Nardil

Phenelzine comes as a tablet to take by mouth. It is usually taken 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 phenelzine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of phenelzine and gradually increase your dose. After your symptoms have improved, your doctor will probably gradually decrease your dose. Follow these directions carefully.

Phenelzine controls the symptoms of depression but does not cure the condition. It may take 4 weeks or longer for you to feel the full benefit of phenelzine. Continue to take phenelzine even if you feel well. Do not stop taking phenelzine without talking to your doctor. Your doctor probably will want to decrease your dose gradually. If you suddenly stop taking phenelzine, you may experience withdrawal symptoms such as nightmares, agitation, loss of contact with reality, nausea, vomiting, and weakness.

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

Call your doctor at once if you have any new or worsening symptoms 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.

Stop using phenelzine and call your doctor at once if you have any of these serious side effects:

• sudden and severe headache, rapid heartbeat, stiffness in your neck, nausea, vomiting, cold sweat, sweating, vision problems, sensitivity to light;
• chest pain, fast or slow heart rate;
• swelling, rapid weight gain;
• agitation, unusual thoughts or behavior; or
• feeling light-headed, fainting.

Less serious side effects may include:

• dizziness;
• feeling weak or drowsy;
• sleep problems (insomnia);
• constipation, upset stomach;
• dry mouth, decreased urination; or
• impotence, difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

While you are taking phenelzine you must not eat foods that are high in tyramine, including:

• aged or smoked meats, fermented meats, dry sausage (including salami, pepperoni, Lebanon bologna), liver, pickled herring;
• any spoiled or improperly stored meats, fish, or dairy products;
• beer and wine (including non-alcoholic beer or wine);
• cheese (other than cottage cheese or cream cheese);
• sauerkraut;
• over-the-counter supplements or cough and cold medicines that contain dextromethorphan or tyramine;
• large amounts of chocolate or caffeine;
• yogurt;
• fava beans;
• meat extracts; or
• yeast extracts (including Brewer's yeast).

You should become very familiar with the list of foods and medicines you must avoid while you are taking phenelzine. Eating tyramine while you are taking phenelzine can raise your blood pressure to dangerous levels which could cause life-threatening side effects.

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

There are many other medicines that can cause serious or life-threatening medical problems if you take them together with phenelzine. Do not take phenelzine before telling your doctor about all other prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor, dentist, or other healthcare provider who treats you.

Nardil is a prescription medication used to treat depression. Because of its potentially serious side effects, it is often used only after other antidepressants haven't worked. Nardil belongs to a group of drugs called monoamine oxidase (MAO) inhibitors. It works by increasing the levels of certain natural chemicals in the brain that affect your mood and help maintain mental balance.

Nardil comes in tablet form. It is usually taken 3 times daily, with or without food.

Common side effects include dizziness, headache, and insomnia. Nardil can cause drowsiness. Do not drive or operate heavy machinery until you know how it affects you.

Nardil is a prescription medication used to treat depression, when other medications have failed.

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

Take Nardil exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Nardil dose your doctor recommends will be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication 

The usual starting dose of Nardil is one tablet (15 mg) three times a day.

Dosage should be increased to at least 60 mg per day. After maximum benefit from Nardil is achieved, dosage should be reduced slowly over several weeks. Maintenance dose may be as low as one tablet, 15 mg, a day or every other day, and should be continued for as long as is required.

While you are taking phenelzine you must not eat foods that are high in tyramine, including:

• aged or smoked meats, fermented meats, dry sausage (including salami, pepperoni, Lebanon bologna), liver, pickled herring;

• any spoiled or improperly stored meats, fish, or dairy products;

• beer and wine (including non-alcoholic beer or wine);

• cheese (other than cottage cheese or cream cheese);

• sauerkraut;

• over-the-counter supplements or cough and cold medicines that contain dextromethorphan or tyramine;

• large amounts of chocolate or caffeine;

• yogurt;

• fava beans;

• meat extracts; or

• yeast extracts (including Brewer's yeast).

You should become very familiar with the list of foods and medicines you must avoid while you are taking phenelzine. Eating tyramine while you are taking phenelzine can raise your blood pressure to dangerous levels which could cause life-threatening side effects.

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 any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms 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.

Stop using phenelzine and call your doctor at once if you have any of these serious side effects:

• sudden and severe headache, rapid heartbeat, stiffness in your neck, nausea, vomiting, cold sweat, sweating, vision problems, sensitivity to light;

• chest pain, fast or slow heart rate;

• swelling, rapid weight gain;

• agitation, unusual thoughts or behavior; or

• feeling light-headed, fainting.

Less serious side effects may include:

• dizziness;

• feeling weak or drowsy;

• sleep problems (insomnia);

• constipation, upset stomach;

• dry mouth, decreased urination; or

• impotence, difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Drugs Associated with Serotonin Syndrome

Potential pharmacologic interaction (serotonin syndrome) with serotonergic agents.100 b j k Avoid concomitant administration of phenelzine and serotonergic agents and allow sufficient amount of time to elapse between discontinuance of serotonergic drugs and initiation of phenelzine.100 b e (See Specific Drugs and Foods under Interactions.)

Specific Drugs and Foods

In the U.S.

• Nardil

Available Dosage Forms:

• Tablet

Therapeutic Class: Antidepressant

Pharmacologic Class: Monoamine Oxidase Inhibitor, Nonselective

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For depression:
    • Adults—At first, 15 milligrams (mg) three times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 90 mg per day.
    • Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects.

You will also need to have your blood pressure measured before starting this medicine and while you are using it. If you notice any change to your recommended blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

When taken with certain foods, drinks, or other medicines, phenelzine can cause very dangerous reactions, such as sudden high blood pressure (also called hypertensive crisis). To avoid such reactions, follow these rules of caution:

• Do not eat foods that have dopamine and a high tyramine content (most common in foods that are aged or fermented to increase their flavor), such as cheese (especially strong or aged kinds), caviar, sour cream, liver, canned figs, soy sauce, sauerkraut, fava beans, yeasts, and yogurt. Avoid smoked or pickled meat, poultry, or fish, such as sausage, pepperoni, salami, anchovies, or herring. Do not eat dried fruit (such as raisins), bananas, avocados, raspberries, or very ripe fruit.
• Do not drink alcoholic beverages. This includes Chianti wine, sherry, beer, non-alcohol or low alcohol beer and wine, and liqueurs.
• Do not eat or drink too much caffeine. Caffeine can be found in coffee, cola, chocolate, tea, and many other foods and drinks. Ask your doctor how much caffeine is safe to use.

Phenelzine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.

Call your doctor or hospital emergency room right away if you have a severe headache, stiff or sore neck, chest pains, fast heartbeat, sweating, dizziness, or nausea and vomiting while you are taking this medicine. These may be symptoms of a serious side effect called hypertensive crisis.

This medicine may cause blurred vision or make some people drowsy or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are unable to see well or not alert.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. When you get up from lying down, sit on the edge of the bed with your feet dangling for 1 or 2 minutes, then stand up slowly. If the problem continues or gets worse, check with your doctor.

Do not stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine or have used it within the past 10 days. Taking phenelzine together with medicines that are used during surgery, dental, or emergency treatments may increase the risk of serious side effects.

Your doctor may want you to carry an identification card stating that you are using this medicine.

This medicine may affect blood sugar levels. If you are diabetic, be especially careful in testing for sugar in your blood or urine. If you have any questions about this, check with your doctor.

After you stop using this medicine, you must continue to exercise caution for at least 2 weeks with your foods, drinks, and other medicines, since these items may continue to react with phenelzine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Initial dose

The usual starting dose of Nardil is one tablet (15 mg) three times a day.

Early phase treatment

Dosage should be increased to at least 60 mg per day at a fairly rapid pace consistent with patient tolerance. It may be necessary to increase dosage up to 90 mg per day to obtain sufficient MAO inhibition. Many patients do not show a clinical response until treatment at 60 mg has been continued for at least 4 weeks.

Maintenance dose

After maximum benefit from Nardil is achieved, dosage should be reduced slowly over several weeks. Maintenance dose may be as low as one tablet, 15 mg, a day or every other day, and should be continued for as long as is required.

Animal studies at doses exceeding the recommended human dose showed a significant decrease in the number of viable offspring, and growth retardation. There are no controlled data in human pregnancy. Epidemiological studies suggest an increased risk of congenital abnormalities with antidepressant use during pregnancy as well as an increase in pre-term delivery. Neonates exposed to antidepressants late in the third trimester have shown drug withdrawal symptoms such as dyspnea, lethargy, colic irritability, hypotension or hypertension, and tremor or spasms. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Safety has not been established during pregnancy; do not use during pregnancy, especially during the first and last trimesters, unless the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: Not assigned