Pronunciation:

tran-il-SIP-roe-meen

Brand Names:

• Parnate

Dosage Forms:

• Tablet

Warnings:

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors. Tranylcypromine sulfate is not approved for use in pediatric patients.Excessive consumption of foods or beverages with significant tyramine content or the use of certain drugs with tranylcypromine sulfate or after tranylcypromine sulfate discontinuation can precipitate hypertensive crisis. Monitor blood pressure and allow for medication-free intervals between administration of tranylcypromine sulfate and interacting drugs. Instruct patients to avoid ingestion of foods and beverages with high tyramine content .

Classifications:

Therapeutic—

Antidepressant

Pharmacologic—

Monoamine Oxidase Inhibitor, Nonselective

Uses of This Medicine:

Tranylcypromine is used to treat certain types of depression. It belongs to the group of medicines called monoamine oxidase inhibitors (MAOI). This medicine works by blocking the action of a chemical substance known as monoamine oxidase (MAO) in the nervous system.

Although this medicine is very effective for certain patients, it may also cause some unwanted reactions if taken the wrong way. It is very important to avoid certain foods, beverages, and medicines while you are using tranylcypromine. Your doctor may provide a list as a reminder of which products you should avoid.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of tranylcypromine in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tranylcypromine in the elderly. However, elderly patients are more likely to have unwanted effects (eg, low blood pressure) or age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving tranylcypromine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Acrivastine
• Almotriptan
• Amezinium
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Antazoline
• Apraclonidine
• Atomoxetine
• Azatadine
• Benzphetamine
• Brimonidine
• Bromodiphenhydramine
• Brompheniramine
• Buclizine
• Bupropion
• Buspirone
• Carbamazepine
• Carbidopa
• Carbinoxamine
• Chlorpheniramine
• Chlorphenoxamine
• Cinnarizine
• Citalopram
• Clemastine
• Clomipramine
• Clovoxamine
• Codeine
• Cyclizine
• Cyclobenzaprine
• Cyproheptadine
• Desipramine
• Desvenlafaxine
• Deutetrabenazine
• Dexbrompheniramine
• Dexchlorpheniramine
• Dexfenfluramine
• Dexmethylphenidate
• Dextroamphetamine
• Dextromethorphan
• Dibenzepin
• Diethylpropion
• Dimenhydrinate
• Dimethindene
• Diphenhydramine
• Dobutamine
• Dopamine
• Dopexamine
• Dothiepin
• Doxepin
• Doxylamine
• Droxidopa
• Duloxetine
• Eletriptan
• Entacapone
• Ephedrine
• Epinephrine
• Escitalopram
• Etilefrine
• Femoxetine
• Fenfluramine
• Flunarizine
• Fluoxetine
• Fluvoxamine
• Frovatriptan
• Furazolidone
• Gepirone
• Guanadrel
• Guanethidine
• Hydroxytryptophan
• Hydroxyzine
• Imipramine
• Iproniazid
• Isocarboxazid
• Isoetharine
• Isometheptene
• Levodopa
• Levomethadyl
• Levomilnacipran
• Linezolid
• Lisdexamfetamine
• Lofepramine
• Maprotiline
• Mazindol
• Meclizine
• Melitracen
• Meperidine
• Mephentermine
• Metaraminol
• Methamphetamine
• Methdilazine
• Methotrimeprazine
• Methoxamine
• Methyldopa
• Methylene Blue
• Methylphenidate
• Midodrine
• Milnacipran
• Mirtazapine
• Moclobemide
• Naratriptan
• Nefazodone
• Nefopam
• Nialamide
• Norepinephrine
• Nortriptyline
• Opicapone
• Opipramol
• Oxatomide
• Oxilofrine
• Ozanimod
• Pargyline
• Paroxetine
• Phendimetrazine
• Phenelzine
• Pheniramine
• Phenmetrazine
• Phentermine
• Phenylalanine
• Phenylephrine
• Phenylpropanolamine
• Phenyltoloxamine
• Procarbazine
• Promethazine
• Propylhexedrine
• Protriptyline
• Pseudoephedrine
• Pyrilamine
• Rasagiline
• Reserpine
• Rizatriptan
• S-Adenosylmethionine
• Safinamide
• Selegiline
• Serdexmethylphenidate
• Sertraline
• Sibutramine
• Solriamfetol
• Sumatriptan
• Tapentadol
• Terbutaline
• Tetrabenazine
• Tianeptine
• Tramadol
• Trazodone
• Trimipramine
• Tripelennamine
• Triprolidine
• Tryptophan
• Venlafaxine
• Vilazodone
• Viloxazine
• Vortioxetine
• Zolmitriptan

Using this medicine 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
• Alfentanil
• Atropine
• Benzhydrocodone
• Buprenorphine
• Butalbital
• Butorphanol
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Disulfiram
• Dolasetron
• Droperidol
• Ethchlorvynol
• Fentanyl
• Formoterol
• Granisetron
• Guarana
• Hydrocodone
• Hydromorphone
• Iobenguane I 123
• Iobenguane I 131
• Kava
• Lasmiditan
• Levorphanol
• Licorice
• Lithium
• Lorcaserin
• Ma Huang
• Mate
• Metaxalone
• Methadone
• Metoclopramide
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Ondansetron
• Oxcarbazepine
• Oxycodone
• Oxymetazoline
• Oxymorphone
• Palonosetron
• Pentazocine
• Reboxetine
• Remifentanil
• St John's Wort
• Sufentanil
• Tegafur
• Tolcapone
• Tyrosine
• Valbenazine
• Vilanterol
• Ziprasidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose
• Chlorpropamide
• Ginseng
• Glimepiride
• Glipizide
• Glyburide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Metformin
• Nateglinide
• Repaglinide
• Tolazamide
• Tolbutamide

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

• Caffeine
• Tyramine Containing Food

Using this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Avocado
• Bitter Orange

Other medical problems—

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

• Bipolar disorder (manic-depressive illness), history of or
• Diabetes or
• Epilepsy (seizures) or
• Hyperthyroidism (overactive thyroid) or
• Hypomania, history of or
• Hypotension (low blood pressure) or
• Mania, history of—Use with caution. May make these conditions worse.

• Headache, history of or
• Heart or blood vessel disease or
• Hypertension (high blood pressure) or
• Liver disease, history of or
• Paraganglioma (adrenaline-releasing tumor) or
• Pheochromocytoma (adrenal gland tumor) or
• Stroke, history of—Should not be used in patients with these conditions.

• Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

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, 30 milligrams (mg) per day, given in divided doses. Your doctor may adjust your dose as needed. However, the dose is usually not more than 60 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.

Precautions While Using This Medicine:

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 treatment with 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.

Do not use this medicine if you have used another MAO inhibitor within the past 14 days. Do not take an MAO inhibitor for at least 7 days after you stop this medicine.

Do not use this medicine if you are taking buspirone (Buspar®), carbamazepine (Tegretol®), cyclobenzaprine (Flexeril®), methyldopa (Aldomet®), milnacipran (Savella®), rasagiline (Azilect®), reserpine (Serpasil®), tapentadol (Nucynta®, Palexia®, Tapal®), or tetrabenazine (Nitoman®, Xenazine®).

When taken with certain foods, drinks, or other medicines, tranylcypromine 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 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.

Tranylcypromine 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.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

This medicine may cause blurred vision, drowsiness, or make some people less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

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 tranylcypromine 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 tranylcypromine.

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.

Side Effects of This Medicine:

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.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Absence of or decrease in body movement

actions that are out of control

agitation

anxiety

black, tarry stools

bleeding gums

blood in the urine or stools

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

chest pain

chills

confusion

confusion about identity, place, and time

cough

dark urine

decrease in frequency of urination

decrease in urine volume

decreased awareness or responsiveness

depression

difficulty in passing urine (dribbling)

dizziness

dry mouth

fast, irregular, pounding, or racing heartbeat or pulse

fever with or without chills

general feeling of tiredness or weakness

headache

hoarseness

hostility

hyperventilation

increased need to urinate

irritability

light-colored stools

longer than usual time to ejaculation of semen

loss of bladder control

loss of consciousness

lower back or side pain

muscle twitching

nausea

nervousness

painful or difficult urination

pale skin

passing urine more often

pinpoint red spots on the skin

rapid weight gain

restlessness

seizures

severe sleepiness

shakiness and unsteady walk

sore throat

sores, ulcers, or white spots on the lips or in the mouth

sudden jerky movements of the body

swelling of the face, ankles, or hands

swollen glands

talking, feeling, and acting with excitement

trouble with sleeping

troubled breathing with exertion

unsteadiness, trembling, or other problems with muscle control or coordination

unusual bleeding or bruising

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

upper right abdominal pain

vomiting

yellow eyes and skin

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:

Incidence not known

Blurred vision

constipation

continuing ringing or buzzing or other unexplained noise in the ears

decreased interest in sexual intercourse

diarrhea

drowsiness

dry mouth

hair loss or thinning of the hair

hearing loss

hives or welts, itching, skin rash

inability to have or keep an erection

loss in sexual ability, desire, drive, or performance

loss of appetite

memory loss

muscle spasm

redness of the skin

stomach pain

unable to sleep

weakness

weight loss

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.