Protriptyline hydrochloride (By mouth)

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have heart disease, diabetes, glaucoma, problems with urination, seizures, or thyroid disease.
• For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. All of the warnings in this leaflet are true for a child, teenager, or young adult who is using this medicine. Tell your doctor right away if you start to feel more depressed. Also tell your doctor right away if you have thoughts about hurting yourself. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly. Make sure your caregiver knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell your doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.
• Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• This medicine may make you dizzy or drowsy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

Brand Name(s)

Vivactil

When This Medicine Should Not Be Used

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Confusion, agitation, hallucinations, hostility, or other unusual behaviors.
• Excessive sleepiness.
• Fast or irregular heartbeat.
• Feeling anxious, restless, or irritable.
• Unusual behavior or thoughts of hurting yourself or others.

If you notice these less serious side effects, talk with your doctor:

• Dizziness or lightheadedness, especially when standing up.
• Headache.
• Nausea or vomiting.

How to Use This Medicine

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may need to take this medicine for a few weeks before you begin to feel better.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

Introduction

Protriptyline Hydrochloride (proe-TRIP-ti-leen hye-droe-KLOR-ide)

Treats depression. This medicine is a tricyclic antidepressant.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using cimetidine (Tagamet®), tramadol (Ultram?), medicine for heart rhythm problems (such as verapamil, Cardioquin®, Rythmol®, Sectral®, or Tambocor®), medicine for high blood pressure or thyroid problems, or other medicines to treat depression or mental illness.
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you are using any medicines that make you sleepy. These include sleeping pills, cold and allergy medicine, narcotic pain relievers, and sedatives.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088