Drugs Details

Drugs Info of Nardil
Drugs Details
  • Drugs Type  : FDA
  • Date : 21st Feb 2015 08:07 am
  • Brand Name : Nardil
  • Generic Name : phenelzine (Pronunciation: FEN el zeen)
Descriptions

NARDIL® (phenelzine sulfate) is a potent inhibitor of monoamine oxidase (MAO). Phenelzine sulfate is a hydrazine derivative. It has a molecular weight of 234.27 and is chemically described as C8 H12 N2 • H2SO4. Its chemical structure is shown below:

Nardil (phenelzine sulfate)  structural formula illustration

Molecular weight: 234.27

Each NARDIL (phenelzine) film-coated tablet for oral administration contains phenelzine sulfate equivalent to 15 mg of phenelzine base and the following inactive ingredients: mannitol, USP; croscarmellose sodium, NF; povidone, USP; edetate disodium, USP; magnesium stearate, NF; isopropyl alcohol, USP; purified water, USP; opadry orange Y30-13242A; simethicone emulsion, USP.

What are the possible side effects of phenelzine (Nardil)?

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.

Call your doctor at once if you have any new or worsening symptoms 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 phenelzine and call your doctor at once if you have any of these serious side...

Read All Potential Side Effects and See Pictures of Nardil »

What are the precautions when taking phenelzine (Nardil)?

Before taking phenelzine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain kind of adrenal gland tumor (pheochromocytoma), cerebrovascular disease (e.g., stroke), heart problems (e.g., congestive heart failure, heart attack), high blood pressure, history of severe/frequent headaches, liver problems, severe kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:...

Read All Potential Precautions of Nardil »

This monograph has been modified to include the generic and brand name in many instances.

Indications

NARDIL (phenelzine) has been found to be effective in depressed patients clinically characterized as “atypical,” “nonendogenous,” or “neurotic.” These patients often have mixed anxiety and depression and phobic or hypochondriacal features. There is less conclusive evidence of its usefulness with severely depressed patients with endogenous features.

NARDIL (phenelzine) should rarely be the first antidepressant drug used. Rather, it is more suitable for use with patients who have failed to respond to the drugs more commonly used for these conditions.

Dosage Administration

Initial dose: The usual starting dose of NARDIL (phenelzine) is one tablet (15 mg) three times a day.

Early phase treatment: Dosage should be increased to at least 60 mg per day at a fairly rapid pace consistent with patient tolerance. It may be necessary to increase dosage up to 90 mg per day to obtain sufficient MAO inhibition. Many patients do not show a clinical response until treatment at 60 mg has been continued for at least 4 weeks.

Maintenance dose: After maximum benefit from NARDIL (phenelzine) is achieved, dosage should be reduced slowly over several weeks. Maintenance dose may be as low as one tablet, 15 mg, a day or every other day, and should be continued for as long as is required.

How Supplied

Each NARDIL (phenelzine) tablet is orange, biconvex, film-coated, and engraved with “P-D 270” and contains phenelzine sulfate equivalent to 15 mg of phenelzine base.

NDC 0071-0350-60. Bottle of 60

Storage:

Store between 15° - 30°C (59° - 86°F).

Distributed by Parke-Davis., Division of Pfizer Inc, NY, NY 10017 Revised May 2007. FDA Rev date: 8/2/2007

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

NARDIL (phenelzine) is a potent inhibitor of monoamine oxidase. Because this enzyme is widely distributed throughout the body, diverse pharmacologic effects can be expected to occur. When they occur, such effects tend to be mild or moderate in severity (see below), often subside as treatment continues, and can be minimized by adjusting dosage; rarely is it necessary to institute counteracting measures or to discontinue NARDIL (phenelzine) .

Common side effects include:

Nervous System — Dizziness, headache, drowsiness, sleep disturbances (including insomnia and hypersomnia), fatigue, weakness, tremors, twitching, myoclonic movements, hyperreflexia.

Gastrointestinal — Constipation, dry mouth, gastrointestinal disturbances, elevated serum transaminases (without accompanying signs and symptoms).

Metabolic — Weight gain.

Cardiovascular — Postural hypotension, edema.

Genitourinary — Sexual disturbances, eg, anorgasmia and ejaculatory disturbances and impotence.

Less common mild to moderate side effects (some of which have been reported in a single patient or by a single physician) include:

Nervous System —Jitteriness, palilalia, euphoria, nystagmus, paresthesias.

Genitourinary — Urinary retention.

Metabolic — Hypernatremia.

Dermatologic — Pruritus, skin rash, sweating.

Special Senses — Blurred vision, glaucoma.

Although reported less frequently, and sometimes only once, additional severe side effects include:

Nervous System — Ataxia, shock-like coma, toxic delirium, manic reaction, convulsions, acute anxiety reaction, precipitation of schizophrenia, transient respiratory and cardiovascular depression following ECT.

Gastrointestinal —To date, fatal progressive necrotizing hepatocellular damage has been reported in very few patients. Reversible jaundice.

Hematologic — Leukopenia.

Immunologic — Lupus-like syndrome

Metabolic — Hypermetabolic syndrome (which may include, but is not limited to, hyperpyrexia, tachycardia, tachypnea, muscular rigidity, elevated CK levels, metabolic acidosis, hypoxia, coma and may resemble an overdose).

Respiratory — Edema of the glottis.

General — Fever associated with increased muscle tone.

Withdrawal may be associated with nausea, vomiting, and malaise.

An uncommon withdrawal syndrome following abrupt withdrawal of NARDIL (phenelzine) has been infrequently reported. Signs and symptoms of this syndrome generally commence 24 to 72 hours after drug discontinuation and may range from vivid nightmares with agitation to frank psychosis and convulsions. This syndrome generally responds to reinstitution of low-dose NARDIL (phenelzine) therapy followed by cautious downward titration and discontinuation.

Read the Nardil (phenelzine) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

In patients receiving nonselective monoamine oxidase (MAO) inhibitors in combination with serotoninergic agents (e.g., dexfenfluramine, fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, venlafaxine) there have been reports of serious, sometimes fatal, reactions. Because NARDIL (phenelzine) is a monoamine oxidase (MAO) inhibitor, NARDIL (phenelzine) should not be used concomitantly with a serotoninergic agent (See CONTRAINDICATIONS).

Administration of guanethidine to patients receiving an MAO inhibitor can produce moderate to severe hypertension due to release of catecholamines. At least two weeks should elapse between withdrawal of the MAO inhibitor and the initiation of guanethidine. (see CONTRAINDICATIONS)

Read the Nardil Drug Interactions Center for a complete guide to possible interactions

Learn More »

This monograph has been modified to include the generic and brand name in many instances.

Warnings

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 4400 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 1000 patients treated) are provided in Table 1.

Table 1

Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated
  Increases Compared to Placebo
<18 14 additional cases
18-24 5 additional cases
  Decreases Compared to Placebo
25-64 1 fewer case
≥65 6 fewer cases

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 health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for Nardil (phenelzine) 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 Nardil (phenelzine) is not approved for use in treating bipolar depression.

It should be noted that NARDIL (phenelzine) is not approved for use in treating any indications in the pediatric population.

The most serious reactions to NARDIL (phenelzine) involve changes in blood pressure.

Hypertensive Crises: The most important reaction associated with NARDIL (phenelzine) administration is the occurrence of hypertensive crises, which have sometimes been fatal.

These crises are characterized by some or all of the following symptoms: occipital headache which may radiate frontally, palpitation, neck stiffness or soreness, nausea, vomiting, sweating (sometimes with fever and sometimes with cold, clammy skin), dilated pupils, and photophobia. Either tachycardia or bradycardia may be present and can be associated with constricting chest pain.

NOTE: Intracranial bleeding has been reported in association with the increase in blood pressure.

Blood pressure should be observed frequently to detect evidence of any pressor response in all patients receiving NARDIL (phenelzine) . Therapy should be discontinued immediately upon the occurrence of palpitation or frequent headaches during therapy.

Recommended treatment in hypertensive crisis: If a hypertensive crisis occurs, NARDIL (phenelzine) should be discontinued immediately and therapy to lower blood pressure should be instituted immediately. On the basis of present evidence, phentolamine is recommended. (The dosage reported for phentolamine is 5 mg intravenously.) Care should be taken to administer this drug slowly in order to avoid producing an excessive hypotensive effect. Fever should be managed by means of external cooling.

Warning to the Patient: All patients should be warned that the following foods, beverages, and medications must be avoided while taking NARDIL (phenelzine) , and for two weeks after discontinuing use.

Foods and Beverages To Avoid

Meat and Fish
  Pickled herring
  Liver
  Dry sausage (including Genoa salami, hard salami, pepperoni, and Lebanon bologna)

Vegetables
  Broad bean pods (fava bean pods)
  Sauerkraut

Dairy Products
  Cheese (cottage cheese and cream cheese are allowed)
  Yogurt

Beverages
  Beer and wine
  Alcohol-free and reduced-alcohol beer and wine products

Miscellaneous
  Yeast extract (including brewer's yeast in large quantities)
  Meat extract
  Excessive amounts of chocolate and caffeine

Also, any spoiled or improperly refrigerated, handled, or stored protein-rich foods such as meats, fish, and dairy products, including foods that may have undergone protein changes by aging, pickling, fermentation, or smoking to improve flavor should be avoided.

OTC Medications To Avoid

Cold and cough preparations (including those containing dextromethorphan)

Nasal decongestants (tablets, drops, or spray)

Hay-fever medications

Sinus medications

Asthma inhalant medications

Antiappetite medicines

Weight-reducing preparations

“Pep” pills

L-tryptophan containing preparations

Also, certain prescription drugs should be avoided. Therefore, patients under the care of another physician or dentist should inform him/her that they are taking NARDIL (phenelzine) .

Patients should be warned that the use of the above foods, beverages, or medications may cause a reaction characterized by headache and other serious symptoms due to a rise in blood pressure, with the exception of dextromethorphan which may cause reactions similar to those seen with meperidine. Also, there has been a report of an interaction between NARDIL (phenelzine) and dextromethorphan (ingested as a lozenge) causing drowsiness and bizarre behavior.

Patients should be instructed to report promptly the occurrence of headache or other unusual symptoms.

Concomitant Use with Dibenzazepine Derivative Drugs

If the decision is made to administer NARDIL (phenelzine) concurrently with other antidepressant drugs, or within less than 10 days after discontinuation of antidepressant therapy, the patient should be cautioned by the physician regarding the possibility of adverse drug interaction.

A List of Dibenzazepine Derivative Drugs by Generic Name Follows:

nortriptyline hydrochloride

amitriptyline hydrochloride

perphenazine and amitriptyline hydrochloride

clomipramine hydrochloride

desipramine hydrochloride

imipramine hydrochloride

doxepin

carbamazepine

cyclobenzaprine HCl

amoxapine

maprotiline HCl

trimipramine maleate

protriptyline HCl

mirtazapine

NARDIL (phenelzine) should be used with caution in combination with antihypertensive drugs, including thiazide diuretics and β-blockers, since exaggerated hypotensive effects may result.

Use in Pregnancy: The safe use of NARDIL (phenelzine) during pregnancy or lactation has not been established. The potential benefit of this drug, if used during pregnancy, lactation, or in women of childbearing age, should be weighed against the possible hazard to the mother or fetus.

Doses of NARDIL (phenelzine) in pregnant mice well exceeding the maximum recommended human dose have caused a significant decrease in the number of viable offspring per mouse. In addition, the growth of young dogs and rats has been retarded by doses exceeding the maximum human dose.

Precautions

Information for Patients

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Nardil (phenelzine) and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for Nardil (phenelzine) . The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Nardil (phenelzine) .

Clinical Worsening and Suicide Risk: Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

Pediatric Use - Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS — Clinical Worsening and Suicide Risk).

Anyone considering the use of NARDIL (phenelzine) in a child or adolescent must balance the potential risks with the clinical need.

Nardil (phenelzine) , as with other hydrazine derivatives, has been reported to induce pulmonary and vascular tumors in an uncontrolled lifetime study in mice.

In depressed patients, the possibility of suicide should always be considered and adequate precautions taken. It is recommended that careful observations of patients undergoing NARDIL (phenelzine) treatment be maintained until control of depression is achieved. If necessary, additional measures (ECT, hospitalization, etc) should be instituted.

All patients undergoing treatment with NARDIL (phenelzine) should be closely followed for symptoms of postural hypotension. Hypotensive side effects have occurred in hypertensive as well as normotensive and hypotensive patients. Blood pressure usually returns to pretreatment levels rapidly when the drug is discontinued or the dosage is reduced.

Because the effect of NARDIL (phenelzine) on the convulsive threshold may be variable, adequate precautions should be taken when treating epileptic patients.

Of the more severe side effects that have been reported with any consistency, hypomania has been the most common. This reaction has been largely limited to patients in whom disorders characterized by hyperkinetic symptoms coexist with, but are obscured by, depressive affect; hypomania usually appeared as depression improved. If agitation is present, it may be increased with NARDIL (phenelzine) . Hypomania and agitation have also been reported at higher than recommended doses or following long-term therapy.

NARDIL (phenelzine) may cause excessive stimulation in schizophrenic patients; in manic-depressive states it may result in a swing from a depressive to a manic phase.

NARDIL (phenelzine) should be used with caution in diabetes mellitus; increased insulin sensitivity may occur. Requirements for insulin or oral hypoglycemics may be decreased.

MAO inhibitors, including NARDIL (phenelzine) , potentiate hexobarbital hypnosis in animals. Therefore, barbiturates should be given at a reduced dose with NARDIL (phenelzine) .

MAO inhibitors inhibit the destruction of serotonin and norepinephrine, which are believed to be released from tissue stores by rauwolfia alkaloids. Accordingly, caution should be exercised when rauwolfia is used concomitantly with an MAO inhibitor, including NARDIL (phenelzine) .

There is conflicting evidence as to whether or not MAO inhibitors affect glucose metabolism or potentiate hypoglycemic agents. This should be kept in mind if NARDIL (phenelzine) is administered to diabetics.

Geriatric Use

Clinical studies of NARDIL (phenelzine) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

Note — For management of hypertensive crises see WARNINGS section.

Accidental or intentional overdosage may be more common in patients who are depressed. It should be remembered that multiple drugs and/or alcohol may have been ingested.

Depending on the amount of overdosage with NARDIL (phenelzine) , a varying and mixed clinical picture may develop, including signs and symptoms of central nervous system and cardiovascular stimulation and/or depression. Signs and symptoms may be absent or minimal during the initial 12-hour period following ingestion and may develop slowly thereafter, reaching a maximum in 24-48 hours. Death has been reported following overdosage. Therefore, immediate hospitalization, with continuous patient observation and monitoring throughout this period, is essential.

Signs and symptoms of overdosage may include, alone or in combination, any of the following: drowsiness, dizziness, faintness, irritability, hyperactivity, agitation, severe headache, hallucinations, trismus, opisthotonus, rigidity, convulsions, and coma; rapid and irregular pulse, hypertension, hypotension, and vascular collapse; precordial pain, respiratory depression and failure, hyperpyrexia, diaphoresis, and cool, clammy skin.

Treatment

Intensive symptomatic and supportive treatment may be required. Induction of emesis or gastric lavage with instillation of charcoal slurry may be helpful in early poisoning, provided the airway has been protected against aspiration. Signs and symptoms of central nervous system stimulation, including convulsions, should be treated with diazepam, given slowly intravenously. Phenothiazine derivatives and central nervous system stimulants should be avoided. Hypotension and vascular collapse should be treated with intravenous fluids and, if necessary, blood pressure titration with an intravenous infusion of dilute pressor agent. It should be noted that adrenergic agents may produce a markedly increased pressor response.

Respiration should be supported by appropriate measures, including management of the airway, use of supplemental oxygen, and mechanical ventilatory assistance, as required.

Body temperature should be monitored closely. Intensive management of hyperpyrexia may be required. Maintenance of fluid and electrolyte balance is essential.

There are no data on the lethal dose in man. The pathophysiologic effects of massive overdosage may persist for several days, since the drug acts by inhibiting physiologic enzyme systems. With symptomatic and supportive measures, recovery from mild overdosage may be expected within 3 to 4 days.

Hemodialysis, peritoneal dialysis, and charcoal hemoperfusion may be of value in massive overdosage, but sufficient data are not available to recommend their routine use in these cases.

Toxic blood levels of phenelzine have not been established, and assay methods are not practical for clinical or toxicological use.

ContrainDications

NARDIL (phenelzine) should not be used in patients who are hypersensitive to the drug or its ingredients, with pheochromocytoma, congestive heart failure, severe renal impairment or renal disease, a history of liver disease, or abnormal liver function tests.

The potentiation of sympathomimetic substances and related compounds by MAO inhibitors may result in hypertensive crises (see WARNINGS). Therefore, patients being treated with NARDIL (phenelzine) should not take sympathomimetic drugs (including amphetamines, cocaine, methylphenidate, dopamine, epinephrine, and norepinephrine) or related compounds (including methyldopa, L-dopa, L-tryptophan, L-tyrosine, and phenylalanine). Hypertensive crises during NARDIL (phenelzine) therapy may also be caused by the ingestion of foods with a high concentration of tyramine or dopamine. Therefore, patients being treated with NARDIL (phenelzine) should avoid high protein food that has undergone protein breakdown by aging, fermentation, pickling, smoking, or bacterial contamination. Patients should also avoid cheeses (especially aged varieties), pickled herring, beer, wine, liver, yeast extract (including brewer's yeast in large quantities), dry sausage (including Genoa salami, hard salami, pepperoni, and Lebanon bologna), pods of broad beans (fava beans), and yogurt. Excessive amounts of caffeine and chocolate may also cause hypertensive reactions.

NARDIL (phenelzine) should not be used in combination with dextromethorphan or with CNS depressants such as alcohol and certain narcotics. Excitation, seizures, delirium, hyperpyrexia, circulatory collapse, coma, and death have been reported in patients receiving MAOI therapy who have been given a single dose of meperidine. NARDIL (phenelzine) should not be administered together with or in rapid succession to other MAO inhibitors because HYPERTENSIVE CRISES and convulsive seizures, fever, marked sweating, excitation, delirium, tremor, coma, and circulatory collapse may occur.

Concomitant use with meperidine is contraindicated (see WARNINGS).

A List of MAO Inhibitors by Generic Name Follows:

pargyline hydrochloride

pargyline hydrochloride and methylclothiazide

furazolidone

isocarboxazid

procarbazine

tranylcypromine

NARDIL (phenelzine) should also 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 14 days should elapse between the discontinuation of NARDIL (phenelzine) and the institution of another antidepressant or buspirone HCl, or the discontinuation of another MAO inhibitor and the institution of NARDIL (phenelzine) .

There have been reports of serious reactions (including hyperthermia, rigidity, myoclonic movements and death) when serotoninergic drugs (e.g., dexfenfluramine, fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, venlafaxine) have been combined with an MAO inhibitor. Therefore, the concomitant use of NARDIL (phenelzine) with serotoninergic agents is contraindicated (see PRECAUTIONS-DRUG INTERACTIONS). At least 14 days should elapse between the discontinuation of an MAO inhibitor and the start of a serotonin re-uptake inhibitor or vice-versa, with the exception of fluoxetine. Allow at least five weeks between discontinuation of fluoxetine and initiation of NARDIL (phenelzine) and at least 14 days between discontinuation of NARDIL (phenelzine) and initiation of fluoxetine, or other serotoninergic agents. Before initiating NARDIL (phenelzine) after using other serotoninergic agents, a sufficient amount of time must be allowed for clearance of the serotoninergic agent and its active metabolites.

The combination of MAO inhibitors 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 signs.

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

Patients taking NARDIL (phenelzine) 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 NARDIL (phenelzine) and spinal anesthesia should be kept in mind. NARDIL (phenelzine) should be discontinued at least 10 days prior to elective surgery.

MAO inhibitors, including NARDIL (phenelzine) , are contraindicated in patients receiving guanethidine.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Monoamine oxidase is a complex enzyme system, widely distributed throughout the body. Drugs that inhibit monoamine oxidase in the laboratory are associated with a number of clinical effects. Thus, it is unknown whether MAO inhibition per se, other pharmacologic actions, or an interaction of both is responsible for the clinical effects observed. Therefore, the physician should become familiar with all the effects produced by drugs of this class.

Pharmacokinetics

Absorption — Following a single 30 mg dose of NARDIL® (phenelzine) (2 X 15 mg tablets), a mean peak plasma concentration (Cmax) of 19.8 ng/mL occurred at a time (Tmax) of 43 minutes postdose.

Metabolism — NARDIL® (phenelzine) is extensively metabolized, primarily by oxidation via monoamine oxidase. After oral administration of 13C6-phenelzine, 73% of the administered dose was recovered in urine as phenylacetic acid and parahydroxyphenylacetic acid within 96 hours. Acetylation to N2-acetylphenelzine is a minor pathway.

Elimination — The mean elimination half-life after a single 30 mg dose is 11.6 hours. Multiple dose pharmacokinetics have not been studied in man.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Medication Guide

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about:

  • all risks and benefits of treatment with antidepressant medicines
  • all treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

  1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  2. 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.
  3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
  • 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 the 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 or your family member has 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 very agitated or restless
  • panic attacks
  • an extreme increase in activity and talking (mania)
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

  • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.

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

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

PHENELZINE - ORAL

 

(FEN-el-zeen)

 

COMMON BRAND NAME(S): Nardil

 

WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor immediately if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

 

USES: Phenelzine is an antidepressant (monoamine oxidase inhibitor). This medication treats depression by restoring the balance of certain natural substances (neurotransmitters) in the brain. Phenelzine 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: Read the Medication Guide available from your pharmacist before you start using phenelzine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth, usually 1 to 3 times a day 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.

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 immediately.

Inform your doctor if your condition persists or worsens.

Consumer Overview Side Effect

SIDE EFFECTS: See also Warning section.

Dizziness, drowsiness, tiredness, weakness, problems sleeping, constipation, and dry mouth may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, mental/mood changes (e.g., agitation, confusion), muscle stiffness/twitching, changes in sexual ability/interest, shaking (tremor), shivering, swollen ankles/legs, unusual weight gain, vision changes (e.g., double/blurred vision).

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: severe stomach/abdominal pain, persistent nausea/vomiting, seizures, dark urine, yellowing eyes/skin.

This drug may rarely cause an attack of extremely high blood pressure (hypertensive crisis), which may be fatal. Many drug and food interactions can increase this risk (See also Drug Interaction section.) Stop taking phenelzine and seek immediate medical attention if any of these serious side effects occur: frequent/severe headache, fast/slow/irregular/pounding heartbeat, chest pain, neck stiffness/soreness, severe nausea/vomiting, sweating/clammy skin (sometimes with fever), widened pupils, sudden sensitivity to light (photophobia).

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Nardil (phenelzine) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking phenelzine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain kind of adrenal gland tumor (pheochromocytoma), cerebrovascular disease (e.g., stroke), heart problems (e.g., congestive heart failure, heart attack), high blood pressure, history of severe/frequent headaches, liver problems, severe kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal/family history of mental/mood disorders (e.g., schizophrenia, bipolar disorder), family history of high blood pressure, heart disease (e.g., coronary artery disease, history of chest pain), mild/moderate kidney disease, diabetes, certain nervous system diseases (Parkinson's syndrome, seizures), overactive thyroid (hyperthyroidism).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To minimize dizziness and the risk of fainting, get up slowly when rising from a sitting or lying position.

Before having surgery or any procedures requiring use of contrast dye (e.g., myelography), tell your doctor or dentist you are on this medication. You may need to stop taking this drug beforehand. Follow your doctor's instructions carefully.

If you have heart disease, this medication may mask chest pain. Avoid strenuous exercise while taking this medication.

If you have diabetes, phenelzine may lower your blood sugar levels. Check your blood sugar regularly, and share the results with your doctor. Tell your doctor immediately if you have symptoms of low blood sugar such as cold sweat, shaking, rapid heart rate, fainting, and hunger. Your anti-diabetic medication or diet may need to be adjusted.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the effects on blood pressure.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious (possibly fatal) interactions may occur: other antidepressants (including maprotiline, mirtazapine, nefazodone, SNRIs such as duloxetine/venlafaxine, SSRIs such as citalopram/fluoxetine/paroxetine, TCAs such as amitriptyline/nortriptyline), appetite suppressants (e.g., diethylpropion), drugs for attention deficit disorder (e.g., atomoxetine, methylphenidate), certain antihistamines (azatadine, carbetapentane, chlorpheniramine), apraclonidine, bupropion, buspirone, carbamazepine, cyclobenzaprine, dextromethorphan, certain drugs for high blood pressure (e.g., guanethidine, methyldopa), other MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, procarbazine, rasagiline, selegiline, tranylcypromine), certain narcotic medications (such as fentanyl, meperidine, methadone, tapentadol), certain drugs for Parkinson's (e.g., entacapone, levodopa, tolcapone), street drugs (e.g., MDMA/"ecstasy", LSD, mescaline), stimulants (e.g., amphetamines, cocaine, dopamine, epinephrine, phenylalanine), tetrabenazine, "triptan" migraine drugs (e.g., sumatriptan, rizatriptan), tramadol, tyrosine, tryptophan.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting phenelzine. Do not take these medications within the 2 weeks before, during or after treatment with phenelzine. If you have been taking fluoxetine, wait at least 5 weeks after stopping fluoxetine before starting phenelzine. Discuss with your doctor how much time to wait between starting or stopping any of these drugs and taking phenelzine.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs for high blood pressure (e.g., beta blockers such as atenolol, clonidine, rauwolfia alkaloids such as reserpine, "water pills"/diuretics such as hydrochlorothiazide).

Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with phenelzine such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., imipramine) among others. Consult your doctor or pharmacist for details.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., phenytoin), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, lithium, risperidone, trazodone).

Check the labels on all your medicines (e.g., allergy, cough-and-cold products, decongestants, diet pills) because they may contain dextromethorphan, decongestants, stimulants, or drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

It is very important that you follow special dietary restrictions in order to limit the amount of tyramine in your diet. Avoid drinking large amounts of beverages containing caffeine (coffee, tea, colas) or eating large amounts of chocolate. Caffeine can increase the side effects of this medication. Foods and beverages high in tyramine should be avoided while you are taking this medication and for at least 2 weeks after you stop using this medication.

Foods high in tyramine include: aged cheeses (cheddar, camembert, emmenthaler, brie, stilton blue, gruyere, gouda, brick, bleu, roquefort, boursault, parmesan, romano, provolone, liederdranz, colby, edam), aged/dried/fermented/salted/smoked/pickled/processed meats and fish (includes bacon, summer sausage, liverwurst, hot dogs, corned beef, pepperoni, salami, bologna, ham, mortadella, pickled or dried herring), banana peel, beef/chicken liver (stored, not fresh), bouillon cubes, commercial gravies, concentrated yeast extracts, fava beans, Italian green beans, broad beans, fermented bean curd, homemade yeast-leavened bread, kim chee (Korean fermented cabbage), orange pulp, overripe or spoiled fruits, packaged soups, red wine, sauerkraut, sherry, snow pea pods, sourdough bread, soy sauce, soybeans, soybean paste/miso, tofu, tap beer and ale, vermouth.

Moderate-to-low tyramine content foods include: alcohol-free beer, avocados, bananas, bottled beer and ale, chocolate and products made with chocolate, coffee, cola, cultured dairy products (e.g. buttermilk, yogurt, sour cream), distilled spirits, eggplant, canned figs, fish roe (caviar), green bean pods, pate, peanuts, port wine, raisins, raspberries, red plums, spinach, tomatoes, white wine.

Tell your doctor or pharmacist immediately if you notice symptoms of high blood pressure such as fast/slow heartbeat, vomiting, sweating, headache, chest pain, sudden vision changes, weakness on one side of the body, or slurred speech.

Contact your healthcare professionals (e.g., doctor, pharmacist, dietician) for more information, including recommendations for your diet.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood pressure, liver function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, take as soon as you remember unless the next scheduled dose is within 2 hours. In that case, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

 

Information last revised September 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Nardil

Generic Name: phenelzine (Pronunciation: FEN el zeen)

  • What is phenelzine (Nardil)?
  • What are the possible side effects of phenelzine (Nardil)?
  • What is the most important information I should know about phenelzine (Nardil)?
  • What should I discuss with my doctor before taking phenelzine (Nardil)?
  • How should I take phenelzine (Nardil)?
  • What happens if I miss a dose (Nardil)?
  • What happens if I overdose (Nardil)?
  • What should I avoid while taking phenelzine (Nardil)?
  • What other drugs will affect phenelzine (Nardil)?
  • Where can I get more information?

What is phenelzine (Nardil)?

Phenelzine is a monoamine oxidase inhibitor (MAOI) that works by increasing the levels of certain chemicals in the brain.

Phenelzine is used to treat symptoms of depression that may include feelings of sadness, fear, anxiety, or worry about physical health (hypochondria). This medication is usually given after other anti-depressants have been tried without successful treatment of symptoms. Phenelzine is not for treating severe depression or bipolar disorder (manic depression).

Phenelzine may also be used for other purposes not listed in this medication guide.

Nardil 15 mg

round, orange, imprinted with PD 270

What are the possible side effects of phenelzine (Nardil)?

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.

Call your doctor at once if you have any new or worsening symptoms 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 phenelzine and call your doctor at once if you have any of these serious side effects:

  • sudden and severe headache, rapid heartbeat, stiffness in your neck, nausea, vomiting, cold sweat, sweating, vision problems, sensitivity to light;
  • chest pain, fast or slow heart rate;
  • swelling, rapid weight gain;
  • agitation, unusual thoughts or behavior; or
  • feeling light-headed, fainting.

Less serious side effects may include:

  • dizziness;
  • feeling weak or drowsy;
  • sleep problems (insomnia);
  • constipation, upset stomach;
  • dry mouth, decreased urination; or
  • impotence, difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Nardil (phenelzine) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about phenelzine (Nardil)?

There are many other medicines that can cause serious or life-threatening medical problems if you take them together with phenelzine. Do not take phenelzine before telling your doctor about all other prescription and over-the-counter medications you use, including vitamins, minerals, and herbal products. Keep a list with you of all the medicines you use and show this list to any doctor, dentist, or other healthcare provider who treats you.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms 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.

While you are taking phenelzine, you must not drink alcohol or eat foods that are high in tyramine, listed in the "What should I avoid while taking phenelzine?" section of this leaflet. Eating tyramine while you are taking phenelzine can raise your blood pressure to dangerous levels, causing symptoms that include sudden and severe headache, rapid heartbeat, stiffness in your neck, nausea, vomiting, cold sweat, vision problems, and sensitivity to light. Stop taking phenelzine and call your doctor at once if you have any of these symptoms.

Phenelzine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Side Effects Centers
  • Nardil

Patient Detailed How Take

What should I discuss with my doctor before taking phenelzine (Nardil)?

Do not use this medication if you have used another MAOI such as isocarboxazid (Marplan), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take phenelzine before another MAOI has cleared from your body.

Do not take phenelzine if you are allergic to it, or if you have:

  • pheochromocytoma (tumor of the adrenal gland);
  • congestive heart failure;
  • a history of liver problems; or
  • if you need any type of surgery with anesthesia.

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

  • diet pills, caffeine, stimulants, ADHD medication, asthma medication, over-the-counter cough and cold or allergy medicines;
  • tryptophan (also called L-tryptophan);
  • levodopa (Larodopa, Parcopa, Sinemet), methyldopa (Aldomet);
  • meperidine (Demerol, Mepergan);
  • furazolidone (Furoxone);
  • procarbazine (Matulane);
  • buspirone (BuSpar);
  • bupropion (Wellbutrin, Zyban);
  • dexfenfluramine (Redux);
  • guanethidine (Ismelin);
  • alcohol or medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety); or
  • antidepressants such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor).

If you have any of these other conditions, you may need a phenelzine dose adjustment or special tests:

  • high blood pressure, heart disease;
  • diabetes;
  • schizophrenia;
  • epilepsy or other seizure disorder; or
  • if you have taken another antidepressant within the past 5 weeks.

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.

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

It is not known whether phenelzine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take phenelzine (Nardil)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Your blood pressure will need to be checked often. Visit your doctor regularly.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment.

Store at room temperature away from moisture and heat.

Side Effects Centers
  • Nardil

Patient Detailed Avoid Taking

What happens if I miss a dose (Nardil)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Nardil)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include feeling drowsy or dizzy, severe headache, neck pain or stiffness, hallucinations, shallow breathing, fast and uneven heart rate, cold sweats, feeling like you might pass out, or seizure (convulsions).

What should I avoid while taking phenelzine (Nardil)?

While you are taking phenelzine you must not eat foods that are high in tyramine, including:

  • aged or smoked meats, fermented meats, dry sausage (including salami, pepperoni, Lebanon bologna), liver, pickled herring;
  • any spoiled or improperly stored meats, fish, or dairy products;
  • beer and wine (including non-alcoholic beer or wine);
  • cheese (other than cottage cheese or cream cheese);
  • sauerkraut;
  • over-the-counter supplements or cough and cold medicines that contain dextromethorphan or tyramine;
  • large amounts of chocolate or caffeine;
  • yogurt;
  • fava beans;
  • meat extracts; or
  • yeast extracts (including Brewer's yeast).

You should become very familiar with the list of foods and medicines you must avoid while you are taking phenelzine. Eating tyramine while you are taking phenelzine can raise your blood pressure to dangerous levels which could cause life-threatening side effects.

Phenelzine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What other drugs will affect phenelzine (Nardil)?

There are many other medicines that can cause serious or life-threatening medical problems if you take them together with phenelzine. Do not take phenelzine before telling your doctor about all other prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor, dentist, or other healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about phenelzine.


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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 2.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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