Tranylcypromine

For the treatment of Major Depressive Episode Without Melancholia.

Tranylcypromine (Tranylcypromine) should be used in adult patients who can be closely supervised. It should rarely be the first antidepressant drug given. Rather, the drug is suited for patients who have failed to respond to the drugs more commonly administered for depression.

The effectiveness of Tranylcypromine (Tranylcypromine) has been established in adult outpatients, most of whom had a depressive illness which would correspond to a diagnosis of Major Depressive Episode Without Melancholia. As described in the American Psychiatric Association's Diagnostic and Statistical Manual, third edition (DSM III), Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning and includes at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.

The effectiveness of Tranylcypromine (Tranylcypromine) in patients who meet the criteria for Major Depressive Episode with Melancholia (endogenous features) has not been established.

Summary of Contraindications

Tranylcypromine (Tranylcypromine) 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 (Tranylcypromine) 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.

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.

Usual Adult Dose for Depression

Major Depressive Episode Without Melancholia:

Initial dose: 10 mg orally twice a day

Maintenance dose: Usually 30 mg/day in divided doses is effective; however, dosage should be adjusted to individual needs

Improvement should be seen within 48 hours to 3 weeks after initiation of therapy. If there are no signs of improvement after 2 weeks, then the dosage may be increased in 10 mg/day at intervals of 1 to 3 weeks, up to a maximum of 60 mg/day.

Renal Dose Adjustments

The manufacturer recommends caution when administering this drug to patients with impaired renal function.

Liver Dose Adjustments

The use of Tranylcypromine is contraindicated in patients with a history of liver disease and in patients with abnormal liver function tests.

Dose Adjustments

If the patient is being transferred to Tranylcypromine from another monoamine oxidase inhibitor or from a dibenzazepine-related entity (e.g., tricyclic antidepressants), a medication-free interval of at least a week should be allowed, then Tranylcypromine should be initiated at half the normal starting dosage for at least the first week of therapy.

Precautions

Children, adolescents, and young adults (18 to 24 years of age) with major depressive disorder and other psychiatric disorders may be at an increased risk of suicidal thinking and suicidality with antidepressant use. This risk should be balanced with clinical need when considering the use of Tranylcypromine or any other antidepressant in a child, adolescent, or young adult. All patients who are treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior, particularly during the first few months of treatment, or when the dose either increases or decreases. Discontinuing or modifying the current drug therapy should be considered in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality (particularly if symptoms are severe, abrupt in onset, or were not part of the presenting symptoms). Prescriptions for Tranylcypromine and other psychotropic drugs should be written for the smallest quantity feasible in order to reduce the risk of an attempt to overdose. Health care providers should instruct patients, their families, and their caregivers to be alert for the emergence of agitation, irritability, and other symptoms, as well as the emergence of suicidality and worsening depression, and to report such symptoms immediately to their health care provider.

Tranylcypromine is not approved for treating bipolar disorder. Patients should be adequately screened to determine if they are at risk for bipolar disorder prior to initiating therapy with Tranylcypromine so that they can be appropriately monitored during treatment. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

The use of Tranylcypromine is contraindicated in patients with a history of liver disease and in patients with abnormal liver function tests. Tranylcypromine increases pressor amines and is contraindicated in patients with cardiovascular disease, hypertension, a history of severe or frequent headaches, or a confirmed or suspected cerebrovascular defect. Tranylcypromine is also contraindicated in patients with pheochromocytoma, since such tumors secrete pressor substances.

Tranylcypromine is contraindicated in combination with monoamine oxidase (MAO) inhibitors or with dibenzazepine-related entities. Tranylcypromine should not be administered together or in rapid succession with other MAO inhibitors or dibenzazepine-related entities (e.g., tricyclic antidepressants, cyclobenzaprine, carbamazepine) because coadministration may lead to hypertensive crises or severe convulsive seizures. At least 7 to 14 days should elapse between discontinuation of Tranylcypromine therapy and initiation of treatment with these drugs, and vice versa.

Coadministration of an MAO inhibitor and bupropion is contraindicated. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with bupropion.

Tranylcypromine is contraindicated in combination with selective serotonin reuptake inhibitors (SSRI) or selective norepinephrine reuptake inhibitors (SNRI). SSRIs and SNRIs should not be used within 14 days of discontinuing treatment with an MAO inhibitor. Patients previously treated with fluoxetine should discontinue the drug for a minimum of 5 weeks prior to initiating Tranylcypromine therapy. At least 2 weeks should be allowed after discontinuing sertraline or paroxetine before starting an MAO inhibitor. Patients discontinuing an SNRI should wait at least 1 week prior to initiating an MAO inhibitor.

Tranylcypromine is contraindicated in combination with buspirone. At least 10 days should elapse between discontinuation of Tranylcypromine therapy and initiation of buspirone.

Tranylcypromine is contraindicated in combination with sympathomimetics, including amphetamines which may be found in many herbal preparations as well as over-the-counter drugs such as cold, hay fever, or weight-reducing preparations that contain vasoconstrictors. Use of sympathomimetics and other drugs such as guanethidine, methyldopa, reserpine, dopamine, levodopa, and tryptophan with Tranylcypromine may precipitate hypertension, headache, and related symptoms. Cerebral hemorrhage may also occur. The combination of MAO inhibitors and tryptophan has been reported to cause behavioral and neurological syndromes.

Tranylcypromine is contraindicated in combination with meperidine. Meperidine should not be used concomitantly with MAO inhibitors or within 2 or 3 weeks following MAO inhibitor therapy. Serious reactions (including coma, severe hypertension or hypotension, severe respiratory depression, convulsions, malignant hyperpyrexia, excitation, peripheral vascular collapse, and death) have been reported with concomitant use.

Tranylcypromine is contraindicated in combination with dextromethorphan. Brief episodes of psychosis or bizarre behavior have been reported with the combination of MAO inhibitors and dextromethorphan.

Tranylcypromine is contraindicated in combination with cheese or other foods with a high tyramine content. A serious and sometimes fatal hypertensive reaction may occur when excessive amounts of tyramine are consumed in conjunction with Tranylcypromine, or within 2 weeks of stopping treatment. Foods with a high tyramine content and that may have been reported to induce a serious hypertensive reaction when consumed with Tranylcypromine include all matured or aged cheeses; all aged, cured, or fermented meat, fish, or poultry; all fermented soybean products; sauerkraut; fava or broad bean pods; banana peel (but not the pulp); concentrated yeast extracts; and all tap/draught beers (some bottled beers, including nonalcoholic beer, may also pose a risk). Patients should minimize or avoid all use of alcoholic beverages while taking Tranylcypromine. Patients should be instructed to buy and eat only fresh foods or those which have been properly frozen, should avoid eating foods if unsure of storage conditions or freshness, and should be cautious of foods of unknown age or composition even if refrigerated.

Hypertensive crisis (sometimes fatal) is the most important reaction associated with Tranylcypromine therapy and is characterized by some or all of the following symptoms: occipital headache that may radiate frontally, palpitation, neck stiffness or soreness, nausea or vomiting, sweating (sometimes with fever and sometimes with cold, clammy skin), pupil dilatation, photophobia, tachycardia or bradycardia, and constricting chest pain. Intracranial bleeding, which can be fatal, has been reported with the paradoxical increase in blood pressure. Hypertensive crises may be precipitated by concomitant administration of sympathomimetic drugs or related compounds, other MAO inhibitors, or dibenzazepine-related entities. Ingestion of foods with a high concentration of tyramine may also cause a hypertensive crisis. Blood pressure should be monitored closely in all patients to detect any pressor response. Patients should be observed frequently, as blood pressure readings should not be relied upon completely. Therapy should be discontinued immediately upon the occurrence of palpitation or frequent headaches, as these signs may be prodromal of a hypertensive crisis.

If a hypertensive crisis occurs, Tranylcypromine should be discontinued and therapy to lower blood pressure, usually intravenous phentolamine 5 mg, should be instituted immediately. Do not use parenteral reserpine. Fever should be managed by external cooling.

Tranylcypromine is contraindicated in patients undergoing elective surgery. Elective surgery requiring general anesthesia is not recommended during treatment with Tranylcypromine. Concomitant use of cocaine or local anesthesia containing sympathomimetic vasoconstrictors should also be avoided during treatment with Tranylcypromine. Additive hypotensive effects may occur when MAO inhibitor therapy is combined with spinal anesthesia. Tranylcypromine should be discontinued at least 10 days prior to any elective surgery.

Tranylcypromine should not be used in combination with some central nervous system depressants such as narcotics and alcohol, or with hypotensive agents. A marked potentiating effect on these classes of drugs has been reported.

Excessive use of caffeine in any form should be avoided in patients receiving Tranylcypromine.

Antiparkinsonism drugs should be used with caution in patients receiving Tranylcypromine because severe reactions have been reported.

Hypotension may occur during Tranylcypromine therapy. Symptoms of postural hypotension are most commonly but not exclusively observed in patients with preexistent hypertension. Blood pressure usually returns rapidly to pretreatment levels upon discontinuation of the drug. At dosages above 30 mg daily, postural hypotension is a major side effect and may result in syncope. Dosage increases should be more gradual for patients showing signs of hypotension at the beginning of therapy. Concomitant administration of Tranylcypromine with antihypertensive drugs (including thiazides and diuretics), phenothiazine derivatives, sedatives, or anesthetic drugs may result in additive hypotensive effects.

There have been reports of drug dependency in patients using significantly excessive doses of Tranylcypromine. In some cases, there was a history of previous substance abuse. Withdrawal symptoms have included restlessness, anxiety, depression, confusion, hallucination, headache, weakness, and diarrhea. Physicians should carefully evaluate patients for history of drug abuse and follow such patients closely.

Tranylcypromine should be used with caution in the elderly population. Older patients may suffer more morbidity than younger patients during and following an episode of hypertension or malignant hyperthermia, and they may have less compensatory reserve to cope with any serious adverse reaction.

Although excretion of Tranylcypromine is rapid, MAO inhibition may persist up to 10 days following discontinuation.

Tranylcypromine should be used with caution in hyperthyroid, diabetic, and epileptic patients. Drugs that lower the seizure threshold, including MAO inhibitors, should not be used with metrizamide. Tranylcypromine should be discontinued at least 48 hours before myelography and should not be resumed for at least 24 hours after the procedure.

Tranylcypromine is a potent agent which may produce serious side effects. It is not recommended in depressive reactions where other antidepressant agents may be effective. Tranylcypromine should be reserved for patients who can be closely monitored and who have not responded to other, more commonly used antidepressant agents.

Safety and efficacy have not been established in pediatric patients (less than 18 years of age). Tranylcypromine is not approved for use in pediatric patients.

Dialysis

Data not available

See also:
What is the most important information I should know about Tranylcypromine?

Tranylcypromine (Tranylcypromine) is contraindicated:

In patients with cerebrovascular defects or cardiovascular disorders

Tranylcypromine (Tranylcypromine) should not be administered to any patient with a confirmed or suspected cerebrovascular defect or to any patient with cardiovascular disease or hypertension.

In the presence of pheochromocytoma

Tranylcypromine (Tranylcypromine) should not be used in the presence of pheochromocytoma since such tumors secrete pressor substances.

In combination with MAO inhibitors or with dibenzazepine-related entities

Tranylcypromine (Tranylcypromine) should not be administered together or in rapid succession with other MAO inhibitors or with dibenzazepine-related entities. Hypertensive crises or severe convulsive seizures may occur in patients receiving such combinations.

In patients being transferred to Tranylcypromine (Tranylcypromine) from another MAO inhibitor or from a dibenzazepine-related entity, allow a medication-free interval of at least a week, then initiate Tranylcypromine (Tranylcypromine) using half the normal starting dosage for at least the first week of therapy. Similarly, at least a week should elapse between the discontinuance of Tranylcypromine (Tranylcypromine) and the administration of another MAO inhibitor or a dibenzazepine-related entity, or the readministration of Tranylcypromine (Tranylcypromine).

The following list includes some other MAO inhibitors, dibenzazepine-related entities and tricyclic antidepressants, and the companies which market them.

Other MAO Inhibitors

In combination with bupropion

The concurrent administration of an MAO inhibitor and bupropion hydrochloride (Wellbutrin®, Wellbutrin SR®, Wellbutrin XL®, Zyban®, GlaxoSmithKline) is contraindicated. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with bupropion hydrochloride.

In combination with selective serotonin reuptake inhibitors (SSRIs) or selective norepinephrine reuptake inhibitors (SNRIs)

As a general rule, Tranylcypromine (Tranylcypromine) should not be administered in combination with any SSRI or SNRI. There have been reports of serious, sometimes fatal, reactions (including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma) in patients receiving a SSRI (e.g., fluoxetine, Prozac®, Eli Lilly and Company) or a SNRI (e.g., venlafaxine, Effexor®, Effexor XR®, Wyeth) in combination with a monoamine oxidase inhibitor (MAOI), and in patients who have recently discontinued a SSRI or SNRI and are then started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. Therefore SSRIs and SNRIs should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI.

Since fluoxetine and its major metabolite have very long elimination half-lives, at least 5 weeks should be allowed after stopping fluoxetine before starting an MAOI.

At least 2 weeks should be allowed after stopping sertraline (Zoloft®, Pfizer) or paroxetine (Paxil®, Paxil CR®, GlaxoSmithKline) before starting an MAOI.

At least one week should be allowed after stopping a SNRI (e.g., venlafaxine) before starting a MAOI.

In combination with buspirone

Tranylcypromine (Tranylcypromine) should not be used in combination with buspirone HCl, since several cases of elevated blood pressure have been reported in patients taking MAO inhibitors who were then given buspirone HCl. At least 10 days should elapse between the discontinuation of Tranylcypromine (Tranylcypromine) and the institution of buspirone HCl.

In combination with sympathomimetics

Tranylcypromine (Tranylcypromine) should not be administered in combination with sympathomimetics, including amphetamines which may be found in many herbal preparations as well as over-the-counter drugs such as cold, hay fever or weight-reducing preparations that contain vasoconstrictors.

During therapy with Tranylcypromine (Tranylcypromine), it appears that certain patients are particularly vulnerable to the effects of sympathomimetics when the activity of certain enzymes is inhibited. Use of sympathomimetics and compounds such as guanethidine, methyldopa, reserpine, dopamine, levodopa, and tryptophan with Tranylcypromine (Tranylcypromine) may precipitate hypertension, headache, and related symptoms. Cerebral hemorrhage may also occur. The combination of MAOIs and tryptophan has been reported to cause behavioral and neurologic syndromes including disorientation, confusion, amnesia, delirium, agitation, hypomanic signs, ataxia, myoclonus, hyperreflexia, shivering, ocular oscillations, and Babinski's signs.

In combination with meperidine

Do not use meperidine concomitantly with MAO inhibitors or within 2 or 3 weeks following MAOI therapy. Serious reactions have been precipitated with concomitant use, including coma, severe hypertension or hypotension, severe respiratory depression, convulsions, malignant hyperpyrexia, excitation, peripheral vascular collapse, and death. It is thought that these reactions may be mediated by accumulation of 5-HT (serotonin) consequent to MAO inhibition.

In combination with dextromethorphan

The combination of MAO inhibitors and dextromethorphan has been reported to cause brief episodes of psychosis or bizarre behavior.

In combination with cheese or other foods with a high tyramine content

When excessive amounts of tyramine are consumed in conjunction with Tranylcypromine, or within 2 weeks of stopping treatment, a serious and sometimes fatal hypertensive reaction may occur.

Tyramine occurs naturally in some foods or may occur from the bacterial breakdown of protein in foods which are fermented, aged, or spoiled. Foods that have reliably been shown to contain a high tyramine content and may also have been reported to induce a serious hypertensive reaction when consumed with Tranylcypromine are:

• all matured or aged cheeses (note: all cheeses are considered matured or aged except fresh cottage cheese, cream cheese, ricotta, and processed cheese. All non-cheese dairy products can be consumed providing they are fresh)
• all aged, cured or fermented meat, fish, or poultry (note: meat, fish, or poultry that has not undergone aging, curing or fermenting and that is bought fresh, stored correctly and eaten fresh is not contraindicated)
• all fermented soybean products (e.g., soy sauce, miso, fermented tofu)
• sauerkraut
• fava or broad bean pods
• banana peel (but not the pulp)
• concentrated yeast extracts (e.g., Marmite or Vegemite spread)
• all tap/draught beers (note: some bottled beers, including non-alcoholic beer, may also pose a risk).

Patients should be advised to minimize or avoid use of all alcoholic beverages while taking Tranylcypromine (Tranylcypromine). Patients should be advised to adhere to the following dietary guidance about eating fresh foods:

Foods may be deliberately aged as part of their processing and these are contraindicated. Foods may also naturally age over time, even if they are refrigerated. It is therefore extremely important that patients are instructed to buy and eat only fresh foods or those which have been properly frozen. They should avoid eating foods if they are unsure of their storage conditions or freshness and they should be cautious of foods of unknown age or composition even if refrigerated.

The longer food is left to deteriorate and the larger the quantity of food eaten, the greater the potential quantity of tyramine ingested. Where there is any doubt, patients should be advised to either avoid the food or consume it in strict moderation if it is not otherwise contraindicated.

Patients should also be warned that tyramine levels may vary by brand or even batch and a person may absorb different amounts of tyramine from a particular food at different times. Therefore, if they have accidentally consumed a prohibited food on one occasion and not had a reaction, this does not mean that they will not have a serious hypertensive reaction if they consume the same food on a different occasion.

In patients undergoing elective surgery

Patients taking Tranylcypromine (Tranylcypromine) should not undergo elective surgery requiring general anesthesia. Also, they should not be given cocaine or local anesthesia containing sympathomimetic vasoconstrictors. The possible combined hypotensive effects of Tranylcypromine (Tranylcypromine) and spinal anesthesia should be kept in mind. Tranylcypromine (Tranylcypromine) should be discontinued at least 10 days prior to elective surgery.

Additional Contraindications

In general, the physician should bear in mind the possibility of a lowered margin of safety when Tranylcypromine (Tranylcypromine) is administered in combination with potent drugs.

1. Tranylcypromine (Tranylcypromine) should not be used in combination with some central nervous system depressants such as narcotics and alcohol, or with hypotensive agents. A marked potentiating effect on these classes of drugs has been reported.
2. Anti-parkinsonism drugs should be used with caution in patients receiving Tranylcypromine (Tranylcypromine) since severe reactions have been reported.
3. Tranylcypromine (Tranylcypromine) should not be used in patients with a history of liver disease or in those with abnormal liver function tests.
4. Excessive use of caffeine in any form should be avoided in patients receiving Tranylcypromine (Tranylcypromine).

Warnings to Physicians

Clinical Worsening and Suicide Risk: Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.

The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1,000 patients treated) are provided in Table 1.

Table 1

No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.

It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers.

Prescriptions for Tranylcypromine (Tranylcypromine) should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Screening Patients for Bipolar Disorder: A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that Tranylcypromine (Tranylcypromine) is not approved for use in treating bipolar depression.

Tranylcypromine (Tranylcypromine) is a potent agent with the capability of producing serious side effects.

Tranylcypromine (Tranylcypromine) is not recommended in those depressive reactions where other antidepressant drugs may be effective. It should be reserved for patients who can be closely supervised and who have not responded satisfactorily to the drugs more commonly administered for depression.

Before prescribing, the physician should be completely familiar with the full material on dosage, side effects, and contraindications on these pages, with the principles of MAO inhibitor therapy and the side effects of this class of drugs. Also, the physician should be familiar with the symptomatology of mental depressions and alternate methods of treatment to aid in the careful selection of patients for therapy with Tranylcypromine (Tranylcypromine).

Pregnancy Warning: Use of any drug in pregnancy, during lactation or in women of childbearing age requires that the potential benefits of the drug be weighed against its possible hazards to mother and child.

Animal reproductive studies show that Tranylcypromine (Tranylcypromine) passes through the placental barrier into the fetus of the rat, and into the milk of the lactating dog. The absence of a harmful action of Tranylcypromine (Tranylcypromine) on fertility or on postnatal development by either prenatal treatment or from the milk of treated animals has not been demonstrated. Tranylcypromine is excreted in human milk.

Warning to the Patient

Patients should be instructed to report promptly the occurrence of headache or other unusual symptoms, i.e., palpitation and/or tachycardia, a sense of constriction in the throat or chest, sweating, dizziness, neck stiffness, nausea, or vomiting.

Patients should be warned against eating the foods listed in Section 11 under Contraindications while on therapy with Tranylcypromine (Tranylcypromine). Also, they should be told not to drink alcoholic beverages. The patient should also be warned about the possibility of hypotension and faintness, as well as drowsiness sufficient to impair performance of potentially hazardous tasks such as driving a car or operating machinery.

Patients should also be cautioned not to take concomitant medications, whether prescription or over-the-counter drugs such as cold, hay fever, or weight-reducing preparations, without the advice of a physician. They should be advised not to consume excessive amounts of caffeine in

any form. Likewise, they should inform other physicians, and their dentist, about their use of Tranylcypromine.

Use Tranylcypromine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Tranylcypromine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Tranylcypromine refilled.
• Take Tranylcypromine by mouth with or without food.
• Continue to take Tranylcypromine even if you feel well. Do not miss any doses.
• If you miss a dose of Tranylcypromine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tranylcypromine.

Tranylcypromine is an antidepressant (monoamine oxidase inhibitor). This medication treats depression by restoring the balance of certain natural substances (neurotransmitters) in the brain. Tranylcypromine can improve your mood and feelings of well-being. Usually, this medication is used in persons who have not responded to treatment with other drugs.

How to use Tranylcypromine

Read the Medication Guide available from your pharmacist before you start using Tranylcypromine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth, usually in divided doses or as directed by your doctor. This medication may be taken with or without food. Dosage is based on your medical condition and response to therapy and usually will not be more than 60 milligrams per day.

To reduce your risk of side effects, your doctor may start you at a low dose and gradually increase your dose. Once your condition improves and you are better for a while, your doctor may work with you to reduce your regular dose. Follow your doctor's instructions carefully. Do not take more or less medication or take it more frequently than prescribed. Your condition will not improve any faster and your risk of side effects will increase.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. It may take several weeks for the full benefits of this medication to be noticed. Do not stop taking this medication without consulting your doctor.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, confusion, hallucinations, headache, weakness, and diarrhea) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

Inform your doctor if your condition persists or worsens.

See also:
What other drugs will affect Tranylcypromine?

Never take Tranylcypromine with the following drugs; the combination can trigger seizures or a dangerous spike in blood pressure: dibenzapine-related and other drugs classified as tricyclic antidepressants, such as amitriptyline, amoxapine, carbamazepine, clomipramine, cyclobenzaprine, desipramine, doxepin, imipramine, maprotiline, nortriptyline, perphenazine and amitriptyline, protriptyline, trimipramine maleate; other MAOIs such as furazolidone, isocarboxazid, pargyline, procarbazine, and phenelzine.

When switching from one of these drugs to Tranylcypromine, or vice versa, allow an interval of at least 1 week between medications.

If Tranylcypromine is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Tranylcypromine with the following: alcohol, amphetamines, anesthetics, antidepressants classified as SSRIs, antihistamines, blood pressure medication, blood-vessel constricting medicines for colds, hay fever and weight loss, bupropion, buspirone, cocaine, cough remedies containing dextromethorphan, dexfenfluramine, disulfiram, diuretics (water pills), dopamine, guanethidine, meperidine and other narcotic painkillers, methyldopa, Parkinson’s disease medications, reserpine, sedatives (such as triazolam, pentobarbital, and secobarbital), and tryptophan

See also:
What are the possible side effects of Tranylcypromine?

Applies to Tranylcypromine: oral tablet

As well as its needed effects, Tranylcypromine (the active ingredient contained in Tranylcypromine) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Tranylcypromine, check with your doctor immediately:

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
• coma
• confusion
• confusion about identity, place, and time
• cough or hoarseness
• dark urine
• decrease in frequency of urination
• decrease in urine volume
• depression
• difficulty in passing urine (dribbling)
• dizziness
• dry mouth
• fast, irregular, pounding, or racing heartbeat or pulse
• fever
• fever with or without chills
• general feeling of tiredness or weakness
• headache
• hostility
• hyperventilation
• increased need to urinate
• irregular heartbeats
• irritability
• lethargy
• light-colored stools
• longer than usual time to ejaculation of semen
• loss of bladder control
• lower back or side pain
• muscle twitching
• nausea and vomiting
• nervousness
• painful or difficult urination
• pale skin
• passing urine more often
• pinpoint red spots on the skin
• rapid weight gain
• restlessness
• seizures
• shakiness and unsteady walk
• shortness of breath
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stupor
• sudden jerky movements of the body
• swelling
• 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 tiredness or weakness
• upper right abdominal pain
• yellow eyes and skin

Minor Side Effects

Some Tranylcypromine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Incidence not known:

• Abdominal or stomach pain
• 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
• inability to have or keep an erection
• itching
• loss in sexual ability, desire, drive, or performance
• loss of appetite
• memory loss
• muscle spasm
• redness of the skin
• skin rash
• sleeplessness
• unable to sleep
• weakness
• weight loss

A propylamine formed from the cyclization of the side chain of amphetamine. This monoamine oxidase inhibitor is effective in the treatment of major depression, dysthymic disorder, and atypical depression. It also is useful in panic and phobic disorders. (From AMA Drug Evaluations Annual, 1994, p311)