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Nortriptyline

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 24 years of age. 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 if 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/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 .

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

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

changes in sex drive or ability

excessive sweating

Some side effects may be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

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 (http://www. fda. gov/Safety/MedWatch ) or by phone (1-800-332-1088).

What should I know about storage and disposal of 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 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.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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