HomeNDC LookupIngredientsPhenelzine Sulfate › 43386-0360-21
Phenelzine Sulfate 15 mg Tablet, 60-count — NDC 43386-0360-21 package photo

Phenelzine Sulfate 15 mg Tablet, 60-count

by Lupin Pharmaceuticals,Inc. · 60 TABLET in 1 BOTTLE (43386-360-21)
NDC 43386-0360-21
🏷️ FDA NDC (as labeled) 43386-360-21 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 43386-360-21
Product NDC 43386-360
11-digit billing NDC 43386036021
NCPDP billing unit EA — each (per item)
RxCUI 312347
UNII 2681D7P965
UPC 0343386360215
Application # ANDA200181
SPL Set ID 40483372-448f-4284-976c-8462ef256661
Established class (EPC) Monoamine Oxidase Inhibitor
Mechanism of action Monoamine Oxidase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-12-14
Route ORAL
Dosage form TABLET
Substance PHENELZINE SULFATE
GPI-14 58100020100305
GPI class Phenelzine Sulfate
GCN Seq No 046263
GCN 16417
HICL code 001639
Ingredient (HICL) Phenelzine Sulfate
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H7
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)
HIC3 code H7J
Therapeutic class — specific (HIC3) Maois -Non-Selective,Irreversible Antidepressants
AHFS code 28:16.04.12
AHFS class Monoamine Oxidase Inhibitors
FDB label name PHENELZINE SULFATE 15 MG TAB
FDB brand name Phenelzine Sulfate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 43386-360-21 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 43386-0360-21. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Monoamine Oxidase Inhibitor class.

Pharmacologic class Monoamine Oxidase Inhibitor
Drug family (ATC) Monoamine oxidase inhibitors, non-selective
How it works Monoamine Oxidase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerLupin Pharmaceuticals,Inc.
Application holderNOVEL LABORATORIES INC
FDA applicationANDA200181 (ANDA)
Labeler code43386
First marketedDec 2010
Product typeHuman Prescription Drug
Portfolio89 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PHENELZINE SULFATE 15 MG TAB Ingredient Phenelzine Sulfate
📖 What it is MedlinePlus · NLM

Phenelzine is used to treat depression in people who have not been helped by other medications. Phenelzine is in a class of medications called monoamine oxidase inhibitors (MAOIs). It works by increasing the amounts of certain natural substances that are needed to maintain mental balance.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Phenelzine is typically prescribed when other antidepressants — like SSRIs — haven't worked well enough. It tends to be most effective for a type of depression called atypical depr...
  • Why did my doctor prescribe phenelzine instead of a more common antidepressant?
  • This is really important — eating certain foods while on phenelzine can cause a dangerous spike in blood pressure called a hypertensive crisis. You need to avoid aged cheeses, cure...
  • What foods do I absolutely need to avoid while taking phenelzine?
📖 Read our full Phenelzine guide →
1
Nutrient depletion considerations

Phenelzine Sulfate may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color Orange
ShapeRound
ImprintNL;360
Size9 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.570 $34.22 / 60 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.5812 $34.87 / 60 tablets
NADAC price history (per ea) — tap or hover for the price & month
Oct 2021 Jan 2022 May 2022 Oct 2023 $0.589 $0.496
▼ Down 2% over the last 6 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phenelzine Sulfate 15 mgthis 43386-0360-21 Lupin 60 tablets $0.570 AB FDA listed
phenelzine sulfate 15 mg 59762-0119-01 Mylan 60 tablets $0.587 AB Availability likely +3%
Nardil 15 mg 00071-0350-60 Parke-Davis 60 tablets $2.534 AB FDA listed +344%
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2010
On the market since
Dec 2010
📍
2026
Currently FDA-listed
16 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Phenelzine Sulfate — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Phenelzine Sulfate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$245.4K
Claims incl. refills
2.5K
Beneficiaries
1.4K
Spend / beneficiary
$171.28
Spend / claim
$96.52
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Phenelzine Sulfate — the ingredient across all brands.

Top reported reactions

Depression187
Headache138
Anxiety129
Weight Increased122
Insomnia104
Drug Interaction100
Dizziness99

Age at onset

Adult26
Elderly23

Reporter sex

1,563 reports
Male · 38%
Female · 61%
Unknown · 1%

Serious outcomes

Hospitalization331
Disabling84
Life-threatening69
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 121 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
43386-0360-21 You're viewing this 60 TABLET in 1 BOTTLE (43386-360-21) 2011-02-14 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 189 words

Suicidality and Antidepressant Drugs 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 )

🎯 Indications and Usage 85 words

INDICATIONS AND USAGE Phenelzine Sulfate Tablets, USP 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 Tablets 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 and Administration 130 words

DOSAGE AND ADMINISTRATION Initial dose The usual starting dose of Phenelzine Sulfate Tablets 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 Phenelzine Sulfate Tablets 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.

Contraindications ~2 min read

CONTRAINDICATIONS Phenelzine Sulfate 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 Sulfate 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 Sulfate Tablets 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.

Phenelzine Sulfate Tablets 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 Phenelzine Sulfate 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 Sulfate 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 Sulfate Tablets 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 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, hypoman…

⚠️ Warnings ~3 min read

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 the…

🤒 Adverse Reactions ~2 min read

ADVERSE REACTIONS Phenelzine Sulfate Tablets 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 Phenelzine Sulfate Tablets.

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, angle-closure 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 Phenelzine Sulfate Tablets 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 Phenelzine Sulfate Tablets therapy followed by cautious downward titration and discontinuation.

🔄 Drug Interactions 181 words

Drug 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 Phenelzine Sulfate Tablets is a monoamine oxidase (MAO) inhibitor, Phenelzine Sulfate Tablets 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 ) Geriatric Use Clinical studies of Phenelzine Sulfate Tablets 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.

🆘 Overdosage ~2 min read

OVERDOSAGE 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 Phenelzine Sulfate Tablets, 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.

🧬 Clinical Pharmacology 180 words

CLINICAL PHARMACOLOGY 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 Phenelzine Sulfate Tablets (2 × 15 mg tablets), a mean peak plasma concentration (C max ) of 19.8 ng/mL occurred at a time (T max ) of 43 minutes postdose. Metabolism Phenelzine Sulfate Tablets is extensively metabolized, primarily by oxidation via monoamine oxidase.

After oral administration of 13 C 6 -phenelzine, 73% of the administered dose was recovered in urine as phenylacetic acid and parahydroxyphenylacetic acid within 96 hours. Acetylation to N 2 -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.

📦 How Supplied / Storage and Handling 83 words

HOW SUPPLIED Each Phenelzine Sulfate Tablets is orange, biconvex, film-coated tablets, debossed with "NL" on one side and "360" on the other side. Contains phenelzine sulfate equivalent to 15 mg of phenelzine base. NDC 43386-360-21.

Bottle of 60 Storage Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] . Preserve in tight containers, protected from heat and light. Rx only Manufactured by: Novel Laboratories Inc, Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc.

Baltimore, MD 21202 PI3600000204 Rev. 05/2016

📋 Description 110 words

DESCRIPTION Phenelzine Sulfate Tablets, USP (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 C 8 H 12 N 2 • H 2 SO 4 .

Its chemical structure is shown below: Each Phenelzine Sulfate Tablets film-coated for oral administration contains phenelzine sulfate equivalent to 15 mg of phenelzine base and the following inactive ingredients: mannitol, USP; colloidal silicon dioxide, NF; povidone, USP; edetate disodium, USP; magnesium stearate, NF; purified water, USP; polyvinyl alcohol part hydrolyzed USP, polyethylene glycol-3350 NF, FD&C yellow # 6, talc USP and titanium dioxide USP. 4e68c327-figure-01

💬 Medication Guide ~3 min read

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?

Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 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. 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 Visual problems: eye pain, changes in vision, swelling or redness in or around the eye.

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.

Visual problems: Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. 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. Call your doctor for medical advice about side effects, You may report side effects to FDA at 1-800- FDA-1088 Medication Guide revised on May 2016 This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Manufactured by: Novel Laboratories, In…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.