Amitriptyline is a tricyclic antidepressant. Perphenazine is a phenothiazine (feen-oh-THYE-a-zeen).

Amitriptyline and perphenazine is a combination medicine used to treat depression, anxiety, and agitation.

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

You should not use this medicine if you are allergic to amitriptyline or perphenazine, or if:

• you have recently had a heart attack; or
• you have recently used alcohol, sedatives, tranquilizers, or opioid medications.

This medicine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Do not use amitriptyline and perphenazine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone.

Tell your doctor if you have ever had:

• glaucoma;
• bipolar disorder (manic-depression), schizophrenia or other mental illness;
• epilepsy or other seizure disorder;
• urination problems;
• heart problems;
• a heart attack or stroke;
• a thyroid disorder;
• liver disease; or
• breast cancer.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking amitriptyline and perphenazine without your doctor's advice.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Do not give this medicine to anyone under 18 years old without medical advice.

Use Etrafon 2-25 (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

Report any new or worsening symptoms to your doctor, 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.

High doses or long-term use of this medicine can cause a serious movement disorder that may not be reversible. The longer you use amitriptyline and perphenazine, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• a light-headed feeling, like you might pass out;
• fast, slow, or uneven heart rate;
• chest pain or pressure, pain spreading to your jaw or shoulder;
• easy bruising, unusual bleeding, purple or red spots under your skin;
• dark urine, jaundice (yellowing of the skin or eyes);
• a seizure (convulsions);
• low white blood cell counts--fever, chills, sore throat, mouth sores, skin sores, sore throat, cough, trouble breathing; or
• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, fainting.

Common side effects may include:

• drowsiness;
• high blood pressure;
• problems with speech;
• involuntary muscle movements;
• feeling restless or unable to sit still;
• dry mouth;
• headache; or
• breast changes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not drink alcohol. Dangerous side effects or death can could occur.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid exposure to sunlight or tanning beds. Perphenazine can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.