Indicated for the treatment of depression.

Because of its potentially serious side effects, MARPLAN is not an antidepressant of first choice in the treatment of newly diagnosed depressed patients. It is not recommended as initial therapy but should be reserved for patients who have not responded satisfactorily to other antidepressants.

It should be noted that MARPLAN is not approved for use in treating bipolar depression.

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies with Major Depressive Disorder (MDD) and other psychiatric disorders.

The antidepressant effectiveness of MARPLAN in hospitalized depressed patients, or in endogenomorphically-retarded and delusionally depressed patients, has not been adequately studied.

The effectiveness of  MARPLAN in long-term use, that is, for more than 6 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use MARPLAN for extended periods should periodically evaluate the long-term usefulness of the drug for the individual patient.

The most important reaction associated with MAO inhibitors is the occurrence of hypertensive crises, which have sometimes been fatal, resulting from the coadministration of MAOIs and certain drugs and foods. Blood pressure should be followed closely in patients taking MARPLAN to detect any pressor response.

Therapy should be discontinued immediately if palpitations or frequent headaches occur during MARPLAN therapy as these symptoms may be prodromal of a hypertensive crisis.

MARPLAN should not be administered to any patient with a confirmed or suspected cerebrovascular defect or to any patient with cardiovascular disease, hypertension, or history of headache.

MARPLAN should not be used in patients with a history of liver disease, or in those with abnormal liver function tests.

MARPLAN should not be used in patients with severe impairment of renal function.

MAO inhibitors can suppress anginal pain that would otherwise serve as a warning of myocardial ischemia.

Hypotension has been observed during MARPLAN therapy.

Some MAO inhibitors have contributed to hypoglycemic episodes in diabetic patients receiving insulin or glycemic agents. MARPLAN should therefore be used with caution in diabetics using these drugs.

MARPLAN may aggravate coexisting symptoms in depression, such as anxiety and agitation.

Use MARPLAN with caution in hyperthyroid patients because of their increased sensitivity to pressor amines.

MARPLAN should be used cautiously in hyperactive or agitated patients, as well as in schizophrenic patients, because it may cause excessive stimulation. Activation of mania/hypomania has been reported in a small proportion of patients with major affective disorder who were treated with marketed antidepressants.

MARPLAN should not be used in the presence of pheochromocytoma, as such tumors secrete pressor substances whose metabolism may be inhibited by MARPLAN.

MARPLAN should not be administered in combination with any of the following: MAO inhibitors or dibenzazepine derivatives; sympathomimetics (including amphetamines); some central nervous system depressants (including narcotics and alcohol); antihypertensive, diuretic, antihistaminic, sedative or anesthetic drugs, bupropion HCL, buspirone HCL, dextromethorphan, cheese or other foods with a high tyramine content; or excessive quantities of caffeine.

The combination of MAO inhibitors and dextromethorphan has been reported to cause brief episodes of psychosis or bizarre behavior.

MARPLAN should not be administered together with, or in close proximity to, other MAO inhibitors or dibenzazepine-related entities. Hypertensive crises, severe convulsive seizures, coma, or circulatory collapse may occur in patients receiving such combinations.

In patients being transferred to MARPLAN from another MAO inhibitor or from a dibenzazepine-related entity, a medication-free interval of at least 1 week should be allowed, after which MARPLAN therapy should be started using half the normal starting dosage for at least the first week of therapy. Similarly, at least 1 week should elapse between the discontinuation of MARPLAN and initiation of another MAO inhibitor or dibenzazepine-related entity, or the readministration of  MARPLAN.

The concurrent administration of a MAO inhibitor and bupropion hydrochloride (Wellbutrin, and Zyban, Glaxo Wellcome) is contraindicated. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with bupropion hydrochloride.

MARPLAN should not be used in combination with some central nervous system depressants, such as narcotics, barbiturates, or alcohol.

Excessive use of caffeine in any form should be avoided in patients receiving MARPLAN.

Drugs that lower the seizure threshold, including MAO inhibitors, should not be used with Amipaque.

MARPLAN should not be used in combination with buspirone HCL (Buspar); several cases of elevated blood pressure have been reported in patients taking MAO inhibitors who were then given buspirone HCL. At least 10 days should elapse between the discontinuation of MARPLAN and the institution of buspirone HCL. Serious reactions may also occur when MAO inhibitors are given with serotonergic drugs (e.g., dexfenfluramine, fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, venlafaxine).

MARPLAN should not be administered in combination with sympathomimetics, including amphetamines, or with over-the-counter drugs such as cold, hay fever, or weight-reducing preparations that contain vasoconstrictors.

MARPLAN should not be used in combination with antihypertensive agents, including thiazide diuretics. A marked potentiating effect on these drugs has been reported, resulting in hypotension.

Use of sympathomimetics and compounds such as guanethidine, methyldopa, methylphenidate, reserpine, epinephrine, norepinephrine, phenylalanine, dopamine, levodopa, tyrosine, and tryptophan with MARPLAN may precipitate hypertension, headache, and related symptoms. The combination of MAO inhibitors and tryptophan has been reported to cause behavioral and neurologic symptoms, including disorientation, confusion, amnesia, delirium, agitation, hypomanic signs, ataxia, myoclonus, hyperreflexia, shivering, ocular oscillations, and Babinski signs.

MARPLAN should not be administered in combination with any SSRI.

As with other MAO inhibitors, MARPLAN should be discontinued at least 48 hours before myelography and should not be resumed for at least 24 hours post-procedure.

Patients taking MARPLAN should not undergo elective surgery requiring general anesthesia. Also, they should not be given cocaine or local anesthesia containing sympathomimetic vasoconstrictors. The possible combined hypotensive effects of MARPLAN and spinal anesthesia should be kept in mind. MARPLAN should be discontinued at least 10 days before elective surgery.

It is not known whether isocarboxazid can cause embryo/fetal harm when administered to a pregnant woman or can affect reproductive capacity.

Levels of excretion of isocarboxazid and/or its metabolites in human milk have not been determined, and effects on the nursing infant are unknown.

GoToSource

• Dosage greater than 80 mg per day. GoToSource

• Use in patients under the age of 18. GoToSource

• Anxiety disorder. GoToSource

• Social anxiety disorder. GoToSource

• Prophylactic treatment of migraines. GoToSource

• Bulimia nervosa. GoToSource

• Angina pectoris. GoToSource

• Use as initial-line therapy. GoToSource 

• Trichotillomania. GoToSource

“Cheese reaction” (tyramine-induced hypertensive crisis). GoToSource

Transient hypertensive episodes, edema (swelling caused by fluid in tissues), muscle pain and myoclonus (involuntary jerking of muscles). GoToSource

Weight gain and sexual dysfunction. GoToSource

Serotonin syndrome (potentially life-threatening drug reaction). GoToSource 

Liver injury. GoToSource

Increased risk of suicidal thoughts and behaviors. GoToSource

Orthostatic hypotension (sudden low blood pressure after assuming a standing position). GoToSource

Severe daytime somnolence. GoToSource 

Sudden death after abrupt change in monoamine oxidase inhibitors. GoToSource

Tachycardia (rapid heart rate), hyperthermia (elevated body temperature), hypertension (high blood pressure) and agitation. GoToSource

Paresthesias (abnormal sensation). GoToSource

Mania after withdrawal. GoToSource

Lawsuits filed for suicidal thoughts and behavior.