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

Isocarboxazid is used to treat symptoms of depression that may include anxiety, panic, or phobias. Isocarboxazid is usually given after other antidepressants have been tried without successful treatment of symptoms.

Isocarboxazid may also be used for purposes not listed in this medication guide.

There are many other medicines that can cause serious medical problems or death if you take them together with isocarboxazid. Before taking isocarboxazid, tell your doctor about all medicines you have used within the past 5 weeks.

Do not use isocarboxazid if you have used another MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include linezolid, methylene blue injection, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine, and others.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using isocarboxazid. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Report any new or worsening symptoms to your doctor, 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 isocarboxazid, you must not drink alcohol or eat foods that are high in tyramine, listed in the "What should I avoid while taking isocarboxazid?" section of this leaflet. Eating tyramine while you are taking isocarboxazid can raise your blood pressure to dangerous levels.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your blood pressure will need to be tested often. You may also need frequent blood tests to check your liver function.

It may take up to 6 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

If you need surgery, tell the surgeon ahead of time that you are using isocarboxazid. You may need to stop using the medicine for at least 10 days before surgery.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Depression:

Initial dose: 10 mg orally 2 times a day
-Increase in 10 mg increments every 2 to 4 days, until 40 mg/day is reached (by the end of the first week of treatment); doses should be divided into 2 to 4 doses per day.
-After the first week, the dose may be increased in increments of up to 20 mg per week, if needed and tolerated.
Maximum dose: 60 mg/day

Comments:
-Doses should be adjusted based on careful observation of the patient.
-After the maximum clinical response is achieved, prescribers should consider reducing the dose slowly over several weeks without jeopardizing therapeutic response.
-Benefits may not be seen for 3 to 6 weeks; if a response does not occur within this time, continued use is unlikely to help.
-Efficacy has not been established in studies lasting longer than 6 weeks; patients requiring treatment longer than 6 weeks should be evaluated for usefulness.
-Use with caution if doses above 40 mg/day are used.

Use: Second-line treatment of depression, especially major depressive disorder in patients with or without signs/symptoms of anxiety (e.g., anxious mood, panic, phobic symptoms) who have not responded satisfactorily to other antidepressants

You should not take isocarboxazid if you are allergic to it, or if you have:

• pheochromocytoma (tumor of the adrenal gland);

• liver disease;

• kidney disease;

• a history of stroke or blood clots;

• heart disease, high blood pressure; or

• a history of severe or frequent headaches.

There are many other medicines that can cause serious medical problems or death if you take them together with isocarboxazid.

Before taking isocarboxazid, tell your doctor about all medicines you have used within the past 5 weeks. The following drugs should not be used while you are taking isocarboxazid:

• buspirone (Buspar);

• carbamazepine;

• levodopa;

• methyldopa;

• tryptophan;

• certain antidepressants--amitriptylline, bupropion, citalopram, clomipramine, desipramine, doxepin, escitalopram, fluoxetine, fluvoxamine, imipramine, maprotiline, nortriptyline, paroxetine, protriptyline, sertraline, trimipramine (known by brand names such as Celexa, Lexapro, Luvox, Norpramin, Prozac, Paxil, Wellbutrin, and Zoloft);

• narcotic pain medicine--morphine, tramadol, Demerol, OxyContin, Percocet, Vicodin, and others;

• ADHD medicine--Adderall, Concerta, Ritalin, Vyvanse, and others;

• diet pills; or

• over-the-counter cough or cold medicine.

Do not use isocarboxazid if you have used another MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include linezolid, methylene blue injection, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine, and others.

To make sure isocarboxazid is safe for you, tell your doctor if you have:

• a history of heart disease or high blood pressure;

• diabetes;

• a thyroid disorder;

• schizophrenia;

• epilepsy or other seizure disorder; or

• if you have taken any other antidepressant within the past 5 weeks.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using isocarboxazid. Your family or other caregivers should also be alert to changes in your mood or symptoms.

FDA pregnancy category C. It is not known whether isocarboxazid will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using isocarboxazid.

It is not known whether isocarboxazid passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give isocarboxazid to anyone younger than 16 years old without the advice of a doctor.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include shallow breathing, fast heart rate, sweating, fever, slow reflexes, feeling light-headed, fainting, or seizure (convulsions).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

You may experience a serious reaction if you eat foods that are high in tyramine during your treatment with isocarboxazid. Tyramine is found in many foods, including meat, poultry, fish, or cheese that has been smoked, aged, improperly stored, or spoiled; certain fruits, vegetables, and beans; alcoholic beverages; and yeast products that have fermented. Your doctor or dietitian will tell you which foods you must avoid completely, and which foods you may eat in small amounts. You should also avoid foods and drinks that contain caffeine during your treatment with isocarboxazid. Follow these directions carefully. Ask your doctor or dietitian if you have any questions about what you may eat and drink during your treatment.

Avoid coffee, tea, cola, energy drinks, or other products that contain caffeine.

While you are taking isocarboxazid you must not drink alcohol or eat foods that are high in tyramine, including:

• cheese (especially strong or aged cheeses);

• sour cream and yogurt;

• beer (including non-alcoholic beer), sherry, Chianti wine, liqueurs;

• dry sausage (such as hard salami, pepperoni), anchovies, caviar, liver, pickled herring;

• canned figs, raisins, bananas;

• avocados;

• chocolate;

• soy sauce;

• sauerkraut;

• fava beans;

• yeast extracts;

• meat extracts; or

• meat prepared with tenderizer.

You should become very familiar with the list of foods and medicines you must avoid while you are taking isocarboxazid. Eating tyramine while you are taking isocarboxazid can raise your blood pressure to dangerous levels which could cause life-threatening side effects.

Isocarboxazid may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

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.

Report any new or worsening symptoms to your doctor, 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 taking isocarboxazid and call your doctor at once if you have:

• sudden and severe headache, rapid heartbeat, stiffness in your neck, nausea, vomiting, cold sweat, vision problems, sensitivity to light;

• chest pain, fast or slow heart rate;

• swelling, rapid weight gain;

• jaundice (yellowing of the skin or eyes); or

• a light-headed feeling, like you might pass out.

Common side effects of isocarboxazid may include:

• headache, dizziness, drowsiness;

• tremors;

• sleep problems (insomnia);

• constipation, nausea; or

• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking isocarboxazid with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking isocarboxazid with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can interact with isocarboxazid, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with isocarboxazid. Give a list of all your medicines to any healthcare provider who treats you.

Keep all appointments with your doctor and the laboratory. Your doctor will check your blood pressure often and will order certain lab tests to check your body's response to isocarboxazid.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.