Brand name:

Tofranil

Why is Tofranil prescribed?

Tofranil is used to treat depression. It is a member of the family of drugs called tricyclic antidepressants.

Tofranil is also used on a short-term basis, along with behavioral therapies, to treat bed-wetting in children aged 6 and older. Its effectiveness may decrease with longer use.

Some doctors also prescribe Tofranil to treat bulimia, attention deficit disorder in children, obsessive-compulsive disorder, and panic disorder.

Tofranil-PM, which is usually taken once daily at bedtime, is approved to treat major depression.

Most important fact about Tofranil

Serious, sometimes fatal, reactions have been known to occur when drugs such as Tofranil are taken with another type of antidepressant called an MAO inhibitor. Drugs in this category include Nardil and Parnate. Do not take Tofranil within 2 weeks of taking one of these drugs. Make sure your doctor and pharmacist know of all the medications you are taking.

How should you take Tofranil?

Tofranil may be taken with or without food.

You should not take Tofranil with alcohol.

Do not stop taking Tofranil if you feel no immediate effect. It can take from 1 to 3 weeks for improvement to begin.

Tofranil can cause dry mouth. Sucking hard candy or chewing gum can help this problem.

--If you miss a dose...

If you take 1 dose a day at bedtime, contact your doctor. Do not take the dose in the morning because of possible side effects.

If you take 2 or more doses a day, take the forgotten dose as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at once.

--Storage instructions...

Store at room temperature in a tightly closed container.

Tofranil side effects

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Tofranil.

• Side effects may include:
  Breast development in males, breast enlargement in females, breast milk production, confusion, diarrhea, dry mouth, hallucinations, hives, high blood pressure, low blood pressure upon standing, nausea, numbness, tremors, vomiting

• The most common side effects in children being treated for bedwetting are:
  Nervousness, sleep disorders, stomach and intestinal problems, tiredness

• Other side effects in children are:
  Anxiety, collapse, constipation, convulsions, emotional instability, fainting

Why should Tofranil not be prescribed?

Tofranil should not be used if you are recovering from a recent heart attack.

People who take drugs known as MAO inhibitors, such as the antidepressants Nardil and Parnate, should not take Tofranil. You should not take Tofranil if you are sensitive or allergic to it.

Special warnings about Tofranil

In clinical studies, antidepressants increased the risk of suicidal thinking and behavior in children and adolescents with depression and other psychiatric disorders. Anyone considering the use of Tofranil or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Tofranil has not been studied in children less than 6 years old. Tofranil-PM is not approved for use in children.

Additionally, the progression of major depression is associated with a worsening of symptoms and/or the emergence of suicidal thinking or behavior in both adults and children, whether or not they are taking antidepressants. Individuals being treated with Tofranil and their caregivers should watch for any change in symptoms or any new symptoms that appear suddenly--especially agitation, anxiety, hostility, panic, restlessness, extreme hyperactivity, and suicidal thinking or behavior--and report them to the doctor immediately. Be especially observant at the beginning of treatment or whenever there is a change in dose.

You should use Tofranil cautiously if you have or have ever had: narrow-angle glaucoma (increased pressure in the eye); difficulty in urinating; heart, liver, kidney, or thyroid disease; or seizures. Also be cautious if you are taking thyroid medication.

General feelings of illness, headache, and nausea can result if you suddenly stop taking Tofranil. Follow your doctor's instructions closely when discontinuing Tofranil.

Tell your doctor if you develop a sore throat or fever while taking Tofranil.

This drug may impair your ability to drive a car or operate potentially dangerous machinery. Do not participate in any activities that require full alertness if you are unsure about your ability.

This drug can make you sensitive to light. Try to stay out of the sun as much as possible while you are taking it.

If you are going to have elective surgery, your doctor will take you off Tofranil.

Both increased and decreased blood sugar levels have been reported during Tofranil therapy. If you have diabetes or low blood sugar (hypoglycemia), your doctor will monitor you closely.

Be sure your doctor knows if you have a history of mental disorders. Tofranil could cause a manic episode in people with bipolar disorder or a psychotic episode in those with schizophrenia.

Unless it's absolutely essential, Tofranil is not recommended for people undergoing electroconvulsive therapy (ECT).

Possible food and drug interactions when taking Tofranil

Never combine Tofranil with an MAO inhibitor (see "Most important fact about Tofranil"). If Tofranil is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Tofranil with the following:

Albuterol (Proventil, Ventolin)
Antidepressants that act on serotonin, including Prozac, Paxil, and Zoloft
Antipsychotic drugs such as Mellaril and chlorpromazine
Barbiturates such as Nembutal and Seconal
Blood pressure medications such as Catapres
Carbamazepine (Tegretol)
Cimetidine (Tagamet)
Decongestants such as Sudafed
Drugs that control spasms, such as Cogentin
Epinephrine (EpiPen)
Flecainide (Tambocor)
Guanethidine
Methylphenidate (Ritalin)
Norepinephrine
Other antidepressants such as Elavil and Pamelor
Phenytoin (Dilantin)
Propafenone (Rythmol)
Quinidine
Thyroid medications such as Synthroid
Tranquilizers and sleep aids such as Halcion, Xanax, and Valium

Extreme drowsiness and other potentially serious effects can result if Tofranil is combined with alcohol or other mental depressants, such as narcotic painkillers (Percocet), sleeping medications (Halcion), or tranquilizers (Valium).

If you are switching from Prozac, wait at least 5 weeks after your last dose of Prozac before starting Tofranil.

Special information if you are pregnant or breastfeeding

The effects of Tofranil during pregnancy have not been adequately studied. Pregnant women should use Tofranil only when the potential benefits clearly outweigh the potential risks. If you are pregnant or plan to become pregnant, inform your doctor immediately. Tofranil may appear in breast milk and could affect a nursing infant. If this medication is essential to your health, your doctor may advise you to stop breastfeeding until your treatment is finished.

Recommended dosage for Tofranil

ADULTS

Overdosage

Any medication taken in excess can have serious consequences. An overdose of Tofranil can cause death. It has been reported that children are more sensitive than adults to overdoses of Tofranil. If you suspect an overdose, seek medical help immediately.

• Symptoms of Tofranil overdose may include:
  Agitation, bluish skin, coma, convulsions, difficulty breathing, dilated pupils, drowsiness, heart failure, high fever, involuntary writhing or jerky movements, irregular or rapid heartbeat, lack of coordination, low blood pressure, overactive reflexes, restlessness, rigid muscles, shock, stupor, sweating, vomiting