Marplan

They work by blocking the action of a chemical substance known as monoamine oxidase (MAO) in the nervous system .

Although these medicines are very effective for certain patients, they may also cause some unwanted reactions if not taken in the right way. It is very important to avoid certain foods, beverages, and medicines while you are being treated with an MAO inhibitor . Your health care professional will help you obtain a list to carry in your wallet or purse as a reminder of which products you should avoid.

These medicines are available only with your doctor`s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems . Although these uses are not included in product labeling, phenelzine and tranylcypromine are used in certain patients with the following medical conditions:

• Headache


• Panic disorder

Dangerous reactions such as sudden high blood pressure may result when MAO inhibitors are taken with certain foods or drinks. The following foods should be avoided:

• Foods that have a high tyramine content (most common in foods that are aged or fermented to increase their flavor), such as cheeses; fava or broad bean pods; yeast or meat extracts; smoked or pickled meat, poultry, or fish; fermented sausage (bologna, pepperoni, salami, summer sausage) or other fermented meat; sauerkraut; or any overripe fruit. If a list of these foods and beverages is not given to you, ask your health care professional to provide one.


• Alcoholic beverages or alcohol-free or reduced-alcohol beer and wine.


• Large amounts of caffeine-containing food or beverages such as coffee, tea, cola, or chocolate.

This product is available in the following dosage forms:

• Capsule


• Tablet


• Tablet, Disintegrating

Before Using

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Antidepressants must be used with caution in children, teenagers, and young adults with depression. Studies have shown occurrences of children, teenagers, and young adults thinking about suicide or attempting suicide in clinical trials for this medicine. More study is needed to be sure antidepressants are safe and effective in children, teenagers, and young adults .

Animal studies have shown that these medicines may slow growth in the young. Therefore, be sure to discuss with your doctor the use of these medicines in children.

Geriatric

Dizziness or lightheadedness may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to these effects of MAO inhibitors.

Pregnancy

A limited study in pregnant women showed an increased risk of birth defects when these medicines were taken during the first 3 months of pregnancy. In animal studies, MAO inhibitors caused a slowing of growth and increased excitability in the newborn when very large doses were given to the mother during pregnancy.

Breastfeeding

Tranylcypromine passes into the breast milk; it is not known whether isocarboxazid or phenelzine passes into breast milk. Problems in nursing babies have not been reported.

Drug Interactions

Using medicines in this class with any of the following medicines is not recommended . Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Amitriptyline


• Amoxapine


• Amphetamine


• Apraclonidine


• Atomoxetine


• Benzphetamine


• Brimonidine


• Bupropion


• Buspirone


• Carbamazepine


• Citalopram


• Clomipramine


• Clovoxamine


• Cocaine


• Cyclobenzaprine


• Cyproheptadine


• Desipramine


• Desvenlafaxine


• Dexfenfluramine


• Dexmethylphenidate


• Dextroamphetamine


• Dextromethorphan


• Diethylpropion


• Dobutamine


• Dopamine


• Dothiepin


• Doxepin


• Duloxetine


• Ephedrine


• Epinephrine


• Escitalopram


• Femoxetine


• Fenfluramine


• Fluoxetine


• Fluvoxamine


• Furazolidone


• Guanadrel


• Guanethidine


• Imipramine


• Isocarboxazid


• Isometheptene


• Isoproterenol


• Levodopa


• Levomethadyl


• Linezolid


• Lisdexamfetamine


• Lofepramine


• Maprotiline


• Mazindol


• Meperidine


• Mephentermine


• Metaraminol


• Methadone


• Methamphetamine


• Methotrimeprazine


• Methoxamine


• Methyldopa


• Methylphenidate


• Milnacipran


• Mirtazapine


• Morphine


• Morphine Sulfate Liposome


• Nefazodone


• Nefopam


• Norepinephrine


• Nortriptyline


• Opipramol


• Oxcarbazepine


• Pargyline


• Paroxetine


• Phendimetrazine


• Phenelzine


• Phenmetrazine


• Phentermine


• Phenylalanine


• Phenylephrine


• Phenylpropanolamine


• Procarbazine


• Propoxyphene


• Protriptyline


• Pseudoephedrine


• Rasagiline


• Reserpine


• Rizatriptan


• Selegiline


• Sertraline


• Sibutramine


• St John`s Wort


• Sumatriptan


• Tapentadol


• Tetrabenazine


• Tramadol


• Tranylcypromine


• Trimipramine


• Tryptophan


• Venlafaxine


• Zolmitriptan

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Albuterol


• Altretamine


• Amitriptyline


• Amoxapine


• Arformoterol


• Avocado


• Bambuterol


• Bitolterol


• Bitter Orange


• Broxaterol


• Buspirone


• Citalopram


• Clenbuterol


• Clomipramine


• Clovoxamine


• Desipramine


• Difenoxin


• Diphenoxylate


• Disulfiram


• Dopamine


• Dothiepin


• Doxepin


• Droperidol


• Duloxetine


• Entacapone


• Ephedrine


• Escitalopram


• Ethchlorvynol


• Femoxetine


• Fenoterol


• Fentanyl


• Fluoxetine


• Fluvoxamine


• Formoterol


• Guarana


• Hexoprenaline


• Imipramine


• Isoetharine


• Kava


• Levalbuterol


• Levodopa


• Licorice


• Lithium


• Lofepramine


• Ma Huang


• Maprotiline


• Mate


• Mephentermine


• Metaraminol


• Methoxamine


• Metoclopramide


• Nefazodone


• Nortriptyline


• Oxycodone


• Paroxetine


• Pentazocine


• Phenylephrine


• Pirbuterol


• Procaterol


• Protriptyline


• Reboxetine


• Rimiterol


• Ritodrine


• Salmeterol


• Sertraline


• Sibutramine


• St John`s Wort


• Sumatriptan


• Terbutaline


• Tolcapone


• Tramadol


• Trimipramine


• Tryptophan


• Tulobuterol


• Tyrosine


• Venlafaxine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following is not recommended . Your doctor may decide not to treat you with a medication in this class, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

• Caffeine


• Dopamine Containing Food


• Tyramine Containing Food

Using medicines in this class with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use your medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Tyramine Containing Food

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abusea€”Drinking alcohol while you are taking an MAO inhibitor may cause serious side effects.

• Angina (chest pain) or


• Headaches (severe or frequent)a€”These conditions may interfere with warning signs of serious side effects of MAO inhibitors.

• Asthma or bronchitisa€”Some medicines used to treat these conditions may cause serious side effects when used while you are taking an MAO inhibitor .

• Diabetes mellitus (sugar diabetes)a€”These medicines may change the amount of insulin or oral antidiabetic medication that you need .

• Epilepsya€”Seizures may occur more often.

• Heart or blood vessel disease or


• Liver disease or


• Mental illness (or history of) or


• Parkinson`s disease or


• Recent heart attack or strokea€”MAO inhibitors may make the condition worse.

• High blood pressurea€”Condition may be affected by these medicines.

• Kidney diseasea€”Higher blood levels of MAO inhibitors may occur, which increases the chance of side effects.

• Overactive thyroid or


• Pheochromocytoma (PCC)a€”Serious side effects may occur.

Proper Use

Sometimes this medicine must be taken for several weeks before you begin to feel better. Your doctor should check your progress at regular visits, especially during the first few months of treatment, to make sure that this medicine is working properly and to check for unwanted effects.

Take this medicine only 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.

MAO inhibitors may be taken with or without food or on a full or empty stomach. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed .

Dosing

The dose medicines in this class 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 these medicines. 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 isocarboxazid

• For oral dosage form (tablets):
  
  
  
  • For treatment of depression:
    
    
    
    • Adultsa€”To start, 10 milligrams (mg) twice a day. Your doctor may increase your dose gradually as needed. However, the dose usually is not more than 60 mg a day.
    
    
    • Children younger than 16 years of agea€”Use and dose must be determined by the doctor .
    
    
    
    
  
  
  
  

For phenelzine

• For oral dosage form (tablets):
  
  
  
  • For treatment of depression:
    
    
    
    • Adultsa€”Dose is based on your body weight . To start, the usual dose is 1 milligram (mg) per kilogram (kg) of body weight (0.45 mg per pound) a day. Your doctor may decrease or increase your dose as needed. However, the dose usually is not more than 90 mg a day.
    
    
    • Children younger than 16 years of agea€”Use and dose must be determined by the doctor .
    
    
    • Older adultsa€”To start, 15 mg in the morning . Your doctor may increase your dose gradually as needed. However, the dose usually is not more than 60 mg a day.
    
    
    
    
  
  
  
  

For tranylcypromine

• For oral dosage form (tablets):
  
  
  
  • For treatment of depression:
    
    
    
    • Adultsa€”To start, 30 milligrams (mg) a day. Your doctor may increase your dose gradually as needed. However, the dose usually is not more than 60 mg a day.
    
    
    • Children younger than 16 years of agea€”Use and dose must be determined by the doctor .
    
    
    • Older adultsa€”To start, 2.5 to 5 mg a day. The doctor may increase your dose as needed. However, the dose usually is not more than 45 mg a day.
    
    
    
    
  
  
  
  

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.

If you miss a dose of this medicine, take it as soon as possible. However, if it is within 2 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

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

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.

Precautions

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

• Do not eat foods that have a high tyramine content (most common in foods that are aged or fermented to increase their flavor), such as cheeses; fava or broad bean pods; yeast or meat extracts; smoked or pickled meat, poultry, or fish; fermented sausage (bologna, pepperoni, salami, and summer sausage) or other fermented meat; sauerkraut; or any overripe fruit. If a list of these foods is not given to you, ask your health care professional to provide one.


• Do not drink alcoholic beverages or alcohol-free or reduced-alcohol beer and wine.


• Do not eat or drink large amounts of caffeine-containing food or beverages such as coffee, tea, cola, or chocolate.


• Do not take any other medicine unless approved or prescribed by your doctor . This especially includes nonprescription (over-the-counter [OTC]) medicine, such as that for colds (including nose drops or sprays), cough, asthma, hay fever, and appetite control; a€śkeep awake`` products; or products that make you sleepy.

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, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Check with your doctor or hospital emergency room immediately if severe headache, stiff neck, chest pains, fast heartbeat, or nausea and vomiting occur while you are taking this medicine. These may be symptoms of a serious side effect that should have a doctor`s attention .

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

Dizziness, lightheadedness, or fainting may occur, especially when you get up 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 .

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 are not alert.

Antidepressants 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.

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 2 weeks. Taking MAO inhibitors together with medicines that are used during surgery or 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.

For patients with angina (chest pain):

• This medicine may cause you to have an unusual feeling of good health and energy . However, do not suddenly increase the amount of exercise you get without discussing it with your doctor . Too much activity could bring on an attack of angina .

For diabetic patients:

• This medicine may affect blood sugar levels. While you are using this medicine, 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 obey the rules of caution for at least 2 weeks concerning food, drink, and other medicine, since these things may continue to react with MAO inhibitors.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Symptoms of unusually high blood pressure (hypertensive crisis)

• Chest pain (severe)


• Enlarged pupils


• Fast or slow heartbeat


• Headache (severe)


• Increased sensitivity of eyes to light


• Increased sweating (possibly with fever or cold, clammy skin)


• Nausea and vomiting


• Stiff or sore neck

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Dizziness or lightheadedness (severe), especially when getting up from a lying or sitting position

Less common

• Diarrhea


• Fast or pounding heartbeat


• Swelling of feet or lower legs


• Unusual excitement or nervousness

Rare

• Dark urine


• Fever


• Skin rash


• Slurred speech


• Sore throat


• Staggering walk


• Yellow eyes or skin

Symptoms of overdose

• Anxiety (severe)


• Confusion


• Convulsions (seizures)


• Cool, clammy skin


• Dizziness (severe)


• Drowsiness (severe)


• Fast and irregular pulse


• Fever


• Hallucinations (seeing, hearing, or feeling things that are not there)


• Headache (severe)


• High or low blood pressure


• Muscle stiffness


• Sweating


• Trouble in sleeping (severe)


• Troubled breathing


• Unusual irritability

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Blurred vision


• Decreased amount of urine


• Decreased sexual ability


• Dizziness or lightheadedness (mild), especially when getting up from a lying or sitting position


• Drowsiness


• Headache (mild)


• Increased appetite (especially for sweets) or weight gain


• Increased sweating


• Muscle twitching during sleep


• Nausea


• Restlessness


• Shakiness or trembling


• Tiredness and weakness


• Trouble in sleeping

Less common or rare

• Chills


• Constipation


• Decreased appetite


• Dryness of mouth

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.