Protriptyline (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 protriptyline 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 protriptyline, but in some cases, a doctor may decide that protriptyline 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 protriptyline 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 protriptyline, 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 protriptyline. 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

Protriptyline is used to treat depression. Protriptyline is in a class of medications called tricyclic antidepressants. It works by increasing the amounts of certain natural substances in the brain that help maintain mental balance.

How should this medicine be used

Protriptyline comes as a tablet to take by mouth. It is usually taken three or four times a day. Take protriptyline 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 protriptyline 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 protriptyline and gradually increase your dose. Your doctor may decrease your dose after your condition is controlled.

Protriptyline controls depression but does not cure it. Continue to take protriptyline even if you feel well. Do not stop taking protriptyline without talking to your doctor. If you suddenly stop taking protriptyline, you may experience withdrawal symptoms such as nausea, headache, and lack of energy.

Other uses for this medicine

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

What special precautions should I follow

Before taking protriptyline:

• tell your doctor and pharmacist if you are allergic to protriptyline or any other medications.
• tell your doctor if you are taking cisapride (Propulsid) (not available in the U.S.) or monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan); phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have taken an MAO inhibitor during the past 14 days. Your doctor will probably tell you that you should not take protriptyline.
• tell your doctor and pharmacist what other 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: amiodarone (Cordarone, Pacerone); antihistamines; bupropion (Wellbutrin); celecoxib (Celebrex); cimetidine (Tagamet); doxorubicin (Adriamycin); guanethidine (Ismelin); ipratropium (Atrovent); medications for anxiety, asthma, colds, diabetes, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; medications for irregular heartbeat such as flecainide (Tambocor), moricizine (Ethmozine), and propafenone (Rythmol); methadone (Dolophine); metoclopramide (Reglan); other antidepressants; quinidine; ranitidine (Zantac); reserpine (Serpasil); ritonavir (Norvir); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); sedatives; sleeping pills; terbinafine (Lamisil); thyroid medications; tramadol (Ultram); and tranquilizers. Tell your doctor or pharmacist if you have stopped taking fluoxetine (Prozac, Sarafem) in the past 5 weeks. *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 will probably tell you not to take protriptyline.
• tell your doctor if you drink large amounts of alcohol; if you are undergoing electroshock therapy (procedure in which small electric shocks are administered to the brain to treat certain mental illnesses); or if you have or have ever had glaucoma (an eye disease), an enlarged prostate (a male reproductive organ), difficulty urinating, mental illness, seizures, hyperthyroidism (an overactive thyroid gland), or diabetes.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking protriptyline, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking protriptyline.
• you should know that protriptyline 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.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. *Protriptyline may make your skin sensitive to sunlight.
• you should know that protriptyline may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking protriptyline. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

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

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

• nausea
• vomiting
• diarrhea
• loss of appetite
• weight changes
• unusual taste in the mouth
• stomach pain or cramps
• heartburn
• dry mouth
• constipation
• drowsiness
• dizziness
• nightmares
• headaches
• frequent urination, especially at night
• difficulty urinating
• wide pupils
• changes in sex drive or ability
• breast enlargement in men and women
• unsteadiness
• ringing in ears
• hair loss
• flushing
• sweating
• black tongue

Severe side effects

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

• slow or difficult speech
• weakness or numbness of an arm or a leg
• crushing chest pain
• rapid, pounding, or irregular heartbeat
• rash or hives
• itching
• swelling of the face or tongue
• yellowing of the skin or eyes
• jaw, neck, and back muscle spasms
• uncontrollable shaking of a part of the body
• fainting
• blurred vision
• difficulty walking
• unusual bleeding or bruising
• seizures
• confusion
• hallucination (seeing things or hearing voices that do not exist)
• believing things that are not true
• fever
• pain, burning, or tingling in the hands or feet

Protriptyline 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].

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
• loss of consciousness
• fainting
• seizures
• confusion
• problems concentrating
• hallucination (seeing things or hearing voices that do not exist)
• agitation
• drowsiness
• stiff muscles
• vomiting
• fever
• cold body temperature

What other information should I know

Keep all appointments with your doctor.

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

Brand names

• Vivactil®