TRIFLUOPERAZINE HYDROCHLORIDE · IVAX PHARMS
Trifluoperazine hydrochloride is indicated for the management of schizophrenia and the short-term treatment of generalized non-psychotic anxiety. It is not considered a first-line therapy for anxiety because it carries risks, such as persistent and potentially irreversible tardive dyskinesia, that are not associated with common alternatives like benzodiazepines. When prescribed for non-psychotic anxiety, clinical use is restricted to a maximum dosage of 6 mg per day and a duration of no more than 12 weeks. It has not been demonstrated as effective for managing behavioral complications in patients with mental retardation.
How TRIFLUOPERAZINE HYDROCHLORIDE Works
Trifluoperazine is a piperazine phenothiazine derivative that acts as a potent antagonist at postsynaptic dopamine D2 receptors, primarily within the mesolimbic and mesocortical pathways of the brain. By inhibiting dopaminergic neurotransmission, it diminishes psychotic symptoms. It also exhibits alpha-adrenergic blocking effects and weak anticholinergic activity. Its exact mechanism in relieving anxiety is not fully established but is thought to be related to its central dopamine receptor antagonism.
Details
- Status
- Discontinued
- First Approved
- 1959-04-16
- Routes
- ORAL
- Dosage Forms
- TABLET, CONCENTRATE
Companies
TRIFLUOPERAZINE HYDROCHLORIDE Approval History
What TRIFLUOPERAZINE HYDROCHLORIDE Treats
2 indicationsTRIFLUOPERAZINE HYDROCHLORIDE is approved for 2 conditions since its original approval in 1981. These indications span multiple therapeutic areas including oncology, immunology, and more.
TRIFLUOPERAZINE HYDROCHLORIDE Boxed Warning
WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week contro...
WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Trifluoperazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS ).
TRIFLUOPERAZINE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TRIFLUOPERAZINE HYDROCHLORIDE FDA Label Details
Indications & Usage
For the management of schizophrenia. Trifluoperazine HCl is effective for the short-term treatment of generalized non-psychotic anxiety. However, trifluoperazine HCl is not the first drug to be used in therapy for most patients with non-psychotic anxiety because certain risks associated with its use are not shared by common alternative treatments (i.e., benzodiazepines). When used in the treatment of non-psychotic anxiety, trifluoperazine HCl should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine HCl at higher doses or for l...
WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients takin...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.