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Perphenazine Full Prescribing Information

Brand Name: Etrafon, Trilafon
Generic Name: Perphenazine

Etrafon (Perphenazine and Amitriptyline combination) is used to treat depression, anxiety and agitation. Usage, dosage, side effects of Etrafon.

Outside U.S., Brand Names also known as: PMS Levazine

Contents:

Description
Pharmacology
Indications and Usage
Contraindications
Warnings
Precautions
Drug Interactions
Adverse Reactions
Overdose
Dosage
Supplied

Etrafon, Trilafon Patient Information Sheet (in plain English)

Description

This medicine, perphenazine, is a phenothiazine and tricyclic antidepressant combination used to treat anxiety and depression. Phenothiazines are used to treat nervous, mental, and emotional disorders. Some are used also to control anxiety or agitation in certain patients, severe nausea and vomiting, severe hiccups, and moderate to severe pain in some hospitalized patients.

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Pharmacology

Category of Use: Anxiolytic, Antipsychotic, Antiemetic

Several days to a few weeks may pass before you feel the full effect of this medicine. Do not stop taking this medicine without checking with your doctor.

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Indications and Usage

For use in the management of the manifestations of psychotic disorders and for the control of severe nausea and vomiting in adults.

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Contraindications

 

In comatose or greatly obtunded patients and in patients receiving large doses of CNS depressants (barbiturates, alcohol, analgesics or antihistamines); in the presence of blood dyscrasias, bone marrow depression or liver damage; and in patients who have shown hypersensitivity to the components of the injection or related compounds.

It is also contraindicated in patients with suspected or established subcortical brain damage, with or without hypothalamic damage.

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Warnings

Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary dyskinetic movements, may develop in patients treated with neuroleptic (antipsychotic) drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of neuroleptic treatment, which patients are likely to develop the syndrome. Whether neuroleptic drug products differ in their potential to cause tardive dyskinesia is unknown.

Perphenazine can lower the convulsive threshold in susceptible individuals; therefore, it should be used with caution in alcohol withdrawal and in patients with convulsive disorders. If the patient is being treated with an anticonvulsive agent, increased dosage of that agent may be required when perphenazine is used concomitantly.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that cause drowsiness). Check with your doctor before taking any such depressants while you are taking this medicine.

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Precautions

Do not stop taking this medicine without checking with your doctor.

Before having any kind of surgery or dental or emergency treatment, tell the physician or dentist in charge that you are taking this medicine.

The drug may cause exacerbation of psychosis in schizophrenic patients.

Perphenazine should be used with caution in patients with psychic depression.

The possibility of suicide in depressed patients continues during treatment until significant remission occurs. Potentially suicidal patients should not have access to large quantities of perphenazine.

Since perphenazine treatment increases serum prolactin levels, caution is suggested in the use of phenothiazine derivatives in breast cancer patients.

The possible occurrence of liver damage, corneal and lenticular deposits, retinal changes and irreversible dyskinesia should be considered when patients are on long-term therapy.

Do not become overheated in hot weather, during exercise, or other activities since heat stroke may occur while you are using this medicine. This medicine may cause increased sensitivity to the sun. Avoid exposure to the sun or sunlamps until you know how you react to this medicine. Use a sunscreen or protective clothing if you must be outside for a prolonged period.

Pregnancy and Withdrawl: In newborn infants of mothers treated with phenothiazines during pregnancy, extrapyramidal reactions, including agitation, hypertonicity, opisthotonus, tremors, hyperreflexia and bizarre motor activity have been reported. In rare cases the movement disorders persisted for 3 to 12 months. Respiratory depression persisting for several days occurred in a newborn whose mother had received a phenothiazine for schizophrenia. Congenital cataracts occurred in an infant whose mother had been treated with promazine during pregnancy.

Perphenazine should not be used in pregnant women prior to labor unless in the judgment of the physician the potential benefits to the mother outweigh the potential risks to the infant. Since both the usual drugs given to the woman in labor and phenothiazine drugs cross the placental barrier, the infant may be exposed to unwanted individual and combined effects of therapy.

Because of the potential for serious adverse effects in nursing infants from perphenazine injection, a decision should be made whether to discontinue nursing or to discontinue the medication, taking into account the importance of therapy to the mother.

Usage in Children:: Safety and effectiveness of perphenazine in children less than 12 years of age have not been established.

Interference with Cognitive or Motor Performance: Perphenazine may impair the mental and/or physical abilities. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine.

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Drug Interactions

Concurrent administration of phenothiazines may potentiate CNS depressant effects of opiates, barbiturates or other sedatives, anesthetics, tranquilizers and alcohol.

BEFORE USING THIS MEDICINE: INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. This includes anticoagulants, guanethidine, clonidine, and guanfacine. Inform your doctor of any other medical conditions, allergies, pregnancy, or breast-feeding.

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Adverse Reactions

Some people who take this medicine may become more sensitive to sunlight. Stay out of direct sunlight. Wear a hat, protective clothing, and sunglasses. Use a full-protection sunscreen lotion. Do not use a sunlamp.

This medicine may make you sweat less, causing your body temperature to rise. Do not become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke.

Side effects, that may go away during treatment, include drowsiness, dizziness, dry mouth, nausea, diarrhea or constipation. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience itching or hives; uncontrollable movements of the tongue, mouth, or face; restlessness; weakness or rigidity of the arms or legs; or muscle rigidity. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Less common or rare side effects: Abdominal or stomach pain; aching muscles or joints; back or leg pain; confusion; constipation; difficult urination; eye pain; fever and chills; hair loss; hallucinations; hot, dry skin or lack of sweating; increased skin sensitivity to sun; irritability; loss of appetite; muscle weakness or twitching; nausea, vomiting, or diarrhea; nosebleeds; prolonged, painful penile erection; ringing or other noises in ears; skin rash and itching; slow pulse or irregular heartbeat; sore throat and fever; swelling of testicles; unusual bleeding or bruising; yellow eyes or skin

Physical/Psychological Dependence:
In general, phenothiazines do not produce psychic dependence. However, following abrupt cessation of high-dose therapy, gastritis, nausea, vomiting, dizziness, tremulousness and motor hyperactivity have been reported. These symptoms may be reduced by continuing concomitant antiparkinsonian agents for several weeks after phenothiazine withdrawal.

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Overdose

Signs and Symptoms

Emergency treatment should be started immediately. Patients should be hospitalized as soon as possible. Concurrent ingestion of alcohol or other drugs or some medical explanation for the patient's condition should be considered.

Symptoms of overdose may include drowsiness; rapid pulse; dilated pupils; convulsions; lightheadedness; vomiting; muscle rigidity; and uncontrollable movements of the tongue, mouth, or face.

Treatment

If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.

Treatment is symptomatic and supportive. There is no specific antidote. The patient should be induced to vomit even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac syrup is a preferred method. It should be noted that ipecac has central mode of action in addition to its local gastric irritant properties, and the central mode of action may be blocked by the antiemetic effect of perphenazine products. Vomiting should not be induced in patients with impaired consciousness.

Maintain airway and other supportive measures.

Dosage

Do not exceed the recommended dosage or take this medicine for longer than prescribed.

  • Follow the directions for using this medicine provided by your doctor.
  • Store this medicine at room temperature, in a tightly-closed container, away from heat and light.
  • If you miss a dose of this medicine, take it as soon as possible. If you are taking 1 dose at bedtime and do not remember until the next morning, skip the missed dose and go back to your regular dosing schedule.

Additional Information:: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.

IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

The dose of perphenazine will be different for different patients.

Tablets:: For nervous, mental, or emotional disorders:

Adults & Teenagers: 4 to 16 mg two to four times a day.

For Nausea and Vomiting:

Adults and teenagers: 8 to 16 mg a day, taken in smaller doses during the day. Your doctor will lower your dose as soon as possible.

Children Under 13: Not recommended for use in children.

For oral solution form:

For Nervous, Mental, or Emotional Disorders:

Adults and teenagers: 8 to 16 milligrams (mg) two to four times a day.

For oral syrup dosage form:

For Nervous, Mental, or Emotional Disorders:

Adults and teenagers: 2 to 16 mg two to four times a day.

For Nausea and Vomiting:

Adults and teenagers: Adults and teenagers - 2 to 4 mg two to four times a day.

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How Supplied

Available by oral solution, syrup and injection.

Tablets:: Each tablet contains: Perphenazine 2 mg, 4 mg or 8 mg (stamped black). All tablets tartrazine-free.

Etrafon, Trilafon Patient Information Sheet (in plain English)

Detailed Info on Signs, Symptoms, Causes, Treatments of Depression

Detailed Info on Signs, Symptoms, Causes, Treatments of Anxiety Disorders


The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.

Copyright © 2007 Healthyplace Inc. All rights reserved.

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back to: Psychiatric Medications Pharmacology Homepage

Last Updated: 09 April 2017
Reviewed by Harry Croft, MD

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