are not part of the presenting symptoms may require discontinuation of therapy This drug is not approved for use in pediatric patientsContraindications Hypersensitivity Pheochromocytoma, congestive heart failure Within 10 days of elective surgery using general anesthesia or spinal anesthesia Liver disease, abnormal liver function tests, or history of hepatic disease Renal disease, severe renal impairment, ESRD Cautions Orthostatic hypotension may occur Hypertensive reactions may occur from consumption of foods high in tyramine or supplements containing caffeine, tyrosine, tryptophan, phenylalanine, or phenylalanine Not first-line therapy Discontinue 10 days before surgery Therapy not approved for treating any indications in the pediatric population Most serious reactions involve changes in blood pressure Therapy may cause excessive stimulation in schizophrenic patients Drug potentiates hexobarbital hypnosis in animals; barbiturates should be given at a reduced dose with phenelzine Drug should be used with caution in diabetes mellitus; increased insulin sensitivity may occur; requirements for insulin or oral hypoglycemics may be decreased; there is conflicting evidence as to whether or not MAO inhibitors affect glucose metabolism or potentiate hypoglycemic agents; this should be kept in mind if drug is administered to diabetics Hypertensive crises Most important reaction associated with therapy is the occurrence of hypertensive crises, which have sometimes been fatal The crises are characterized by occipital headache which may radiate frontally, palpitation, neck stiffness or soreness, nausea, vomiting, sweating (sometimes with fever and sometimes with cold, clammy skin), dilated pupils, and photophobia; either tachycardia or bradycardia may be present and can be associated with constricting chest pain Intracranial bleeding has been reported in association with increase in blood pressure; blood pressure should be observed frequently to detect evidence of any pressor response in all patients receiving therapy; therapy should be discontinued immediately upon occurrence of palpitation or frequent headaches during therapy If a hypertensive crisis occurs, drug should be discontinued immediately and therapy to lower blood pressure should be instituted immediately; on the basis of present evidence, phentolamine is recommended; dosage reported for phentolamine is 5 mg intravenously; care should be taken to administer this drug slowly in order to avoid producing an excessive hypotensive effect; fever should be managed by means of external cooling 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 Unknown whether the suicidality risk extends to longer-term use, ie, 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 decrease The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, 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 emergence of such symptoms and either the worsening of depression and/or emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality Consider changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about need to monitor patients for emergence of agitation, irritability, unusual changes in behavior; monitoring should include daily observation by families and caregivers; prescriptions should be written for smallest quantity of tablets consistent with good patient management, in order to reduce risk of overdose Bipolar disorder A major depressive episode may be initial presentation of bipolar disorder; it is generally believed that treating such an episode with an antidepressant alone may increase likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder; whether any of the symptoms of depression described represent such a conversion is unknown Of the more severe side effects reported with any consistency, hypomania has been the most common; this reaction has been largely limited to patients in whom disorders characterized by hyperkinetic symptoms coexist with, but are obscured by, depressive affect; hypomania usually appeared as depression improved; if agitation is present, may be increased with therapy; hypomania and agitation have also been reported at higher than recommended doses or following long-term therapy Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression; therapy is not approved to treat bipolar depression Drug interaction overview In patients receiving nonselective monoamine oxidase (MAO) inhibitors in combination with serotoninergic agents there have been reports of serious, sometimes fatal, reactions; phenelzine should not be used concomitantly with a serotoninergic agent Administration of guanethidine to patients receiving a MAO inhibitor can produce moderate to severe hypertension due to release of catecholamines; at least two weeks should elapse between withdrawal of MAO inhibitor and initiation of guanethidine Pregnancy Category: C Lactation: unknown; use cautionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Nonselective monoamine oxidase inhibitor; may inhibit the enzyme monoamine oxidase, which is responsible for the breakdown of dopamine, serotonin, epinephrine, and norepinephrine, in turn causing an increase in endogenous concentrations of these neurotransmitters. Pharmacokinetics Peak Plasma Time: 43 min Metabolism: by MAO Onset of action: 2-4 weeks Duration: Therapeutic effects and interactions may continue for up to 2 weeks after discontinuing therapy Metabolites: phenylacetic acid & parahydroxyphenylacetic acid Half-Life, Elimination: 11.6 hr Excretion: Urine BRAND FORM. UNIT PRICE PILL IMAGE phenelzine oral- 15 mg tabletphenelzine oral- 15 mg tabletNardil oral- 15 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationphenelzine oral PHENELZINE - ORAL (FEN-el-zeen) COMMON BRAND NAME(S): Nardil WARNING: Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. It is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed. USES: Phenelzine is an antidepressant (monoamine oxidase inhibitor). This medication treats depression by restoring the balance of certain natural substances (neurotransmitters) in the brain. Phenelzine can improve your mood and feelings of well-being. Usually, this medication is used in persons who have not responded to treatment with other drugs. HOW TO USE: Read the Medication Guide available from your pharmacist before you start using phenelzine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually 1 to 3 times a day. The dosage is based on your medical condition and response to treatment.To reduce your risk of side effects, your doctor may start you at a low dose and gradually increase your dose. Once your condition improves and you are better for a while, your doctor may work with you to reduce your regular dose. Follow your doctor's instructions carefully. Do not take more or less medication or take it more often than prescribed. Your condition will not improve any faster and your risk of side effects will increase.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. It may take several weeks for the full benefits of this medication to be noticed. Do not stop taking this medication without consulting your doctor.If you suddenly stop using this medication, you may have withdrawal symptoms (such as restlessness, confusion, hallucinations, headache, weakness, and diarrhea). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used phenelzine for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.Inform your doctor if your condition lasts or gets worse. SIDE EFFECTS: See also Warning section.Dizziness, drowsiness, tiredness, weakness, problems sleeping, constipation, and dry mouth may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: fainting, mental/mood changes (such as agitation, confusion), muscle stiffness, changes in sexual ability/interest, shaking (tremor), shivering, swollen ankles/legs, unusual weight gain, eye pain/swelling/redness, vision changes (such as double/blurred vision), signs of liver problems (such as nausea/vomiting that doesn't stop, stomach/abdominal pain, yellowing eyes/skin, dark urine), seizures.This drug may rarely cause an attack of extremely high blood pressure (hypertensive crisis), which may be fatal. Many drug and food interactions can increase this risk (See also Drug Interaction section.) Stop taking phenelzine and get medical help right away if any of these serious side effects occur: frequent/severe headache, fast/slow/irregular/pounding heartbeat, chest pain, neck stiffness/soreness, severe nausea/vomiting, sweating/clammy skin (sometimes with fever), widened pupils, sudden sensitivity to light (photophobia).This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. PRECAUTIONS: Before taking phenelzine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain kind of adrenal gland tumor (pheochromocytoma), cerebrovascular disease (such