risperidone (Risperdal Consta, Johnson & Johnson), has since been developed. This article discusses the efficacy, tolerability and cost-effectiveness of long-acting risperidone in schizophrenia and bipolar disorder patients, and suggests possibilities for how its role in clinical practice may change over the next 5 years.
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The database for the analyses comprised 22 studies including 16 open-label and six placebo-controlled studies. Based on the quality, sample size, and study design of studies prior to 2000, the database was then restricted to articles published after the year 2000. Effect sizes were calculated for each reported measure within a study to calculate an average effect size per study.
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From our study, it was concluded that these optimized microspheres showed great potential for a better depot preparation than the marketed Risperdal Consta™ and, therefore, could further improve patient compliance.
The study was carried out in 32 healthy volunteers under fasting conditions. Risperidone and 9-hydroxyrisperidone concentrations in plasma were determined using HPLC/MS/MS.
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Types of studies included unconfounded, randomised trials with concealed allocation of subjects. For inclusion trials had to have assessed patients pre- and post-treatment. Where cross-over studies are included, only data from the first part of the study were examined. Interrupted time series were excluded. Length of trial and number of measurements did not influence the selection of trials for study. Where indicated, individual patient data were requested for further examination.
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A randomized, 2-treatment, 2-period, 2-sequence, single dose, crossover with a washout period of 2 weeks, was conducted in 24 healthy Thai male volunteers. Blood samples were collected at 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 and 96 h following drug administration. Plasma concentrations of risperidone and 9-hydroxyrisperidone were determined using a validated LC-MS-MS method. The pharmacokinetic parameters of risperidone and 9-hydroxyrisperidone were determined using a non-compartmental model.
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The liquid SELFs were designed using various oils, nonionic surfactants and converted into solid at various SELF: NUS2 (%m/m) mixing ratios. The characterization of solid SELF powder was performed by using SEM, XRD, FT-IR & DSC to investigate the physical nature of the drug. The in vitro dissolution experiments were conducted to compare the representative formulations with marketed product risperdal®. In vitro digestion experiments were performed using a pH-stat at pH 6.8 for 30mins to predict the fate of risperidone in the GI tract after exposure of the solid SELF to pancreatic enzymes and bile.
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A retrospective chart review within-subject mirror-image study using actual practice chart review data was used to compare annual hospital bed-days and annual hospital episodes for adults with schizophrenia or schizoaffective disorder before and after switching to Risperdal Consta in the period 1 January 2003 to 30 June 2005. Secondary endpoints included mean length of hospital stay per episode, the cost of hospitalization, and the cost of antipsychotic treatment. The base case analytical approach allocated all hospital episodes overlapping the switch date entirely to pre-switch treatment. In order to investigate the impact of inpatient care ongoing at the time of the switch, the change in bed-days per year was also estimated using an alternative analytical approach inspired by economic modelling.
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The data from this study in healthy adult male Chinese subjects suggest that the test formulation met the regulatory criteria for bioequivalence to the reference formulation, on the basis of the rate and extent of absorption. Both formulations were well tolerated.