Amitriptyline (patient information)

IMPORTANT WARNING

Studies have shown that children and teenagers who take antidepressants ('mood elevators') such as amitriptyline may be more likely to think about harming or killing themselves or to plan or try to do so than children who do not take antidepressants. Children younger than 18 years of age should not normally take amitriptyline.

If your child's doctor has prescribed amitriptyline for your child, you should watch his or her behavior very carefully, especially at the beginning of treatment and any time his or her dose is increased or decreased. Your child may develop serious symptoms very suddenly, so it is important to pay attention to his or her behavior every day. Call your child's doctor right away if he or she experiences any of these symptoms: new or worsening depression; thinking about harming or killing him- or herself or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; irritability; aggressive behavior; acting without thinking; severe restlessness; frenzied abnormal excitement, or any other sudden or unusual changes in behavior.

Your child's doctor will want to see your child often while he or she is taking amitriptyline, especially at the beginning of his or her treatment.Your child's doctor may also want to speak with you or your child by telephone from time to time. Be sure that your child keeps all appointments for office visits or telephone conversations with his or her doctor.

Your child's doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when your child begins treatment with amitriptyline. Read the information carefully and ask your child's doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/cder/drug/antidepressants/MG_template.pdf.

Talk to your child's doctor about the risks of giving amitriptyline to your child.

Why this medication is prescribed

Amitriptyline is used to treat symptoms of depression. Amitriptyline is in a class of medications called tricyclic antidepressants. It works by increasing the amounts of certain natural substances in the brain.

How this medication should be used

Amitriptyline comes as a tablet to take by mouth. It is usually taken one to four times a day. To help you remember to take amitriptyline, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take amitriptyline exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of amitriptyline and gradually increase your dose.

It may take a few weeks or longer before you feel the full benefit of amitriptyline. Continue to take amitriptyline even if you feel well. Do not stop taking amitriptyline without talking to your doctor. Stopping amitriptyline suddenly may cause withdrawal symptoms (upset stomach, headache, and lack of energy). Your doctor will probably decrease your dose gradually.

Other uses for this medicine

Amitriptyline is also sometimes used to treat chronic pain, eating disorders, and certain skin problems. Talk to your doctor about the possible risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special Precautions

Before taking amitriptyline:

• tell your doctor and pharmacist if you are allergic to amitriptyline or any other medications.
• do not take amitriptyline if you are taking monoamine oxidase (MAO) inhibitors, including phenelzine (Nardil) and tranylcypromine (Parnate), or have stopped taking them within the past 2 weeks; or if you are taking cisapride (Propulsid).
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: antihistamines; cimetidine (Tagamet); diet pills; disulfiram (Antabuse); ethchlorvynol (Placidyl); guanethidine (Ismelin); ipratropium (Atrovent); quinidine (Quinidex); medications for irregular heartbeats such as flecainide (Tambocor) and propafenone (Rythmol); medications for anxiety, asthma, colds, irritable bowel disease, mental illness, nausea, Parkinson's disease, seizures, ulcers, or urinary problems; other antidepressants; phenobarbital (Bellatal, Solfoton); sedatives; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); sleeping pills; thyroid medications; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you or anyone in your family has or has ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), or mania (frenzied, abnormally excited mood), or if you or anyone in your family has thought about or attempted suicide. Also tell your doctor if you drink large amounts of alcohol; if you have recently had a heart attack; and if you have or have ever had glaucoma; an enlarged prostate; difficulty urinating; seizures; an overactive thyroid gland (hyperthyroidism); diabetes; or liver, kidney, or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking amitriptyline, call your doctor immediately.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking amitriptyline.
• you should know that amitriptyline may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• remember that alcohol can add to the drowsiness caused by this medication.
• you should know that your mental health may change in unexpected ways, especially at the beginning of your treatment and any time that your dose is increased or decreased. These changes may occur at any time if you have depression or another mental illness, whether or not you are taking amitriptyline or any other medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor when you are unable to seek treatment on your own.

Special dietary instructions

Unless your doctor tells you otherwise, continue your normal diet.

What to do if you forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side Effects

Minor Side Effects

Amitriptyline may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• upset stomach
• vomiting
• drowsiness
• weakness or tiredness
• excitement or anxiety
• difficulty falling asleep or staying asleep
• nightmares
• restlessness
• headaches
• dry mouth
• constipation
• difficulty urinating
• blurred vision
• pain, burning, or tingling in the hands or feet
• changes in sex drive or ability
• excessive sweating
• changes in appetite or weight
• confusion
• unsteadiness

Severe Side Effects

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• slow or difficult speech
• dizziness or faintness
• weakness or numbness of an arm or a leg
• crushing chest pain
• rapid, pounding, or irregular heartbeat
• severe skin rash or hives
• swelling of the face and tongue
• yellowing of the skin or eyes
• jaw, neck, and back muscle spasms
• shaking hands that you cannot control
• difficulty sitting still
• fainting
• unusual bleeding or bruising
• seizures
• seeing things or hearing voices that do not exist (hallucinating)

Amitriptyline may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• irregular hearbeat
• seizures
• coma
• confusion
• problems concentrating
• seeing things that do not exist (hallucinating)
• agitation
• drowsiness
• rigid muscles
• vomiting
• fever
• cold body temperature

Other information

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to amitriptyline.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names of combination products

• Limbitrol® containing amitriptyline and chlordiazepoxide
• Limbitrol® DS containing amitriptyline and chlordiazepoxide