Product Description.:
Transdermal system , translucent , clear
EMSAM? (selegiline transdermal system) is a transdermally administered antidepressant. When applied to intact skin, EMSAM is designed to continuously deliver selegiline over a 24-hour period. Selegiline base is a colorless to yellow liquid, chemically described as (-)-(N)-Methyl- N-[(1 R)-1-methyl-2- phenylethyl]prop-2-yn-1-amine.
INDICATIONS
EMSAM is indicated for the treatment of major depressive disorder.
The efficacy of EMSAM in the treatment of major depressive disorder was established in 6- and 8-week placebo-controlled trials of outpatients with diagnoses of DSM-IV category of major depressive disorder (see Clinical Efficacy Trials).
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 suicide attempt or suicidal ideation.
The benefit of maintaining patients with major depressive disorder on therapy with EMSAM after achieving a responder status for an average duration of about 25 days was demonstrated in a controlled trial (see Clinical Efficacy Trials under CLINICAL PHARMACOLOGY). The physician who elects to use EMSAM for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
The antidepressant action of EMSAM in hospitalized depressed patients has not been studied.
