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Thioridazine (Thioridazine Hydrochloride) - Summary

 
 



WARNING

THIORIDAZINE HAS BEEN SHOWN TO PROLONG THE QTc INTERVAL IN A DOSE RELATED MANNER, AND DRUGS WITH THIS POTENTIAL, INCLUDING THIORIDAZINE, HAVE BEEN ASSOCIATED WITH TORSADE DE POINTES-TYPE ARRHYTHMIAS AND SUDDEN DEATH. DUE TO ITS POTENTIAL FOR SIGNIFICANT, POSSIBLY LIFE-THREATENING, PROARRHYTHMIC EFFECTS, THIORIDAZINE SHOULD BE RESERVED FOR USE IN THE TREATMENT OF SCHIZOPHRENIC PATIENTS WHO FAIL TO SHOW AN ACCEPTABLE RESPONSE TO ADEQUATE COURSES OF TREATMENT WITH OTHER ANTIPSYCHOTIC DRUGS, EITHER BECAUSE OF INSUFFICIENT EFFECTIVENESS OR THE INABILITY TO ACHIEVE AN EFFECTIVE DOSE DUE TO INTOLERABLE ADVERSE EFFECTS FROM THOSE DRUGS. (SEE WARNINGS, CONTRAINDICATIONS, AND INDICATIONS).

 

THIORIDAZINE SUMMARY

THIORIDAZINE HYDROCHLORIDE TABLETS, USP

Thioridazine hydrochloride is 2-methylmercapto-10-[2-(N-methyl-2-piperidyl) ethyl] phenothiazine.

Thioridazine is indicated for the management of schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. Due to the risk of significant, potentially life-threatening, proarrhythmic effects with thioridazine treatment, thioridazine should be used only in patients who have failed to respond adequately to treatment with appropriate courses of other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs. Consequently, before initiating treatment with thioridazine, it is strongly recommended that a patient be given at least 2 trials, each with a different antipsychotic drug product, at an adequate dose, and for an adequate duration (see WARNINGS and CONTRAINDICATIONS).

However, the prescriber should be aware that thioridazine has not been systematically evaluated in controlled trials in treatment refractory schizophrenic patients and its efficacy in such patients is unknown.


See all Thioridazine indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Thioridazine

Discovery of novel drug target may lead to better treatment for schizophrenia
Source: Psychology / Psychiatry News From Medical News Today [2014.12.12]
Scientists at the Centre for Addiction and Mental Health (CAMH) have identified a novel drug target that could lead to the development of better antipsychotic medications.Dr.

Study Finds Need for Improved Schizophrenia Care
Source: MedicineNet Schizophrenia Specialty [2014.12.04]
Title: Study Finds Need for Improved Schizophrenia Care
Category: Health News
Created: 12/4/2014 12:00:00 AM
Last Editorial Review: 12/4/2014 12:00:00 AM

Excess protein during brain development causes abnormalities and faulty connections in laboratory studies, may trigger schizophrenia
Source: Schizophrenia News From Medical News Today [2014.11.26]
A gene associated with schizophrenia plays a role in brain development and may help to explain the biological process of the disease, according to new Rutgers research.

Brain network vulnerable to Alzheimer's and schizophrenia identified
Source: MRI / PET / Ultrasound News From Medical News Today [2014.11.25]
A specific brain network within grey matter develops later than the rest of the brain and degenerates first in older age, says new study, shedding light on neurological disorders.

Help for schizophrenia patients and their caregivers
Source: Caregivers / Homecare News From Medical News Today [2014.11.14]
University of Miami researchers are developing a novel, culturally informed, family therapy for schizophreniaResearchers at the University of Miami (UM) have developed a family-focused...

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Published Studies Related to Thioridazine

Comparison of the effects of thioridazine and mesoridazine on the QT interval in healthy adults after single oral doses. [2007.11]
We compared the effects of single doses of thioridazine and mesoridazine on the heart rate-corrected QT (QTc) interval in healthy adult volunteers. QTc intervals and plasma concentrations of thioridazine, mesoridazine, and metabolites were measured after single oral doses of thioridazine hydrochloride 50 mg, mesoridazine besylate 50 mg, or placebo in a double-blind, crossover study...

Repeated dosing with donepezil does not affect the safety, tolerability or pharmacokinetics of single-dose thioridazine in young volunteers. [2004.11]
AIM: To investigate the effects of donepezil at steady state on the safety, tolerability and pharmacokinetics of a single dose of thioridazine, in healthy subjects... CONCLUSIONS: Repeated dosing with donepezil, 5 mg daily for 2 weeks, had no significant effect on the safety, tolerability or pharmacokinetics of thioridazine. Thioridazine was poorly tolerated.

Effect of fluoxetine and imipramine on the pharmacokinetics and tolerability of the antipsychotic quetiapine. [2002.04]
The effects of fluoxetine and imipramine on the pharmacokinetics and nonpsychiatric side effect profile of quetiapine fumarate were investigated in 26 patients with schizophrenia, schizoaffective disorder, or bipolar disorder in a multicenter, two-period, multiple-dose, open-label, randomized trial.

Psychomotor effects of zaleplon and thioridazine coadministration. [2000.06]
OBJECTIVE: To assess the potential pharmacokinetic and pharmacodynamic interaction of zaleplon and thioridazine administered concomitantly in healthy volunteers... CONCLUSION: The results of single-dose administration showed an additive pharmacodynamic interaction between zaleplon and thioridazine at 1 h in one of four tests and supra-additivity for 4 h in another test. This interaction is relatively short in duration due to the short half-life of zaleplon.

Withdrawal of haloperidol, thioridazine, and lorazepam in the nursing home: a controlled, double-blind study. [1999.08.09]
BACKGROUND: Ongoing regimens of haloperidol, thioridazine, and lorazepam are commonly administered to manage behavior problems in nursing home residents. Nevertheless, there is controversy over whether periodic drug withdrawal should be attempted when those medications are prescribed. This study addressed that issue by examining the effects of discontinuing treatment with haloperidol, thioridazine, and lorazepam among residents of a large suburban nursing home... CONCLUSIONS: Results of this work suggest that longterm use of haloperidol, thioridazine, and lorazepam in nursing homes to manage agitation should be closely monitored for their efficacy. Furthermore, routine attempts at drug withdrawal should be considered for most residents taking psychotropic medication.

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Clinical Trials Related to Thioridazine

Feasibility of Thioridazine as a Mobilizing Agent for CD34+ Hematopoietic Progenitor Cells [Recruiting]
This study will investigate the possibility of using the drug thioridazine (also called Mellaril) to increase the number of certain types of cells moving from the bone marrow to the circulation in a group of healthy humans. The types of cells we hope to collect are called CD34+ progenitor, or stem cells. These cells can be used in the laboratory to better understand a number of diseases and suggest new strategies for therapy. Perhaps the most important potential application of human stem cells is the generation of cells and tissues that could be used for cell-based therapies, as a renewable source of replacement cells and tissues to treat diseases including Alzheimer's diseases, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis, and rheumatoid arthritis.

Safety Study of Thioridazine in Combination With Cytarabine to Treat Relapsed or Refractory Acute Myeloid Leukemia [Recruiting]
This is a Phase I trial investigating the safety of using thioridazine in addition to cytarabine in elderly patients with relapsed or refractory Acute Myeloid Leukemia.

Study With IT-Aided Preventive Program in Schizophrenia [Not yet recruiting]
Information Technology-aided Program of Relapse Prevention in Schizophrenia (ITAREPS) will decrease the number of hospitalizations in patients with schizophrenia or schizoaffective disorder who are treated in the outpatient psychiatric setting, as evidenced by the reduction of the total number of hospitalizations due to relapse of psychosis at the end of the 12-months follow-up period in the active ITAREPS group compared to the control (treatment-as-usual) group.

Changes in Heart Rhythms Associated With Antipsychotic Drug Treatment [Recruiting]
This study is being done to look at the electrical activity of the heart. This study will help decide whether taking recordings for a 24-hour period gives more useful information than recording it for a few seconds in a doctor's office. The study will compare 24 hour ECG results of patients taking thioridazine (Mellaril) to those of other patients taking different medications that took part in another study.

YouScript IMPACT Registry [Recruiting]
This multicenter observational study aims to investigate the benefits of providing pharmacogenetic testing with the YouScript Personalized Prescribing System which includes a clinical decision support tool and individualized pharmacist recommendations to elderly polypharmacy patients who are most at risk of adverse drug events. The YouScript system is unique in identifying drug-gene, and drug-drug-gene interactions that are missed by existing systems, and represent over 35% of significant interaction warnings. Data analysis will assess the impact of recommendations for medication changes on clinical decision making, patient outcomes, and healthcare resource utilization to determine which medications, specialties, or patient segments derive the greatest benefit from this intervention. Data gathered from patients enrolled in this study will be compared to patients matched on key characteristics from Inovalon's MORE2 healthcare database.

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Page last updated: 2014-12-12

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