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

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

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

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

There is limited information regarding Phenelzine Drug Interactions in the drug label.

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.

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