Tofranil

Why is Tofranil prescribed?

Tofranil is used for the treatment of depression. It is a member of the family of drugs called tricyclic antidepressants.

Tofranil is also used on a short-term basis, along with the 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 never 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 a sugar candy or chewing a gum can help to solve 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 the possible side effects.

If you take 2 or more doses per day, take the forgotten dose as soon as you remember about it. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. You should never take 2 doses at once.

• Storage instructions...
  Store at the room temperature in a tightly closed container.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity occur, 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 that being treated for the 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 increase the risk of suicidal thinking and behavior in children and teens with depression and other psychiatric disorders. Anyone considering the use of Tofranil or any other antidepressant in a child or a teen must balance this risk with the clinical need. Tofranil has not been studied among children younger than 6 years old. Tofranil-PM is not approved for use by children.

Additionally, the progression of a major depression is associated with the 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 the treatment or whenever there is a dose change.

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 might occur 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 the light. Try to stay out of the sun as much as possible while you are taking it.

If you are going to have an elective surgery, your doctor should 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 should monitor you closely.

Be sure that your doctor knows if you have a history of mental disorders. Tofranil can 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 the breast milk and could affect a nursing infant. If Tofranil is essential to your health, your doctor may advise you to stop breastfeeding until your treatment is finished.

Recommended dosage for Tofranil

ADULTS

The usual starting dose is 75 milligrams per day. The doctor may increase this to 150 milligrams per day. The maximum daily dose is 200 milligrams. People who need to take 75 milligrams or more a day may use Tofranil-PM capsules instead of the regular tablets.

CHILDREN

Tofranil is not to be used in children to treat any condition but bedwetting, and its use will be limited to the short-term therapy. Safety and effectiveness in children under the age of 6 have not been established. Tofranil-PM should not be used in children for any reason.

Total daily dosages for children should not exceed 2.5 milligrams for each 2.2 pounds of the child's weight.

Doses usually begin at 25 milligrams per day. This amount should be taken an hour before bedtime. If needed, this dose may be increased after 1 week to 50 milligrams (ages 6 through 11) or 75 milligrams (ages 12 and up), taken in one dose at bedtime or divided into 2 doses, 1 taken at mid-afternoon and 1 at bedtime.

OLDER ADULTS AND TEENS

People in these two age groups should start with 25 to 50 milligrams per day of Tofranil tablets, since Tofranil-PM capsules are not available in these dosage strengths. The dose may be increased as necessary, but effective dosages usually do not exceed 100 milligrams per day.

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