Tofranil/Tofranil-PM

Generic name: Imipramine

What is Tofranil/Tofranil-PM?

Tofranil and Tofranil-PM are used to treat depression. Tofranil is also used on a short-term basis, along with behavioral therapies, to treat bedwetting in children ages 6 and older.

What is the most important information I should know about Tofranil/Tofranil-PM?

Antidepressants can increase the risk of suicidal thinking and behavior in children and teenagers. Adult and pediatric patients taking antidepressants should be watched closely for changes in moods or actions, especially when they first start therapy or when their dose is increased or decreased. Patients and their families should contact the doctor immediately if new symptoms develop or seem to get worse. Signs to watch for include anxiety, hostility, insomnia, restlessness, impulsive or dangerous behavior, and thoughts about suicide or dying.

Never take Tofranil if you are taking another antidepressant drug called a monoamine oxidase inhibitor (MAOI) or if you have stopped taking an MAOI in the last 14 days. MAOI drugs include phenelzine, tranylcypromine, and isocarboxazid. Taking Tofranil within 2 weeks of an MAOI can result in serious—sometimes fatal—reactions, including high body temperature, coma, and seizures.

You should not take this medicine if you are recovering from a heart attack.

Who should not take Tofranil/Tofranil-PM?

Do not take Tofranil if you are recovering from a heart attack, if you are sensitive to the drug, or if you are using MAOI drugs or have used an MAOI in the last 14 days.

What should I tell my doctor before I take the first dose of Tofranil/Tofranil-PM?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Tofranil. Also, talk to your doctor about your complete medical history, especially if you have a history of heart disease, congestive heart failure, abnormal heart rhythm, have had a heart attack, stroke, rapid heartbeat, glaucoma (increased pressure in the eye), urinary retention, an enlarged prostate, overactive thyroid, seizure disorder, schizophrenia, bipolar disorder, kidney or liver disease, diabetes, if you will be undergoing surgery, or if you will be undergoing electroconvulsive therapy (ECT).

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Depression

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

Elderly and adolescents: The usual dose is 30 to 40 mg daily. Effective dosages usually do not exceed 100 mg a day.

Bedwetting

Children 6 years and older: The starting dose is 25 mg daily taken 1 hour before bedtime. If needed, this dose may be increased after 1 week to 50 mg (ages 6 to 11) or 75 mg (ages 12 and up), taken in one dose at bedtime or divided into 2 doses, 1 taken at mid-afternoon and 1 at bedtime.

The 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.

How should I take Tofranil/Tofranil-PM?

Take Tofranil exactly as prescribed by your doctor. Do not stop taking Tofranil if you feel no immediate effect. It can take anywhere from 1-3 weeks before you feel better. An abrupt decrease in dose could result in general feelings of illness, headache, and nausea.

Tofranil may be taken with or without food. It may be taken several times a day or in one daily dose at bedtime.

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

What should I avoid while taking Tofranil/Tofranil-PM?

Do not drive or operate machinery, or participate in any activities that require full alertness until you know how this drug affects you.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking Tofranil.

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

What are possible food and drug interactions associated with Tofranil/Tofranil-PM?

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, antidepressants, antipsychotic drugs, barbiturates such as phenobarbital, benztropine, blood pressure medications, carbamazepine, cimetidine, epinephrine, flecainide, guanethidine, methylphenidate, narcotic painkillers such as codeine and oxycodone, norepinephrine, phenytoin, propafenone, pseudoephedrine, quinidine, thyroid medications, and tranquilizers.

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

What are the possible side effects of Tofranil/Tofranil-PM?

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

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

Side effects in children being treated for bedwetting include: anxiety, collapse, constipation, convulsions, emotional instability, fainting, fatigue, nervousness, sleep disorders, stomach and intestinal problems

Can I receive Tofranil/Tofranil-PM if I am pregnant or breastfeeding?

The effects of Tofranil during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

What should I do if I miss a dose of Tofranil/Tofranil-PM?

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

If you take two 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 two doses at once.

How should I store Tofranil/Tofranil-PM?

Store at room temperature in a tightly closed container.