Trifluoperazine

What is Trifluoperazine?

• Trifluoperazine (Stelazine) is a phenothiazine and antipsychotic agent used to treat the symptoms of schizophrenia and also used on a short-term basis to treat anxiety in people who have not been helped by other medications.

Trifluoperazine

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What are the uses of this medicine?

• Trifluoperazine (Stelazine) used for the management of schizophrenia.
• It is also used for the short-term treatment of generalized non-psychotic anxiety in people who have not been helped by other medications.

Limitations of use:

• When used in the treatment of non-psychotic anxiety, trifluoperazine hydrochloride tablets should not be administered at doses of more than 6 mg per day or for longer than 12 weeks because the use of trifluoperazine hydrochloride tablets at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible.
• Trifluoperazine hydrochloride tablets have not been shown effective in the management of behavioral complications in patients with mental retardation.

How does this medicine work?

• Trifluoperazine (trye" floo oh per' a zeen) is a piperazine phenothiazine derivative which acts by postsynaptic inhibition of dopamine receptors.
• Trifluoperazine has other peripheral and central nervous system effects, producing both alpha adrenergic stimulation and blocking histamine- and serotonin-mediated effects.
• Trifluoperazine is indicated for the therapy of acute and chronic psychosis and rarely for nonpsychotic anxiety.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known hypersensitivity to phenothiazines.
• comatose or greatly depressed states due to central nervous system depressants.
• existing blood dyscrasias.
• bone marrow depression.
• preexisting liver damage.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• anticoagulants (blood thinners) such as warfarin (Coumadin)
• antidepressants
• antihistamines
• atropine (in Motofen, in Lomotil, in Lonox)
• barbiturates such as pentobarbital (Nembutal), phenobarbital (Luminal), and secobarbital (Seconal)
• diuretics ('water pills')
• epinephrine (Epipen)
• guanethidine (not available in the US)
• ipratropium (Atrovent)
• lithium (Eskalith, Lithobid)
• medications for anxiety, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, ulcers, or urinary problems
• medications for seizures such as phenytoin (Dilantin)
• narcotic medications for pain
• propranolol (Inderal)
• sedatives
• sleeping pills
• tranquilizers

Is this medicine FDA approved?

• Trifluoperazine was approved for use in the United States in 1959 and was formerly a commonly prescribed antipsychotic medication, but has been replaced in recent years in large part by the atypical antipsychotics, which have fewer extrapyramidal side effects.

How should this medicine be used?

Recommended dosage: Recommended Adult Dosage: For Non-Psychotic Anxiety:

• Usual dosage is 1 mg or 2 mg twice daily.
• Do not administer at doses of more than 6 mg per day or for longer than 12 weeks.

For Schizophrenia: Oral:

• Usual starting dosage is 2 mg to 5 mg b.i.d.
• Most patients will show optimum response on 15 mg or 20 mg daily, although a few may require 40 mg a day or more.
• Optimum therapeutic dosage levels should be reached within 2 or 3 weeks.

Geriatric patients:

• In general, dosages in the lower range are sufficient for most elderly patients.

Recommended Dosage in pediatric patients ages 6 to 12:

• Dosage should be adjusted to the weight of the child and severity of the symptoms.

Oral:

• The starting dosage is 1 mg administered once a day or b.i.d.
• Dosage may be increased gradually until symptoms are controlled or until side effects become troublesome.
• While it is usually not necessary to exceed dosages of 15 mg daily, some older children with severe symptoms may require higher dosages.

Administration:

• Trifluoperazine comes as a tablet to take by mouth.
• It is usually taken one or two times a day.
• Take trifluoperazine at around the same times every day.
• Your doctor will probably start you on a low dose of trifluoperazine and gradually increase your dose.
• Your doctor may decrease your dose once your symptoms are controlled.
• Trifluoperazine may help control your symptoms, but it will not cure your condition.
• Continue to take trifluoperazine even if you feel well.
• Do not stop taking trifluoperazine without talking to your doctor.
• If you suddenly stop taking trifluoperazine, you may experience withdrawal symptoms such as nausea, vomiting, dizziness, and shakiness.
• Your doctor will probably want to decrease your dose gradually.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As film-coated tablet, for oral administration, contains trifluoperazine hydrochloride, USP equivalent to 1 mg, 2 mg, 5 mg, or 10 mg trifluoperazine.

This medicine is available in fallowing brand namesː

• Stelazine

What side effects can this medication cause?

The most common side effects of this medicine include:

• Drowsiness, dizziness, skin reactions, rash, dry mouth, insomnia, amenorrhea, fatigue, muscular weakness, anorexia, lactation, blurred vision and neuromuscular (extrapyramidal) reactions

Additional side effects may include:

• restlessness
• agitation or jitteriness
• insomnia
• Spasm of the neck muscles
• sometimes progressing to tightness of the throat
• swallowing difficulty
• difficulty breathing
• protrusion of the tongue
• mask-like facies
• drooling
• tremors
• pill-rolling motion
• cogwheel rigidity
• shuffling gait
• Tardive Dyskinesia
• Neuroleptic Malignant Syndrome

What special precautions should I follow?

• 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.
• Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs. If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome.
• A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs.
• The management of NMS should include 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.
• There is evidence that phenothiazines are excreted in the breast milk of nursing mothers. Because of the potential for serious adverse reactions in nursing infants from trifluoperazine, a decision should be made whether to discontinue nursing or to discontinue the drug.
• Thrombocytopenia and anemia have been reported in patients receiving the drug. Agranulocytosis and pancytopenia have also been reported. If white blood cell and differential counts indicate cellular depression, stop treatment and start antibiotic and other suitable therapy.
• Jaundice of the cholestatic type of hepatitis or liver damage has been reported.
• Hypotension has occurred, large doses and parenteral administration should be avoided in patients with impaired cardiovascular systems. If hypotension occurs from parenteral or oral dosing, place patient in head-low position with legs raised. If a vasoconstrictor is required, norepinephrine bitartrate and phenylephrine hydrochloride are suitable.
• Since certain phenothiazines have been reported to produce retinopathy, the drug should be discontinued if ophthalmoscopic examination or visual field studies should demonstrate retinal changes.
• An antiemetic action of trifluoperazine hydrochloride may mask the signs and symptoms of toxicity or overdosage of other drugs and may obscure the diagnosis and treatment of other conditions such as intestinal obstruction, brain tumor and Reye’s syndrome.
• Antipsychotic drugs elevate prolactin levels; the elevation persists during chronic administration.
• Trifluoperazine may make your skin sensitive to sunlight. plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen.
• You should know that trifluoperazine may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to do vigorous exercise or be exposed to extreme heat.
• As with all drugs which exert an anticholinergic effect, and/or cause mydriasis, trifluoperazine should be used with caution in patients with glaucoma.
• Trifluoperazine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• If you are having a myelogram (x-ray examination of the spine), tell your doctor and the radiographer that you are taking trifluoperazine. Your doctor will probably tell you not to take trifluoperazine for 2 days before the myelogram and for one day after the myelogram.
• Trifluoperazine may make you drowsy and may affect your thinking and movements, especially at the beginning of your treatment. Do not drive a car or operate machinery until you know how this medication affects you.
• Alcohol can make the side effects of trifluoperazine worse. Ask your doctor about the safe use of alcohol during your treatment with trifluoperazine.

What to do in case of emergency/overdose?

Symptoms of overdosage may include: Dystonic symptoms include:

• spasm of the neck muscles
• sometimes progressing to tightness of the throat
• swallowing difficulty
• difficulty breathing
• protrusion of the tongue.
• somnolence
• coma
• Agitation
• restlessness
• convulsions
• EKG changes and cardiac arrhythmias
• fever and autonomic reactions such as hypotension, dry mouth and ileus.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Treatment is essentially symptomatic and supportive.
• Early gastric lavage is helpful.
• Keep patient under observation and maintain an open airway, since involvement of the extrapyramidal mechanism may produce dysphagia and respiratory difficulty in severe overdosage.
• 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.
• 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.
• If hypotension occurs, the standard measures for managing circulatory shock should be initiated.
• If it is desirable to administer a vasoconstrictor, norepinephrine bitartrate and phenylephrine hydrochloride are most suitable.
• Other pressor agents, including epinephrine, are not recommended.
• Limited experience indicates that phenothiazines are not dialyzable.

Can this medicine be used in pregnancy?

• Trifluoperazine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

Can this medicine be used in children?

• Safety and efficacy in children ages 6 to 12, have been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• trifluoperazine hydrochloride

Inactive ingredients:

• colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium dioxide, and triacetin. The 5 mg and 10 mg tablets also contain D&C Red No. 30 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake and FD&C Yellow No. 6 Aluminum Lake.

Who manufactures and distributes this medicine?

Manufactured for:

• Mylan Pharmaceuticals Inc.
• Morgantown, WV U.S.A.

Manufactured by:

• Mylan Laboratories Limited
• Hyderabad, India

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Antipsychotic agents

First Generation

• Phenothiazines
  • Chlorpromazine, Fluphenazine, Perphenazine, Prochlorperazine, Thioridazine, Trifluoperazine

• Other
  • Haloperidol, Lithium, Loxapine, Molindone, Pimozide

Second Generation (Atypicals)

• Aripiprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Olanzapine, Paliperidone, Pimavanserin, Quetiapine, Risperidone, Ziprasidone

• Dailymed label info on Trifluoperazine
• FDA Trifluoperazine

Trifluoperazine Resources
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