Vivactil (Protriptyline) Patient Information Sheet

Generic Name: protriptyline
Brand Names: Vivactil, Triptil

Vivactil (protriptyline) Full Prescribing Information

Vivactil (protriptyline) Medication Guide

What is Vivactil (protriptyline)?

Protriptyline is in a group of drugs called tricyclic antidepressants. Protriptyline affects chemicals in the brain that may become unbalanced.

Protriptyline is used to treat symptoms of depression.

Protriptyline may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Vivactil (protriptyline)?

Do not use protriptyline if you have recently had a heart attack, or if you have taken cisapride (Propulsid) or used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.
You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself

What should I discuss with my healthcare provider before taking Vivactil (protriptyline)?

Do not use this medication if you are allergic to protriptyline, or if you have recently had a heart attack. Do not use protriptyline if you have taken cisapride (Propulsid) or used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take protriptyline before the MAO inhibitor has cleared from your body. Before taking protriptyline, tell your doctor if you are allergic to any drugs, or if you have:

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• heart disease;
• a history of heart attack, stroke, or seizures;
• bipolar disorder (manic-depression);
• schizophrenia or other mental illness;
• diabetes (protriptyline may raise or lower blood sugar);
• glaucoma; or
• problems with urination.

If you have any of these conditions, you may not be able to use protriptyline, or you may need a dosage adjustment or special tests during treatment.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether protriptyline passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone under 18 years old without the advice of a doctor.

How should I take Vivactil (protriptyline)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from this medication. Follow the directions on your prescription label.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking protriptyline. You may need to stop using the medicine for a short time.

Do not stop using protriptyline without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping this medication suddenly could cause you to have unpleasant side effects. It may take a few weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve during treatment with protriptyline. Store protriptyline at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of protriptyline can be fatal. Symptoms of a protriptyline overdose may include extreme drowsiness, confusion, agitation, hallucinations, blurred vision, muscle stiffness, feeling hot or cold, seizure (convulsions), or coma.

What should I avoid while taking Vivactil (protriptyline)?

Avoid drinking alcohol. It can cause dangerous side effects when taken together with protriptyline.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, medicine for seizures, or other antidepressants). They can add to sleepiness caused by protriptyline.

Grapefruit and grapefruit juice may interact with protriptyline. Discuss the use of grapefruit products with your doctor before increasing or decreasing the amount of grapefruit products in your diet.

Protriptyline can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Protriptyline can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Vivactil (protriptyline) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• fast, pounding, or uneven heart rate;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
• sudden numbness or weakness, especially on one side of the body;
• sudden headache, confusion, problems with vision, speech, or balance;
• confusion, hallucinations, or seizure (convulsions);
• easy bruising or bleeding, unusual weakness;
• restless muscle movements in your eyes, tongue, jaw, or neck;
• urinating less than usual or not at all;
• extreme thirst with headache, nausea, vomiting, and weakness; or
• feeling light-headed or fainting.

Less serious side effects may be more likely to occur, such as:

• nausea, vomiting, stomach pain, loss of appetite;
• constipation or diarrhea;
• dry mouth, unpleasant taste;
• weakness, lack of coordination;
• feeling anxious, restless, dizzy, drowsy, or tired;
• sleep problems (insomnia), nightmares;
• blurred vision, headache, ringing in your ears;
• breast swelling (in men or women); or
• decreased sex drive, impotence, or difficulty having an orgasm.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Vivactil (protriptyline)?

Before taking protriptyline, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

Before taking protriptyline, tell your doctor if you are currently using any of the following drugs:

• cimetidine (Tagamet);
• guanethidine (Ismelin);
• tramadol (Ultram);
• heart rhythm medications such as flecainide (Tambocor), propafenone (Rhythmol), or quinidine (Cardioquin, Quinidex, Quinaglute); or
• anti-psychotic medications such as chlorpromazine (Thorazine), haloperidol (Haldol), thioridazine (Mellaril), clozapine (Clozaril), olanzapine (Zyprexa, Zydis), quetiapine (Seroquel), risperidone (Risperdal), ziprasidone (Geodon), and others.

If you are using any of these drugs, you may not be able to use protriptyline, or you may need dosage adjustments or special tests during treatment.

There are many other medicines that can interact with protriptyline. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

• Your pharmacist has information about protriptyline written for health professionals that you may read.

What does my medication look like?

Protriptyline is available with a prescription under the brand name Vivactil. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication especially if it is new to you.

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Last revision: 05/22/2007

Vivactil (protriptyline) Full Prescribing Information

Vivactil (protriptyline) Medication Guide

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