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

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 DESCRIPTION



Trifluoperazine Hydrochloride

C21H24F3N3SM.W. 480.43


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 (see BOXED WARNING).

Tardive Dyskinesia





PRECAUTIONSandADVERSE REACTIONS.

Neuroleptic Malignant Syndrome (NMS)









Usage in Pregnancy



Pregnancy





Nursing Mothers

PRECAUTIONS

General





















Long-Term Therapy


Leukopenia, Neutropenia and Agranulocytosis



TRIFLUOPERAZINE HYDROCHLORIDE ADVERSE REACTIONS



Neuromuscular (Extrapyramidal) Reactions



Motor Restlessness



Dystonia




Pseudoparkinsonism
Symptoms may include: mask-like facies; drooling; tremors; pill-rolling motion; cogwheel rigidity; and shuffling gait. Reassurance and sedation are important. In most cases these symptoms are readily controlled when an antiparkingsonism agent is administered concomitantly. Antiparkinsonism agents should be used only when required. Generally, therapy of a few weeks to 2 or 3 months will suffice. After this time, patients should be evaluated to determine their need for continued treatment. (Note: Levodopa has not been found effective in pseudoparkinsonism.) Occasionally it is necessary to lower the dosage of trifluoperazine hydrochloride or to discontinue the drug.


Tardive Dyskinesia




Adverse Reactions Reported with Trifluoperazine Hydrochloride or Other Phenothiazine Derivatives

WARNINGS.)



OVERDOSAGE

ADVERSE REACTIONS.)

Symptoms


Treatment
Do not attempt to induce emesis because a dystonic reaction of the head or neck may develop that could result in aspiration of vomitus.Extrapyramidal symptoms may be treated with antiparkinsonism drugs, barbiturates, or diphenhydramine hydrochloride. See prescribing information for these products. Care should be taken to avoid increasing respiratory depression. If administration of a stimulant is desirable, amphetamine, dextroamphetamine, or caffeine with sodium benzoate is recommended. Stimulants that may cause convulsions (e.g., picrotoxin or pentylenetetrazol) should be avoided.


DOSAGE & ADMINISTRATION

ADULTS




Elderly Patients


Non-Psychotic Anxiety


Schizophrenia





DOSAGE AND ADMINISTRATION-SCHIZOPHRENIA IN CHILDREN


Oral


HOW SUPPLIED


T3 on one side of the tablet andM on the other side. They are available as follows:


T4 on one side of the tablet andM on the other side. They are available as follows:



T5 on one side of the tablet andM on the other side. They are available as follows:


T6 on one side of the tablet andM on the other side. They are available as follows:


STORAGE AND HANDLING

Store at 20 to 25 C(68 to 77 F). [See USP Controlled Room Temperature.]

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Trifluoperazine Hydrochloride


Trifluoperazine Hydrochloride

Trifluoperazine Hydrochloride

TRIFLUOPERAZINE HYDROCHLORIDE TABLET, FILM COATED

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52125-118(NDC:0378-2405)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
TRIFLUOPERAZINE HYDROCHLORIDE TRIFLUOPERAZINE 5 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYDEXTROSE
polyethylene glycol
STARCH, CORN
SODIUM LAURYL SULFATE
titanium dioxide
triacetin
D&C RED NO. 30
FD&C BLUE NO. 2
FD&C YELLOW NO. 6

Product Characteristics

Color Size Imprint Code Shape
purple 8 mm M;T5 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52125-118-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040209 2012-09-27


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Be sure to consult your doctor before taking any medication!
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