Tranylcypromine

Black Box Warnings

In short-term studies, antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults (<24 yr of age) taking antidepressants for major depressive disorders and other psychiatric illnesses

This increase was not seen in patients aged >24 years; a slight decrease in suicidal thinking was seen in adults >65 years

In children and young adults, risks must be weighed against the benefits of taking antidepressants

Patients should be monitored closely for changes in behavior, clinical worsening, and suicidal tendencies; this should be done during initial 1-2 months of therapy and dosage adjustments

The patient’s family should communicate any abrupt changes in behavior to the healthcare provider

Worsening behavior and suicidal tendencies that are not part of the presenting symptoms may require discontinuation of therapy

This drug is not approved for use in pediatric patients

Contraindications

Hypersensitivity

Pheochromocytoma, CHF, cerebrovascular defect, CVD, HTN

Schizophrenia

History of severe or frequent headaches, liver disease

Contraindicated with MAOIs or dibenzazepine-related drugs, sympathomimetics (including amphetamines, which may be found in many herbal preparations), some CNS depressants (eg, narcotics, alcohol), antihypertensives, diuretics, antihistamines, sedatives, anesthetics, bupropion, buspirone, dextromethorphan, meperidine, SSRIs (eg, fluoxetine, paroxetine, sertraline), SNRIs (eg, venlafaxine)

Coadministration with sympathomimetics may cause cerebral hemorrhage

Discontinue 10 days before surgery

High tyramine content food (eg, cheese, beer, Chianti wine, avocados, anchovies, herring, overripe fruit, chocolate, soy sauce, yeasts, yogurt, meat tenderizers, sauerkraut, broad beans)

Cautions

Clinical worsening & suicide ideation may occur despite medication in adolescents & young adults (18-24 years)

Caution in patients with diabetes mellitus (monitor glucose closely), glaucoma, hepatic/renal impairment, history of seizures, thyroid dysfunction

Drug may worsen psychosis in patients with bipolar disorder

Your pharmacist can provide more information about tranylcypromine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Tranylcypromine is a prescription medication used to treat depression, when other medications have failed.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tranylcypromine may be found in some form under the following brand names:

• Parnate

Serious side effects have been reported. See "Drug Precautions" section.

Common side effects include:

• dry mouth
• dizziness
• diarrhea
• headaches
• nausea
• stomach pain
• constipation
• insomnia
• drowsiness
• weakness
• low blood pressure when standing or sitting up
• difficulting urinating
• shakiness

This is not a complete list of tranylcypromine side effects. Ask your doctor or pharmacist for more information.

• Take tranylcypromine exactly as prescribed.
• Tranylcypromine comes in tablet form and is usually taken twice a day.
• It can be taken with or without food.
• If tranylcypromine upsets your stomach, try taking it with food.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of tranylcypromine at the same time.

Do not use this medication if you have used another MAOI such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam) within the past 14 days. Serious, life-threatening side effects can occur if you take tranylcypromine before another MAOI has cleared from your body. If you are switching to tranylcypromine from another MAOI, your doctor may start you at a low dose.

There are many other medicines that can cause serious medical problems if you take them together with tranylcypromine. The following drugs should not be used while you are taking tranylcypromine:

• an antidepressant;

• blood pressure medicine such as guanethidine (Ismelin), methyldopa (Aldomet), and reserpine;

• diet pills, stimulants, ADHD medications, over-the-counter cough and cold or allergy medicines;

• doxepin (Adapin, Sinequan);

• carbamazepine (Carbatrol, Tegretol);

• cyclobenzaprine (Flexeril);

• maprotiline (Ludiomil);

• procarbazine (Matulane);

• bupropion (Wellbutrin, Zyban);

• venlafaxine (Effexor);

• buspirone (BuSpar);

• tryptophan (also called L-tryptophan);

• levodopa (Larodopa, Parcopa, Sinemet); or

• meperidine (Demerol, Mepergan).

To make sure you can safely take tranylcypromine, tell your doctor if you have any of these other conditions:

• heart disease, high blood pressure, circulation problems, or a history of stroke;

• a history of headaches (migraine, cluster, or other types);

• diabetes; or

• a seizure disorder such as epilepsy.

You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Tranylcypromine may be habit forming and should be used only by the person it was prescribed for. Never share tranylcypromine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

It is not known whether tranylcypromine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Tranylcypromine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Older adults may be more likely to have side effects from tranylcypromine.

Do not give this medicine to a child younger than 18 years old without medical advice.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Stop using tranylcypromine and call your doctor at once if you have any of these serious side effects:

• frequent headaches, vision problems, sensitivity to light;

• fast or pounding heart beats, tight feeling in your chest or throat;

• swelling of your ankles or feet;

• pale skin, easy bruising or bleeding, unusual weakness;

• nausea, vomiting, dizziness, sweating, stiffness in your neck;

• confusion, lack of coordination, feeling light-headed, fainting; or

• tremors, muscle twitches you cannot control.

Less serious side effects may include:

• feeling restless, weak, or drowsy;

• nausea, diarrhea or constipation, loss of appetite, stomach pain;

• chills, numbness or tingly feeling;

• dry mouth, decreased urination;

• blurred vision, ringing in your ears; or

• impotence, difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

Although tranylcypromine 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.

tranylcypromine is available only with your doctor's prescription.

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 tranylcypromine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tranylcypromine 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

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.

Geriatric

No information is available on the relationship of age to the effects of tranylcypromine in geriatric patients. However, elderly patients are more likely to have age-related kidney 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.

Interactions with 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 tranylcypromine, 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 tranylcypromine 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.

• Amitriptyline
• Amoxapine
• Amphetamine
• Apraclonidine
• Atomoxetine
• Benzphetamine
• Brimonidine
• Bupropion
• Buspirone
• Carbamazepine
• Carbidopa
• Carbinoxamine
• Citalopram
• Clomipramine
• Clovoxamine
• Codeine
• Cyclobenzaprine
• Cyproheptadine
• Desipramine
• Desvenlafaxine
• Deutetrabenazine
• Dexfenfluramine
• Dexmethylphenidate
• Dextroamphetamine
• Dextromethorphan
• Diethylpropion
• Dopamine
• Dothiepin
• Doxepin
• Doxylamine
• Duloxetine
• Entacapone
• Epinephrine
• Escitalopram
• Femoxetine
• Fenfluramine
• Fluoxetine
• Fluvoxamine
• Furazolidone
• Guanadrel
• Guanethidine
• Hydroxytryptophan
• Imipramine
• Isocarboxazid
• Isometheptene
• Levodopa
• Levomethadyl
• Levomilnacipran
• Linezolid
• Lisdexamfetamine
• Lofepramine
• Maprotiline
• Mazindol
• Meperidine
• Mephentermine
• Methamphetamine
• Methotrimeprazine
• Methyldopa
• Methylene Blue
• Methylphenidate
• Milnacipran
• Mirtazapine
• Nefopam
• Nortriptyline
• Opicapone
• Opipramol
• Pargyline
• Paroxetine
• Phendimetrazine
• Phenelzine
• Phenmetrazine
• Phentermine
• Phenylalanine
• Phenylephrine
• Phenylpropanolamine
• Procarbazine
• Protriptyline
• Pseudoephedrine
• Rasagiline
• Reserpine
• Rizatriptan
• Safinamide
• Selegiline
• Sertraline
• Sibutramine
• Sumatriptan
• Tapentadol
• Tetrabenazine
• Tramadol
• Trazodone
• Trimipramine
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Zolmitriptan

Using tranylcypromine 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.

• Alfentanil
• Altretamine
• Atropine
• Buprenorphine
• Butorphanol
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Disulfiram
• Dolasetron
• Droperidol
• Ephedrine
• Ethchlorvynol
• Fentanyl
• Frovatriptan
• Granisetron
• Guarana
• Hydrocodone
• Hydromorphone
• Iobenguane I 123
• Kava
• Levorphanol
• Licorice
• Lorcaserin
• Ma Huang
• Mate
• Metaraminol
• Methadone
• Methoxamine
• Metoclopramide
• Midodrine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Oxycodone
• Oxymetazoline
• Oxymorphone
• Palonosetron
• Pentazocine
• Reboxetine
• Remifentanil
• St John's Wort
• Sufentanil
• Tegafur
• Tolcapone
• Tyrosine
• Valbenazine
• Ziprasidone

Using tranylcypromine 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

Interactions with Food/Tobacco/Alcohol

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 tranylcypromine 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 tranylcypromine 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 tranylcypromine, 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 tranylcypromine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bipolar disorder (manic-depressive illness) or
• Headache, history of or
• Heart or blood vessel disease or
• Hypertension (high blood pressure) or
• Liver disease, history of or
• Pheochromocytoma (an adrenal problem) or
• Stroke, history of—Should not be used in patients with these conditions.

• Diabetes or
• Hyperthyroidism (overactive thyroid or
• Hypotension (low blood pressure)—Use with caution. May make these conditions worse.

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

• It is used to treat low mood (depression). It is most often given after other drugs have failed to help.

Tranylcypromine sulfate tablets should not be administered in combination with any of the following: MAO inhibitors or dibenzazepine derivatives; sympathomimetics (including amphetamines); some central nervous system depressants (including narcotics and alcohol); antihypertensive, diuretic, antihistaminic, sedative, or anesthetic drugs; bupropion HCl; buspirone HCl; dextromethorphan; cheese or other foods with a high tyramine content; or excessive quantities of caffeine.

Tranylcypromine sulfate tablets should not be administered to any patient with a confirmed or suspected cerebrovascular defect or to any patient with cardiovascular disease, hypertension, or history of headache.

(For complete discussion of contraindications and warnings, see below.)

Symptoms: The characteristic symptoms that may be caused by overdosage are usually those described above.

However, an intensification of these symptoms and sometimes severe additional manifestations may be seen, depending on the degree of overdosage and on individual susceptibility. Some patients exhibit insomnia, restlessness and anxiety, progressing in severe cases to agitation, mental confusion, and incoherence. Hypotension, dizziness, weakness, and drowsiness may occur, progressing in severe cases to extreme dizziness and shock. A few patients have displayed hypertension with severe headache and other symptoms. Rare instances have been reported in which hypertension was accompanied by twitching or myoclonic fibrillation of skeletal muscles with hyperpyrexia, sometimes progressing to generalized rigidity and coma.

Treatment: Because strategies for the management of overdose are continually evolving, it is advisable to contact a Poison Control Center to determine the latest recommendations for the management of an overdose of any drug. Telephone numbers for the certified Poison Control Centers are listed in the Physicians’ Desk Reference (PDR).

Treatment should normally consist of general supportive measures, close observation of vital signs and steps to counteract specific symptoms as they occur, since MAO inhibition may persist. The management of hypertensive crises is described under WARNINGS in the HYPERTENSIVE CRISES section.

External cooling is recommended if hyperpyrexia occurs. Barbiturates have been reported to help relieve myoclonic reactions, but frequency of administration should be controlled carefully because Tranylcypromine sulfate tablets may prolong barbiturate activity. When hypotension requires treatment, the standard measures for managing circulatory shock should be initiated. If pressor agents are used, the rate of infusion should be regulated by careful observation of the patient because an exaggerated pressor response sometimes occurs in the presence of MAO inhibition. Remember that the toxic effect of Tranylcypromine sulfate tablets may be delayed or prolonged following the last dose of the drug. Therefore, the patient should be closely observed for at least a week. It is not known if Tranylcypromine is dialyzable.

Bottle Label

NDC 0591-5590-01

Tranylcypromine Sulfate Tablets
10 mg

Federal Law requires dispensing of Tranylcypromine Sulfate Tablets with the Medication Guide under this label.

Actavis

100 Tablets
Rx Only

open here

Each tablet contains Tranylcypromine, 10 mg, as the sulfate.
Dispense in a tight, light-resistant container.
Important: Use safety closures when dispensing this product unless otherwise directed by physician or requested by purchaser.
Usual Dosage: 30 mg per day, usually given in divided doses. See accompanying prescribing information.
Store tablets between 15o and 30oC (59o and 86oF).
Distributed by: Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Made in Italy
Rev. 08/15

A137270

Select dose with caution; refer to adult dosing.

There are no dosage adjustments provided in the manufacturer's labeling; use with caution, possible cumulative effects may occur.

Information related to the use of tranylcypromine in pregnancy is limited (Kennedy 2000).

Pregnant women exposed to antidepressants during pregnancy are encouraged to enroll in the National Pregnancy Registry for Antidepressants (NPRAD). Women 18 to 45 years of age or their health care providers may contact the registry by calling 844-405-6185. Enrollment should be done as early in pregnancy as possible.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience fatigue, constipation, insomnia, dry mouth, abdominal pain, diarrhea, or loss of strength and energy. Have patient report immediately to prescriber signs of depression (suicidal ideation, anxiety, emotional instability, illogical thinking), signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), chills, angina, shortness of breath, severe behavioral changes, severe headache, severe nausea, vomiting, severe dizziness, passing out, arrhythmia, sweating a lot, neck rigidity, sensitivity to light, severe anxiety, irritability, mood changes, agitation, blurred vision, sexual dysfunction, bradycardia, tachycardia, or larger pupils (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Data not available

Contraindicated