Phenelzine is a monoamine oxidase inhibitor (MAOI) that is used to treat symptoms of atypical depression in adults when other medicines have not been effective.

Phenelzine is not for treating severe depression or bipolar disorder (manic depression).

Phenelzine 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 dangerously high blood pressure if you take them together with phenelzine. 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.

Symptoms of dangerously high blood pressure 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 phenelzine for a short time before any type of surgery or medical procedure. Tell any doctor who treats you that you take phenelzine.

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

Do not stop using phenelzine 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:

Early phase treatment:
-Initial dose: 15 mg orally 3 times a day
-Dose titration: Increase to at least 60 mg per day fairly rapidly, as tolerated
-Maximum dose: 90 mg/day

Maintenance:
-Maintenance dose may be as low as 15 mg orally once a day or 15 mg orally every other day
-Duration of therapy: As long as required

Comments:
-This drug should rarely be the first antidepressant used; it is more suitable for patients unresponsive to more commonly used medications.
-This drug is effective in depressed patients characterized as atypical, nonendogenous, or neurotic, who often have mixed anxiety and depression and phobic or hypochondriacal features.
-Evidence of usefulness in severely depressed patients with endogenous features is less conclusive.
-Clinical response may not be seen until at least 4 weeks at 60 mg per day dosing
-After maximal benefit is achieved, reduce dose slowly over several weeks.

Use: Treatment of clinically characterized atypical, nonendogenous, or neurotic depression, especially in patients who have failed first-line treatments

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

• pheochromocytoma (tumor of the adrenal gland).

• congestive heart failure;

• severe kidney disease; or

• a history of liver problems or abnormal liver function tests.

A dangerous drug interaction can occur between phenelzine and certain other medicines you use within 14 days before or after taking phenelzine. Your doctor may change your treatment plan if you need to use any of these medicines, including:

• epinephrine or norepinephrine;

• bupropion, buspirone, carbamazepine, guanethidine, levodopa, meperidine, methyldopa, tryptophan;

• ADHD medication;

• diet pills, cough and cold or allergy medicines;

• opioid medicine;

• other antidepressants;

• another MAO inhibitor--furazolidone, isocarboxazid, linezolid, methylene blue injection, procarbazine, rasagiline, selegiline, tranylcypromine, 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.

This is not a complete list and there may be other medicines you should not take while you are taking phenelzine.

Tell your doctor if you have ever had:

• high blood pressure, heart disease;

• diabetes;

• schizophrenia;

• epilepsy or other seizure disorder; or

• if you have taken another antidepressant within the past 5 weeks.

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.

Tell your doctor if you are pregnant or breastfeeding.

Phenelzine 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 drowsy or dizzy, severe headache, neck pain or stiffness, hallucinations, shallow breathing, fast and uneven heart rate, cold sweats, feeling like you might pass out, or seizure (convulsions).

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 phenelzine. 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 phenelzine. 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 certain foods, including:

• air dried, aged, smoked, or fermented meats, including sausage, pepperoni, Lebanon bologna, or salami;

• beer, wine, reduced-alcohol or alcohol-free beer or wine;

• 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;

• sauerkraut;

• yogurt;

• yeast extracts, Marmite; or

• excessive amounts of chocolate or caffeine.

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

Phenelzine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty 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.

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

• sudden and severe headache, neck pain or stiffness;

• pounding heartbeats or fluttering in your chest;

• fast or slow heartbeats;

• chest pain;

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

• sweating (sometimes with fever and sometimes with cold, clammy skin);

• nausea, vomiting; or

• dilated pupils (your eyes may be more sensitive to light).

Common side effects of phenelzine may include:

• dizziness, feeling light-headed;

• drowsiness, sleep problems;

• headache;

• feeling weak or tired;

• tremors, muscle twitching;

• dry mouth, stomach discomfort, constipation;

• swelling, weight gain; or

• sexual problems.

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 phenelzine, 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 phenelzine. 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 and the laboratory. Your doctor will check your blood pressure regularly during your treatment with phenelzine.

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.