What is the most important information I should know about Elavil?

While you are taking Elavil you may need to be monitored for worsening symptoms of depression and/ or suicidal thoughts at the start of therapy or when doses are changed. This concern about the increased risk of suicidal thoughts or behaviors may be greater if you are 18 years of age or younger and are taking Elavil. In patients younger than 18 years, the period of risk may extend beyond start of therapy or when doses are changed. Your doctor may want you to monitor for the following symptoms: anxiety, irritability, panic attacks, difficulty sleeping, hostility, impulsivity, severe restlessness and mania (mental and/ or physical hyperactivity). These symptoms may be associated with the development of worsening symptoms of depression and/ or suicidal thoughts or actions. Contact your healthcare provider if you develop any new or worsening mental health symptoms during treatment with Elavil. Do not stop taking Elavil.

It may be 4 weeks or more before you start to feel better, but do not stop taking Elavil without talking to your doctor first.

Use alcohol cautiously. Alcohol may increase dizziness and drowsiness while you are taking Elavil.

Use caution when operating machinery , driving or performing other hazardous activities. Elavil may cause drowsiness or dizziness. If you experience drowsiness or dizziness avoid these activities.

Dizziness is likely to occur when you rise from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall.

What is Elavil?

Elavil is in a class of drugs called tricyclic antidepressants. Elavil affects chemicals in the brain that may become unbalanced and cause depression.

Elavil is used to relieve symptoms of depression such as feelings of sadness, loss of interest in daily activities; worthlessness or guilt; changes in appetite; tiredness; sleeping too much; insomnia; and thoughts of death or suicide. Elavil is also sometimes used to treat certain types of pain.

Elavil may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Elavil?

Do not take Elavil if you have taken a monoamine oxidase inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil) or tranylcypromine (Parnate) within the last 14 days.

Before taking Elavil, tell your doctor if you have

kidney disease;

high blood pressure or heart disease;

liver disease;

diabetes;

asthma;

glaucoma.

thyroid disease;

stomach or intestinal problems;

had a heart attack in the last 6 weeks;

an enlarged prostate or difficulty urinating; or

You may not be able to take Elavil or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

While you are taking Elavil you may need to be monitored for worsening symptoms of depression and/ or suicidal thoughts at the start of therapy or when doses are changed. This concern about the increased risk of suicidal thoughts or behaviors may be greater if you are 18 years of age or younger and are taking Elavil. In patients younger than 18 years, the period of risk may extend beyond start of therapy or when doses are changed. Your doctor may want you to monitor for the following symptoms: anxiety, difficulty sleeping, panic attacks, irritability, hostility, impulsivity, severe restlessness and mania (mental and/ or physical hyperactivity). These symptoms may be associated with the development of worsening symptoms of depression and/ or suicidal thoughts or actions. Contact your healthcare provider if you develop any new or worsening mental health symptoms during treatment with Elavil. Do not stop taking Elavil.

Do not take Elavil without talking to your doctor first if you are pregnant or could become pregnant during treatment. Elavil may be harmful to an unborn baby.

Do not take Elavil without talking to your doctor first if you are breast-feeding a baby. Elavil passes into breast milk and may affect a nursing baby.

If you are over 60 years of age, you may be more likely to experience side effects such as drowsiness, dizziness, unsteadiness, feeling un-coordinated, and low blood pressure. Your doctor may prescribe a lower dose of this medication.

How should I take Elavil?

Take Elavil exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse or doctor to explain them to you.

Each dose should be taken with a full glass (8 oz) of water.

Elavil may be taken several times a day or in one daily dose (usually at bedtime). Follow your doctor's instructions.

Do not stop taking Elavil suddenly. This could cause symptoms such as nausea, headache, and malaise.

It may be 4 weeks or more before you start to feel better, but do not stop taking Elavil without talking to your doctor first.

Store Elavil at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention.

Symptoms of an Elavil overdose include seizures, confusion, drowsiness, agitation, hallucinations, and low blood pressure (dizziness, fatigue, fainting).

What should I avoid while taking Elavil?

Use caution when operating machinery, driving or performing other hazardous activities. Elavil may cause drowsiness or dizziness. If you experience drowsiness or dizziness, avoid these activities.

Dizziness is likely to occur when you rise from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while you are taking Elavil.

Do not stop taking Elavil suddenly. This could cause symptoms such as nausea, headache, and malaise.

What are the possible side effects of Elavil?

If you experience any of the following serious side effects, stop taking Elavil and contact your doctor immediately or seek emergency medical treatment:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, face, or tongue; or hives);

seizures;

a fast or irregular heartbeat;

a heart attack;

high blood pressure (blurred vision, headache);

difficulty urinating; or

fever with increased sweating, muscle stiffness or severe muscle weakness.

Other, less serious side effects may be more likely to occur. Continue to take Elavil and talk to your doctor if you experience

drowsiness or dizziness;

dry mouth and eyes;

constipation;

mild tremor;

sweating;

mild agitation, weakness or headache;

ringing in the ears;

nausea; or

loss of weight or appetite.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Elavil?

Do not take Elavil if you have taken a monoamine oxidase inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil) or tranylcypromine (Parnate) within the last 14 days.

Elavil may increase the effects of other drugs that cause drowsiness, including other antidepressants, anxiety medicines, alcohol, sedatives (used to treat insomnia), antihistamines, pain relievers and muscle relaxants. Tell your doctor about all medicines that you are taking and do not take any other prescription or over-the-counter medicines without talking to your doctor first.

Drugs other than those listed here may also interact with Elavil. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.