See Supplemental Patient Information
- Worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior may occur in patients with major depressive disorder (MDD); risk may persist until significant remission occurs [US Black Box Warning]
- Younger patients are more prone to suicidality; suicidality risk did not increase in patients >24 yrs of age, and risk decreased in patients >65 yrs of age [US Black Box Warning]
- Monitor and closely observe patients for clinical worsening, suicidality, or unusual changes in behavior specially during the initial few months of a course of drug therapy, or at times of dose modifications [US Black Box Warning]
- Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have occurred in adult and pediatric patients
- Consider changing the therapeutic regimen or discontinuing therapy on persistent worsening of depression, on experiencing emergent suicidality or abrupt onset of severe symptoms, suggesting worsening of depression or suicidality or symptoms that were not part of the patient's presenting symptoms
- Advise families and caregivers to monitor patients for the emergence of agitation, irritability, unusual changes in behavior as well as the emergence if suicidality, if such symptoms occur report immediately to physician
- Ask for a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression before initiating therapy
- Phenelzine is not recommended as initial therapy
- Hypertensive crises which can be sometimes fatal may occur with the co-administration of MAOIs, certain drugs and foods. Occipital headache palpitation, neck stiffness, soreness, nausea, vomiting, sweating, photophobia, tachycardia/bradycardia, chest pain and dilated pupils may occur with use of phenelzine, if occurs report immediately to physician
- Intracranial bleeding (sometimes fatal), associated with an increase in blood pressure, has been reported. Monitor BP closely to detect any pressor response after taking the medication
- Discontinue the therapy if palpitations or frequent headaches occur, as these symptoms may be prodromal of a hypertensive crisis
- Warn patient not to consume cheese, other foods with a high tyramine-content, or alcoholic beverages
- Avoid using concomitant medications (prescription or OTC drugs) and excessive amounts of caffeine in any form
Cautions: Use cautiously in
- Renal impairment
- Bipolar disorder
- History of Mania
- Suicide risk
- Alcohol use
- Hyperthyroidism
- Diabetes mellitus
- Seizure disorder
- Parkinson disorder
- Patients <25 yrs
- Elderly patients
- Hypotension
- Schizophrenia
- Dose >40 mg/day
Supplemental Patient Information
- Advise families and caregivers of the need for close observation and communication with the prescriber
- Instruct patients/caregivers to read the medication guide and assist them in understanding its contents
- Advise patient to start medication at a low dose and then increase as tolerated until maximum benefit is obtained
- Advise caregivers to remain alert to clinical worsening of symptoms and risk of suicidality
- Advise patients to refrain from activities requiring mental alertness such as operating a hazardous machinery or driving an automobile
Pregnancy Category:C
Breastfeeding: Safety Unknown. Because of the lack of data on use during breastfeeding, other antidepressants are preferred during breastfeeding. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 8 June 2011).
Pricing data from www.DrugStore.com in U.S.A.
- Nardil 15 MG TABS [Bottle] (PFIZER U.S.)
100 mg = $107.99
300 mg = $301.96 - Phenelzine Sulfate 15 MG TABS [Bottle] (GAVIS PHARMACEUTICALS)
30 mg = $29.99
90 mg = $70.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: Nardil 15 MG Oral Tablet
Ingredient(s): Phenelzine
Imprint: P;D;270
Color(s): Orange
Shape: Round
Size (mm): 10.00
Score: 1
Inactive Ingredient(s): mannitol / croscarmellose sodium / povidone / edetate disodium / magnesium stearate / isopropyl alcohol / water
Drug Label Author:
Parke-Davis
DEA Schedule:
Non-Scheduled
