Fluphenazine

What is Fluphenazine?

• Fluphenazine (Permitil; Prolixin) is a trifluoromethyl phenothiazine derivative used to treat schizophrenia and psychotic symptoms such as hallucinations, delusions, and hostility.

Fluphenazine structural formulae

Fluphenazine ball-and-stick

Fluphenazine2D

What are the uses of this medicine?

• Fluphenazine (Permitil; Prolixin) used for the management of manifestations of psychotic disorders.

Limitattions of use:

• Fluphenazine HCl has not been shown effective in the management of behavioral complications in patients with mental retardation.

How does this medicine work?

• Fluphenazine (floo fen' a zeen) is a tricyclic aliphatic phenothiazine which acts by postsynaptic inhibition of dopamine receptors.
• Fluphenazine has other peripheral and central nervous system effects, producing both alpha adrenergic stimulation and blocking histamine- and serotonin-mediated effects.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• suspected or established subcortical brain damage
• receiving large doses of hypnotics
• in comatose or severely depressed states
• hypersensitivity to fluphenazine and phenothiazine derivatives.

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:

• antidepressants
• antihistamines
• bromocriptine (Parlodel)
• diet pills
• lithium (Eskalith, Lithobid)
• medication for high blood pressure, seizures, Parkinson's disease, asthma, colds, or allergies
• meperidine (Demerol)
• methyldopa (Aldomet)
• muscle relaxants
• propranolol (Inderal)
• sedatives
• sleeping pills
• thyroid medications
• tranquilizers

Is this medicine FDA approved?

• Fluphenazine was approved in the United States in 1972 for use in the therapy of acute and chronic psychosis.
• It was formerly a commonly prescribed antipsychotic medication, but in recent years has been replaced in large part by the atypical antipsychotics, which have fewer extrapyramidal side effects.
• Fluphenazine is currently used as parentral therapy of psychosis and is available generically in solution for depot injection.

How should this medicine be used?

Recommended dosage: Recommended Adult Dosage:

• Total daily dosage for psychotic patients may range initially from 2.5 to 10 mg and should be divided and given at six- to eight-hour intervals.
• Therapeutic effect is often achieved with doses under 20 mg daily.
• Patients remaining severely disturbed or inadequately controlled may require upward titration of dosage.
• Daily doses up to 40 mg may be necessary; controlled clinical studies have not been performed to demonstrate safety of prolonged administration of such doses.
• When symptoms are controlled, dosage can generally be reduced gradually to daily maintenance doses of 1 to 5 mg, often given as a single daily dose.

Geriatric patients:

• For patients, the suggested starting dose is 1 to 2.5 mg daily, adjusted according to the response of the patient.

Administration:

• Fluphenazine comes as a tablet or oral liquid (elixir and concentrate) to take by mouth.
• It is usually taken two or three times a day and may be taken with or without food.
• Fluphenazine oral liquid comes with a specially marked dropper for measuring the dose.
• Ask your pharmacist to show you how to use the dropper.
• Do not allow the liquid to touch your skin or clothing; it can cause skin irritation.
• Dilute the concentrate in water, Seven-Up, carbonated orange beverage, milk, or V-8, pineapple, apricot, prune, orange, tomato, or grapefruit juice just before taking it.
• Do not use beverages containing caffeine (coffee, tea, and cola) or apple juice.
• Continue to take fluphenazine even if you feel well.
• Do not stop taking fluphenazine without talking to your doctor, especially if you have taken large doses for a long time.
• Your doctor probably will want to decrease your dose gradually.
• This drug must be taken regularly for a few weeks before its full effect is felt.

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

This medicine is available in fallowing doasage form:

• As a tablet or oral liquid (elixir and concentrate)

This medicine is available in fallowing brand namesː

• Permitil; Prolixin

What side effects can this medication cause?

The most common side effects of this medicine include:

• drowsiness, dizziness, headache, blurred vision, dry mouth, constipation, tremor, restlessness, muscle spasms and weight gain.
• upset stomach
• weakness or tiredness
• excitement or anxiety
• insomnia
• nightmares
• skin more sensitive to sunlight than usual
• changes in appetite or weight

Fluphenazine may cause serious side effects, including:

• suicidal thoughts or behaviors, neuroleptic malignant syndrome and tardive dyskinesia.
• constipation
• difficulty urinating
• frequent urination
• blurred vision
• dizziness, feeling unsteady, or having trouble keeping your balance
• changes in sex drive or ability
• excessive sweating

What special precautions should I follow?

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Fluphenazinehydrochloride 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 neuroleptic (antipsychotic) drugs. If signs and symptoms of tardive dyskinesia appear in a patient on neuroleptics, 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 use of this drug may impair the mental and physical abilities required for driving a car or operating heavy machinery.
• Potentiation of the effects of alcohol may occur with the use of this drug.
• Events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including fluphenazine hydrochloride. Patients with neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count <1000/mm ) should discontinue fluphenazine hydrochloride USP and have their WBC followed until recovery.
• Because of the possibility of cross-sensitivity, fluphenazine hydrochloride should be used cautiously in patients who have developed cholestatic jaundice, dermatoses or other allergic reactions to phenothiazine derivatives.
• Psychotic patients on large doses of a phenothiazine drug who are undergoing surgery should be watched carefully for possible hypotensive phenomena.
• Fluphenazine hydrochloride should be used cautiously in patients exposed to extreme heat or phosphorus insecticides.
• Neuroleptic drugs elevate prolactin levels; the elevation persists during chronic administration.
• Given the likelihood that some patients exposed chronically to neuroleptics will develop tardive dyskinesia, it is advised that all patients in whom chronic use is contemplated be given, if possible, full information about this risk.
• Tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this drug.
• You should know that fluphenazine 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.
• Fluphenazine can cause mild and transient serum enzyme elevations and has been linked to rare instances of clinically apparent cholestatic liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• dystonic reactions
• somnolence or coma
• Agitation and restlessness
• Convulsions
• EKG changes and cardiac arrhythmias
• fever
• 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 HCl.
• 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 HCl 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?

• Fluphenazine 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?

• Since there is no adequate experience in children who have received this drug, safety and efficacy in children have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• fluphenazine hydrochloride

Inactive ingredients:

• D & C Yellow #10 Aluminum Lake, lactose (monohydrate), hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, starch (corn), titanium dioxide, and Polysorbate 80. The and also contain D & C Red #30 Aluminum Lake and FD & C Red #40 Aluminum Lake; also contains FD & C Blue #2 Aluminum Lake and FD & C Yellow #6 Aluminum Lake; the also contains FD & C Blue #2 Aluminum Lake and FD & C Red #40 Aluminum Lake.

Who manufactures and distributes this medicine?

• Sandoz Inc.
• Princeton, NJ

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

• Store at 20°-25°C (68°-77°F).
• Dispense in a tight, light-resistant container.

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 Fluphenazine
• FDA Fluphenazine

Fluphenazine Resources
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