Nortriptyline (patient information)

IMPORTANT WARNING:

A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants ('mood elevators') such as nortriptyline during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take nortriptyline, but in some cases, a doctor may decide that nortriptyline is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take nortriptyline or other antidepressants even if you are an adult over age 24. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. 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.

Your healthcare provider will want to see you often while you are taking nortriptyline, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with nortriptyline. Read the information carefully and ask your 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/antidepressants_MG_2007.pdf.

No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

Why is this medication prescribed

Nortriptyline is used to treat depression. Nortriptyline is in a group of medications called tricyclic antidepressants. It works by increasing the amounts of certain natural substances in the brain that are needed to maintain mental balance.

How should this medicine be used

Nortriptyline comes as a capsule and an oral liquid to take by mouth. It is usually taken one to four times a day and may be taken with or without food. Take nortriptyline at around the same times 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 nortriptyline 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 nortriptyline and gradually increase your dose.

Continue to take nortriptyline even if you feel well. Do not stop taking nortriptyline without talking to your doctor. If you suddenly stop taking nortriptyline, you may experience withdrawal symptoms such as headache, nausea, and weakness. Your doctor will probably want to decrease your dose gradually.

Other uses for this medicine

Nortriptyline is also sometimes used to treat panic disorders and post-herpetic neuralgia (the burning, stabbing pains, or aches that may last for months or years after a shingles infection). Nortriptyline is also sometimes used to help people stop smoking.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

What special precautions should I follow

Before taking nortriptyline

• tell your doctor and pharmacist if you are allergic to nortriptyline and other tricyclic antidepressants such as desipramine (Norpramin), clomipramine (Anafranil), imipramine (Tofranil), trimipramine (Surmontil),or any other medications.
• tell your doctor if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take nortriptyline.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants (blood thinners) such as warfarin (Coumadin); antihistamines; chlorpropamide (Diabinese); cimetidine (Tagamet); flecainide (Tambocor); guanethidine (Ismelin); lithium (Eskalith, Lithobid); medication for high blood pressure, seizures, Parkinson's disease, diabetes, asthma, nausea, mental illness, colds, or allergies; methylphenidate (Ritalin); muscle relaxants; propafenone (Rhythmol); quinidine; sedatives; selective serotonin reuptake inhibitors such as selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft);sleeping pills; thyroid medication; 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 have recently had a heart attack. Your doctor may tell you not to take nortriptyline.
• tell your doctor if you have or have ever had glaucoma (an eye condition), an enlarged prostate (a male reproductive gland), difficulty urinating, diabetes, seizures, schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions), an overactive thyroid gland, 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 nortriptyline, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking nortriptyline.
• you should know that this medication may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• talk to your doctor about the safe use of alcohol while you are taking this medication.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. *Nortriptyline may make your skin sensitive to sunlight.

What special dietary instructions should I follow

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

What should I do if I 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

Mild side effects

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

• nausea
• drowsiness
• weakness or tiredness
• excitement or anxiety
• nightmares
• dry mouth
• changes in appetite or weight
• constipation
• difficulty urinating
• frequent urination
• blurred vision
• changes in sex drive or ability
• excessive sweating

Severe side effects

Some side effects may be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• jaw, neck, and back muscle spasms
• slow or difficult speech
• shuffling walk
• uncontrollable shaking of a part of the body
• fever
• difficulty breathing or swallowing
• rash
• yellowing of the skin or eyes
• irregular heartbeat

Nortriptyline may cause other side effects. Call your doctor if you have any unusual problems while you are 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].

What storage conditions are needed for this medicine

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 heartbeat
• seizures
• coma (loss of consciousness for a period of time)
• confusion
• hallucination (seeing things that do not exist)
• widened pupils (dark circles in the middle of the eyes)
• drowsiness
• agitation
• fever
• low body temperature
• stiff muscles
• vomiting

What other information should I know

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to nortriptyline.

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

Brand names

• Aventyl®
• Pamelor®