Trimipramine (patient information)

IMPORTANT WARNING

Studies have shown that children and teenagers who take antidepressants ('mood elevators') such as trimipramine 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. Children younger than 18 years of age should not normally take trimipramine.

If your child's doctor has prescribed trimipramine 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 trimipramine, 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 trimipramine. 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 trimipramine to your child.

Why is this medication prescribed

Trimipramine is used to treat depression. Trimipramine is in a class of medications called tricyclic antidepressants. It works by increasing the amount of certain natural substances in the brain.

How should this medicine be used

Trimipramine comes as a capsule to take by mouth. It is usually taken one to three times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take trimipramine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will start you on a low dose of trimipramine and gradually increase your dose.

It may take up to 4 weeks before you feel the benefit of trimipramine. Continue to take trimipramine even if you feel well. Do not stop taking trimipramine without talking to your doctor.

Other uses for this medicine

Trimipramine is also used sometimes to treat ulcers. Talk to your doctor about the possible risks of using this drug for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before taking trimipramine

• tell your doctor and pharmacist if you are allergic to trimipramine, clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), or any other medications.
• do not take trimipramine if you are taking monoamine oxidase (MAO) inhibitors, including phenelzine (Nardil) and tranylcypromine (Parnate). You must wait at least 2 weeks after stopping to take MAO inibitors before starting to take trimipramine.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: cimetidine (Tagamet); decongestants; guanethidine (Ismelin); ipratropium (Atrovent); medications for irritable bowel disease, motion sickness, Parkinson's disease, ulcers, or urinary problems; medications for irregular heartbeats such as quinidine (Quinidex), flecainide (Tambocor), and propafenone (Rythmol); other antidepressants; and selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac, Sarafem), paroxetine (Paxil), and sertraline (Zoloft), even if you have stopped taking them within the past 5 weeks. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• 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 recently had a heart attack and if you have or have ever had glaucoma, urinary retention (benign prostatic hypertrophy), thyroid disease, seizures, or heart, kidney, or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking trimipramine, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking trimipramine.
• you should know that trimipramine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• remember that alcohol can add to the drowsiness caused by this medication.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Trimipramine may make your skin sensitive to sunlight.
• 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 trimipramine 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 special dietary instructions should I follow

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side Effects

Mild side effects

Trimipramine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• upset stomach
• vomiting
• diarrhea
• stomach pain
• drowsiness
• weakness or tiredness
• excitement or anxiety
• confusion
• dizziness
• headache
• difficulty falling asleep or staying asleep
• nightmares
• dry mouth
• changes in appetite or weight
• constipation
• difficulty urinating
• frequent urination
• blurred vision
• changes in sex drive or ability
• excessive sweating
• ringing in the ears
• painful, burning, or tingling feeling in the hands or feet

Severe side effects

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them 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 and sore throat
• difficulty breathing or swallowing
• severe skin rash
• yellowing of the skin or eyes
• seizures
• seeing things or hearing voices that do not exist (hallucinating)
• chest pain
• pounding or irregular heartbeat

Trimipramine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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].

What storage conditions are needed for this medicine

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.

What other information should I know

Keep all appointments with your doctor.

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

Brand names

• Surmontil®