Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 08 February 2017
General Given the likelihood that some patients exposed chronically to
The decision to inform patients and/or their guardians must obviously take into account the clinical circumstances and the competency of the patient to understand the information provided.
Thrombocytopenia and anemia have been reported in patients receiving the drug.
Agranulocytosis and pancytopenia have also been reported -
Jaundice of the cholestatic type of
If fever with grippe-like symptoms occurs,
If tests indicate an
Because hypotension has occurred,
To minimize the occurrence of hypotension after injection, keep
If hypotension occurs from parenteral or oral dosing,
If a vasoconstrictor is required,
Other pressor agents, including epinephrine, should not be used as they may cause a
Since certain phenothiazines have been reported to produce retinopathy,
An antiemetic action of trifluoperazine HCl may mask the signs and symptoms of toxicity or overdosage of other drugs and
Neuroleptic drugs elevate prolactin levels; the elevation persists during
Tissue culture experiments indicate that approximately one-third of
Neither clinical nor epidemiologic studies conducted to date, however, have shown an association between
Because phenothiazines may interfere with thermoregulatory mechanisms,
As with all drugs which exert an anticholinergic effect, and/or cause mydriasis, trifluoperazine should be used with
Phenothiazines can produce alpha-adrenergic blockade.
Concomitant administration of propranolol with phenothiazines results in
Antihypertensive effects of guanethidine and related compounds may be counteracted when phenothiazines are used concurrently.
Thiazide diuretics may accentuate the orthostatic hypotension that may occur with phenothiazines.
Phenothiazines may lower the convulsive threshold; dosage
Potentiation of anticonvulsant effects does not occur.
However, it has been reported that phenothiazines may interfere with the metabolism of phenytoin and thus precipitate phenytoin toxicity.
Drugs which lower the seizure threshold, including phenothiazine derivatives, should not be used with metrizamide.
As with other phenothiazine derivatives,
The presence of phenothiazines may produce
Long-Term Therapy To lessen the likelihood of
Extrapyramidal Symptoms These symptoms are seen in a
They may be characterized by motor
Depending on the
If therapy is reinstituted, it should be at a lower dosage.
Should these symptoms occur in children or pregnant patients, the drug should be stopped and not reinstituted.
In most cases, barbiturates by
(Or, injectable diphenhydramine hydrochloride may be useful.)
Dystonia Class Effect: Symptoms of dystonia,
Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat,
While these symptoms can occur at low doses, they occur more frequently and with
At times these symptoms may be similar to the original
Pseudo-parkinsonism Symptoms may include: mask-like facies; drooling,
In most cases, these symptoms are readily controlled when an anti-parkinsonism agent is administered concomitantly.
Anti-parkinsonism agents should be used only when
Generally, therapy of a few weeks to two to
After this time patients should be evaluated to determine their
Occasionally it is necessary to lower the dosage of trifluoperazine HCl or to
Tardive Dyskinesia As with all antipsychotic agents, tardive dyskinesia may appear in some patients on
This syndrome appears in all age groups.
The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements).
Sometimes these may be accompanied by involuntary movements of extremities.
A variant of tardive dyskinesia, tardive dystonia, has also been described.
Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, the syndrome may be masked.
It has been reported that
) Not all of the following
intensification and prolongation of the action of central
EKG changes - particularly nonspecific, usually reversible Q and T wave
Although phenothiazines cause neither psychic nor physical dependence, sudden discontinuance in
There have been occasional reports of sudden
In some cases,
When maximum response is achieved,
Because of the inherent long action of the drug, patients may be controlled on
When trifluoperazine HCl is administered by intramuscular injection, equivalent oral dosage may be substituted once symptoms have been controlled.
Although there is
Elderly PatientsIn general,
Non-psychotic AnxietyUsual dosage is 1 or 2 mg twice daily.
Do not administer at doses of more than 6 mg per day or for longer than 12 weeks.
Most patients will show
Optimum therapeutic dosage levels should be reached within two or three weeks.
These dosages are for children ages 6 to 12, who are hospitalized or under
ORAL: The starting dosage is 1 mg administered once
While it is usually not necessary to
|Date Last Revised||24-03-2011|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||STAT RX USA LLC|
|Warnings||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. Ana|