Trimipramine Maleate

Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

See also the Warning section.

Before taking trimipramine, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (such as amitriptyline, imipramine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (such as agranulocytosis, thrombocytopenia), breathing problems (such as asthma, chronic obstructive pulmonary disorder-COPD), diabetes, electroshock therapy, personal or family history of glaucoma (angle-closure type), heart problems (such as recent heart attack, arrhythmias, coronary artery disease), intestinal problems (such as chronic constipation, ileus), kidney problems, liver problems, other mental/mood conditions (such as bipolar disorder, psychosis), family history of mental/mood conditions (such as suicide, bipolar disorder), seizures, conditions that may increase your risk of seizures (such as bulimia, organic brain disease, alcohol withdrawal), overactive thyroid (hyperthyroidism), problems urinating (urinary retention, enlarged prostate).

Trimipramine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using trimipramine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using trimipramine safely.

This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

This drug may rarely make your blood sugar rise, which can cause or worsen diabetes. If you have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Older adults may be more sensitive to the side effects of this drug, especially dizziness (more likely when standing up), drowsiness, confusion, constipation, trouble urinating or QT prolongation (see above). Drowsiness, dizziness, or confusion can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Infants born to mothers who have taken similar medications during pregnancy may develop trouble urinating, lethargy, shaking (tremors), and seizures. Discuss the risks and benefits with your doctor.

Since untreated mental/mood problems (such as depression) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Overdose of this medication may be fatal, and symptoms include seizures, delirium and loss of consciousness.

Do not share this medication with others.

Lab and/or medical tests (such as blood counts, kidney/liver function) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

See also the Warning section.

Dizziness, drowsiness, difficulty urinating, headache, weakness, changes in appetite/weight, dry mouth, blurred vision, and constipation may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water or use a saliva substitute.

To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as confusion, depression, nervousness), numbness/tingling of the hands/feet, ringing in the ears, sexual problems, shakiness (tremors), severe vomiting/constipation, severe headache, pain/redness/swelling of arms or legs.

Get medical help right away if you have any very serious side effects, including: slow/fast/irregular heartbeat, severe dizziness, fainting, seizures, trouble speaking, weakness on one side of the body, eye pain/swelling/redness, widened pupils, vision changes (such as seeing rainbows around lights at night), chest/jaw/left arm pain.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

This medication may rarely cause serious blood problems (such as agranulocytosis, thrombocytopenia) or liver problems. Tell your doctor right away if you notice any of the following serious side effects: easy bleeding/bruising, signs of infection (such as sore throat that doesn't go away, fever, chills), stomach/abdominal pain, dark urine, yellowing eyes/skin.

A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Medication Guide provided by your pharmacist before you start taking trimipramine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually 1 to 3 times daily. If taking this medication once daily, take it at bedtime to decrease the risk of drowsiness. The dosage is based on your medical condition and response to treatment. Your doctor may start you at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

This medication does not work right away. It may take 2 to 4 weeks before you experience the full benefits.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.

Keep taking this medication even if you feel well. Do not suddenly stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Nausea, headache and a feeling of being ill may also occur. Your dose may need to be gradually decreased.

Tell your doctor if your condition does not get better or if it gets worse.