Phenelzine sulfate 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.

Phenelzine sulfate 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.

It should be noted that Nardil is not approved for use in treating bipolar depression.

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. 

NARDIL should not be used in patients with pheochromocytoma, congestive heart failure, severe renal impairment or renal disease, a history of liver disease, or abnormal liver function test.

The most important reaction associated with NARDIL administration is the occurrence of hypertensive crises, which have sometimes been fatal.

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

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.

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 with serotoninergic agents is contraindicated.

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 and at least 14 days between discontinuation of NARDIL and initiation of fluoxetine, or other serotoninergicagents. Before initiating NARDIL after using other serotoninergic agents, a sufficient amount of time must be allowed for clearance of the serotoninergic agent and its active metabolites.

NARDIL 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 should not be administered together with or in rapid succession to other MAO inhibitors. 

Phenelzine sulfate 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 phenelzine sulfate and the institution of another antidepressant or buspirone HCl, or the discontinuation of another MAO inhibitor and the institution of phenelzine sulfate.

If the decision is made to administer NARDIL 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.he potentiation of sympathomimetic substances and related compounds by MAO inhibitors may result in hypertensive crises.

Patients being treated with NARDIL 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 phenelzine sulfate therapy may be caused by the ingestion of foods with a high concentration of tyramine or dopamine.

All patients should be warned that the following foods, beverages, and medications must be avoided while taking NARDIL, and for two weeks after discontinuing use: Pickled herring, liver, dry sausage (including genoa salami, hard salami, pepperoni, lebanon bologna), broad bean pods (fava bean pods), sauerkraut, cheese (cottage cheese and cream cheese are allowed), yogurt, beer,wine, 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.

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

Concomitant use with meperidine is contraindicated.

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

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

The safe use of NARDIL 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.

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• Use in patients under the age of 18. GoToSource 

• Dosage greater than 90 mg per day. GoToSource

• Selective mutism. GoToSource

• General anxiety disorder, panic disorder, agoraphobia, obsessive-compulsive disorder and phobic disorder, including social phobia. GoToSource

• Adult nightmare disorder. GoToSource 

• Post-traumatic stress disorder. GoToSource

• Inflammatory bowel disease. GoToSource

• Bulimia nervosa. GoToSource

• Borderline personality disorder. GoToSource

Myocardial injury. GoToSource

Serotonin syndrome (life-threatening drug interaction). GoToSource

Sexual dysfunction. GoToSource

Addiction. GoToSource 

Liver damage. GoToSource

Peripheral neuropathy (damage to or disease affecting nerves). GoToSource 

Delusional parasitosis (a delusional belief of parasite infestation). GoToSource

Hypertensive crisis. GoToSource

Suicidal thinking and behavior (suicidality). GoToSource

Acute parkinsonian syndrome. GoToSource

Lawsuits filed for suicidal behavior.