BrBristol-Myers Squibb and Somerset; market exclusivity expires 2009.
Major Depressive Disorder
Monoamine Oxidase Inhibitor (MAOI)
Supplied in 6 mg, 9 mg, and 12 mg patches.
Start at 6 mg/day, titrate gradually up to 12 mg/day as needed.
No dose adjustment needed in mild to moderate hepatic or renal impairment.
Most common are insomnia, diarrhea, rash at patch application site, orthostatic hypotension. Other MAOIs cause side effects such as sexual dysfunction and sedation.
When taken with high tyramine foods, EMSAM doses 9 mg/day or higher can cause acute hypertension with symptoms such as intense headache, blurred vision, and stroke.
When taken with serotonergic medications (especially SSRIs), all doses of EMSAM can cause serotonin syndrome, with tremor, rigidity, fever, tachycardia, confusion.
Black Box Warning: In clinical trials, SSRIs and SNRIs increased the risk of suicidality in children (from 2% to 4%). No actual suicides occurred in these trials, and none of the trials included MAOIs, but all antidepressants are required to carry this warning anyway.
Contraindicated with all known antidepressants, including St. John’s Wort and other MAOIs (although many clinicians have safely combined MAOIs with tricyclics, trazodone, and mirtazepine); certain pain medications: meperidine, methadone, Darvon (caution advised with Ultram); the triptans Imitrex and Maxalt (other triptans are safe); dextromethorphan (in Robitussin DM; other forms of Robitussin are fine); Sudafed (other cold remedies and all antihistamines are safe).
At 9 mg/day or higher, contraindicated with high tyramine foods (a high tyramine food list is available at www.TheCarlatReport.com).
Pregnancy Risk Category C
While dietary restrictions are recommended above 6 mg/day, in clinical trials the 9 mg/day dose caused only rare tyramine reactions.
Called “EMSAM” after “Emily” and “Sam,” the children of a Somerset employee.