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This study supports our previous work demonstrating weight gain and increased feeding behavior induced by olanzapine and could have important implications for enhancing our understanding of the mechanisms by which olanzapine and other atypical antipsychotics induce weight gain in the clinic.
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Psychomotor agitation can be associated with a wide range of medical conditions. Although clinical practice advocates the use of several drugs for the management of psychomotor agitation, there are still very few controlled studies comparing the profiles of action and the adverse effects of different drugs that induce tranquilization.
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Atypical antipsychotic (AAP) treatment is associated with weight gain and metabolic disturbances such as dyslipidemia and dysglycemia. The metabolic disturbances are usually considered to develop secondary to weight gain. We performed the comparison of metabolic disturbances of three AAP group with different risk of metabolic side effect after adjusting for body mass to investigate whether any metabolic disturbances develop independently from body mass index (BMI).
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Ziprasidone produced rapid, sustained improvements relative to baseline and placebo on all primary and most secondary efficacy measures at endpoint. Significant improvements were typically observed within 2 days after treatment commenced and were maintained throughout the 3 weeks. Ziprasidone was well tolerated and associated with a low rate of extrapyramidal symptoms; neither weight gain nor clinically significant changes in vital signs or other safety parameters were observed with ziprasidone.
Second-generation antipsychotics (SGA) are being used more often than ever before in children and adolescents with psychotic and a wide range of non-psychotic disorders. Several SGA have received regulatory approval for some paediatric indications in various countries, but off-label use is still frequent. The aim of this paper was to perform a systematic review and critically evaluate the literature on cardiometabolic and endocrine side-effects of SGA in children and adolescents through a Medline/Pubmed/Google Scholar search of randomized, placebo controlled trials of antipsychotics in children and adolescents (<18 years old) until February 2010. In total, 31 randomized, controlled studies including 3595 paediatric patients were identified. A review of these data confirmed that SGA are associated with relevant cardiometabolic and endocrine side-effects, and that children and adolescents have a high liability to experience antipsychotic induced hyperprolactinaemia, weight gain and associated metabolic disturbances. Only weight change data were sufficiently reported to conduct a formal meta-analysis. In 24 trials of 3048 paediatric patients with varying ages and diagnoses, ziprasidone was associated with the lowest weight gain (-0.04kg, 95% confidence interval [CI]: -0.38 to +0.30), followed by aripiprazole (0.79kg, 95% CI: 0.54 to 1.04], quetiapine (1.43kg, 95% CI: 1.17 to 1.69) and risperidone (1.76kg, 95% CI: 1.27 to 2.25) were intermediate, and olanzapine was associated with weight gain the most (3.45kg, 95% CI: 2.93 to 3.97). Significant weight gain appeared to be more prevalent in patients with autistic disorder who were also younger and likely less exposed to antipsychotics previously. These data clearly suggest that close screening and monitoring of metabolic side effects is warranted and that the least cardiometabolically problematic agents should be used first whenever possible. A good collaboration between child- and adolescent psychiatrists, general practitioners and paediatricians is essential to maximize overall outcomes and to reduce the likelihood of premature cardiovascular morbidity and mortality.
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Meta-analyses published in 1990 and 1998 were used as a starting point for information about conventional antipsychotics. Articles reporting the results of controlled trials of conventional antipsychotics published since the second meta-analysis (October 1998) were included. Also included were articles reporting the results of controlled clinical trials of atypical antipsychotics (i.e., clozapine, risperidone, olanzapine, quetiapine, ziprasidone) for the treatment of dementia in the elderly. Studies and post hoc analyses of special patient populations (Parkinson's disease, schizophrenia, treatment-refractory BPSD) were excluded. One open-label extension and one post hoc analysis were included because they provide valuable information about the long-term use of atypical antipsychotics. One poster was included, as it contained the only data available from a controlled trial of quetiapine.
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Overall outcomes were favorable, with major toxicity in <1% of exposures. Risperidone and quetiapine exposures resulted in less toxicity. This finding may be attributed to higher frequency of therapeutic errors for risperidone but the reason for less toxicity with quetiapine is unclear.
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There were considerable limitations to the evidence base of maintenance treatment with SGA in bipolar disorder. Most studies used stabilized patients, i.e. enrichment design (selection bias), had considerable dropout levels (attrition bias), and variable degree of reporting bias. No long-term RCT data on efficacy is available beyond 2 years, and almost all studies are on bipolar disorder type I patients only. Despite these limitations, we elucidate quantitative findings from meta-analyses conducted on the randomized trials published on the topic.
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Second-generation antipsychotics (SGAs) are associated with weight gain, metabolic abnormalities, sedation/sleep disturbance, and prolactin abnormalities, especially in youths. Although stimulants have opposing dopamine receptor and adverse effects, it is unclear whether stimulant co-treatment counteracts the therapeutic or side effects of antipsychotics.
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After stabilization for 8 consecutive weeks on open-label ziprasidone plus lithium or valproate, stabilized subjects were randomized to two groups, ziprasidone with lithium or valproate (ziprasidone group), or placebo with lithium or valproate (placebo group) for 16 weeks. Four remission criteria included (i) Mania Rating Scale (MRS) score ≤7, (ii) MRS ≤7 + Montgomery-Åsberg Depression Rating Scale (MADRS) score ≤10, (iii) MRS ≤7 + Clinical Global Impression-Improvement (CGI-I) = 1, (iv) MRS score ≤7 + MADRS score ≤10 + CGI-I score = 1. We examined the percentages of subjects in each treatment group achieving symptomatic point (i.e. at each visit) and sustained (i.e. for ≥8 weeks) remission during the double-blind phase.
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We found that EWG occurred in 7.7-17.0% of SGA users. At one year, the average weight gain was nearly 10kg among SGA users who experienced EWG. Olanzapine was the SGA most commonly associated with EWG with a rate of 17.0 per 100 users [95% confidence interval (CI): 14.2-20.5], while ziprasidone was least commonly associated with EWG (7.7 per 100 users; 95% CI: 4.6-13.0).
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Trials, baseline characteristics, outcomes, all-cause dropouts, and deaths were extracted by one reviewer; treatment exposure was obtained or estimated. Data were checked by a second reviewer.
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Health-related quality of life (QoL) represents important measure of treatment outcome in mental disorders. Numerous studies indicate that QoL of people with schizophrenia and bipolar disorder is similar to that of patients with chronic physical conditions. It has been shown that schizophrenia patients can themselves reliably assess their QoL; in addition to the objective scales various self-reporting instruments are used. Patients with bipolar disorder have QoL consistently higher than patients with schizophrenia and similar to that found in people with unipolar depression. Quality of life can be negatively affected by drug-induced side-effects and subjective treatment response. The second-generation antipsychotics (SGA) have superior efficacy on QoL over classical antipsychotics in approximately half of the studies with schizophrenia; in the other half those groups are comparable. However, in none of the trials novel antipsychotics were inferior. All SGA (clozapine, olanzapine, risperidone, amisulpride, quetiapine, ziprasidone, or remoxipride) have been found to be beneficial for patients well-being. The most investigated drugs that convincingly improve QoL in schizophrenia are olanzapine and risperidone (including depot form). Results of several studies indicate that individual antipsychotics may differ in their effects on QoL, with suggested superiority of olanzapine. In bipolar disorder, SGA consistently showed their superiority over placebo in effects on QoL. The most studied SGA in bipolar disorder is olanzapine. More long-term controlled double-blind trials are needed to definitively uphold superiority and different effects of individual SGA on QoL of patients with schizophrenia and bipolar disorder.
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Antipsychotics are widely used in geriatric psychiatric disorders. A growing number of atypical antipsychotics are available, expanding clinical options but complicating decision-making. Many questions about use of antipsychotics in older patients remain unanswered by available clinical literature. We therefore surveyed expert opinion on antipsychotic use in older patients (65 years of age or older) for recommendations concerning indications for antipsychotics, choice of antipsychotics for different conditions (e.g., delirium, dementia, schizophrenia, delusional disorder, psychotic mood disorders) and for patients with comorbid conditions or history of side effects, dosing strategies, duration of treatment, and medication combinations.
Two authors selected trials, assessed quality and extracted data, independently.
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We report a case of severe hyponatremia related to duloxetine and ziprasidone. A 50-year-old woman on duloxetine and ziprasidone treatment for major depressive disorder developed polydipsia, polyuria, and two episodes of seizures, followed by admission to the emergency department on the 10th day of treatment. Laboratory investigations revealed elevated creatine kinase (CK) as well as hyponatremia, hypo-osmolality, and increased urine sodium. Syndrome of Inappropriate Antidiuretic Hormone (SIADH) was considered, although urine osmolality was not measured. Duloxetine and ziprasidone were discontinued and the CK gradually normalized after correction of hyponatremia. Clinicians should be aware of the possibility of antipsychotic-induced hyponatremia, particularly in patients with symptoms of polydipsia.
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Steroid responsive encephalopathy associated with autoimmune thyroiditis (SREAT) is a condition of presumed autoimmune etiology that can present with a variety of neuropsychiatric signs and symptoms.
Retrospective cohort study using medical and pharmacy claims data.
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Manic-depression or bipolar disorder (BD) is a multi-faceted illness with an inevitably complex treatment.
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These findings serve as a benchmark for lipid and blood glucose monitoring among patients who switch SGA therapy. Veterans' metabolic dysregulation was more likely to be monitored after SGA switch for those receiving pharmacologic treatment for metabolic dysregulation, monitored before the switch, and aged 50 years or older. Implementation of monitoring guidelines in daily practice is emphasized to ensure that individuals living with schizophrenia-related disorders and taking SGAs achieve optimal physical health.
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To describe the proportions of veterans living with schizophrenia-related disorders monitored for dyslipidemia and hyperglycemia and to investigate whether the likelihood of metabolic dysregulation monitoring was influenced by veterans' sociodemographic characteristics, preswitch pharmacologic treatment, and monitoring before the switch from one second-generation antipsychotic (SGA) to another.
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The current review includes eight studies (22 papers), of which three studies are 4-6 weeks in duration and only one study is of more than 12 weeks' duration. Newer atypical drugs seemed to be broadly similar to clozapine using a clinical global index or trialists' definitions of improvement, but this result was obtained from a relatively small number of studies. Due to the small number of studies and patients, wide confidence intervals were seen when their effectiveness as measured by symptom rating scales was compared. Social functioning was better in patients on newer atypical medication (risperidone) than in those on clozapine, but this finding is based on a single underpowered trial and has to be interpreted with caution. Clozapine and newer atypical drugs showed their adverse effect profile to be dissimilar: while clozapine produced more fatigue, hypersalivation, nausea, and orthostatic dizziness, new atypical drugs, with the exception of olanzapine, produced more extrapyramidal symptoms. The impact of these drugs and their effects on patients' day-to-day quality of life, service use, hospital admission, and pharmacoeconomics was not measured.
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There were 562 patients in matched paliperidone ER (n = 95), risperidone (n = 94), aripiprazole (n = 94), olanzapine (n = 89), ziprasidone (n = 95) or quetiapine (n = 95) cohorts. The paliperidone ER cohort had fewer mean psychiatric-related ambulatory visits than the risperidone cohort (p = 0.05). The paliperidone ER cohort had significantly lower mean psychiatric-related medical costs than the olanzapine, quetiapine and ziprasidone cohorts (p < 0.05) and lower total costs than the ziprasidone and olanzapine cohorts (p = 0.02). No other outcomes were significantly different.
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Ziprasidone (ZIP) shows a low propensity for metabolic side effects but can prolong QTc time. It is unclear how these features translate into clinical reality. Charts of inpatients with schizophrenia and switched from (ZIP - , n = 27) or to ZIP (ZIP + , n = 24) were reviewed. Clinical data including documented switch reasons were anonymously analyzed. Comorbidity, body mass index (BMI) at admission, illness severity, side effects, illness duration, and length of stay were comparable in both groups. About 2/3 of ZIP+ were women (1/3 of ZIP - , P = 0.035); ZIP+ patients were younger (P = 0.017), had higher BMI values (P = 0.042), and received higher chlorpromazine equivalents before switch (P = 0.004) whereas ZIP doses were comparable (136 versus 141 mg/d). More patients in ZIP- versus ZIP+ were switched because of previous weight gain (P = 0.006) and depression (P = 0.085) whereas single reasons for ZIP- versus ZIP+ were mainly persisting positive symptoms (P = 0.089) and patients' choice (P = 0.10). The results of the naturalistic study corroborate controlled trials.