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Marplan

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Marplan

INDICATIONS

Marplan (isocarboxazid) is indicated for the treatment of depression. Because of its potentially serious side effects, Marplan (isocarboxazid) is not an antidepressant of first choice in the treatment of newly diagnosed depressed patients.

The efficacy of Marplan (isocarboxazid) in the treatment of depression was established in 6-week controlled trials of depressed outpatients. These patients had symptoms that corresponded to the DSM-IV category of major depressive disorder; however, they often also had signs and symptoms of anxiety (anxious mood, panic, and/or phobic symptoms) (See CLINICAL PHARMACOLOGY).

A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation.

The antidepressant effectiveness of Marplan (isocarboxazid) in hospitalized depressed patients, or in endogenomorphically retarded and delusionally depressed patients, has not been adequately studied.

The effectiveness of Marplan (isocarboxazid) 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 (isocarboxazid) for extended periods should periodically evaluate the long-term usefulness of the drug for the individual patient.

DOSAGE AND ADMINISTRATION

For maximum therapeutic effect, the dosage of Marplan (isocarboxazid) must be individually adjusted on the basis of careful observation of the patient. Dosage should be started with one tablet (10 mg) of Marplan (isocarboxazid) twice daily. If tolerated, dosage may be increased by increments of one tablet (10 mg) every 2 to 4 days to achieve a dosage of four tablets daily (40 mg) by the end of the first week of treatment. Dosage can then be increased by increments of up to 20 mg/week, if needed and tolerated, to a maximum recommended dosage of 60 mg/day. Daily dosage should be divided into two to four dosages. After maximum clinical response is achieved, an attempt should be made to reduce the dosage slowly over a period of several weeks without jeopardizing the therapeutic response. Beneficial effect may not be seen in some patients for 3 to 6 weeks. If no response is obtained by then, continued administration is unlikely to help.

Because of the limited experience with systematically monitored patients receiving Marplan (isocarboxazid) at the higher end of the currently recommended dose range of up to 60 mg/day, caution is indicated in patients for whom a dose of 40 mg/day is exceeded (see ADVERSE REACTIONS).

HOW SUPPLIED

Tablets, 10 mg isocarboxazid each, peach-colored, scored-bottles of 100 (NDC 30698-032-01).

Manufactured by Amneal Pharmaceuticals, Paterson, New Jersey 07504 for Validus Pharmaceuticals, Inc., Parsippany, New Jersey 07054. 1-866-9VALIDUS (1-866-982-5438) info@validuspharma.com. Printed in U.S.A.
Revised: June 2007. FDA rev date: 8/10/2007

Last reviewed on RxList: 9/14/2007
This monograph has been modified to include the generic and brand name in many instances.

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