What is the most important information I should know about tofranil?

Do not use tofranil if you have recently had a heart attack, or if you have 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 suicidal thoughts or behavior when you start taking an antidepressant, especially if you are under 18 years old. You will need to be monitored for worsening symptoms of depression or suicidal thoughts. Your doctor should check you at regular visits during the first 12 weeks of treatment, or whenever your dose is changed.

Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/or physical hyperactivity), thoughts of suicide or hurting yourself.

What is tofranil?

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

Tofranil is used to treat symptoms of depression.

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

What should I discuss with my healthcare provider before taking tofranil?

Do not use this medication if you are allergic to tofranil, or if you have recently had a heart attack. Do not use tofranil if you have 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 tofranil before the MAO inhibitor has cleared from your body.

Before taking tofranil, tell your doctor if you are allergic to any drugs, or if you have:

• heart disease;
• a history of heart attack, stroke, or seizures;
• bipolar disorder (manic-depression);
• kidney or liver disease;
• overactive thyroid;
• diabetes (tofranil may raise or lower blood sugar);
• adrenal gland tumor (pheochromocytoma);
• glaucoma; or
• problems with urination.

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

You may have an increased risk of suicidal thoughts or behavior at the start of treatment with an antidepressant medication, especially if you are under 18 years old. While you are taking tofranil, you will need to be monitored for worsening symptoms of depression and/or suicidal thoughts during the first weeks of treatment, or whenever your dose is changed.

In addition to you watching for changes in your own symptoms, your family or other caregivers should 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.

Contact your doctor promptly if you have any of the following side effects, especially if they are new symptoms or if they get worse: mood changes, anxiety, panic attacks, trouble sleeping, irritability, agitation, aggressiveness, severe restlessness, mania (mental and/or physical hyperactivity), thoughts of suicide or hurting yourself. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Tofranil can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication. Do not give this medication to anyone under 18 years old without the advice of a doctor.

How should I take tofranil?

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 tofranil. You may need to stop using the medicine for a short time.

Do not stop using tofranil 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 up to 3 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 after 3 weeks of treatment. Store tofranil 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 tofranil can be fatal.

Symptoms of an tofranil overdose may include uneven heartbeats, extreme drowsiness, agitation, vomiting, blurred vision, sweating, muscle stiffness, swelling, shortness of breath, blue lips or fingernails, feeling light-headed, fainting, seizure (convulsions), or coma.

What should I avoid while taking tofranil?

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

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 tofranil.

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

Tofranil 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). Tofranil 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.

What are the possible side effects of tofranil?

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 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;
• feeling short of breath, even with mild exertion;
• swelling, rapid weight gain;
• confusion, hallucinations, or seizure (convulsions);
• easy bruising or bleeding, unusual weakness;
• restless muscle movements in your eyes, tongue, jaw, or neck;
• urinating more or less than usual;
• extreme thirst with headache, nausea, vomiting, and weakness;
• skin rash, bruising, severe tingling, numbness, pain, or muscle weakness.

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;
• weight changes;
• 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 tofranil?

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

• cimetidine (Tagamet);
• clonidine (Catapres);
• guanethidine (Ismelin);
• methylphenidate (Concerta, Ritalin, Daytrana); or
• heart rhythm medications such as flecainide (Tambocor), propafenone (Rhythmol), or quinidine (Cardioquin, Quinidex, Quinaglute).

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

There are many other medicines that can interact with tofranil. 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.