Indicated for the treatment of adults with major depressive disorder (MDD).

EMSAM should be applied to dry, intact skin on the upper torso (below the neck and above the waist), upper thigh or the outer surface of the upper arm once every 24 hours. The recommended starting dose and target dose for EMSAM is 6 mg per 24 hours.

Patients should be informed that tyramine-rich foods and beverages should be avoided beginning on the first day of EMSAM 9 mg per 24 hours or 12 mg per 24 hours treatment and should continue to be avoided for 2 weeks after a dose reduction to EMSAM 6 mg per 24 hours or following the discontinuation of EMSAM 9 mg per 24 hours or 12 mg per 24 hours.

EMSAM inhibits the catabolism of dietary amines, such as tyramine, and has the potential to produce a hypertensive crisis following the ingestion of tyramine-rich foods or beverages.

Patients should be advised to avoid exposing the EMSAM application site to external sources of direct heat, such as heating pads or electric blankets, heat lamps, saunas, hot tubs, heated water beds, and prolonged direct sunlight.

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes.

It should be noted that EMSAM is not approved for use in treating bipolar depression. Prior to initiating treatment with EMSAM or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania.

EMSAM (selegiline transdermal system) is contraindicated with the following agents because of a risk of serotonin syndrome:

• selective serotonin reuptake inhibitors (SSRIs, e.g., fluoxetine, sertraline, and paroxetine)
• serotonin and norepinephrine reuptake inhibitors (SNRIs, e.g., venlafaxine and duloxetine)
• tricyclic antidepressants clomipramine and imipramine
• opiate analgesics meperidine, tramadol, methadone, pentazocine, and propoxyphene

• antitussive agent dextromethorphan

EMSAM is contraindicated in patients with pheochromocytoma because MAOIs may precipitate a hypertensive crisis in such patients.

Carbamazepine is contraindicated with EMSAM because of a possible increased risk of hypertensive crisis.

At least 2 weeks should elapse after stopping EMSAM before starting therapy with any drug that is contraindicated with EMSAM.

After stopping treatment with drugs contraindicated with EMSAM, a time period equal to 4 to 5 half-lives (approximately one week) of the drug or any active metabolite should elapse before starting therapy with EMSAM. Because of the long half-life of fluoxetine and its active metabolite, at least 5 weeks should elapse between discontinuation of fluoxetine and initiation of treatment with EMSAM.

The use of EMSAM with adrenergic drugs or buspirone may produce substantial increases in
blood pressure. Therefore, monitor blood pressure if EMSAM is used with any of the following drugs: buspirone, amphetamines, or cold products or weight-reducing preparations that contain sympathomimetic amines (e.g., pseudoephedrine, phenylephrine, phenylpropanolamine, and ephedrine).

The available data on EMSAM use in pregnant women are not sufficient to inform a drug-associated risk of adverse pregnancy-related outcomes. Animal studies: decrease in fetal weight and slight increases in malformations.

It is unknown whether selegiline is present in human milk; however, selegiline and its metabolites are present in the milk of lactating rats. Because of the potential for serious adverse reactions in breastfed infants from EMSAM, including the potential for hypertensive crisis, advise a woman that breastfeeding is not recommended during treatment with EMSAM and for 5 days after the final dose.

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• Use in patients under the age of 18. GoToSource

• Parkinson’s disease. GoToSource

• Smoking cessation. GoToSource

• Alzheimer’s disease. GoToSource 

• Tardive syndromes. GoToSource

• Anxiety and anergic bipolar depression. GoToSource

• HIV-associated cognitive impairment. GoToSource

• Segawa syndrome. GoToSource

• Cocaine dependence. GoToSource

• Severe apathetic syndrome following traumatic brain injury. GoToSource

• Narcolepsy. GoToSource

• Negative symptoms associated with schizophrenia. GoToSource

• Global ischemia. GoToSource

• Facilitate recovery after stroke. GoToSource

• Attention deficit hyperactivity disorder. GoToSource

Suicidal thoughts or behaviors. GoToSource

Restless legs syndrome, periodic limb movements in sleep, REM behavior disorder and REM sleep without atonia. GoToSource

Serotonin syndrome (life-threatening drug reaction). GoToSource

Hypersexuality and paraphilia (sexual deviation). GoToSource

Delirium, hallucinations, agitation, orthostatic hypotension (sudden drop in blood pressure after standing) and arterial hypertension. GoToSource

Hypoglycemia (low blood sugar). GoToSource

Application-site reactions, infection, insomnia and headache. GoToSource

Lawsuits filed for serotonin syndrome.