Tranylcypromine is a monoamine oxidase inhibitor (MAOI) that works by increasing the levels of certain chemicals in the brain.

Tranylcypromine is used to treat major depressive episodes in adults when other medicines have not been effective.

Tranylcypromine may also be used for purposes not listed in this medication guide.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

There are many other drugs, foods, and beverages that can cause serious medical problems if you take them together with tranylcypromine. Tell your doctor about all your current medicines and any you start or stop using. Avoid drinking alcohol, and learn about the foods you should avoid.

Eating foods that contain a lot of tyramine while taking tranylcypromine can cause dangerously high blood pressure. Symptoms include a sudden and severe headache, nausea, vomiting, fever, cold sweat, dilated pupils, light sensitivity, fast or pounding heartbeats, neck stiffness, weakness, or problems with vision or speech.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your blood pressure will need to be checked often.

You may need to stop using tranylcypromine for a short time before any type of surgery or medical procedure. Tell any doctor who treats you that you take tranylcypromine.

It may take a few weeks before you receive the full benefit of taking tranylcypromine. Your doctor will determine how long to treat you with tranylcypromine.

Do not stop using tranylcypromine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Depression:

30 mg per day, orally, in divided doses
-If improvement does not occur in a reasonable period (up to 2 weeks), the dose may be increased by 10 mg per day at 1 to 3 week intervals.
-Maximum dose: 60 mg/day

Comments:
-Adjust dosage to the requirements of the individual patient.
-Improvement usually occurs within 48 hours to 3 weeks after starting therapy.
-Suitable candidates for treatment are patients who have failed to respond to drugs more commonly used to treat depression.
-The effectiveness in patients with major depression with melancholia (endogenous features) has not been established.

Use: Treatment of major depressive episode without melancholia

You should not use tranylcypromine if you are allergic to it, or if you have:

• pheochromocytoma (tumor of the adrenal gland).

A dangerous drug interaction could occur between tranylcypromine and certain other medications you used in the past 14 days. You should not take tranylcypromine if you also use:

• other antidepressants;

• buspirone, carbamazepine, reserpine, tapentadol, tetrabenazine, tryptophan, SAM-e;

• diet pills, stimulants, ADHD medications, cough and cold or allergy medicines;

• another MAO inhibitor--isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and others; or

• drugs that affect serotonin levels in your body--stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.

Tell your doctor if you have ever had:

• heart disease, high or low blood pressure, circulation problems, or a stroke;

• bipolar disorder (manic depression);

• liver disease;

• a thyroid disorder;

• headaches;

• diabetes (tranylcypromine may cause low blood sugar); or

• a seizure.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Tranylcypromine may harm an unborn baby. Tell your doctor if you are pregnant or if you become pregnant.

You should not breast-feed while using tranylcypromine.

Tranylcypromine is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include feeling restless or anxious, sleep problems, agitation, confusion, weakness, severe headache, neck pain or stiffness, pounding heartbeats, or loss of consciousness.

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

You may experience a serious reaction if you eat foods that are high in tyramine during your treatment with tranylcypromine. Tyramine is found in many foods, including meat, poultry, fish, or cheese that has been smoked, aged, improperly stored, or spoiled; certain fruits, vegetables, and beans; alcoholic beverages; and yeast products that have fermented. Your doctor or dietitian will tell you which foods you must avoid completely, and which foods you may eat in small amounts. You should also avoid foods and drinks that contain caffeine during your treatment with tranylcypromine. Follow these directions carefully. Ask your doctor or dietitian if you have any questions about what you may eat and drink during your treatment.

Do not drink alcohol. Dangerous side effects could occur.

You must not eat foods that are high in tyramine, including:

• air dried, aged or fermented meats, including sausage or salami;

• beer on tap (not in a bottle or can);

• pickled herring;

• aged cheeses, including blue, boursault, brie, camembert, cheddar, gruyere, mozzarella, parmesan, Romano, Roquefort, and Swiss;

• moldy or improperly stored meat, fish, poultry, or liver;

• soy sauce, miso soup, bean curd, fava beans; or

• yeast extracts, Marmite.

Eating tyramine while you are taking tranylcypromine can raise your blood pressure to dangerous levels, causing life-threatening side effects. Also avoid tyramine for 2 weeks after you stop taking tranylcypromine.

Avoid driving or hazardous activity until you know how tranylcypromine will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Tranylcypromine may cause serious side effects. Call your doctor at once if you have:

• dilated pupils, vision problems, sensitivity to light;

• sudden and severe headache, neck pain or stiffness;

• numbness or weakness, problems with vision or speech;

• fast or pounding heartbeats;

• fever, cold sweat, nausea, vomiting;

• a light-headed feeling, like you might pass out;

• a seizure;

• manic episodes--racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative;

• high levels of serotonin in the body--agitation, hallucinations, sweating, shivering, muscle stiffness, twitching, loss of coordination, vomiting, diarrhea; or

• liver problems--loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes).

Serious side effects may be more likely in older adults.

Common side effects of tranylcypromine may include:

• dizziness, drowsiness;

• constipation;

• dry mouth, blurred vision;

• trouble sleeping;

• headache; or

• feeling shaky or excited.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

When you start or stop taking tranylcypromine, your doctor may need to adjust the doses of any other medicines you take on a regular basis.

There are many other drugs that can cause serious medical problems if you take them together with tranylcypromine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor. Your doctor will check your blood pressure often during your treatment with tranylcypromine.

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.