Triavil

Amitriptyline is a tricyclic antidepressant. Perphenazine is a phenothiazine (feen-oh-THYE-a-zeen). These medicines affect chemicals in the brain that may be unbalanced in people with depression or mental illness.

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 take this medicine if you have liver damage, a weak immune system, a blood cell disorder (such as anemia), or if you recently had a heart attack. Amitriptyline and perphenazine is not approved for use in psychotic conditions related to dementia.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Do not take this medicine in larger amounts than recommended, or for longer than prescribed. High doses or long-term use of perphenazine can cause a serious muscle movement disorder that may not be reversible. The longer you take perphenazine, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in older adults, especially women.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

While using this medicine, you may need frequent blood tests. Your kidney or liver function may also need to be checked.

If you need surgery, tell the surgeon ahead of time that you are using amitriptyline and perphenazine. You may need to stop using the medicine for a short time.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using amitriptyline and perphenazine.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amitriptyline and perphenazine can be fatal.

Overdose symptoms may include uneven heartbeats, extreme drowsiness, confusion, agitation, hallucinations, vomiting, feeling hot or cold, muscle stiffness, fainting, seizure (convulsions), or coma.

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.

Call your doctor at once if you have any of these signs of a serious movement disorder:

• tremors or shaking in your arms or legs;

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement); or

• any new or unusual muscle movements you cannot control.

Also call your doctor at once if you have:

• severe constipation;

• 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, nausea, sweating;

• sudden numbness or weakness, slurred speech, problems with vision or balance;

• sudden ill feeling, fever, chills, sore throat, easy bruising, unusual bleeding, pale skin;

• dark urine, jaundice (yellowing of the skin or eyes);

• urinating more or less than usual;

• a seizure (convulsions); or

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects may include:

• drowsiness, headache;

• strange dreams or nightmares;

• sleep problems (insomnia);

• blurred vision;

• dry mouth, loss of appetite;

• nausea, vomiting, diarrhea, constipation;

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