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]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

TITLE See full prescribing information for complete Boxed Warning. Condition Name: (Content)

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

TITLE See full prescribing information for complete Boxed Warning. Condition Name: (Content)

There is limited information regarding Phenelzine Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

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

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

{{#ask: Page Name::Phenelzine |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Phenelzine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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.

{{#subobject:

 |Page Name=Phenelzine
 |Pill Name=No _image.jpg
 |Drug Name=Phenelzine
 |Pill Ingred=mannitol, silicon dioxide, povidone, edetate disodium, magnesium stearate, polyvinyl alcohol, polyethylene glycol 3350, fd&c yellow no. 6, talc, titanium dioxide|+sep=;
 |Pill Imprint=N/A
 |Pill Dosage=15.00 mg
 |Pill Color=Orange|+sep=;
 |Pill Shape=Round
 |Pill Size (mm)=261
 |Pill Scoring=1
 |Pill Image=
 |Drug Author=Novel Laboratories, Inc.
 |NDC=40032-360-21

}}

{{#subobject:

 |Label Page=Phenelzine
 |Label Name=Phel1.PNG

}}

{{#subobject:

 |Label Page=Phenelzine
 |Label Name=Phel2.PNG

}}