Generic Name and Formulations:
Selegiline 6mg/24hrs, 9mg/24hrs, 12mg/24hrs; transdermal system.
Mylan Specialty L.P.
Indications for EMSAM:
Major depressive disorder.
Apply to dry, intact skin on upper torso, upper thigh, or outer surface of upper arm. Rotate application sites. Do not cut patches. ≥18yrs: initially one 6mg/24hrs patch once daily. May titrate at intervals of ≥2 weeks in increments of 3mg/24hrs; max 12mg/24hrs. Elderly (≥65yrs): 6mg/24hrs once daily. Doses above 6mg/24hrs: see full labeling for tyramine dietary modifications.
≤17yrs: not recommended.
Concomitant SSRIs (eg, fluoxetine, sertraline, paroxetine), SNRIs (eg, venlafaxine, duloxetine), TCAs (eg, clomipramine, imipramine), opiates (eg, meperidine, tramadol, methadone, pentazocine, propoxyphene), dextromethorphan. Concomitant carbamazepine. Children <12yrs of age. Pheochromocytoma.
Suicidal thoughts and behaviors.
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor for clinical worsening or unusual changes. Monitor for serotonin syndrome or hypertensive crisis; discontinue if occurs. History of bipolar disorder, mania/hypomania. Severe hepatic impairment, ESRD, dialysis: not studied. Avoid exposing patch to external heat sources. Reevaluate periodically. Elderly. Pregnancy. Nursing mothers: not recommended (during and for 5 days after the last dose).
See Contraindications. To avoid potentially severe or fatal interactions, allow sufficient drug-free interval between selegiline and contraindicated drugs (see full labeling). Increased risk of serotonin syndrome with concomitant other serotonergic drugs. Hypertensive crisis with carbamazepine. Monitor BP with concomitant buspirone, amphetamines, cold products or weight-reducing preparations with sympathomimetic amines (eg, pseudoephedrine, phenylephrine, phenylpropanolamine, ephedrine). Avoid alcohol, dietary supplements with tyramine.
Application site reaction, headache, insomnia, diarrhea, dry mouth, dyspepsia, rash, pharyngitis, sinusitis; serotonin syndrome, hypertensive crisis.
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