MEDICATION GUIDE

What is the most important information I should know about Tranylcypromine Sulfate tablets?
Tranylcypromine Sulfate 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 Sulfate 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 Sulfate is 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:

• A sudden, severe increase in blood pressure (hypertensive crisis). A hypertensive crisis can happen when you eat certain foods and drink certain beverages during or after Tranylcypromine Sulfate 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:

A hypertensive crisis can also happen if you take Tranylcypromine Sulfate with certain other medicines. See, “Who should not take Tranylcypromine Sulfate?” 
Avoid foods and drinks with a lot of tyramine while taking Tranylcypromine Sulfate 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 Sulfate see, “What should I avoid while taking Tranylcypromine Sulfate?”

What is Tranylcypromine Sulfate?
Tranylcypromine Sulfate is 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 Sulfate belongs 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 Sulfate is not for use as the first medicine to treat MDD.
• It is not known if Tranylcypromine Sulfate is safe and effective for use in children.

Who should not take Tranylcypromine Sulfate?
Taking Tranylcypromine Sulfate 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 Sulfate?” and “What are the possible side effects of Tranylcypromine Sulfate?”

Do not take Tranylcypromine Sulfate 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
  • resperine
  • 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 Sulfate, 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 Sulfate may harm your unborn baby.
• are breastfeeding or plan to breastfeed. Tranylcypromine Sulfate passes into your breast milk. Do not breastfeed during treatment with Tranylcypromine Sulfate. Talk to your healthcare provider about the best way to feed your baby while taking Tranylcypromine Sulfate.

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

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

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

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 Sulfate tablets?

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

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

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how Tranylcypromine Sulfate tablets affects you.
• Do not drink alcohol while taking Tranylcypromine Sulfate tablets.

How do I store Tranylcypromine Sulfate tablets?

• Store Tranylcypromine Sulfate tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]
• Store Tranylcypromine Sulfate tablets in a tight, light resistant container.

Keep Tranylcypromine Sulfate tablets and all medicines out of the reach of children.

General information about the safe and effective use of  Tranylcypromine Sulfate tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not take  Tranylcypromine Sulfate tablets for a condition for which it was not prescribed. Do not give  Tranylcypromine Sulfate 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 Sulfate tablets that is written for health professionals.

What are the ingredients in Tranylcypromine Sulfate tablets?
Active Ingredient: tranylcypromine sulfate
Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate anhydrous, magnesium stearate, microcrystalline cellulose, talc, and Opadry® II pink 85F14289. Opadry pink is used for purposed of coating and contains the following: FD&C Red # 40, polyethylene glycol 3350, polyvinyl alcohol, talc and titanium dioxide.

Manufactured by:
Par Pharmaceutical

Chestnut Ridge, NY 10977

For more information, contact Par Pharmaceutical at 1-800-828-9393