Trifluoperazine Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Trifluoperazine Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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 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


Trifluoperazine Hydrochloride




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

General





















Long-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 REACTIONS

Symptoms


Treatment




DOSAGE & ADMINISTRATION

Adults




Elderly Patients


Non-psychotic Anxiety


Psychotic Disorders



Psychotic Children




HOW SUPPLIED

























STORAGE AND HANDLING




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Trifluoperazine Hydrochloride

Trifluoperazine Hydrochloride

Trifluoperazine Hydrochloride

Trifluoperazine Hydrochloride TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-638(NDC:0781-1030)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
TRIFLUOPERAZINE HYDROCHLORIDE TRIFLUOPERAZINE 1 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
titanium dioxide
povidone
polyethylene glycol
MAGNESIUM STEARATE
lactose monohydrate
HYPROMELLOSES
hydroxypropyl cellulose
FD&C BLUE NO. 2
D&C RED NO. 30

Product Characteristics

Color Size Imprint Code Shape
purple 6 mm GG51;1 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-638-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA085785 2011-12-08


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