TRANYLCYPROMINE SULFATE: Package Insert and Label Information (Page 3 of 4)

7.2 Tyramine-Containing Foods and Beverages

Tranylcypromine Sulfate inhibits intestinal MAO, which is responsible for the catabolism of tyramine in food and beverages. As a result of this inhibition, large amounts of tyramine may enter the systemic circulation and precipitate a sudden elevation in blood pressure or hypertensive crisis [see Warnings and Precautions (5.2)]. Instruct tranylcypromine sulfate-treated patients to avoid foods and beverages with significant tyramine content during treatment with tranylcypromine sulfate or within 2 weeks of stopping treatment (see Table 5 for a list of food and beverages containing significant amounts of tyramine).

Table 5: Foods and Beverages with and without Significant Amounts of Tyramine

Class of Food or Beverage Tyramine-Rich Foods and Beverages to Avoid Acceptable Foods and Drinks, Containing No or Little Tyramine
Meat, Poultry, and Fish Air dried, aged and fermented meats, sausages and salamis (including cacciatore, hard salami and mortadella); pickled herring; and any spoiled or improperly stored meat, poultry, and fish (e.g., foods that have undergone changes in coloration, odor, or become moldy); spoiled or improperly stored animal livers Fresh meat, poultry, and fish, including fresh processed meats (e.g., lunch meats, hot dogs, breakfast sausage, and cooked sliced ham)
Vegetables Broad bean pods (fava bean pods) All other vegetables
Dairy Aged cheeses Processed cheeses, mozzarella, ricotta cheese, cottage cheese, and yogurt
Beverages All varieties of tap beer and beers that have not been pasteurized so as to allow for ongoing fermentation and excessive amounts of caffeine. Concomitant use of alcohol with PARNATE is not recommended. (Bottled and canned beers and wines contain little or no tyramine.)
Other Concentrated yeast extract (e.g., Marmite), sauerkraut, most soybean products (including soy sauce andtofu), OTC supplements containing tyramine, and chocolate Brewer’s yeast, baker’s yeast, soy milk, commercial chain restaurant pizzas prepared with cheeses low in tyramine

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are limited published reports of placental infarction and congenital anomalies in association with use of tranylcypromine sulfate during pregnancy; however, these reports may not adequately inform the presence or absence of drug-associated risk with the use of tranylcypromine sulfate during pregnancy. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Animal embryo-fetal development studies were not conducted with tranylcypromine; however, published animal reproduction studies report placental transfer of tranylcypromine in rats and a dose-dependent decrease in uterine blood flow in pregnant sheep. Advise pregnant women of the potential risk to a fetus.

Clinical Considerations

Labor or Delivery

[see Warnings and Precautions (5.6) and Drug Interactions (7.1)].

8.2 Lactation

Risk SummaryTranylcypromine is present in human milk. There is no available information on the effects of tranylcypromine on milk production. There is no available information on the effects of tranylcypromine on a breastfed child; however, because of the potential for serious adverse reactions in a breastfed infant, advise nursing women to discontinue breastfeeding during treatment with tranylcypromine sulfate.

8.4 Pediatric Use

Safety and effectiveness of tranylcypromine sulfate in the pediatric population have not been established. All risks associated with the use of tranylcypromine sulfate, including the risk of suicidal thoughts and behavior, apply to adults and pediatric patients [see Boxed Warning and Warnings and Precautions (5)].

8.5 Geriatric Use

Older patients may be at greater risk of postural hypotension and other serious adverse reactions [see Warnings and Precautions (5)]. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

9 DRUG ABUSE AND DEPENDENCE

9.2 Abuse

Abuse of tranylcypromine sulfate has been reported. Some of these patients had a history of previous substance abuse.

The potential for abuse and the increased risk of serious adverse reactions with higher doses should be taken into account when considering the use of tranylcypromine sulfate for patients at increased risk for substance abuse.

9.3 Dependence

Dependence, evidenced by precipitation of withdrawal effects following abrupt discontinuation of tranylcypromine sulfate has been reported. Reported withdrawal effects included delirium (even with low daily doses), restlessness, anxiety, confusion, hallucinations, headache, weakness, diarrhea, and/or rapid relapse into depression. Thrombocytopenia and liver enzyme increases have also been observed in association with tranylcypromine sulfate withdrawal from high doses [see Overdosage (10.1)]

Withdrawal effects have appeared within 1 to 3 days of discontinuation and have persisted for several weeks after discontinuation. The use of daily doses greater than recommended and longer duration of use appear to be associated with a higher risk of withdrawal effects.

Monitor for withdrawal effects for at least 1 week after discontinuation. Consider discontinuing tranylcypromine sulfate therapy by slow, gradual dose reduction [ see Dosage and Administration (2.3)].

10 OVERDOSAGE

10.1 Overdosage Symptoms, Signs, and Laboratory Abnormalities

Overdose of tranylcypromine sulfate can cause the adverse reactions generally associated with tranylcypromine sulfate administration [see Warnings and Precautions (5) , Adverse Reactions (6) and Drug Interactions (7.1)]. However, these reactions may be more severe, including fatal reactions. Effects reported with overdosage of tranylcypromine sulfate and/or other MAOIs include:

  • Insomnia, restlessness, and anxiety, progressing in severe cases to agitation, mental confusion, and incoherence; delirium; seizures
  • Hypotension, dizziness, weakness, and drowsiness, progressing in severe cases to extreme dizziness and shock
  • Hypertension with severe headache and other symptoms/complications
  • Twitching or myoclonic fibrillation of skeletal muscles, with hyperpyrexia, sometimes progressing to generalized rigidity and coma

10.2 Overdosage Management

There are no specific antidotes for tranylcypromine sulfate. For current information on the management of poisoning or overdosage, contact a poison control center at 1-800-222-1222.
Abrupt withdrawal of tranylcypromine sulfate following overdosage can precipitate withdrawal symptoms, including delirium [see Warnings and Precautions 5.9)and Drug Abuse and Dependence (9.3)].

Medical management should normally consist of general supportive measures, close observation of vital signs, and steps to counteract specific manifestations as they occur [see Warnings and Precautions (5)]. The toxic effects of tranylcypromine sulfate may be delayed or prolonged following the last dose of the drug [see Clinical Pharmacology (12.2)]. Therefore, the patient should be closely observed for at least 1 week.

Data on the dialyzability of tranylcypromine are lacking.

11 DESCRIPTION

Tranylcypromine sulfate, the active ingredient of Tranylcypromine Sulfate Tablets USP, is a non-hydrazine MAOI. The chemical name is (±)‑trans ‑2‑phenylcyclopropylamine sulfate (2:1). The molecular formula is (C9 H11 N)2 •H2 SO4 and its molecular weight is 364.46. The structural formula is:

Structural Formula

Tranylcypromine Sulfate film-coated tablets are intended for oral administration. Each round, dark pink tablet is debossed with “250” on one side and “K” on the other side and contains tranylcypromine sulfate equivalent to 10 mg of tranylcypromine.

Inactive ingredients consist of 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.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The mechanism of action of tranylcypromine sulfate as an antidepressant is not fully understood, but is presumed to be linked to potentiation of monoamine neurotransmitter activity in the central nervous system (CNS) resulting from its irreversible inhibition of the enzyme monoamine oxidase (MAO).

12.2 Pharmacodynamics

Although tranylcypromine is eliminated in 24 hours, recovery MAO activity take up to 3 to 5 days [see Warnings and Precautions (5.9)].

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenesis, mutagenesis, or fertility impairment studies were conducted.

16 HOW SUPPLIED/STORAGE AND HANDLING

Tranylcypromine Sulfate Tablets, USP are supplied as round, dark pink, film-coated tablets debossed with “250” on one side and “K” on the other side and contains tranylcypromine sulfate equivalent to 10 mg of tranylcypromine, in bottle of 100 with a desiccant.

Tranylcypromine Sulfate tablets are available as:

  • 10 mg: bottles of 100 tablets: NDC 49884-032-01

Store between 20° to 25°C (68° and 77°F); excursions permitted to 15° to 30°C (59° and 86°F).

Dispense in a tight, light resistant container.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read FDA-approved patient labeling (Medication Guide).

Suicidal Thoughts and Behaviors
Advise patients and caregivers to look for the emergence of suicidal thoughts and behaviors, especially early during treatment and when the dosage is adjusted up or down [see Box Warning and Warnings and Precautions (5.1)].

Hypertensive Crisis
Advise the patient on possible symptoms and instruct the patient to seek immediate medical attention if related signs or symptoms are present [see Boxed Warning and Warnings and Precautions (5.2)]

Serotonin SyndromeAdvise the patient on possible symptoms, and explain the potentially fatal nature of serotonin syndrome and that it may result from an interaction with other serotonergic drugs. Instruct the patient to seek immediate medical attention if related signs or symptoms are present [see Warnings and Precautions (5.3)]

Interaction with Other Drugs and Dietary Supplements [see Contraindications (4.1)and Drug Interactions (7.1)]

  • Warn the patient not to take concomitant medications, whether prescription or over‑the‑counter drugs, or dietary supplements without prior consultation with a health care provider able to provide advice on the potential for interactions.
  • Explain to the patient that some other drugs may require a medication-free interval even after discontinuation of tranylcypromine sulfate.
  • Advise the patient to inform other physicians, pharmacists, and dentists about the treatment with tranylcypromine sulfate.

Interaction with Foods and Beverages [see Contraindications (4.1) and Drug Interactions (7.2)]

  • Warn the patient to avoid tyramine-rich foods and beverages.
  • Advise the patient to avoid eating foods if storage conditions or freshness is unknown and to be cautious of foods of unknown age or composition even if refrigerated.

Hypotension

Advise the patient to report any symptoms of hypotension in the initial phase of treatment to the healthcare provider, because occurrence of such symptoms may require discontinuation [see Dosage and Administration (2.1) and Warnings and Precautions (5.5)].

Withdrawal Symptoms

Warn the patient not to stop tranylcypromine sulfate treatment abruptly, as withdrawal symptoms may occur and that the effect of tranylcypromine sulfate may continue even after discontinuation [ see Warnings and Precautions (5.8, 5.9)].

Aggravation of Coexisting Symptoms of Depression

Inform the patient that tranylcypromine sulfate may aggravate coexisting symptoms in depression, such as anxiety and agitation and instruct them to contact their healthcare provider if they experience such symptoms [see Warnings and Precautions (5.13)].

Effects on Ability to Drive or Use Machinery [see Warnings and Precautions (5.14)]

  • Warn the patient about the possible adverse reactions that can impair the performance of potentially hazardous tasks such as driving a car or operating machinery.
  • Tell the patient not to operate hazardous machinery and automobiles until they are reasonably certain that their ability to engage in such activities is not impaired.

Manufactured by:

Par Pharmaceutical

Chestnut Ridge, NY 10977

Revised: 08/2018

MEDICATION GUIDE

MEDICATION GUIDE Tranylcypromine Sulfate Tablets, USP (TRAN-il-SIP-roe-meen Suhl-feyt)

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:

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated, restless, angry or irritable
  • panic attacks
  • trouble sleeping
  • new or worse irritability
  • acting aggressive, being angry or violent
  • acting on dangerous impulses
  • an extreme increase in activity or talking (mania)
  • 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 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:
  • sudden, severe headache
  • nausea
  • vomiting
  • stiff or sore neck
  • a fast heartbeat (palpitations) or a change in the way your heart beats
  • excessive sweating, sometimes with fever or cold, clammy skin
  • the pupils in your eyes increase in size
  • light bothers your eyes
  • fast or slow heart beat with chest pain
  • bleeding in your brain

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.

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 Sulfate tablets affects you.
  • Do not drink alcohol while taking Tranylcypromine Sulfate tablets.

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