Etrafon

(Generic versions may still be available.)

DRUG DESCRIPTION

ETRAFON (perphenazine and amitriptyline) Tablets contain perphenazine, USP and amitriptyline hydrochloride, USP. Perphenazine is a piperazinyl phenothiazine having the chemical formula, C 21 H 26 CIN 3 OS. Amitriptyline hydrochloride is a dibenzocycloheptadiene derivative having the chemical formula, C 20 H 23 N.HCl.

ETRAFON (perphenazine and amitriptyline) Tablets are available in multiple strengths to afford dosage flexibility for optimum management. They are available as ETRAFON 2-10 Tablets, 2 mg perphenazine and 10 mg amitriptyline hydrochloride; ETRAFON (perphenazine and amitriptyline) Tablets, 2 mg perphenazine and 25 mg amitriptyline hydrochloride; ETRAFON (perphenazine and amitriptyline) -Forte Tablets, 4 mg perphenazine and 25 mg amitriptyline hydrochloride.

The inactive ingredients for ETRAFON 2-10 Tablets (2-10) include: acacia, butylparaben, calcium phosphate, calcium sulfate, carnauba wax, corn starch, D&C Yellow No. 10 Al Lake, FD&C Yellow No. 6 Al Lake, gelatin, lactose, magnesium stearate, potato starch, sugar, and white wax. May also contain talc.

The inactive ingredients for ETRAFON (perphenazine and amitriptyline) -Forte Tablets (4-25) include: acacia, butylparaben, calcium phosphate, calcium sulfate, carnauba wax, corn starch, FD&C Red No. 40 Al Lake, FD&C Yellow No. 6 Al Lake, gelatin, lactose, magnesium stearate, potato starch, sugar, and white wax. May also contain talc.

What are the possible side effects of amitriptyline and perphenazine (Etrafon 2-10, Etrafon 2-25, Etrafon Forte)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself....

Read All Potential Side Effects and See Pictures of Etrafon

What are the precautions when taking perphenazine and amitriptyline (Etrafon)?

See also Warning section.

Before taking amitriptyline with perphenazine, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (such as nortriptyline); or to other phenothiazines (such as chlorpromazine, fluphenazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, decreased bone marrow function, breathing problems (such as asthma, emphysema), liver problems, low blood pressure, recent heart attack, breast cancer, problems urinating (such as due to enlarged prostate), overactive thyroid...

Read All Potential Precautions of Etrafon


Etrafon Consumer (continued)

SIDE EFFECTS: See also Warning section.

Drowsiness, dizziness, dry mouth, blurred vision, constipation, tiredness, weight gain, or trouble urinating may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

To relieve dry mouth, suck on hard candy or ice chips, chew gum, drink water, or use a saliva substitute.

Perphenazine may cause muscle/nervous system problems (extrapyramidal symptoms-EPS). Your doctor may prescribe another medication to decrease these side effects. Tell your doctor immediately if you notice any of the following side effects: drooling/trouble swallowing, mask-like expression of the face, restlessness/constant need to move, shaking (tremor), shuffling walk, stiff muscles, severe muscle spasms/cramping (such as twisting neck, arching back, eyes rolling up).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bruising/bleeding, signs of infection (such as fever, persistent sore throat), severe stomach/abdominal pain, persistent nausea/vomiting, dark urine, yellowing eyes/skin, persistent heartburn.

Perphenazine may cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any uncontrollable movements such as lip smacking, mouth puckering, tongue thrusting, chewing, or unusual arm/leg movements.

In rare cases, perphenazine may increase your level of a certain substance made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.

This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with certain other drugs (see Drug Interactions section). This medication may also cause a rare serious condition called neuroleptic malignant syndrome (NMS). These 2 conditions can have some of the same symptoms. Seek immediate medical attention if you develop any of the following symptoms: sudden mental/mood changes (such as confusion, hallucinations), unexplained fever, fast heartbeat, increased sweating, widened pupils, muscle stiffness/twitching, loss of coordination, severe nausea/vomiting/diarrhea.

Seek immediate medical attention if any of these rare but very serious side effects occur: signs of stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion), signs of pneumonia from aspiration (such as cough, fever, trouble breathing), chest/jaw/left arm pain, severe dizziness/fainting, fast/irregular heartbeat, black stools, vomit that looks like coffee grounds, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.

Before taking amitriptyline with perphenazine, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (such as nortriptyline); or to other phenothiazines (such as chlorpromazine, fluphenazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, decreased bone marrow function, breathing problems (such as asthma, emphysema), liver problems, low blood pressure, recent heart attack, breast cancer, problems urinating (such as due to enlarged prostate), overactive thyroid (hyperthyroidism), a certain eye problem (glaucoma), personal or family history of bipolar disorder, alcohol/substance abuse, family history of suicide, seizures, diabetes, conditions that may increase your risk of seizures (such as head injury, drug/alcohol withdrawal), a certain severe reaction to other medications (neuroleptic malignant syndrome), a certain adrenal gland tumor (pheochromocytoma), restless legs syndrome, Parkinson's disease.

Perphenazine/amitriptyline may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using perphenazine/amitriptyline, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, vomiting, or eating disorders (such as bulimia). Talk to your doctor about using perphenazine/amitriptyline safely.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having any surgery, procedure, or imaging (such as X-ray, CT-scan), tell your doctor or dentist about this medication and all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen (SPF 30 or greater) and wear protective clothing when outdoors.

Caution is advised during hot weather because the perphenazine in this product can reduce sweating, increasing your risk for a severe reaction to too much heat (heatstroke). Drink plenty of fluids. Avoid strenuous exercise in hot weather. If you become overheated, promptly seek cooler shelter and/or stop exercising. Seek immediate medical attention if your body temperature is above normal or if you have mental/mood changes, headache, or dizziness.

Avoid exposure to certain chemicals used in gardening (organic phosphate insecticides). Seek immediate medical attention if you are exposed to garden chemicals and have an unusual headache, heavy sweating, or difficulty breathing.

If you have diabetes, this drug may increase your blood sugar levels. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms such as increased thirst/urination, shakiness, unusual sweating, or hunger. Your anti-diabetic medication or diet may need to be adjusted.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially dizziness/drowsiness/confusion, bleeding, difficulty urinating, and muscle/nervous system problems such as extrapyramidal symptoms and tardive dyskinesia.

During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.

Since untreated depression can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss the benefits and risks of using this medication during pregnancy with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.


Etrafon Patient Information Including Side Effects

Brand Names: Etrafon 2-10, Etrafon 2-25, Etrafon Forte

Generic Name: amitriptyline and perphenazine (Pronunciation: a mee TRIP ti leen and per FEN a zeen)

  • What is amitriptyline and perphenazine (Etrafon)?
  • What are the possible side effects of amitriptyline and perphenazine (Etrafon)?
  • What is the most important information I should know about amitriptyline and perphenazine (Etrafon)?
  • What should I discuss with my healthcare provider before taking amitriptyline and perphenazine (Etrafon)?
  • How should I take amitriptyline and perphenazine (Etrafon)?
  • What happens if I miss a dose (Etrafon)?
  • What happens if I overdose (Etrafon)?
  • What should I avoid while taking amitriptyline and perphenazine (Etrafon)?
  • What other drugs will affect amitriptyline and perphenazine (Etrafon)?
  • Where can I get more information?

What is amitriptyline and perphenazine (Etrafon)?

Amitriptyline is in a group of drugs called tricyclic antidepressants. Amitriptyline affects chemicals in the brain that may become unbalanced.

Perphenazine is in a group of drugs called phenothiazines (feen-oh-THYE-a-zeens). Perphenazine affects chemicals in the brain that may become unbalanced and cause anxiety.

The combination of amitriptyline and perphenazine is used to treat depression, anxiety, and agitation.

Amitriptyline and perphenazine may also be used for purposes not listed in this medication guide.

What are the possible side effects of amitriptyline and perphenazine (Etrafon)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • tremor (uncontrolled shaking);
  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
  • feeling like you might pass out;
  • seizures (convulsions);
  • problems with urination;
  • fast, or slow heart rate, chest pain or heavy feeling;
  • easy bruising or bleeding;
  • jaundice (yellowing of your skin or eyes); or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • feeling dizzy, drowsy, or tired;
  • strange dreams or nightmares;
  • sleep problems (insomnia);
  • dry mouth, loss of appetite;
  • nausea, vomiting, diarrhea, constipation;
  • blurred vision;
  • breast changes; or
  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about amitriptyline and perphenazine (Etrafon)?

Do not use this medication if you are allergic to amitriptyline (Elavil) or perphenazine (Trilafon), or if you have liver disease, a weak immune system, a blood cell disorder (such as anemia), or if you have recently had a heart attack.

Do not use amitriptyline and perphenazine if you have taken an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Do not drink alcohol while taking amitriptyline and perphenazine. Perphenazine can increase the effects of alcohol.

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