Phenelzine Sulfate

Class: Monoamine Oxidase Inhibitors
VA Class: CN602
Molecular Formula: C8H12N2•H2SO4
CAS Number: 156-51-4
Brands: Nardil

Warning(s)

  • Suicidality
  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.100 104 105 Phenelzine is not approved for use in pediatric patients.100 (See Pediatric Use under Cautions.)

  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.100 104 105

  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.100 104 105 106

  • Appropriately monitor and closely observe all patients who are started on phenelzine therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.100 104 105 106 (See Worsening of Depression and Suicidality Risk and also Pediatric Use, under Cautions.)

Introduction

Hydrazine-derivative, MAO inhibitor antidepressant.100 a b c e f u

Uses for Phenelzine Sulfate

Major Depressive Disorder

Treatment of major depressive disorder.100 101 a b e f

Phenelzine is effective in patients with depression clinically characterized as atypical, nonendogenous, or neurotic; these patients often have mixed anxiety and depression and phobic or hypochondriacal features.100 101 a b f h Less conclusive evidence that drug is useful in severely depressed patients with endogenous features.100 a b f

Slideshow: Depression, the Risk of Suicide, and Treatment Options

Because of potential for serious adverse effects and necessity of dietary restrictions, MAO inhibitors (e.g., phenelzine, tranylcypromine) generally are not used as initial therapy for major depressive disorder, but are reserved for carefully selected patients who can be closely supervised and who have depression refractory to other antidepressants (e.g., SSRIs, SNRIs, TCAs) or in whom other therapies are contraindicated.100 101 a b e

Eating Disorders

Phenelzine has been used with some success in the management of bulimia nervosa.103 a b g i

However, MAO inhibitors are potentially dangerous (e.g., risk of hypertensive crisis) in patients with eating disorders and should be used with caution in patients with chaotic binge eating and purging behaviors.a g MAO inhibitors currently are not recommended as first-line therapy in the management of bulimia nervosa.a g

Phenelzine Sulfate Dosage and Administration

General

  • Allow at least 2 weeks to elapse between discontinuance of phenelzine therapy and initiation of a TCA or buspirone or discontinuance of another MAO inhibitor and initiation of phenelzine.100 b

  • Allow at least 2 weeks to elapse between discontinuance of an SSRI and initiation of phenelzine and vice versa.100 Also allow at least 5 weeks to elapse when switching from fluoxetine.100

  • Allow at least 2 weeks to elapse between discontinuance of phenelzine and initiation of bupropion.100 b

  • Allow at least 5 or 7 days to elapse between discontinuance of duloxetine or venlafaxine, respectively, and initiation of phenelzine and at least 2 weeks between discontinuance of phenelzine and initiation of duloxetine or venlafaxine.100 j k

  • Patients receiving phenelzine should be monitored for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustment. 100 104 105 106 (See Worsening of Depression and Suicidality Risk under Cautions.)

Administration

Oral Administration

Administer orally.100 a

Dosage

Available as phenelzine sulfate; dosage expressed in terms of phenelzine.100 a

Individualize dosage carefully according to individual requirements and tolerance; use lowest possible effective dosage.100 a b

Adults

Major Depressive Disorder
Oral

Usual initial dosage: 15 mg 3 times daily; dosage should then be increased fairly rapidly, depending on the patient’s tolerance and therapeutic response, to ≥60 mg daily.100 a Dosages ≤90 mg daily may be required in some patients to obtain sufficient MAO inhibition.100 a Many patients do not respond clinically until receiving 60 mg daily for ≥4 weeks.100

Maintenance dosage: After maximum benefit is obtained, usually in 2–6 weeks, slowly reduce dosage over several weeks to a maintenance level.100 a Maintenance dosage may be as low as 15 mg daily or every other day.100 a

Eating Disorders
Oral

Dosages used for management of bulimia nervosa have been similar to those used for the treatment of major depressive disorder.g (See Major Depressive Disorder under Dosage and Administration.)

Special Populations

Geriatric Patients

Select dosage cautiously, usually starting with dosage at the lower end of recommended range since renal, hepatic, and cardiovascular function and concomitant disease and other drug therapy are more common.100 b (See Geriatric Use under Cautions.)

Cautions for Phenelzine Sulfate

Contraindications

  • Concomitant use of other MAO inhibitors (e.g., isocarboxazid, transdermal selegiline, tranylcypromine), dibenzazepine derivatives (e.g., amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, maprotiline, nortriptyline, protriptyline, trimipramine, carbamazepine, cyclobenzaprine), centrally acting sympathomimetic agents (e.g., amphetamines) or peripherally acting sympathomimetic agents (prescription or OTC cold, hay fever, or weight-reducing preparations that contain vasoconstrictors), bupropion, buspirone, SNRIs (e.g., duloxetine, venlafaxine), SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline), dexfenfluramine (no longer commercially available in the US), other serotonergic drugs; meperidine and certain other CNS depressants (e.g., opiate analgesics, sedatives, anesthetics, alcohol); dextromethorphan; guanethidine; methyldopa; tryptophan; levodopa; consumption of excessive quantities of caffeine or chocolate; foods or beverages high in tyramine content.100 j k m n p q v (See Interactions.)

  • Elective surgery requiring general anesthesia.100 b Use of cocaine or local anesthesia containing sympathomimetic vasoconstrictors also not recommended.100 b Consider possible combined hypotensive effects of phenelzine and spinal anesthesia.100 b Discontinue phenelzine ≥10 days prior to elective surgery.100 b (See Specific Drugs and Foods under Interactions.)

  • Pheochromocytoma.100

  • CHF.100

  • Severe renal impairment or renal disease.100

  • History of liver disease or abnormal liver function test results.100

  • Known hypersensitivity to phenelzine or any ingredient in the formulation.100

Warnings/Precautions

Warnings

Shares the toxic potentials of other MAO inhibitors; observe the usual precautions and contraindications associated with therapy with these drugs.100 a b Fully advise patients about risks, especially hypertensive crisis and suicidal thinking and behavior (suicidality), associated with MAO inhibitor therapy.100 a b e

Worsening of Depression and Suicidality Risk

Possible worsening of depression and/or emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients with major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs.100 104 105 106 107 However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.100 104 105 106

Appropriately monitor and closely observe patients receiving phenelzine for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.100 104 105 106 (See Boxed Warning and also see Pediatric Use under Cautions.)

Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.100 104 106 Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.104 105 106

Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.100 104

Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder) or nonpsychiatric disorders.100 104

Bipolar Disorder

May unmask bipolar disorder.100 104 (See Activation of Mania or Hypomania under Cautions.) Phenelzine is not approved for use in treating bipolar depression.100

Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.100 104

Hypertensive Crises

Hypertensive crises, sometimes fatal, are one of the most serious adverse effects associated with MAO inhibitors, including phenelzine.100 101 b Although spontaneous cases reported, most cases occurred following ingestion of foods or beverages containing large amounts of tyramine (i.e., cheese reaction) or when MAO inhibitors were used concomitantly with certain prescription or OTC drugs.100 b (See Specific Drugs and Foods under Interactions and see also Advice to Patients.)

Characterized by occipital headache (which may radiate frontally), palpitation, neck stiffness or soreness, nausea or vomiting, sweating (sometimes with fever or cold, clammy skin), mydriasis and/or visual disturbances (e.g., photophobia).100 101 b Tachycardia or bradycardia with associated constricting chest pain and dilated pupils and intracranial hemorrhage, sometimes fatal, also reported.100 101 b

Closely monitor BP in all patients to detect evidence of pressor response; however, full reliance should not be placed on BP determinations alone.100 b Frequently observe patient’s clinical status, particularly for signs and symptoms of hypertension.100 b

If a hypertensive crisis or prodromal signs of hypertensive crisis occur, discontinue MAO inhibitor therapy and immediately institute appropriate therapy to lower BP.100 b Phentolamine considered hypotensive drug of choice for treating MAO inhibitor-induced hypertensive crisis.100 101 b Manage fever by external cooling.100 b Other symptomatic and supportive measures may be necessary in some patients;100 b however, avoid administration of parenteral reserpine.b (See Specific Drugs and Foods under Interactions.)

General Precautions

Activation of Mania or Hypomania

Possible activation of mania and hypomania, particularly in patients with bipolar disorder.100 (See Bipolar Disorder under Cautions.)

Orthostatic Hypotension

Possible orthostatic hypotension.100 b Most commonly observed in patients with preexisting hypertension, but has occurred in normotensive and hypotensive patients.100 b Closely monitor patients for postural hypotension; BP generally returns rapidly to pretreatment levels upon drug discontinuance or dosage reduction.100

Seizures

MAO inhibitors have a variable effect on seizure threshold; use with caution in patients with a seizure disorder.100 b

Nervous System Effects

Possible hypomania; usually occurs in patients with accompanying hyperkinetic symptoms obscured by depressive symptoms.100 Hypomania usually appears as depression improves.100 Phenelzine may worsen preexisting agitation.100 (See Worsening of Depression and Suicidality Risk under Cautions.)

Hypomania and agitation also reported with higher than recommended phenelzine dosages or following long-term therapy.100

Possible excessive stimulation in patients with schizophrenia.100

Endocrine and Metabolic Effects

MAO inhibitors may cause hypoglycemic episodes in diabetic patients receiving insulin or oral antidiabetic agents; use phenelzine with caution in diabetic patients receiving these drugs concurrently.100 b

Use MAO inhibitors with caution in patients with hyperthyroidism, since these patients have an increased sensitivity to pressor amines.b

Withdrawal of Therapy

A withdrawal syndrome has been reported infrequently following abrupt discontinuance of phenelzine.100 b Signs and symptoms of withdrawal evident within 24–72 hours after phenelzine was discontinued included nausea, vomiting, malaise, vivid nightmares with agitation, psychosis, and/or seizures.100 b The syndrome generally responds to reinitiation of low-dose phenelzine therapy followed by cautious downward titration and discontinuance.100 b

Specific Populations

Pregnancy

Category C.d

Lactation

Not known but considered likely to distribute into breast milk.b d Caution if used in nursing women; carefully assess potential benefits and risks.100 b

Pediatric Use

Safety and efficacy in pediatric patients not established.100 a

FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, obsessive-compulsive disorder (OCD), or other psychiatric disorders based on pooled analyses of 24 short-term, placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).100 104 However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.107 No suicides occurred in these pediatric trials.100 104 107

Carefully consider these findings when assessing potential benefits and risks of phenelzine in a child or adolescent for any clinical use.100 104 105 106 107 (See Worsening of Depression and Suicidality Risk under Cautions.)

Geriatric Use

Insufficient experience with phenelzine in patients ≥65 years to determine whether they respond differently than younger patients.100 Other clinical experience with MAO inhibitors has not identified differences in responses between geriatric and younger adults.100

In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.100 104 105 (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)

Possible increased morbidity during or following episodes of hypertension or malignant hyperthermia; geriatric patients have less compensatory reserve to cope with any serious adverse reaction.b

Use with caution.100 b Use low initial dosage and closely observe patients since renal, hepatic, and cardiovascular dysfunction and concomitant disease or other drug therapy are more common in this age group than in younger patients.100 b (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Contraindicated in patients with history of hepatic disease or abnormal liver function test results.100

Renal Impairment

Contraindicated in patients with severe renal impairment or renal disease.100

Common Adverse Effects

Adverse nervous system effects (e.g., dizziness, headache, drowsiness, sleep disturbances [e.g., insomnia, hypersomnia], fatigue, weakness, tremors, twitching, myoclonic movements, hyperreflexia), adverse GI effects (e.g., constipation, dry mouth, GI disturbances), elevated serum transaminase concentrations (without accompanying signs or symptoms of hepatotoxicity), weight gain, adverse cardiovascular effects (e.g., orthostatic hypotension, edema), adverse GU effects (e.g., anorgasmia, ejaculatory disturbances, impotence).100 101 b e

Interactions for Phenelzine Sulfate

Drugs Associated with Serotonin Syndrome

Potential pharmacologic interaction (serotonin syndrome) with serotonergic agents.100 b j k Avoid concomitant administration of phenelzine and serotonergic agents and allow sufficient amount of time to elapse between discontinuance of serotonergic drugs and initiation of phenelzine.100 b e (See Specific Drugs and Foods under Interactions.)

Specific Drugs and Foods

Drug or Food

Interaction

Comments

Alcohol

May potentiate action of alcoholb

Possible hypertensive crisis with tyramine-containing alcoholic beverages (e.g., Chianti wine, beer, liqueurs)100 b o

Avoid alcoholic beverages during therapy and for 2 weeks following phenelzine discontinuance100

Anesthetics

General anesthetics: Possible exaggeration of hypotensive and CNS depressant effects100 b

Local anesthesia with cocaine or local anesthetics that contain sympathomimetic vasoconstrictors: Possible hypertension100 b

Spinal anesthesia: Possible potentiation of the hypotensive effect of local anesthetics100 b

For elective surgery, discontinue phenelzine for ≥10 days prior to elective surgery with general anesthetics; for emergency surgery, carefully adjust dosage of general anesthetics100 b

Local anesthesia with cocaine or local anesthetics that contain sympathomimetic vasoconstrictors: Avoid concomitant use100 b

Spinal anesthesia: Use with caution100 b

Antidepressants, SNRIs (e.g., duloxetine, venlafaxine)

Potentially life-threatening serotonin syndrome100 j k l

Concomitant use contraindicated100 j k

Allow at least 5 or 7 days to elapse between discontinuance of duloxetine or venlafaxine, respectively, and initiation of phenelzine and at least 2 weeks between discontinuance of phenelzine and initiation of duloxetine or venlafaxine100 j k

Antidepressants, SSRIs (e.g., citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline)

Potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome (NMS)100 b e m n

Concomitant use contraindicated100 b

Allow at least 2 weeks to elapse between discontinuance of phenelzine and initiation of an SSRI, and vice versa100 b

Allow at least 5 weeks to elapse between discontinuance of fluoxetine and initiation of phenelzine100 b

Antidepressants, tricyclic (TCAs) (e.g., amitriptyline, desipramine, imipramine, nortriptyline, protriptyline)

Potentially life-threatening serotonin syndrome 100 b

Concomitant use contraindicated 100 b

Allow at least 2 weeks to elapse when switching to or from these drugs100 b

Antidiabetic agents, oral

Possible hypoglycemic episodes100 b

Use with caution; oral antidiabetic agent requirements may decrease during concurrent administration100 b

Barbiturates

Potentiated hypnotic effects reported in animals; may potentiate action of barbiturates in humans100 b

Reduce barbiturate dosage during concomitant administration100

Bupropion

Possible enhanced toxicity of bupropionb

Concomitant administration contraindicated

Allow at least 2 weeks to elapse between discontinuance of phenelzine and initiation of bupropion100 b

Buspirone

Elevated BP reported with concomitant use; possible serotonin syndrome100 b

Concomitant use contraindicated100

Allow at least 2 weeks to elapse between discontinuance of phenelzine and initiation of buspirone100

Caffeine

May precipitate hypertensive crisis if taken in excessive quantities100 b

Concomitant use of excessive quantities of caffeine contraindicated100 b

Carbamazepine

Possible serotonin syndrome100

Concomitant use contraindicated100

Allow at least 2 weeks to elapse between discontinuance of phenelzine and initiation of carbamazepine100

CNS depressants (e.g., opiate analgesics)

May potentiate the action of CNS depressantsb

Concomitant use contraindicated100 b

Cyclobenzaprine

Possible hypertensive crises or severe seizures;100 q serotonin syndrome reportedr

Concomitant use contraindicated100 q

Allow at least 2 weeks to elapse between discontinuance of phenelzine and initiation of cyclobenzaprine100 q

Dextromethorphan

Brief episodes of psychosis or bizarre behavior reported; possible serotonin syndrome100 b e

Concomitant use contraindicated100 b o

Foods and beverages, tyramine-containing (e.g., cheese, sour cream, Chianti wine, sherry, beer, liqueurs, pickled herring, anchovies, caviar, liver, canned figs, dried fruits, bananas, raspberries, overripe fruit, chocolate, soy sauce, sauerkraut, fava beans, yeast extracts, yogurt, dry sausage, meat extracts or meat prepared with tenderizers)

Serious, sometimes fatal hypertensive reactions (e.g., palpitation, headache, nausea, vomiting, photophobia, diaphoresis) reported100 o

Avoid foods and beverages with high tyramine content (e.g., cheese)100 o

Consult specialized references on food constituents or dietician for specific information on tyramine content of foods and beveragesb o

Ginseng (e.g., Panax ginseng)

Manic-like symptoms reportedw

Guanethidine

Possible moderate to severe hypertension100 b

Concomitant use contraindicated

Allow at least 2 weeks to elapse between discontinuance of phenelzine and initiation of guanethidine100 o

Insulin

Possible hypoglycemic episodes100 b

Use with caution; insulin requirements may decrease during concurrent use100 b

Levodopa-carbidopa

Potential for hypertension, headache, hyperexcitability, and related symptoms100 b

Concomitant use contraindicated

Discontinue phenelzine ≥2 weeks prior to initiation of levodopa100 v

MAO inhibitors (e.g., isocarboxazid, transdermal selegiline, tranylcypromine)

Hypertensive crises or severe seizures may occur with concomitant use100 b

Concomitant use contraindicated100 b

Allow at least 2 weeks to elapse between discontinuance of phenelzine and initiation of another MAO inhibitor, or vice versa100

Meperidine

Severe, generally immediate reactions, including excitation, sweating, rigidity, respiratory depression, seizures, hypertension or hypotension, coma, and death, suggestive of serotonin syndrome reported100 b p

Concomitant use contraindicated100 b o p

Allow at least 2 weeks to elapse between discontinuance of phenelzine and administration of meperidine100 p

Methyldopa

Potential for hypertension, headache, hyperexcitability, and related symptoms100 b

Concomitant use contraindicated100

Modafinil

Acute dyskinesia, confusion, and hyperthermia reported during concurrent use of modafinil and tranylcypromine, another MAO inhibitor; possible increased dopaminergic and serotonergic activitys

Use with cautiont

Reserpine

Possible enhanced serotonergic and noradrenergic effects and severe pressor response100 b

Use with caution100 (see Hypertensive Crises under Cautions)

Sympathomimetic agents (e.g., amphetamine, dopamine, OTC cold, hay fever, or weight-reducing preparations)

Possible hypertensive crisis and/or serotonin syndrome100 o

Concomitant use contraindicated100 o

Allow at least 2 weeks to elapse between discontinuance of phenelzine and initiation of therapy with sympathomimetic agents100

Tryptophan

Possible behavioral and neurologic symptoms suggestive of serotonin syndrome100 b

Concomitant use contraindicated100 b

Phenelzine Sulfate Pharmacokinetics

Absorption

Bioavailability

Rapidly and well absorbed following single-dose (30 mg) oral administration, with mean peak plasma concentrations of approximately 20 ng/mL achieved at 43 minutes.100 x y z Steady-state plasma concentrations gradually increase over initial 6–8 weeks of therapy.x y

Onset

Pharmacologic effects of MAO inhibitors are cumulative; onset of action of phenelzine is slower that that of the nonhydrazine-derivative MAO inhibitor tranylcypromine.b Antidepressant effect usually evident within 2–3 weeks.b f cc

Duration

Inhibition of MAO may persist for several days to weeks following drug discontinuance.y

Distribution

Extent

Crosses placenta in mice.100 b Not known but considered likely to distribute into human breast milk.b d

Elimination

Metabolism

Rapidly and extensively metabolized following oral administration principally by oxidation via monoamine oxidase; acetylation appears to be a minor metabolic pathway.100 c f x y z aa bb Role of acetylator status in phenelzine's metabolism unclear; some studies suggest slow acetylators of phenelzine may exhibit greater antidepressant efficacy and/or toxicity compared with fast acetylators while other studies do not support these findings.f x y z aa bb

Elimination Route

Rapidly eliminated from body; excreted principally in urine as metabolites (about 73% as phenylacetic acid and P-hydroxyphenylacetic acid).100 u x y aa

Half-life

1.2–11.6 hours following single-dose administration; multiple-dose pharmacokinetics not studied.100 x y z

Stability

Storage

Oral

Tablets

Tight containers at 15–30°C; protect from excessive exposure to heat and light.100 a

Actions

  • Principal pharmacologic effects of phenelzine are similar to those of other nonselective MAO inhibitors (e.g., tranylcypromine).a b u

  • Potent inhibitor of the MAO enzyme.100 u Phenelzine binds irreversibly to the MAO enzyme while tranylcypromine binds reversibly to the enzyme.b z

  • Precise mechanism of antidepressant action is unknown but may involve increases in free serotonin and norepinephrine and/or alterations in other amine concentrations within the CNS.b u

Advice to Patients

  • Risk of suicidality; importance of patients, family, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.100 104 105 106 FDA recommends providing written patient information (medication guide) explaining risks of suicidality each time the drug is dispensed.100 104 105 106

  • Importance of informing patients to avoid foods and beverages with a high tyramine content during therapy and for 2 weeks following phenelzine discontinuance.100

  • Importance of informing patients to avoid consumption of excessive amounts of caffeine in any form and/or excessive amounts of chocolate.100

  • Importance of informing patients to avoid certain OTC (e.g., cough and cold preparations [including those containing dextromethorphan], nasal decongestants, hay fever and sinus medications, inhaled asthma medications, appetite suppressants and weight-reducing medications, “pep” pills, tryptophan-containing preparations) and certain prescription medications during therapy and for 2 weeks following phenelzine discontinuance.100

  • Importance of informing patients to avoid alcoholic beverages during therapy and for 2 weeks following phenelzine discontinuance.100

  • Risk of serious adverse effects (e.g., hypertensive reactions).100 b Importance of promptly informing clinicians if headache or other unusual symptoms (e.g., palpitation and/or tachycardia, constriction in throat or chest, sweating, dizziness, neck stiffness, nausea or vomiting) occur.100 b

  • Risk of hypotension, faintness, and drowsiness.100 b

  • Importance of patients informing their clinicians and dentist that they are taking phenelzine.100

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.100

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal or nutritional supplements, as well as any concomitant illnesses.100 w

  • Importance of informing patients of other important precautionary information.100 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Phenelzine Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

15 mg (of phenelzine)

Nardil (with povidone)

Pfizer

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Nardil 15MG Tablets (PFIZER U.S.): 100/$107.99 or 300/$301.96

Phenelzine Sulfate 15MG Tablets (GAVIS PHARMACEUTICALS): 30/$29.99 or 90/$70.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

100. Parke-Davis. Nardil (phenelzine sulfate) tablets prescribing information. New York, NY; 2007 Aug.

101. American Psychiatric Association. Practice guideline for the treatment of patients with major depressive disorder (revision). Am J Psychiatry. 2000; 157(Suppl 4):1-45.

102. American Psychiatric Association. Practice guideline for the treatment of patients with eating disorders (revision). Am J Psychiatry. 2000; 157(Suppl 1):1-39.

103. Rothschild R, Quitkin HM, Quitkin FM et al. A double-blind placebo-controlled comparison of phenelzine and imipramine in the treatment of bulimia in atypical depressives. Int J Eat Disord. 1994; 15:1-9. [PubMed 8124322]

104. Food and Drug Administration. Antidepressant use in children, adolescents, and adults: class revisions to product labeling. Rockville, MD; 2007 May 2. From the FDA web site.

105. Food and Drug Administration. FDA news: FDA proposes new warnings about suicidal thinking, behavior in young adults who take antidepressant medications. Rockville, MD; 2007 May 2. From the FDA web site.

106. Food and Drug Administration. Revisions to medication guide: antidepressant medicines, depression and other serious mental illnesses and suicidal thoughts or actions. Rockville, MD; 2007 May 2. From the FDA web site.

107. Bridge JA, Iyengar S, Salary CB. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized controlled trials. JAMA. 2007; 297:1683-96. [PubMed 17440145]

a. AHFS drug information 2008. McEvoy GK, ed. Phenelzine sulfate. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2322.

b. AHFS drug information 2008. McEvoy GK, ed. Monoamine oxidase inhibitors general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2316-22.

c. Feinberg M, De Vigne JP, Kronfol Z, et al. Duration of action of phenelzine in two patients. Am J Psychiatry. 1981; 138:379-80. [PubMed 7468839]

d. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 7th ed. Baltimore, MD: Williams & Wilkins; 2005:1276.

e. Anon. Drugs for psychiatric disorders. Treat Guidel Med Lett. 2006; 4:35-46.

f. Quitkin F, Rifkin A, Klein DF. Monoamine oxidase inhibitors: a review of antidepressant effectiveness. Arch Gen Psychiatry. 1979; 36:749-60. [PubMed 454092]

g. American Psychiatric Association Practice Guidelines. Practice guideline for the treatment of patients with eating disorders, third edition. From the APA website.

h. Stewart JW. Treating depression with atypical features. J Clin Psychiatry. 2007; 68(Suppl. 3):25-9. [PubMed 17348764]

i. Bacaltchuk J, Hay P. Antidepressants versus placebo for people with bulimia nervosa. Cochrane Database of Systematic Reviews. 2003; Issue 4:Article no. CD003391. DOI: 10.1002/14651858.CD003391.

j. Eli Lilly and Company. Cymbalta (duloxetine hydrochloride) delayed-release capsules prescribing information. Indianapolis, IN; 2007 Dec 13.

k. Wyeth Pharmaceuticals Inc. Effexor XR (venlafaxine hydrochloride) extended-release capsules prescribing information. Philadelphia, PA; 2008 Feb.

l. Weiner LA, Smythe M, Cisek J. Serotonin syndrome secondary to phenelzine-venlafaxine interaction. Pharmacotherapy. 1998; 18:399-403. [PubMed 9545162]

m. Feighner JP, Boyer WF, Tyler DL et al. Adverse consequences of fluoxetine-MAOI combination therapy. J Clin Psychiatry. 1990; 51:222-5. [IDIS 267347] [PubMed 2347858]

n. Graber MA, Hoehns TB, Perry PJ. Sertraline-phenelzine drug interaction: a serotonin syndrome reaction. Ann Pharmacother. 1994; 28:732-5. [IDIS 332591] [PubMed 7919561]

o. Livingston MG, Livingston HM. Monoamine oxidase inhibitors: an update on drug interactions. Drug Safety. 1996; 14:219-27. [PubMed 8713690]

p. Sanofi-Synthelabo Inc. Demerol (meperidine hydrochloride) prescribing information. New York, NY; 2002 May.

q. McNeil Consumer & Specialty Pharmaceuticals. Flexeril(cyclobenzaprine HCl) tablets prescribing information. Fort Washington, PA; 2005 Feb.

r. Keegan MT, Brown, DR, Rabinstein AA. Serotonin syndrome from the interaction of cyclobenzaprine with other serotonergic drugs. Anesth Analg. 2006; 103:1466-8. [PubMed 17122225]

s. Vytopil M, Mani R, Adlakha A et al. Acute chorea and hyperthermia after concurrent use of modafinil and tranylcypromine. Am J Psychiatry. 2007; 164:684. [PubMed 17403991]

t. Cephalon, Inc. Provigil (modafinil) tablets prescribing information. Frazer, PA; 2007 Aug.

u. Baker GB, Coutts RT, McKenna KF et al. Insights into the mechanisms of action of the MAO inhibitors phenelzine and tranylcypromine: a review. J Psychiatr Neurosci. 1992; 17:206-11.

v. Bristol-Myers Squibb Company. Sinemet CR (carbidopa-levodopa) sustained-release tablets prescribing information. Princeton, NJ; 2006 Oct.

w. Kiefer D, Pantuso T. Panax ginseng. Am Fam Physician. 2003; 68:1539-42. [PubMed 14596440]

x. Robinson DS, Cooper TB, Jindal SP et al. Metabolism and pharmacokinetics of phenelzine: lack of evidence for acetylation pathway in humans. J Clin Psychopharmacol. 1985; 5:333-7. [PubMed 4066998]

y. Mallinger AG, Smith E. Pharmacokinetics of monoamine oxidase inhibitors. Psychopharmacol Bull. 1991; 27:493-502. [PubMed 1813896]

z. Mutschler E, Möhrke W. Kinetics of MAO inhibitors. Mod Probl Pharmacopsychiatry. 1983; 19:126-34. [PubMed 6408403]

aa. Mattila MJ. Phenelzine, hydralazine, and diphenylhydantoin. Humangenetik. 1970; 8:212-4.

bb. Drayer DE, Reidenberg MM. Clinical consequences of polymorphic acetylation of basic drugs. Clin Pharmacol Ther. 1977; 22:251-8. [PubMed 19187]

cc. AHFS Drug information 2008. McEvoy GK, ed. Tranylcypromine sulfate. Bethesda, MD: American Society of Health-System Pharmacists; 2008:2322-3.

Hide
(web4)