Trifluoperazine Hydrochloride
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- TRIFLUOPERAZINE HYDROCHLORIDE DESCRIPTION
- INDICATIONS & USAGE
- TRIFLUOPERAZINE HYDROCHLORIDE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- TRIFLUOPERAZINE HYDROCHLORIDE ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
BOXED WARNING
WARNINGIncreased 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 (seeWARNINGS).
TRIFLUOPERAZINE HYDROCHLORIDE DESCRIPTION
INDICATIONS & USAGE
WARNINGS
TRIFLUOPERAZINE HYDROCHLORIDE CONTRAINDICATIONS
WARNINGS
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. Trifluoperazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (seeBOXED WARNING).
Tardive Dyskinesia
PRECAUTIONSADVERSE REACTIONS
Neuroleptic Malignant Syndrome (NMS)
Usage In Pregnancy
Non-teratogenic Effects
Nursing Mothers
PRECAUTIONS
GeneralLong-Term Therapy
Leukopenia, Neutropenia and Agranulocytosis
TRIFLUOPERAZINE HYDROCHLORIDE ADVERSE REACTIONS
Extrapyramidal Symptoms
Dystonia
Motor Restlessness
Pseudo-parkinsonism
Tardive Dyskinesia
Adverse Reactions Reported with Trifluoperazine HCl or Other Phenothiazine Derivatives
WARNINGS
OVERDOSAGE
ADVERSE REACTIONSSymptoms
Treatment
DOSAGE & ADMINISTRATION
AdultsElderly Patients
Non-psychotic Anxiety
Psychotic Disorders
Psychotic Children
HOW SUPPLIED
STORAGE AND HANDLING
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Trifluoperazine HydrochlorideTrifluoperazine Hydrochloride TABLET
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
