Phenelzine

Phenelzine
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]

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Black Box Warning

Suicidality and Antidepressant Drugs See full prescribing information for complete Boxed Warning. Condition Name: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. Anyone considering the use of Phenelzine Sulfate Tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. 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 in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. 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. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Phenelzine Sulfate Tablets is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use)

Overview

Phenelzine is a MAOI that is FDA approved for the {{{indicationType}}} of depression-atypical, non-endogenous, or neurotic. There is a Black Box Warning for this drug as shown here. Common adverse reactions include orthostatic hypotension, weight gain, abdominal discomfort, constipation, xerostomia, increased liver aminotransferase level, without accompanying signs and symptoms, asthenia, dizziness, dyssomnia, headache, somnolence, disorder of ejaculation, impotence, orgasm incapacity,fatigue.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Depression-atypical, non-endogenous, or neurotic

• Initial, 15 mg PO 3 times a day; increase to 60-90 mg/day
• Maintenance: after maximal therapeutic effect decrease dose slowly to the minimum effective dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Phenelzine in adult patients.

Non–Guideline-Supported Use

• Agoraphobia
• Bulimia nervosa

• 60-90 mg/day PO

• Panic disorder

• 15 mg PO for 4 days increase gradually over 2 weeks up to 15 mg 3-4 times a day.

• Social phobia

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

safety in children have not been established

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information about Off-Label Guideline-Supported Use of Phenelzine in pediatric patients.

Non–Guideline-Supported Use

There is limited information about Off-Label Non–Guideline-Supported Use of Phenelzine in pediatric patients.

Contraindications

• Phenelzine Tablets 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 Phenelzine Sulfate Tablets 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 Tablets therapy may also be caused by the ingestion of foods with a high concentration of tyramine or dopamine. Therefore, patients being treated with Phenelzine Sulfate Tablets 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.

• Phenelzine Tablets should not be used in combination with dextromethorphan or with CNS depressants such as alcohol and certain narcotics.

• MAOI therapy who have been given a single dose of meperidine. Phenelzine Tablets should not be administered together with or in rapid succession to other MAO inhibitors because hypertensive crisis and convulsive seizures, fever, marked sweating, excitation, delirium, tremor, coma, and circulatory collapse may occur.

• Concomitant use with meperidine is contraindicated.

Warnings

Suicidality and Antidepressant Drugs See full prescribing information for complete Boxed Warning. Condition Name: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. Anyone considering the use of Phenelzine Sulfate Tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. 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 in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. 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. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Phenelzine Sulfate Tablets is not approved for use in pediatric patients. (See Warnings: Clinical Worsening and Suicide Risk, Precautions: Information for Patients, and Precautions: Pediatric Use)

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.

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 Phenelzine Tablets 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 Phenelzine is not approved for use in treating bipolar depression. It should be noted that Phenelzine is not approved for use in treating any indications in the pediatric population. The most serious reactions to Phenelzine Sulfate Tablets involve changes in blood pressure.

Hypertensive Crises

The most important reaction associated with 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 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, 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 Phenelzine Sulfate Tablets, 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 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 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 Phenelzine Tablets 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 Phenelzine should be used with caution in combination with antihypertensive drugs, including thiazide diuretics and β-blockers, since exaggerated hypotensive effects may result.

Adverse Reactions

Clinical Trials Experience

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.

Postmarketing Experience

There is limited information regarding Phenelzine Postmarketing Experience in the drug label.

Drug Interactions

• Serotoninergic agent

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 Phenelzine Tablets is a monoamine oxidase (MAO) inhibitor, Phenelzine should not be used concomitantly with a serotoninergic agent.

A List of MAO Inhibitors by Generic Name Follows:

• Pargyline hydrochloride
• Pargyline hydrochloride and methylclothiazide
• Furazolidone
• Isocarboxazid
• Procarbazine
• Tranylcypromine

Phenelzine tablets 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 Tablets and the institution of another antidepressant or buspirone HCl, or the discontinuation of another MAO inhibitor and the institution of Phenelzine Tablets.

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 Phenelzine Tablets 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 Phenelzine Sulfate Tablets and at least 14 days between discontinuation of Phenelzine Sulfate Tablets and initiation of fluoxetine, or other serotoninergic agents. Before initiating Phenelzine Sulfate Tablets 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 Phenelzine Tablets 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 Tablets and spinal anesthesia should be kept in mind. Phenelzine Tablets should be discontinued at least 10 days prior to elective surgery.

• Guanethidine

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.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Phenelzine in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Phenelzine in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Phenelzine during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Phenelzine in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Phenelzine in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Phenelzine in geriatric settings.

Gender

There is no FDA guidance on the use of Phenelzine with respect to specific gender populations.

Race

There is no FDA guidance on the use of Phenelzine with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Phenelzine in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Phenelzine in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Phenelzine in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Phenelzine in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Phenelzine Administration in the drug label.

Monitoring

There is limited information regarding Phenelzine Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Phenelzine and IV administrations.

Overdosage

There is limited information regarding Phenelzine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Mechanism of Action

There is limited information regarding Phenelzine Mechanism of Action in the drug label.

Structure

There is limited information regarding Phenelzine Structure in the drug label.

Pharmacodynamics

There is limited information regarding Phenelzine Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Phenelzine Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Phenelzine Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Phenelzine Clinical Studies in the drug label.

How Supplied

There is limited information regarding Phenelzine How Supplied in the drug label.

Storage

There is limited information regarding Phenelzine Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Phenelzine Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Phenelzine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Phenelzine Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Phenelzine Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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