Nardil

DRUG DESCRIPTION

NARDIL® (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 C8 H12 N2 • H2SO4. Its chemical structure is shown below:

Nardil (phenelzine sulfate)  structural formula illustration

Molecular weight: 234.27

Each NARDIL (phenelzine) film-coated tablet for oral administration contains phenelzine sulfate equivalent to 15 mg of phenelzine base and the following inactive ingredients: mannitol, USP; croscarmellose sodium, NF; povidone, USP; edetate disodium, USP; magnesium stearate, NF; isopropyl alcohol, USP; purified water, USP; opadry orange Y30-13242A; simethicone emulsion, USP.

What are the possible side effects of phenelzine (Nardil)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Stop using phenelzine and call your doctor at once if...

Read All Potential Side Effects and See Pictures of Nardil »

What are the precautions when taking phenelzine (Nardil)?

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain kind of adrenal gland tumor (pheochromocytoma), cerebrovascular disease (e.g., stroke), heart problems (e.g., congestive heart failure, heart attack), high blood pressure, history of severe/frequent headaches, liver problems, severe kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:...

Read All Potential Precautions of Nardil »


Nardil Consumer (continued)

SIDE EFFECTS: See also Warning section.

Dizziness, drowsiness, tiredness, weakness, problems sleeping, constipation, and dry mouth may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: fainting, mental/mood changes (e.g., agitation, confusion), muscle stiffness/twitching, changes in sexual ability/interest, shaking (tremor), shivering, swollen ankles/legs, unusual weight gain, vision changes (e.g., double/blurred vision).

Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: severe stomach/abdominal pain, persistent nausea/vomiting, seizures, dark urine, yellowing eyes/skin.

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 seek immediate medical attention 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).

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: 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.

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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain kind of adrenal gland tumor (pheochromocytoma), cerebrovascular disease (e.g., stroke), heart problems (e.g., congestive heart failure, heart attack), high blood pressure, history of severe/frequent headaches, liver problems, severe kidney disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal/family history of mental/mood disorders (e.g., schizophrenia, bipolar disorder), family history of high blood pressure, heart disease (e.g., coronary artery disease, history of chest pain), mild/moderate kidney disease, diabetes, certain nervous system diseases (Parkinson's syndrome, seizures), overactive thyroid (hyperthyroidism).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To minimize dizziness and the risk of fainting, get up slowly when rising from a sitting or lying position.

Before having surgery or any procedures requiring use of contrast dye (e.g., myelography), tell your doctor or dentist you are on this medication. You may need to stop taking this drug beforehand. Follow your doctor's instructions carefully.

If you have heart disease, this medication may mask chest pain. Avoid strenuous exercise while taking this medication.

If you have diabetes, phenelzine may lower your blood sugar levels. Check your blood sugar regularly, and share the results with your doctor. Tell your doctor immediately if you have symptoms of low blood sugar such as cold sweat, shaking, rapid heart rate, fainting, and hunger. Your anti-diabetic medication or diet may need to be adjusted.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the effects on blood pressure.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Nardil Patient Information Including Side Effects

Brand Names: Nardil

Generic Name: phenelzine (Pronunciation: FEN el zeen)

  • What is phenelzine (Nardil)?
  • What are the possible side effects of phenelzine (Nardil)?
  • What is the most important information I should know about phenelzine (Nardil)?
  • What should I discuss with my doctor before taking phenelzine (Nardil)?
  • How should I take phenelzine (Nardil)?
  • What happens if I miss a dose (Nardil)?
  • What happens if I overdose (Nardil)?
  • What should I avoid while taking phenelzine (Nardil)?
  • What other drugs will affect phenelzine (Nardil)?
  • Where can I get more information?

What is phenelzine (Nardil)?

Phenelzine is a monoamine oxidase inhibitor (MAOI) that works by increasing the levels of certain chemicals in the brain.

Phenelzine is used to treat symptoms of depression that may include feelings of sadness, fear, anxiety, or worry about physical health (hypochondria). This medication is usually given after other anti-depressants have been tried without successful treatment of symptoms. Phenelzine is not for treating severe depression or bipolar disorder (manic depression).

Phenelzine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of phenelzine (Nardil)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Stop using phenelzine and call your doctor at once if you have any of these serious side effects:

  • sudden and severe headache, rapid heartbeat, stiffness in your neck, nausea, vomiting, cold sweat, sweating, vision problems, sensitivity to light;
  • chest pain, fast or slow heart rate;
  • swelling, rapid weight gain;
  • agitation, unusual thoughts or behavior; or
  • feeling light-headed, fainting.

Less serious side effects may include:

  • dizziness;
  • feeling weak or drowsy;
  • sleep problems (insomnia);
  • constipation, upset stomach;
  • dry mouth, decreased urination; or
  • impotence, difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about phenelzine (Nardil)?

There are many other medicines that can cause serious or life-threatening medical problems if you take them together with phenelzine. Do not take phenelzine before telling your doctor about all other prescription and over-the-counter medications you use, including vitamins, minerals, and herbal products. Keep a list with you of all the medicines you use and show this list to any doctor, dentist, or other healthcare provider who treats you.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

While you are taking phenelzine, you must not drink alcohol or eat foods that are high in tyramine, listed in the "What should I avoid while taking phenelzine?" section of this leaflet. Eating tyramine while you are taking phenelzine can raise your blood pressure to dangerous levels, causing symptoms that include sudden and severe headache, rapid heartbeat, stiffness in your neck, nausea, vomiting, cold sweat, vision problems, and sensitivity to light. Stop taking phenelzine and call your doctor at once if you have any of these symptoms.

You should become very familiar with the list of foods and medicines you must avoid while you are taking phenelzine.

Phenelzine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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