"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
The basic pharmacological activity of Mellaril® (thioridazine HCl) is similar to that of other phenothiazines, but is associated with minimal extrapyramidal stimulation.
However, thioridazine has been shown to prolong the QTc interval in a dose-dependent fashion. This effect may increase the risk of serious, potentially fatal, ventricular arrhythmias, such as torsade de pointes-type arrhythmias. Due to this risk, Mellaril (thioridazine hcl) is indicated only for schizophrenic patients who have not been responsive to or cannot tolerate other antipsychotic agents (see WARNINGS and CONTRAINDICATIONS). However, the prescriber should be aware that Mellaril (thioridazine hcl) has not been systematically evaluated in controlled trials in treatment refractory schizophrenic patients and its efficacy in such patients is unknown.
Last reviewed on RxList: 3/31/2009
This monograph has been modified to include the generic and brand name in many instances.
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