Imipramine (patient information)

IMPORTANT WARNING

Studies have shown that children and teenagers who take antidepressants ('mood elevators') such as imipramine may be more likely to think about harming or killing themselves or to plan or try to do so than children who do not take antidepressants.

If your child's doctor has prescribed imipramine for your child, you should watch his or her behavior very carefully, especially at the beginning of treatment and any time his or her dose is increased or decreased. Your child may develop serious symptoms very suddenly, so it is important to pay attention to his or her behavior every day. Call your child's doctor right away if he or she experiences any of these symptoms: new or worsening depression; thinking about harming or killing him- or herself or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; irritability; aggressive behavior; acting without thinking; severe restlessness; frenzied abnormal excitement, or any other sudden or unusual changes in behavior.

Your child's doctor will want to see your child often while he or she is taking imipramine, especially at the beginning of his or her treatment. Your child's doctor may also want to speak with you or your child by telephone from time to time. Be sure that your child keeps all appointments for office visits or telephone conversations with his or her doctor.

Your child's doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when your child begins treatment with imipramine. Read the information carefully and ask your child's doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/cder/drug/antidepressants/MG_template.pdf.

Talk to your child's doctor about the risks of giving imipramine to your child.

Why this medication is prescribed

Imipramine, an antidepressant, is used to treat depression.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How this medication should be used

Imipramine comes as a tablet to take by mouth. It is usually taken one or more times a day and may be taken with or without food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take imipramine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take imipramine even if you feel well. Do not stop taking imipramine without talking to your doctor, especially if you have taken large doses for a long time. Your doctor probably will want to decrease your dose gradually. This drug must be taken regularly for a few weeks before its full effect is felt.

Other uses for this medicine

Imipramine is also used occasionally to treat chronic pain, eating disorders, and panic disorders. Talk to your doctor about the possible risks of using this drug for your condition.

Special precautions

Before taking imipramine:

• tell your doctor and pharmacist if you are allergic to imipramine or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription drugs you are taking or have taken within the last 2 weeks, especially anticoagulants [warfarin (Coumadin)]; antihistamines; cimetidine (Tagamet); estrogens; fluoxetine (Prozac); levodopa (Sinemet, Larodopa); lithium (Eskalith, Lithobid); MAO inhibitors [phenelzine (Nardil), tranylcypromine (Parnate)]; medication for high blood pressure, seizures, Parkinson's disease, asthma, colds, or allergies; methylphenidate (Ritalin); muscle relaxants; oral contraceptives; sedatives; sleeping pills; thyroid medications; tranquilizers; and vitamins.
• tell your doctor if you or anyone in your family has or has ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), or mania (frenzied, abnormally excited mood), or if you or anyone in your family has thought about or attempted suicide. Also tell your doctor if you have or have ever had glaucoma, an enlarged prostate, difficulty urinating, seizures, an overactive thyroid gland, or liver, kidney, or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking imipramine, call your doctor immediately.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking imipramine.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
• remember that alcohol can add to the drowsiness caused by this drug.
• tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this drug.
• you should know that your mental health may change in unexpected ways, especially at the beginning of your treatment and any time that your dose is increased or decreased. These changes may occur at any time if you have depression or another mental illness, whether or not you are taking imipramine or any other medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied, abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor when you are unable to seek treatment on your own.

What to do if you forget a dose

If you take several doses per day, take the missed dose as soon as you remember it and take any remaining doses for that day at evenly spaced intervals. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule.

If you take imipramine once a day at bedtime and do not remember to take it until the next morning, skip the missed dose. Do not take a double dose to make up for a missed one.

Side effects

Minor side effects

Imipramine may cause side effects.

• upset stomach
• drowsiness
• weakness or tiredness
• excitement or anxiety
• insomnia
• nightmares
• dry mouth
• skin more sensitive to sunlight than usual
• changes in appetite or weight

Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• difficulty urinating
• frequent urination
• blurred vision
• changes in sex drive or ability
• excessive sweating

Severe side effects

If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• jaw, neck, and back muscle spasms
• slow or difficult speech
• shuffling walk
• persistent fine tremor or inability to sit still
• fever
• difficulty breathing or swallowing
• severe skin rash
• yellowing of the skin or eyes
• irregular heartbeat

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Other information

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to imipramine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Brand names

• Tofranil®
• Tofranil® PM