Isocarboxazid (patient information)

IMPORTANT WARNING

Studies have shown that children and teenagers who take antidepressants ('mood elevators') such as isocarboxazid may be more likely to think about harming or killing themselves or to plan or try to do so than children who do not take antidepressants. Children younger than 16 years of age should not normally take isocarboxazid.

If your child's doctor has prescribed isocarboxazid for your child, you should watch his or her behavior very carefully, especially at the beginning of treatment and any time his or her dose is increased or decreased. Your child may develop serious symptoms very suddenly, so it is important to pay attention to his or her behavior every day. Call your child's doctor right away if he or she experiences any of these symptoms: new or worsening depression; thinking about harming or killing him- or herself or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; irritability; aggressive behavior; acting without thinking; severe restlessness; frenzied abnormal excitement, or any other sudden or unusual changes in behavior.

Your child's doctor will want to see your child often while he or she is taking isocarboxazid, especially at the beginning of his or her treatment. Your child's doctor may also want to speak with you or your child by telephone from time to time. Be sure that your child keeps all appointments for office visits or telephone conversations with his or her doctor.

Your child's doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when your child begins treatment with isocarboxazid. Read the information carefully and ask your child's doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website www.fda.gov/cder.

Talk to your child's doctor about the risks of giving isocarboxazid to your child.

Why this medication is prescribed

Isocarboxazid is used to treat depression in people who have not been helped by other antidepressants. Isocarboxazid is in a class of medications called monoamine oxidase inhibitors (MAOIs). It works by increasing the amounts of certain natural substances in the brain that help maintain mental balance.

How this medication should be used

Isocarboxazid comes as a tablet to take by mouth. It is usually taken between two and four times a day. Take isocarboxazid at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take isocarboxazid exactly as directed.

Swallow the tablets with water or another liquid. If you are unable to swallow the tablets, you can crumble them and swallow the crumbled tablets with food or liquid.

Isocarboxazid may be habit-forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.

Your doctor will probably start you on a low dose of isocarboxazid and gradually increase your dose, not more often than once every 2-4 days at first, and then not more often than once every week. After your symptoms improve, your doctor will probably gradually decrease your dose of isocarboxazid.

Isocarboxazid is used to treat depression but does not cure it. It may take 3-6 weeks or longer before you feel the full benefit of isocarboxazid. Tell your doctor if your symptoms do not improve during the first 6 weeks of your treatment with isocarboxazid. If your symptoms do improve during your treatment, continue to take isocarboxazid. Do not stop taking isocarboxazid without talking to your doctor.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Special precautions

Before taking isocarboxazid:

• tell your doctor and pharmacist if you are allergic to isocarboxazid, any other medications, or any of the inactive ingredients in isocarboxazid tablets. Ask your pharmacist for a list of the inactive ingredients.
• do not take isocarboxazid if you are taking or plan to take, any of the following prescription or nonprescription medications: certain other antidepressants 'mood elevators' such as amitriptyline (Elavil), amoxapine (Asendin),clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Tofranil), maprotiline, nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), trimipramine (Surmontil), and selective serotonin reuptake inhibitors (SSRIs) such as duloxetine (Cymbalta), fluoxetine (Prozac), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft);amphetamines such as amphetamine (in Adderall), benzphetamine (Didrex), dextroamphetamine (Dexedrine, Dextrostat, in Adderall), and methamphetamine (Desoxyn); antihistamines; barbiturates such as pentobarbital (Nembutal), phenobarbital (Luminal), and secobarbital (Seconal); bupropion (Wellbutrin, Zyban); buspirone (BuSpar); caffeine (No-Doz, Quick-Pep, Vivarin); cyclobenzaprine (Flexeril); dextromethorphan (Robitussin, others); diuretics ('water pills'); ephedrine (in cough and cold medications, formerly available in the United States as an ingredient in dietary supplements); epinephrine (Epipen); guanethidine (Ismelin; not commercially available in the United States); levodopa (Laradopa, in Sinemet); medications for allergies, asthma, cough, and cold symptoms, including nose drops; medications for high blood pressure, mental illness, anxiety, pain, or weight loss (diet pills); medications for seizures such as carbamazepine (Tegretol); methyldopa (Aldomet); methylphenidate (Concerta, Metadate, Ritalin, others); other MAOIs such as phenelzine (Nardil), procarbazine (Matulane), tranylcypromine (Parnate), and selegiline (Eldepryl); reserpine (Serpalan); sedatives; sleeping pills; tranquilizers; and medications containing alcohol (Nyquil, elixirs, others). Tell your doctor if you have recently taken any of these medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins and herbal products you are taking or plan to take. Be sure to mention any of the following: disulfiram (Antabuse), doxepin cream (Zonalon); insulin, oral medications for diabetes, and medications for upset stomach. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• you should know that isocarboxazid may remain in your body for 2 weeks after you stop taking the medication. Tell your doctor and pharmacist that you have recently stopped taking isocarboxazid before you start taking any new medications during the first 2 weeks after you stop taking isocarboxazid.
• tell your doctor if you are taking any nutritional supplements, especially phenylalanine (DLPA; contained in aspartame sweetened products such as diet sodas and foods, over-the-counter medications, and some prescription medications), tyrosine, or tryptophan.
• tell your doctor if you or anyone in your family has or has ever had depression, bipolar disorder (mood that changes from depressed to abnormally excited), schizophrenia (a mental illness that causes disturbed thinking, loss of interest in life, and strong or unusual emotions); or mania (frenzied, abnormally excited mood), or if you or anyone in your family has thought about or attempted suicide. Also tell your doctor if you have ever used street drugs or overused prescription medications and if you have or have ever had a head injury; hyperactivity; headaches; high blood pressure; chest pain; a heart attack; a stroke or mini-stroke; pheochromocytoma (tumor on a small gland near the kidneys); seizures; diabetes; or liver, kidney, thyroid, or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking isocarboxazid, call your doctor.
• if you are having surgery, including dental surgery, or any x-ray procedure, tell the doctor or dentist that you are taking isocarboxazid.
• you should know that isocarboxazid may make you drowsy. Do not drive a car, pilot an airplane, operate machinery, climb ladders, or work in high places until you know how this medication affects you.
• remember that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while you are taking isocarboxazid.
• you should know that isocarboxazid may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking isocarboxazid. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that your mental health may change in unexpected ways, especially at the beginning of your treatment and any time that your dose is increased or decreased. These changes may occur at any time if you have depression or another mental illness, whether or not you are taking isocarboxazid or any other medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied, abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor when you are unable to seek treatment on your own.

Special dietary instructions

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.

What to do if you forget a dose

Take the missed dose as soon as you remember it. However, if it has been more than 2 hours since you were supposed to take the dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Side effects

Minor side effects

Isocarboxazid may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• dry mouth
• constipation
• diarrhea
• weakness
• extreme tiredness
• difficulty falling asleep or staying asleep
• forgetfulness
• decreased sexual ability
• frequent, painful, or difficult urination

Severe side effects

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• headaches
• fast or pounding heartbeat
• chest pain
• sweating
• fever
• chills
• cold, clammy skin
• dizziness
• tightness in the chest or throat
• stiff or sore neck
• upset stomach
• vomiting
• fainting
• blurred vision
• sensitivity to light
• wide pupils (black circle in the middle of the eye)
• yellowing of the skin or eyes
• need to be more active than usual
• shaking of a part of the body that you cannot control
• sudden jerking of a part of the body
• seizure
• numbness, burning, or tingling in the arms or legs

Isocarboxazid may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for this medication

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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• fast heartbeat
• dizziness
• fainting
• blurred vision
• upset stomach
• coma (loss of consciousness for a length of time)
• seizures
• slowed breathing
• slowed reflexes
• fever
• sweating

Other information

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.

Brand names

• Marplan®