Brand Name(s): | IMPORTANT WARNING | WHY is this medicine prescribed? | HOW should this medicine be used? | Are there OTHER USES for this medicine? | What SPECIAL DIETARY instructions should I follow? | What should I do IF I FORGET to take a dose? | What SIDE EFFECTS can this medicine cause? | What should I know about STORAGE and DISPOSAL of this medication? | What should I do in case of OVERDOSE? | What OTHER INFORMATION should I know? | ahfsCopyRight

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: Web Site.

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.

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 SIDE EFFECTS can this medicine cause?