Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of isocarboxazid or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Isocarboxazid is not approved for use in pediatric patients.
Pooled analyses of short-term (4 weeks to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4,400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials .
Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients .
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antidepressant
Pharmacologic Class: Monoamine Oxidase Inhibitor, Nonselective
Isocarboxazid is used to treat depression. It belongs to the group of medicines called monoamine oxidase inhibitors (MAOI). isocarboxazid works by blocking the action of a chemical substance known as monoamine oxidase (MAO) in the nervous system.
Although isocarboxazid is very effective for certain patients, it may also cause some unwanted reactions if taken the wrong way. It is very important to avoid certain foods, beverages, and medicines while you are using isocarboxazid. Your doctor may provide a list as a reminder of which products you should avoid.
isocarboxazid is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For isocarboxazid, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to isocarboxazid or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of isocarboxazid in the pediatric population. Safety and efficacy have not been established.
No information is available on the relationship of age to the effects of isocarboxazid in geriatric patients. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving isocarboxazid.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using isocarboxazid with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using isocarboxazid with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using isocarboxazid with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using isocarboxazid with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.
The presence of other medical problems may affect the use of isocarboxazid. Make sure you tell your doctor if you have any other medical problems, especially:
Take isocarboxazid exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
isocarboxazid should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
The dose of isocarboxazid will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of isocarboxazid. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of isocarboxazid, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects.
You will also need to have your blood pressure measured before starting isocarboxazid and while you are using it. If you notice any change to your normal blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.
When taken with certain foods, drinks, or other medicines, isocarboxazid can cause very dangerous reactions, such as sudden high blood pressure (also called hypertensive crisis). To avoid such reactions, follow these rules of caution:
Isocarboxazid may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.
Call your doctor or hospital emergency room right away if you have a severe headache, stiff or sore neck, chest pains, fast heartbeat, sweating, dizziness, or nausea and vomiting while you are taking isocarboxazid. These may be symptoms of a serious side effect called hypertensive crisis.
isocarboxazid may make some people dizzy or less alert than they are normally. Make sure you know how you react to isocarboxazid before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.
isocarboxazid will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using isocarboxazid.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. When you get up from lying down, sit on the edge of the bed with your feet dangling for 1 or 2 minutes, then stand up slowly. If the problem continues or gets worse, check with your doctor.
Do not stop taking isocarboxazid without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely.
Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using isocarboxazid or have used it within the past 10 days. Taking isocarboxazid together with medicines that are used during surgery, dental, or emergency treatments may increase the risk of serious side effects.
Your doctor may want you to carry an identification card stating that you are using isocarboxazid.
Check with your doctor right away if you have any symptoms of liver problems, such as dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or the whites of your eyes.
isocarboxazid may affect blood sugar levels. If you are diabetic, be especially careful in testing for sugar in your blood or urine. If you have any questions about this, check with your doctor.
After you stop using isocarboxazid, you must continue to exercise caution for at least 2 weeks with your foods, drinks, and other medicines, since these items may continue to react with isocarboxazid.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:Less common
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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