Application Nr Approved Date Route Status External Links
ANDA089953 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Thioridazine Hydrochloride Tablets Are 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 Hydrochloride Tablets 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 Hydrochloride Tablets, It Is Strongly Recommended That A Patient Be Given At Least Two 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 Hydrochloride Tablets Have Not Been Systematically Evaluated In Controlled Trials In Treatment Refractory Schizophrenic Patients And Its Efficacy In Such Patients Is Unknown.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Thioridazine Hydrochloride THIORIDAZINE HYDROCHLORIDE ZINC1530697

Comments