Why is this drug 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.

Most important fact about this drug

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 this medication?

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.

Missed Doses

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.

What side effects may occur?

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:

• abdominal cramps
• agitation
• anxiety
• black tongue
• bleeding sores
• blood disorders
• blurred vision
• breast development in males
• confusion
• congestive heart failure
• constipation or diarrhea
• cough, fever, sore throat
• delusions
• dilated pupils
• disorientation
• dizziness
• drowsiness
• dry mouth
• episodes of elation or irritability
• excessive or spontaneous flow of milk
• fatigue
• fever
• flushing
• frequent urination or difficulty or delay in urinating
• hair loss
• hallucinations
• headache
• heart attack
• heart failure
• high blood pressure
• high or low blood sugar
• high pressure of fluid in the eyes
• hives
• impotence
• increased or decreased sex drive
• inflammation of the mouth
• insomnia
• intestinal blockage
• irregular heartbeat
• lack of coordination
• light-headedness (especially when rising from lying down)
• loss of appetite
• nausea
• nightmares
• odd taste in mouth
• palpitations
• purple or reddish-brown spots on skin
• rapid heartbeat
• restlessness
• ringing in the ears
• seizures
• sensitivity to light
• skin itching and rash
• stomach upset
• stroke
• sweating
• swelling due to fluid retention (especially in face or tongue)
• swelling of breasts
• swelling of testicles
• swollen glands
• tendency to fall
• tingling, pins and needles, and numbness in hands and feet
• tremors
• visual problems
• vomiting
• weakness
• weight gain or loss
• yellowed skin and whites of eyes

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 this drug 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 this medication

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
• 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.

Possible food and drug interactions when taking this medication

Never combine Tofranil with an MAO inhibitor. 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
• Barbiturates such as Nembutal and Seconal
• Blood pressure medications such as Ismelin, Catapres, and Wytensin
• Carbamazepine (Tegretol)
• Cimetidine (Tagamet)
• Decongestants such as Sudafed
• Drugs that control spasms, such as Cogentin
• Epinephrine (EpiPen)
• Flecainide (Tambocor)
• Major tranquilizers such as Mellaril and Thorazine
• Methylphenidate (Ritalin)
• Norepinephrine
• Other antidepressants such as Elavil and Pamelor
• Phenytoin (Dilantin)
• Propafenone (Rythmol)
• Quinidine (Quinaglute)
• 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

ADULTS

The usual starting dose is 75 milligrams a day. The doctor may increase this to 150 milligrams a day. The maximum daily dose is 200 milligrams.

CHILDREN

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

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 ADOLESCENTS

People in these two age groups should take lower doses. Dosage starts out at 30 to 40 milligrams per day and can go up to no more than 100 milligrams a 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