|Manufacturer:||Validus Pharmaceuticals, Inc.|
Marplan has not been systematically studied in animals or humans for its potential for abuse, tolerance, or physical dependence.
There have been reports of drug dependency in patients using doses of Marplan significantly in excess of the therapeutic range.
Some of these patients had a history of previous substance abuse.
The following withdrawal symptoms have been reported: restlessness, anxiety, depression, confusion, hallucinations, headache, weakness, and diarrhea.Consequently, physicians should carefully evaluate Marplan patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse (eg, development of tolerance, incrementations of dose, drug-seeking behavior).
Marplan is 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.The efficacy of Marplan 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 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.