SPL MEDGUIDE SECTION

MEDICATION GUIDE

Tranylcypromine Tablets, USP

(tran-ill-SIP-row-meen)

 

What is the most important information I should know about tranylcypromine tablets?

Tranylcypromine tablets can cause serious side effects including:

• Increase in suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment and when the tranylcypromine tablets dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have, or have a family history of, bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. Tranylcypromine tablets are not for use in children.
  How can I watch for and try to prevent suicidal thoughts and actions?

• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
• Keep all follow-up visits with your healthcare provider as scheduled.

  

Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call a healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:

• thoughts about suicide or dying
• new or worse depression
• feeling agitated, restless, angry or irritable
• trouble sleeping
• acting aggressive, being angry or violent
• an extreme increase in activity or talking (mania)
• attempts to commit suicide
• new or worse anxiety
• panic attacks
• new or worse irritability
• acting on dangerous impulses
• other unusual changes in behavior or mood

• A sudden, severe increase in blood pressure (hypertensive crisis). A hypertensive crisis can happen when you eat certain foods and drinks certain beverages during or after tranylcypromine tablets treatment. A hypertensive crisis can lead to stroke and death. People who have thyroid problems (hyperthyroidism) may have a higher chance of having a hypertensive crisis. Symptoms of a hypertensive crisis may include:

• sudden, severe headache
• vomiting
• a fast heartbeat (palpitations) or a change in the way your heart beats
• the pupils in your eyes increase in size
• fast or slow heart beat with chest pain
• nausea
• stiff or sore neck
• excessive sweating, sometimes with fever or cold, clammy skin
• light bothers your eyes
• bleeding in your brain

A hypertensive crisis can also happen if you take tranylcypromine tablets with certain other medicines. See, “Who should not take tranylcypromine tablets?”

Avoid foods and drinks with a lot of tyramine while taking tranylcypromine tablets and for 2 weeks after you stop taking it. For a list of some of the foods and drinks you should avoid during treatment with tranylcypromine tablets see, “What should I avoid while taking tranylcypromine tablets?”

What are tranylcypromine tablets?

Tranylcypromine tablets are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder (MDD) who have not responded well to treatment with other medicines used to treat depression (antidepressants). Tranylcypromine tablets belong to a class of medicines called monoamine oxidase inhibitors (MAOIs).

• It is important to talk with your healthcare provider about the risks of treating depression and the risk of not treating it. Talk with your healthcare provider about all your treatment choices.
• Tranylcypromine tablets are not for use as the first medicine to treat MDD.
• It is not known if tranylcypromine tablets are safe and effective for use in children.

Who should not take tranylcypromine tablets?

Taking tranylcypromine tablets with certain antidepressants and certain pain, allergy symptom, and cold and cough symptom medicines may cause a potentially life-threatening hypertensive crisis or a problem called serotonin syndrome. See, “What is the most important information I should know about tranylcypromine tablets?” and “What are the possible side effects of tranylcypromine tablets?”

Do not take tranylcypromine tablets if you:

• take certain medicines, including:

• antidepressants, such as:

• other monoamine oxidase inhibitors (MAOIs)
• selective serotonin reuptake inhibitors (SSRIs) and serotonin and norepinephrine reuptake inhibitors (SNRIs)
• tricyclic antidepressants
• other antidepressants, such as amoxapine, bupropion, maprotiline, nefazodone, trazodone, vilazodone, vortioxetine
• amphetamines and methylphenidates

• medicines that can raise blood pressure (sympathomimetic medicine), such as pseudoephedrine, phenylephrine and ephedrine. These medicines are in some cold, hay fever or weight-loss medicines.
• sympathomimetic herbal medicines or dietary supplements
• antihistamines (allergy medicines)
• triptans
• buspirone
• carbamazepine
• dextromethorphan
• dopamine
• hydroxytryptophan and tryptophan
• levodopa and methyldopa
• meperidine
• rasagline
• reserpine
• s-adenosyl-L-methionine (SAM-e)
• tapentadol
• tetrabenazine

Ask your healthcare provider or pharmacist if you are not sure if you take any of these medicines.

• have a tumor on your adrenal gland called a pheochromocytoma or a type of tumor called a paraganglioma.

Before taking tranylcypromine tablets, tell your healthcare provider about all your medical conditions, including if you:

• have high or low blood pressure
• have heart problems
• have cerebrovascular problems or have had a stroke
• have headaches
• have, or have a family history of, bipolar disorder, mania, or hypomania
• plan to have surgery
• have liver or thyroid problems
• have or have had seizures or convulsions
• have diabetes
• are pregnant or plan to become pregnant. Tranylcypromine tablets may harm your unborn baby.
• are breastfeeding or plan to breastfeed. Tranylcypromine passes into your breast milk. Do not breastfeed during treatment with tranylcypromine tablets. Talk to your healthcare provider about the best way to feed your baby while taking tranylcypromine tablets.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Tranylcypromine tablets and some other medicines may affect each other causing serious side effects. Tranylcypromine tablets may affect the way other medicines work, and other medicines may affect how tranylcypromine tablets work.

Some medicines need to be stopped for a period of time before you can start taking tranylcypromine tablets and for a period of time after you stop taking tranylcypromine tablets.

 Know the medicines you take. Keep a list of them to show your healthcare providers, pharmacist, and dentist when you get a new medicine.

How should I take tranylcypromine tablets?

• Take tranylcypromine tablets exactly as your healthcare provider tells you to take it.
• Your healthcare provider may need to change your dose of tranylcypromine tablets until it is the right dose for you.
• Do not stop taking tranylcypromine tablets without first talking to your healthcare provider. Stopping tranylcypromine tablets suddenly may cause withdrawal symptoms. See, “What are the possible side effects of tranylcypromine tablets?”
• Tell your healthcare provider if you think your condition has gotten worse during treatment with tranylcypromine tablets.

 If you take too much tranylcypromine tablets (overdose) call your healthcare provider or poison control, or go to the nearest hospital emergency room right away.

What should I avoid while taking tranylcypromine tablets?

• Do not eat foods or have drinks that have high amounts of tyramine while taking tranylcypromine tablets or for 2 weeks after you stop taking tranylcypromine tablets.

• All foods you eat should be fresh or properly frozen.
• Avoid foods when you do not know how those foods should be stored.
• Ask your healthcare provider if you are not sure if certain foods and drinks contain tyramine.

The table below lists some of the foods and drinks you should avoid while you take tranylcypromine tablets.

Type of Food and Drink that contain Tyramine
Meat, Poultry, and Fish	air dried, aged and fermented meats, sausages, and salamis pickled herring any spoiled or improperly stored meat, poultry, and fish. These foods have a change in color, odor, or are moldy. spoiled or improperly stored animal livers
Vegetables	broad bean pods (fava bean pods)
Dairy (milk products)	aged cheeses
Drinks	all tap beers and other beers that have not been pasteurized
Other	concentrated yeast extract (such as Marmite) most soybean products (including soy sauce and tofu) sauerkraut ·over-the-counter supplements containing tyramine

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how tranylcypromine tablets affect you.
• You should not drink alcohol while taking tranylcypromine tablets.

What are the possible side effects of tranylcypromine tablets?

Tranylcypromine tablets may cause serious side effects, including:

• See “What is the most important information I should know about tranylcypromine tablets?”
• Serotonin Syndrome. A potentially life-threatening problem called serotonin syndrome can happen when you take tranylcypromine tablets with certain other medicines. See, “Who should not take tranylcypromine tablets?” Symptoms of serotonin syndrome may include:

• agitation, confusion
• coma
• changes in blood pressure
• sweating
• high body temperature (hyperthermia)
• seizures
• becoming unstable
• seeing or hearing things that are not real (hallucinations)
• rapid pulse
• dizziness
• flushing
• fever
• tremors, stiff muscles, or muscle twitching
• nausea, vomiting, diarrhea

If you have any of these symptoms, call your healthcare provider or go to the nearest hospital emergency room right away.

• Mania or hypomania (manic episodes) in people who have a history of bipolar disorder.

• greatly increased energy
• racing thoughts
• unusually grand ideas
• talking more or faster than usual
• severe problems sleeping
• reckless behavior
• excessive happiness or irritability

• Low blood pressure (hypotension) including a drop in your blood pressure when you stand or sit up (postural hypotension). This can happen more often in people who have high blood pressure (hypertension) and when the tranylcypromine tablets dose is changed. Postural hypotension may cause you to feel dizzy and faint (syncope).
• Changes in your blood pressure (hypotension or hypertension) during surgery and during the time around surgery (perioperative). Taking tranylcypromine tablets with certain medicines used for anesthesia can cause hypotension or hypertension. If you plan to have surgery, tell your surgeon or the healthcare provider who will give you anesthesia that you take tranylcypromine tablets. Your healthcare provider should stop tranylcypromine tablets at least 10 days before you have surgery.

• Withdrawal symptoms. Talk with your healthcare provider before you stop taking tranylcypromine tablets. Symptoms of withdrawal may include:

• dizziness
• irritability and agitation
• anxiety
• confusion
• changes in your mood
• seizures
• nausea
• problems sleeping
• abnormal dreams
• electric shock sensation (paresthesia)
• hypomania
• headache
• diarrhea
• sweating
• tiredness
• ringing in your ears (tinnitus)

• Liver problems
• Seizures (convulsions). Seizures have happened in people who take too much tranylcypromine tablets.
• Low blood sugar (hypoglycemia). Hypoglycemia has happened in people with diabetes who take medicines to lower blood sugar. Talk with your healthcare provider about checking your blood sugar during treatment with tranylcypromine tablets. Tell your healthcare provider if your blood sugar gets low.
• Worsening of symptoms that can happen with depression, such as anxiety and agitation.

The most common side effects of tranylcypromine tablets include:

• dry mouth
• problems sleeping
• headache
• constipation
• shakiness (tremor)
• dizziness
• feeling sleepy
• overexcitement
• blurry vision

These are not all the side effects of tranylcypromine tablets.

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

 

How do I store tranylcypromine tablets?

• Store tranylcypromine tablets between 68°F to 77°F (20°C to 25°C).
• Store tranylcypromine tablets in a tight, light resistant container.

Keep tranylcypromine tablets and all medicines out of the reach of children.

 

General information about the safe and effective use of tranylcypromine tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take tranylcypromine tablets for a condition for which it was not prescribed. Do not give tranylcypromine tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about tranylcypromine tablets that is written for health professionals.

What are the ingredients in tranylcypromine tablets?

Active Ingredient: tranylcypromine sulfate

Inactive Ingredients: calcium sulfate, carboxymethyl cellulose sodium, croscarmellose sodium, FD&C Blue No. 2 lake, FD&C Red No. 40 lake, FD&C Yellow No. 6 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.

All trademarks are the property of their respective owners.

Manufactured by:

Novitium Pharma LLC

70 Lake Drive, East Windsor

New Jersey 08520.

Issued: 05/2021

LB4346-00

For more information, contact Novitium Pharma LLC at 1-855-204-1431.

 This Medication Guide has been approved by the U.S. Food and Drug Administration.