A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants (‘mood elevators’) such as maprotiline during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take maprotiline, but in some cases, a doctor may decide that maprotiline is the best medication to treat a child’s condition.

You should know that your mental health may change in unexpected ways when you take maprotiline or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. 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 if you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking maprotiline, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer’s patient information sheet (medication guide) when you begin treatment with maprotiline. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

Maprotiline is used to treat depression, bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods), and anxiety. Maprotiline is in a class of medications called tetracyclic antidepressants. It works by increasing the amounts of certain natural substances in the brain that are needed to maintain mental balance.

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

It may take a few weeks or longer for you to feel the full benefit of maprotiline. Continue to take maprotiline even if you feel well. Do not stop taking maprotiline without talking to your doctor. Your doctor will probably want to decrease your dose gradually.

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

Before taking maprotiline,

• Tell your doctor and pharmacist if you are allergic to maprotiline or any other medications.
• Tell your doctor if you are taking a monoamine oxidase (MAO) inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have taken an MAO inhibitor during the past 14 days. Your doctor will probably tell you that you should not take maprotiline.
• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants (blood thinners) such as warfarin (Coumadin); antihistamines; estrogens; fluoxetine (Prozac); levodopa (Sinemet, Larodopa); lithium (Eskalith, Lithobid); medication for high blood pressure, seizures, Parkinson’s disease, asthma, colds, or allergies; methylphenidate (Ritalin); muscle relaxants; oral contraceptives; sedatives; sleeping pills; thyroid medication; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Tell your doctor if you have or have ever had glaucoma (an eye condition), an enlarged prostate (a male reproductive gland), difficulty urinating, seizures, a brain tumor, a head injury, 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 maprotiline, call your doctor.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking maprotiline.
• You should know that this medication 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.
• Tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this medication.

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

Take the missed dose as soon as you remember it. However, if it is almost time for your 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.

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

• Nausea
• Drowsiness
• Weakness or tiredness
• Nightmares
• Dry mouth
• Skin more sensitive to sunlight than usual
• Changes in appetite or weight
• Constipation
• Difficulty urinating
• Frequent urination
• Blurred vision
• Changes in sex drive or ability
• Excessive sweating

Some side effects can be serious. 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
• Uncontrollable shaking of a part of the body
• Fever, chills, sore throat, or flu-like symptoms
• Difficulty breathing or swallowing
• Rash
• Yellowing of the skin or eyes
• Irregular heartbeat

Maprotiline may cause other side effects. Call your doctor if you have any unusual problems while you are 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

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

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

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.